[Federal Register: May 17, 2005 (Volume 70, Number 94)]
[Rules and Regulations]
[Page 28369-28400]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17my05-16]
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Part III
Department of Health and Human Services
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42 CFR Parts 50 and 93
Public Health Service Policies on Research Misconduct; Final Rule
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Parts 50 and 93
RIN 0940-AA04
Public Health Service Policies on Research Misconduct
AGENCY: U.S. Department of Health and Human Services (HHS).
ACTION: Final rule.
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SUMMARY: This final rule removes 42 CFR part 50, subpart A,
"Responsibilities of Awardee and Applicant Institutions for Dealing
With and Reporting Possible Misconduct in Science," and replaces it
with a new, more comprehensive part 93, "Public Health Service
Policies on Research Misconduct." The proposed part 93 was published
for public comment on April 16, 2004. The final rule reflects both
substantive and non-substantive amendments in response to public
comments and to correct errors and improve clarity, but the general
approach of the NPRM is retained. The purpose of the final rule is to
implement legislative and policy changes applicable to research
misconduct that occurred over the last several years, including the
common Federal policies and procedures on research misconduct issued by
the Office of Science and Technology Policy on December 6, 2000.
DATES: This final rule will become effective June 16, 2005.
ADDRESSES: Address any comments or questions regarding this final rule
to: Chris B. Pascal, J.D., Director, Office of Research Integrity, 1101
Wootton Parkway, Suite 750, Rockville, MD 20852. Some commonly asked
questions and answers to them will be posted on the Office of Research
Integrity Web site prior to the effective date of the regulation. The
URL for the ORI Web site is: http://ori.hhs.gov.
You may submit comments and questions on this final rule by sending
electronic mail (e-mail) to research@osophs.dhhs.gov. Submit electronic
comments as either a WordPerfect file, version 9.1 or higher, or a
Microsoft Word 97 or 2000 file format. You may also submit comments or
questions as an ASCII file avoiding the use of special characters and
any form of encryption.
FOR FURTHER INFORMATION CONTACT: Brenda Harrington, (301) 443-3400.
(This is not a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Public Comments--General
The Notice of Proposed Rulemaking (NPRM) proposing to remove 42 CFR
part 50, subpart A and replace it with a new part 93 was published in
the Federal Register on April 16, 2004 (69 FR 20778). Comments were
requested on or before June 15, 2004. In addition to this invitation
for public comment on any aspect of the proposed rulemaking, the NPRM
requested comment on specific aspects of the proposed rule including:
(A) Whether there should be any limitation on the ability of
institutions to conduct a research misconduct proceeding through a
consortium or other entity qualified by practice and experience to
conduct research misconduct proceedings (Sec. 93.306); (B) the use of
Administrative Law Judges (ALJs) to conduct HHS research misconduct
hearings rather than a panel of three decisionmakers (Sec. 93.502);
(C) treating the decision of the ALJ as a recommended decision to the
Assistant Secretary for Health (ASH) as opposed to the current practice
in which the decision of the panel on the merits of the HHS findings of
misconduct and administrative actions, other than debarment,
constitutes final agency action (Sec. Sec. 93.500(d) and 93.523(c));
(D) authorizing the ALJ to appoint a scientific expert (that
appointment is required if requested by either party) to advise the ALJ
on scientific issues, but not provide testimony for the record (Sec.
93.502(b)); (E) consistent with current practice, permitting HHS to
amend its findings of research misconduct up to 30 days before the
scheduled hearing (Sec. 93.514); (F) extending the period for
retaining records of the research misconduct proceeding, including
inquiries, from 3 to 7 years (Sec. 93.317); (G) imposing a 120-day
deadline for the completion of any institutional appeal from a finding
of research misconduct (Sec. 93.314); and (H) whether the HHS
estimates on the potential burden of information collection
requirements are accurate and whether those requirements are necessary
for the proper performance of HHS functions.
Twenty-eight documents commenting on the NPRM were submitted to HHS
by mail or e-mail. Most of the documents addressed multiple sections of
the proposed rule. A number of the commentators made general positive
comments such as that: the proposed rule is well drafted, provides
valuable guidance for researchers and institutions and is much improved
over the current regulation; the detail and transparency of the
procedures will result in a better focus on the merits of a case rather
than procedural complications; the proposal recognizes the importance
of primary reliance on the institutions to respond to allegations of
research misconduct; and the clarification and harmonization of
definitions, standards, and procedures are appreciated.
Most of the commentators endorsed the changes in the definition of
research misconduct and the incorporation of the three elements
necessary for a finding of research misconduct in conformity with the
Federal Policy on Research Misconduct issued by the Office of Science
and Technology Policy (OSTP). Some expressed support for the PHS
practice of excluding coverage of authorship disputes in the absence of
a clear allegation of plagiarism. There were expressions of support for
the coverage of PHS intramural programs and PHS contractors, the
coverage of the plagiarism of a PHS supported research record, even if
the respondent does not receive such support, the clarification of the
role of the complainant, the adoption of a six-year limitation on the
pursuit of misconduct allegations, separation of adjudication and
appeal from the inquiry and investigation stages, setting a time limit
on the investigation by the institution, and the inclusion of ALJs in
the hearing process. These and other supportive comments may be
discussed in the consideration of specific changes to the proposed rule
that follows.
There were also general, negative comments on the proposed rule,
some of which were in direct opposition to positive comments. Some
commentators feel that the proposal is overly detailed and thus
contrary to the OSTP goal of a more uniform Federal-wide approach.
Another criticizes the continuation in the proposed rule of a trend
toward legalization of scientific disputes by immediately casting
parties into adversarial roles. Other commentators object to the change
from a hearing conducted by a three-member panel to one conducted by an
ALJ, stating that there has not been any showing of a need to change
the current practice. One commentator felt that HHS should be
responsible for investigating allegations of misconduct at institutions
that have repeatedly failed to properly investigate research
misconduct. These and other critical comments may be discussed in the
consideration of specific changes that follow.
Some letters of comment repeated comments that had been made in
response to the OSTP proposal for a government-wide Federal policy on
research misconduct. Because OSTP considered those comments prior to
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issuing its final policy and this final rule is consistent with the
aspects of the OSTP policy addressed in the comments, those comments
will not be further discussed here.
Comments on specific sections of the regulation are addressed below
under headings based on the general issue raised by the comments. If
that issue encompasses more than one section of the regulation, all
those sections will be discussed under that heading.
II. Changes Made in Response to Comments
A. Applicability, Secs. 93.100(b) and 93.102(b)
A number of commentators concluded that the applicability section,
93.102, and the descriptions of applicability in other sections
unreasonably extend HHS jurisdiction beyond PHS supported biomedical or
behavioral research and research training. One commentator recommended
that descriptions of applicability be uniform throughout the
regulation. There were specific objections to: (1) The statement in
Sec. 93.100(b) that covered institutions must comply with the
regulation with respect to allegations of misconduct ``occurring at or
involving research or research training projects or staff of the
institution''; (2) the coverage, in Sec. 93.102(a) and other sections
describing applicability, of ``activities related to that research or
research training;'' and (3) the extension of coverage in Sec.
93.102(a) to allegations of misconduct involving any research record
generated from covered research, research training, or activities
related to that research or training, regardless of whether the user or
reviewer receives PHS support or whether an application resulted in any
PHS support.
Several clarifying changes have been made in response to these
comments, but these changes do not change the intended substance of the
provisions in the NPRM. The current regulation, 42 CFR 50.101, covers
each entity that applies for a ``research, research-training or
research-related grant or cooperative agreement'' under the PHS Act.
Such an entity must establish policies and procedures for investigating
and reporting instances of alleged misconduct involving ``research or
research training or related research activities that are supported
with funds available under the PHS Act.'' Thus, applicability to
research-related activities is not new. The NPRM was not intended to
change the applicability to those activities as it is expressed in the
current regulation and has been applied in practice under that
regulation.
This rulemaking establishes the necessary HHS jurisdiction to
implement the new term ``reviewing research'' in the OSTP definition of
research misconduct. In ORI's experience, plagiarism can occur during
the review process when a manuscript is submitted for publication. In
the great majority of cases where an allegation arises that a PHS
supported research record was plagiarized, we expect that the reviewers
will be current recipients of PHS research funds because the reviewers
are selected based on their subject matter expertise and the research
in question is PHS funded biomedical and behavioral research. In cases
where the respondent is PHS supported or affiliated with a PHS
supported institution, we would expect the misconduct allegation to be
pursued by the PHS supported institution. In those cases where the
reviewer who is alleged to have committed plagiarism is solely funded
by another Federal agency, ORI would refer the allegation to that
agency. In addition, jurisdiction does not attach to allegations of
plagiarism where there is no PHS support for the research record in
question. Thus, we have removed the phrase ``regardless of whether the
user or reviewer currently receives PHS support'' from Sec. 93.102.
To eliminate redundancy and clarify the general policy and
applicability provisions, Secs. 93.100 and 93.102, we have: (1) Moved
the statement of applicability to institutions from Sec. 93.100(b) to
Sec. 93.102(b) and rewritten it to be more concise; and (2) moved
paragraph (c) of Sec. 93.100 to paragraph (a) of that section and
combined the proposed paragraphs (a) and (d) into a new paragraph (b).
The provision setting forth the types of allegations to which the
regulation applies has been moved from Sec. 93.102(a) to paragraph (b)
of that section and has been amended to clarify that the regulation
applies to allegations of research misconduct involving: (i)
Applications or proposals for PHS support for biomedical or behavioral
extramural or intramural research, research training, or activities
related to that research or research training, such as the operation of
tissue or data banks or the dissemination of research information; (ii)
PHS supported biomedical or behavioral extramural or intramural
research; (iii) PHS supported biomedical or behavioral extramural or
intramural research training programs; (iv) PHS supported extramural or
intramural activities that are related to biomedical or behavioral
research or research training, such as the operation of tissue and data
banks or the dissemination of research information; and (v) plagiarism
of research records produced in the course of PHS supported research,
research training, or PHS supported activities related to that research
or research training. The examples of activities that are related to
research or research training are intended to be illustrative, not
exhaustive. They are intended to convey the concept that under its
research and research training authorities, PHS funds many activities
that are closely related to research and research training, but might
not be considered to be within the common understanding of what
constitutes research or research training. Consistent with the intent
of, and practice under the current regulation, allegations of research
misconduct involving those funded activities, or applications for the
funding of those activities, are covered.
In each section that refers to the applicability of the regulation
we have referenced the applicability section or repeated the
applicability of the regulation to PHS supported research, research
training, and activities related to that research or research training.
B. Subsequent Use Exception to Six Year Limitation on Misconduct
Allegations, Sec. 93.105(b)(1)
In response to a comment requesting clarification, we have amended
paragraph (b)(1) of Sec. 93.105. The amendment clarifies that even
though HHS or an institution does not receive an allegation of research
misconduct within six years of when the misconduct is alleged to have
occurred, the regulation would apply if, within six years of when the
allegation is received, the respondent has cited, republished, or
otherwise used for his or her potential benefit the research record
that is the subject of the allegation of misconduct.
C. Rebuttable Presumption of Misconduct in the Absence of Records,
Secs. 93.106(a)(1) and 93.516(b)
Commentators raised several concerns about proposed Sec.
93.106(a)(1) and Sec. 93.516(b) under which the absence of, or
respondent's failure to provide research records adequately documenting
the questioned research establishes a presumption of research
misconduct that can be rebutted by credible evidence corroborating the
research or providing a reasonable explanation for the absence of, or
respondent's failure to provide the research records. The concerns
included: (1) Retroactive application of the provision where there was
no previous requirement for the retention
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of the records; (2) holding the respondent responsible for the
retention of records over which he/she may have no control; and (3)
there is no guidance on what would be a ``reasonable explanation'' for
the absence of records.
In response to these comments, we have eliminated the rebuttable
presumption of research misconduct. Sections 93.106 and 93.516 have
been changed to state that the destruction, absence of, or respondent's
failure to provide records adequately documenting the questioned
research is evidence of research misconduct where the institution or
HHS establishes by a preponderance of the evidence that the respondent
intentionally, knowingly, or recklessly had research records and
destroyed them, had the opportunity to maintain the records but failed
to do so, or maintained the records, but failed to produce them in a
timely manner, and that respondent's conduct constitutes a significant
departure from accepted practices of the relevant research community.
This is in keeping with the definition of falsification to include
omitting data or results such that the research is not accurately
represented in the research record (Sec. 93.103(b)) and with the
requirements for a finding of research misconduct in Sec. 93.104. This
answers the concerns about retroactive application and that the
respondent may not have had control over the records by holding the
respondent to the accepted practices of his/her research community. The
weight to be accorded the evidence of research misconduct under these
circumstances must be determined by the trier of fact in each case.
D. Respondent's Burden To Prove Honest Error or Difference of Opinion,
Secs. 93.106(a)(2) and 93.516(b)
As proposed, Sec. 93.106(a)(2) provided that once the institution
or HHS makes a prima facie showing of research misconduct the
respondent has the burden of proving any affirmative defenses raised,
including honest error or difference of opinion. There were a number of
objections to that section on the grounds that shifting the burden of
proving honest error or difference of opinion to the respondent
effectively shifts the burden of the institution and HHS to prove each
element of research misconduct or, at the least, creates confusion.
Some of the commentators opined that the institution and the HHS have
the burden of proving the absence of honest error or difference of
opinion.
As stated in the preamble of the Federal Register notice
promulgating the final OSTP Research Misconduct Policy (65 FR 76260,
Dec. 6, 2000), the exclusion of honest error or difference of opinion
from the definition of research misconduct does not create a separate
element of proof; institutions and agencies are not required to
disprove possible honest error or difference of opinion. Given that
guidance, this final rule retains honest error or difference of opinion
as an affirmative defense that the respondent has the burden of proving
by a preponderance of the evidence.
However, we recognize that there is an overlap between the
responsibility of respondents to prove this affirmative defense and the
burden of institutions and HHS to prove that research misconduct was
committed intentionally, knowingly, or recklessly. Accordingly,
consistent with the opinion of the United States Supreme Court in
Martin v. Ohio, 480 U.S. 228, 107 S. Ct. 1098 (1987), we have amended
Sec. 93.106 to require consideration of admissible, credible evidence
respondent submits to prove honest error or difference of opinion in
determining whether the institution and HHS have carried their burden
of proving by a preponderance of the evidence that the alleged research
misconduct was committed intentionally, knowingly, or recklessly. This
consideration would be required, regardless of whether respondent
carries his/her burden of proving honest error or difference of opinion
by a preponderance of the evidence.
In light of this change, we have removed the reference to the
institution or HHS making a prima facie showing of research misconduct
as unnecessary and confusing. Because this is the only use of prima
facie in the regulation, we have removed the definition of that term.
E. Coordination With Other Agencies, Sec. 93.109
Some commentators pointed out that Sec. 93.109(a), as proposed, is
not consistent with the statement in the OSTP Policy that a lead agency
should be designated when more than one agency has jurisdiction. We
have amended paragraph (a) to state that if more than one agency of the
Federal government has jurisdiction, HHS will cooperate with the other
agencies in designating a lead agency. We have added a sentence
clarifying that where HHS is not the lead agency, it may, in
consultation with the lead agency, take action to protect the health
and safety of the public, promote the integrity of the PHS supported
research and research process, or to conserve public funds.
F. Definition of Research Record, Sec. 93.224
One commentator recommended that the research record include the
comments of the complainant and respondent on the inquiry and
investigation reports. We agree that documents and materials provided
by the respondent as part of his/her comments on the inquiry and
investigation reports, or at any other stage of the research misconduct
proceeding do not differ significantly from those provided in response
to questions regarding the research. Only the latter were included in
the proposed definition of research record. Accordingly, we have
amended Sec. 93.224 (formerly Sec. 93.226) so that the definition of
research record includes documents and materials that embody the facts
resulting from the research that are provided by the respondent at any
point in the course of the research misconduct proceeding. The purpose
of including documents provided by respondent in the research record is
to hold the respondent responsible for the integrity of those research
documents regardless of when they were prepared or furnished to the
institution or HHS.
Because the complainant is not being held responsible for the
record of data or results that embodies the facts resulting from the
research at issue, we are not including comments provided by the
complainant during the research misconduct proceeding in the definition
of the term ``research record.'' Those comments may be considered by
the institution and/or HHS and they may be admitted as evidence in any
hearing, but they are not part of the research record. If the
complainant possesses documents that embody the facts resulting from
the research that is the subject of the research misconduct proceeding,
those documents are research records and the institution is responsible
for maintaining and securing those documents in the same manner as
other research records. Those documents are distinct from analyses of
research records or results that a complainant may prepare prior to or
in the course of a research misconduct proceeding to support his or her
allegation of misconduct. Any such documents may be considered evidence
pertinent to the allegation, but they are not part of the research
record.
G. Reporting Inquiries to ORI, Sec. 93.300(a)
Several commentators interpreted the general language in proposed
Sec. 93.300(a), requiring institutions to have policies and procedures
for ``reporting
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inquiries and investigations of alleged research misconduct in
compliance with this part,'' to require the reporting of all inquiries
to ORI, contrary to the requirement in Sec. 93.309 for reporting only
those inquiries resulting in a finding that an investigation is
warranted. We have amended Sec. 93.300(a) to clarify that the
institution's policies and procedures must comply with the requirements
of the regulation for addressing allegations of research misconduct.
This includes the requirements of Sec. 93.309.
It was also recommended that this section be amended to require
that the institution's written policies and procedures be provided to
the complainant and other interested parties on request. We have added
a requirement that the policies and procedures be provided to members
of the public upon request to Sec. 93.302(a)(1) because it addresses
the availability of the institution's policies and procedures to HHS
and ORI upon request.
H. Precautions To Protect Against Conflicts of Interest, Secs.
93.300(b) and 93.304(b)
In response to a general comment that the regulation should ensure
that those conducting inquiries and investigations do not have
conflicts of interest, we have amended Secs. 93.300(b) and 93.304(b) to
require institutions to include precautions against conflicts of
interest on the part of those involved in the inquiry or investigation.
This expands upon the requirement in Sec. 93.310(f) that institutions
take reasonable steps to ensure an impartial investigation, ``including
participation of persons with appropriate scientific expertise who do
not have unresolved personal, professional, or financial conflicts of
interest with those involved with the inquiry or investigation.''
I. Reporting of Aggregated Information by Institutions, Sec. 93.302(c)
Several commentators recommended deletion of proposed Sec.
93.302(c) because its broad language would encompass research
misconduct proceedings that are outside the jurisdiction of HHS. We
agree with the intent of these comments and have amended this provision
to refer to aggregated information on the institution's research
misconduct proceedings covered by this part.
J. Responsibility for Securing Research Records and Evidence, Secs.
93.305, 93.307(b) and 93.310(d)
Several commentators recommended that Sec. 93.305 be amended to
ensure that any securing of scientific instruments not interfere with
ongoing research. Scientific instruments are included in the definition
of ``research record'' in Sec. 93.224 to the extent they are, or
contain physical or electronic records of data or results that embody
the facts resulting from scientific inquiry. In response to these
comments we have added language to paragraphs (a) and (c) of Sec.
93.305, paragraph (b) of Sec. 93.307, and paragraph (d) of Sec. 93.310
permitting institutions to secure copies of data or other research
records on shared scientific instruments, so long as those copies are
substantially equivalent in evidentiary value to the instruments
themselves. It is expected that institutions will exercise discretion
in determining whether copies of the data are substantially equivalent
in evidentiary value to the instruments themselves, consulting with ORI
as the institution determines necessary. The evidentiary value of
scientific instruments will vary from case to case. In some cases their
value may be dependent upon the manner in which they record data,
rather than the data they contain. In those cases, it may be reasonable
for the institution to permit continued use of the instrument, so long
as it remains available for inspection by those conducting the inquiry
and investigation.
K. Using a Consortium or Other Entity To Conduct Research Misconduct
Proceedings, Sec. 93.306
One commentator recommended that there should be greater detail
regarding the kinds of practice and experience that would qualify an
outside entity to conduct research misconduct proceedings, how possible
conflicts of interest would be handled, and whose responsibility it
would be to determine whether the outside entity is qualified.
The proposed Sec. 93.306 contains a catchall phrase providing that
an institution may use a consortium or other entity to conduct research
misconduct proceedings, if the institution prefers not to conduct its
own proceeding. In light of the incorporation of this broad discretion
in the proposed section, we have simplified Sec. 93.306 to provide that
an institution may use the services of a consortium or person that the
institution reasonably determines to be qualified by practice and
experience to conduct research misconduct proceedings. Thus, the
institution may decide to use an outside consortium or person for any
reason and it determines whether that outside consortium or person is
qualified. We have substituted the defined term ``person'' for the term
``entity.'' Any outside person conducting a research misconduct
proceeding would be subject to the requirements for precautions against
conflicts of interest in Secs. 93.300(b) and 93.304(b).
L. Standards for Investigation, Sec. 93.310(g) and (h)
A number of commentators felt that the provisions of proposed Sec.
93.310(g) and (h) establish a performance standard that cannot be met
through the use of the terms ``any'' and ``all.'' We have amended
paragraphs (g) and (h) to require, respectively, interviews of each
person who has been reasonably identified as having information
regarding relevant aspects of the investigation, and the pursuit of all
significant issues and leads discovered that are determined relevant to
the investigation. The institutions are responsible for making the
relevancy determinations that are included in these paragraphs.
M. Opportunity To Comment on the Investigation Report and Review the
Supporting Evidence, Sec. 93.312(a) and (b)
One commentator proposed language clarifying the period for the
respondent to comment on the investigation report. Another commentator
felt that the institution should be required to give the respondent an
opportunity to review all research records and evidence upon which the
investigation report is based. We believe that clarification of the 30-
day period for comment by the respondent and for comment by the
complainant, at the discretion of the institution, is needed. We have
amended paragraphs (a) and (b) of Sec. 93.312 accordingly. In addition,
we have amended paragraph (b) to make it clear that institutions have
the discretion to provide the complete investigation report to the
complainant for comment or relevant portions of it.
The OSTP Guidelines for Fair and Timely Procedures, Section IV of
the Uniform Federal Policy, provide that one of the safeguards for
subjects of allegations is reasonable access to the data and other
evidence supporting the allegations and the opportunity to respond to
the allegations, the supporting evidence and the proposed findings of
research misconduct, if any. Consistent with that guidance, we have
amended Sec. 93.312(a) to require institutions to give the respondent,
concurrently with the draft investigation report, a copy of, or
supervised access to, the evidence on which the report is based.
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N. Institutional Appeals, Sec. 93.314(a)
One commentator requested language clarifying that the 120-day
period for completing institutional appeals applies only to appeals
from the finding of misconduct, not appeals from personnel actions. We
have implemented this comment through the addition of appropriate
language to Sec. 93.314(a).
O. Completing the Research Misconduct Process, Sec. 93.316
Several commentators objected to this provision because they
interpreted it as requiring that ORI be notified when an inquiry ends
in a finding of no misconduct. These commentators recommended that the
regulation address the question of whether settlements based on an
admission of misconduct are reportable. In response to these comments
we have amended Sec. 93.316(a) to require that institutions notify ORI
if they plan to close a case at the inquiry, investigation, or appeal
stage on the basis that the respondent has admitted research
misconduct, a settlement with the respondent has been reached, or for
any other reason, except a determination at the inquiry stage that an
investigation is not warranted, or a finding of no misconduct at the
investigation stage, which must be reported to ORI under Sec. 93.315.
We have also changed Sec. 93.316(b) to provide for ORI consultation
with the institution on its basis for closing a case, rather than
simply reviewing the institution's decision, and expanded the actions
ORI may take to include approving or conditionally approving closure of
the case and taking compliance action.
P. Retention and Custody of Records of the Research Misconduct
Proceeding, Sec. 93.317
There were several objections that the seven-year retention period:
(1) Creates storage problems; (2) should not apply to scientific
instruments; and (3) is contrary to the 3-year retention period for
records relating to grants in OMB Circular A-110. One commentator
recommended that the term ``records of research misconduct
proceedings'' be defined to include a relevancy standard.
In order to clarify what must be retained, we have added a new
paragraph (a) to Sec. 93.317 defining records of research misconduct
proceedings by referring to the sections of the regulation that
describe what records institutions must prepare in the course of
research misconduct proceedings. The definition includes a relevancy
standard and requires that an institution document any determination
that records are irrelevant. We have added two exceptions to the
requirement for retention of the records for a period of 7 years that
is now in paragraph (b) of Sec. 93.317. The institution is not
responsible for maintaining the records if they have been transferred
to HHS in accordance with paragraph (c), formerly (b), or ORI has
advised the institution in writing that it no longer needs to retain
the records.
As stated in the preamble of the NPRM (69 FR at 20784) the 7-year
retention period is based on concerns that the 3-year period for
retaining inquiry records in the current regulation, 42 CFR
50.103(d)(6) is too short to permit HHS or the Department of Justice to
investigate potential civil or criminal fraud cases. While the 7-year
retention period is potentially burdensome, that burden will fall on a
limited number of institutions, 53 according to the Paperwork Reduction
Act burden estimate in the preamble to the NPR, and the burden is
mitigated by exceptions for transfer of custody to HHS and for a
written notification from ORI that the records do not have to be
retained by the institution. Upon the effective date of this final
rule, the 7-year retention period for records of research misconduct
proceedings will supercede the more general requirements for the
retention of records relating to grants. We note that the 7-year
retention period is consistent with the provision in the HHS general
grants administration regulation, 45 CFR 74.53(b)(1) providing that if
any review, claim, financial management review, or audit is started
during the 3-year retention period, the pertinent records must be
retained until all such matters have been resolved and final action
taken.
Q. ORI Allegation Assessments, Sec. 93.402
Several commentators recommended requiring that ORI notify the
institution of any allegation received by ORI, regardless of how ORI
disposes of the allegation. Consistent with this recommendation, we
have amended paragraph (d) of Sec. 93.402 to provide that if ORI
decides that an inquiry is not warranted, it will close the case and
may forward the allegation in accordance with paragraph (e) which
provides that allegations not covered by the regulation may be
forwarded to the appropriate HHS component, Federal or State agency,
institution or other appropriate entity. In deciding whether to forward
a specific allegation to the institution, ORI will consider potential
confidentiality issues for the complainant and others. We are open to
further dialogue with the research community on this issue.
R. Standard for the Assistant Secretary for Health's Review of the
ALJ's Decision, Secs. 93.500(d) and 93.523
One commentator recommended that there be criteria for the
Assistant Secretary for Health (ASH) to review the ALJ's decision,
similar to the ``arbitrary and capricious, or clearly erroneous''
standard for the HHS debarring official to review the ALJ's decision
(paragraph (e) of Sec. 93.500).
In response to this comment, we have added to Sec. 93.523(b) a
standard of review for the ASH's review of the decision of the ALJ. The
standard of review for the ASH is the same ``arbitrary and capricious
or clearly erroneous'' standard that applies to the debarring
official's review where debarment or suspension is a recommended HHS
administrative action. In addition, we have amended Secs. 93.500 and
93.523 to establish a procedure for the ASH review, clarify the
relationship between the ASH review and the debarring official's
decision on recommended debarment or suspension actions, and identify
what constitutes the final HHS action. The Assistant Secretary for
Health notifies the parties of an intention to review the ALJ's
recommended decision within 30 days after service of the recommended
decision. Upon review, the ASH may modify or reject the decision in
whole or in part after determining it, or the part modified or
rejected, to be arbitrary and capricious or clearly erroneous. If the
ASH does not notify the parties of an intent to review the recommended
decision within the 30-day period, that decision becomes final and
constitutes the final HHS action, unless debarment or suspension is an
administrative action recommended in the decision. If debarment or
suspension is a recommended HHS action either in a decision of the ALJ
that the ASH does not review, or in the decision of the ASH after
review, the decision constitutes proposed findings of fact to the HHS
debarring official.
As noted in the discussion of changes not based on comments, we
have amended several sections to ensure that the Assistant Secretary
for Health cannot be responsible both for making findings of research
misconduct and for reviewing the ALJ's recommended decision on those
findings, if respondent contests the findings by requesting a hearing.
ORI will be responsible for making those findings, consistent with its
responsibilities as the reviewer of institutional findings of
[[Page 28375]]
research misconduct and as a party to any hearing on those findings.
This maintains the separation between investigation and adjudication,
because any inquiry or investigation would be conducted by the
institution, or if conducted by HHS, it would not be conducted by ORI
(Sec. 93.400(a)(4)).
S. Extension for Good Cause To Supplement the Hearing Request, Sec.
93.501(d)
One commentator recommended that the 30-day limit for supplementing
the hearing request be measured from notification of the appointment of
the ALJ, rather than from receipt of the charge letter. The commentator
notes that the ALJ may not be appointed within 30 days after receipt of
the charge letter and recommends an amendment providing that the ALJ
may grant an additional period of no more than 60 days from the
respondent's receipt of notification of the appointment of the ALJ.
This comment makes a good point, but 60 days from notice of the
appointment of the ALJ is too long a period, given that there may be an
additional 30 days for appointment of the ALJ after the request for a
hearing is filed. Thus, we have amended paragraph (d) to provide that
after receiving notification of the appointment of the ALJ, the
respondent has 10 days to file with the ALJ a proposal for
supplementation of the hearing request that includes a showing of good
cause for supplementation. Note that this 10-day period is consistent
with the period for responding to a motion in Sec. 93.510(c) and that
in accordance with Sec. 93.509(d), the ALJ may modify the 10-day period
for good cause shown.
T. Role of Scientific Expert Appointed by ALJ, Sec. 93.502
It was recommended that advice of the scientific expert appointed
to advise the ALJ be part of the record and available to both parties.
It was further recommended that the scientific expert be available for
questioning by the parties. Another commentator recommended specific
guidance in the regulation to assist ALJs in retaining appropriate
scientific expertise. Another commentator felt that the appointment of
an expert to assist the ALJ should be mandatory in every case, while
others felt such an appointment should be mandatory in those cases
involving complex scientific, medical or technical issues. For the
reasons explained below under the heading, ``Significant Comments Not
Resulting in Changes,'' we are not requiring the appointment of an
expert to assist the ALJ in every case.
The proposed Sec. 93.502 provides some guidance on the selection of
scientific and technical experts by requiring that they have
appropriate expertise to assist the ALJ in evaluating scientific or
technical issues related to the HHS findings of research misconduct.
Furthermore, experts may not have real or apparent conflicts of
interest, or as added in this final rule, bias or prejudice that might
reasonably impair their objectivity in the proceeding.
In paragraph (b)(1) of Sec. 93.502 of this final rule we are
providing further guidance on the selection of an expert to advise the
ALJ. Upon a motion by the ALJ or one of the parties to appoint an
expert to advise the ALJ, the ALJ must permit the parties to submit
nominations. If such a motion is made by a party, the ALJ must appoint
an expert, either: (1) The expert, if any, who is agreeable to both
parties and found to be qualified by the ALJ; or, (2) if the parties
cannot agree upon an expert, the expert chosen by the ALJ.
These provisions will ensure the selection of well-qualified
experts, minimize disputes, speed the appointment process by providing
precise procedural rules, and enhance fairness by providing for greater
involvement of the parties in the process.
Consistent with the greater involvement of the parties in the
selection of the expert and with the comment recommending a more
formalized process for the expert to provide advice, we are adding Sec.
93.502((b)(2) to clarify the role of the expert appointed by the ALJ.
The ALJ may seek advice from the appointed expert at any time during
the discovery or hearing phase of the proceeding. Advice must be
provided in the form of a written report, containing the expert's
background and qualifications, which is served upon the parties. The
report and the expert's qualifications and advice may be challenged by
the parties in the form of a motion or through testimony of the
parties' own experts, unless the ALJ determines such testimony to be
inadmissible in accordance with Sec. 93.519, or that such testimony
would unduly delay the proceeding. In this manner, the report and any
comment on it would be part of the record. These procedures will
greatly enhance the detail and quality of the expert advice available
for consideration by the ALJ and provide greater transparency and
confidence to the scientific community on the expertise provided to the
ALJ.
II. Changes Not Based on Comments
A. Grandfather Exception to Six Year Limitation on Receipt of
Misconduct Allegations, Sec. 93.105(b)(3)
We have changed the condition for the grandfather exception from
``had the allegation of research misconduct under review or
investigation on the effective date of this regulation'' to ``had
received the allegation of research misconduct before the effective
date of this part.'' This makes the condition for the grandfather
exception consistent with the event that tolls the running of the six-
year limitation: the receipt of the misconduct allegation by the
institution or HHS.
B. Confidentiality, 93.108
Consistent with longstanding practice and with Sec. 93.403, we have
added a provision to clarify that ORI is within the category of those
who need to know the identity of the respondent and complainant and
that an institution may not invoke confidentiality to withhold that
information from ORI as it conducts its review under Sec. 93.403.
C. Definition of Deciding Official, Sec. 93.207, and Authority of ORI,
Sec. 93.400.
To ensure that the Assistant Secretary for Health is not
responsible for both making findings of research misconduct and for
reviewing the recommended decision of the ALJ on those findings if
respondent contests the findings by requesting a hearing, Sec. 93.400
has been amended to give ORI the authority to make findings of research
misconduct. That section and Sec. 93.404 have also been amended to
clarify that ORI proposes administrative actions to HHS (defined as the
Secretary or his delegate) and upon HHS approval, proceeds to implement
those proposed actions in accordance with the procedures in the
regulation. Accordingly, the definition of, and references to the term
``deciding official'' have been deleted. Giving ORI the responsibility
for making findings of research misconduct is consistent with its
responsibilities for reviewing institutional findings of research
misconduct and for defending those findings if the respondent
challenges them. This change will maintain the separation between
investigation and adjudication, because ORI will not conduct any
inquiry or investigation on behalf of HHS.
These changes have necessitated changing references to HHS and ORI
and other clarifying changes in Secs. 93.403-406, 93.411, 93.500-501,
93.503, and 93.516-517. As provided in Sec.
[[Page 28376]]
93.406, the ORI finding of research misconduct is the final HHS action
only if the respondent does not contest the charge letter within the
prescribed period. The administrative actions, proposed by ORI and
approved by HHS, become final in the same manner, except that the
debarring official's decision is the final HHS action on any debarment
or suspension action.
C. Definition of Good Faith, Sec. 93.210
Under Secs. 93.227 and 93.300(d), committee members are protected
against retaliation for good faith cooperation with a research
misconduct proceeding. As proposed, Sec. 93.211 (now Sec. 93.210)
defined ``good faith'' for complainants and witnesses, but not for
committee members. We have added such a definition, stating that a
committee member acts in good faith if he/she cooperates with the
research misconduct proceeding by carrying out the duties assigned
impartially for the purpose of helping an institution meet its
responsibilities under this regulation. A committee member does not act
in good faith if his/her acts or omissions on the committee are
dishonest or influenced by personal, professional, or financial
conflicts of interest with those involved in the research misconduct
proceeding.
D. Definition of Institutional Member, Sec. 93.214
We have added more examples of institutional members.
E. Institutional Policies and Procedures--Reporting the Opening of an
Investigation, Sec. 93.304(d)
We have simplified the date for institutions to report the opening
of investigations to ORI. This report must be made on or before the
date on which the investigation begins. Institutions are encouraged to
report the opening of an investigation to ORI as promptly as possible
after the decision to open an investigation is made.
F. Taking Custody of and Securing Records at the Beginning of an
Inquiry, Sec. 93.307(b)
We have added a requirement that on or before the date on which the
respondent is notified of the inquiry, or the inquiry begins, whichever
is earlier, the institution must, to the extent it has not already done
so, promptly take all reasonable and practical steps to obtain custody
of all the research records and evidence needed to conduct the research
misconduct proceeding, inventory the records and evidence and sequester
them in a secure manner, except that where the research records or
evidence encompass scientific instruments shared by a number of users,
custody may be limited to copies of the data or evidence on such
instruments, so long as those copies are substantially equivalent to
the evidentiary value of the instruments. This is consistent with the
identical requirements that become applicable when the institution
notifies the respondent of the allegation and when the respondent is
notified of an investigation. (Secs. 93.305(a) and 93.310(d)). These
requirements are necessary because of the potential for the destruction
or alteration of the research records. To minimize that potential, an
institution should take custody of the records whenever it has reason
to believe that the records may be subject to alteration or destruction
because of an allegation or potential allegation of research
misconduct. This may protect the respondent, as well as the
institution.
G. Interaction With Other Offices, Sec. 93.401
To accurately reflect ORI's authority and practices, we have
expanded this section to authorize ORI to provide expertise and
assistance to the Department of Justice, the HHS Inspector General, PHS
and other Federal offices, and State or local offices involved in
investigating or otherwise pursuing research misconduct allegations or
related matters.
H. Procedures for Debarment or Suspension Actions Based on Misconduct
Findings, Secs. 93.405, 93.500-501, 93.503 and 93.523.
We have amended these sections to clarify the relationship between
the regulations governing debarment and suspension and the procedures
in subpart E for contesting ORI findings of research misconduct and
proposed HHS administrative actions. Section 93.500(d) (comparable to
Sec. 93.500(c) of the NPRM) explains that the procedures under subpart
E provide the notification, opportunity to contest and fact finding
required under the HHS regulation governing debarment and suspension.
Consistent with that regulation, the debarring official provides
notification of the proposed debarment or suspension as part of the
charge letter (Sec. 93.405(a)) and makes the final decision on
debarment and suspension actions whether that decision is based upon
respondent's failure to contest the charge letter (Secs. 93.406,
93.501(a) and 93.503(c)), the decision of the ALJ, or the decision of
the ALJ as modified by the Assistant Secretary for Health (Secs.
93.500(c) and 93.523(b) and (c)).
I. HHS Administrative Action--Recovery of Funds, Sec. 93.407(b)
We have clarified what funds HHS may seek to recover in connection
with a finding of research misconduct by amending Sec. 93.407(b) to
refer to the potential recovery of PHS funds spent in support of
activities that involved research misconduct.
J. Appointment of the ALJ--Description of Functions, Sec. 93.502(a)
We have amended Sec. 93.502(a) to describe the functions of the ALJ
more completely.
K. Limits on the Authority of the ALJ, Sec. 93.506(a) and (c)
We have added references in Secs. 93.506(a) and (c) stating that
the ALJ does not have the authority to find invalid or refuse to follow
Federal statutes or regulations, Secretarial delegations of authority,
or HHS policies. This is consistent with a similar provision in the
regulation upon which the research misconduct hearing process is based,
42 CFR part 1005, which governs the hearing process for OIG exclusion
of health care providers.
L. Actions for Violating an Order or Disruptive Conduct, Sec.
93.515(b)(6)
We have changed ``taking a negative inference from the absence of
research records, documents, or other information'' to ``drawing the
inference that spoliated evidence was unfavorable to the party
responsible for its spoliation.'' This change is intended to clarify
the nature of the negative inference that may be reached by the ALJ and
distinguish the spoliation of evidence during or in anticipation of the
hearing, from the absence or destruction of records that may be
evidence of research misconduct. In this context, spoliation has
essentially the same meaning as is accepted by Federal courts, i.e.,
the destruction or significant alteration of evidence during or in
anticipation of the hearing.
M. Corrections and Minor Changes
In addition to the significant changes not based on comments
described above, we have made changes to: (1) Correct errors, such as
references to PHS rather than HHS, or to a hearing officer, rather than
the ALJ; (2) use uniform language in describing the same condition or
event in different sections of the regulation; (3) adding citations to
other sections, where appropriate, to make cross-references more
concise and
[[Page 28377]]
technically correct; and (4) use plain, and more precise language.
III. Significant Comments Not Resulting in Changes
A. Definition of Research Misconduct, Sec. 93.103
Although most commentators supported the new definition of research
misconduct, there were a number of comments recommending changes,
including that: (1) The definition should be based on deception; (2)
the definition of falsification is inadequate because it does not cover
the nonexperimental manipulation of human or animal subjects with the
goal of influencing research results, or bias in the coding of
qualitative data; (3) the definition of plagiarism should expressly
exclude authorship and credit disputes; and (4) the definition of
misconduct should be expanded to include negligent and intentional
mistreatment of animals.
As explained in the preamble of the NPRM, the proposed definition
of research misconduct, which is included in this final rule without
change, includes OSTP's description of ``fabrication, falsification,
and plagiarism.'' That description is clear and sufficiently concrete
to provide the basis for reasonable determinations of whether research
misconduct has occurred and whether the misconduct was intentional,
knowing, or reckless. Given the careful consideration that has been
given to this definition and the value of a uniform government-wide
definition, we are adopting the definition as it was proposed. We note
that the nonexperimental manipulation of human or animal subjects to
influence the research results would appear to be a manipulation of
research materials or processes within the intendment of the definition
of falsification.
B. Confidentiality, Secs. 93.108, 93.300(e) and 93.304(a)
Several commentators recommended including witnesses and committee
members and strengthening the confidentiality protections to provide
the same protections as the OSTP Policy. Other commentators recommended
that: (1) The rule give examples of what disclosures are limited and
state when an institution is free to announce the results of an
investigation to scientific journals; (2) the identity of the
complainant and his/her statement be disclosed to the respondent; and
(3) that the sanctions for a violation of confidentiality be specified.
We have not changed Sec. 93.108 or the other provisions requiring
institutions to provide confidentiality to respondents, complainants,
and research subjects who are identifiable from research records or
evidence. We believe these provisions provide the same protections as
the OSTP policy. Institutions have considerable discretion in
implementing the confidentiality protections and are free to extend
them to witnesses and committee members. However, consistent with the
limitation of the OSTP confidentiality provision to complainants and
respondents, we are not requiring that they do so.
C. Definition of Allegation--Inclusion of Oral Allegations, Sec. 93.201
Several commentators objected to the inclusion of oral allegations
in the definition of the term ``allegation.'' Although, the current PHS
regulation at 42 CFR part 50, subpart A, does not define the term
allegation, it has been longstanding ORI practice to accept oral
allegations, including oral, anonymous allegations. Experience has
shown that oral allegations may contain relatively complete
information, but if they do not, they are often followed by more
complete allegations, or lead to more complete information.
The definition of allegation must be considered in the context of
the criteria warranting an inquiry. Under Sec. 93.307(a), an inquiry is
warranted if the allegation: (1) Falls within the definition of
research misconduct; (2) involves PHS supported biomedical or
behavioral research, research training, or activities related to that
research or research training; and (3) is sufficiently credible and
specific so that potential evidence of research misconduct may be
identified. Information sufficient to make these determinations can be
transmitted orally. If such information is not transmitted orally or by
other means, the institution cannot initiate an inquiry based upon the
oral allegation. Under Sec. 93.300(b), an institution is obligated to
respond to each allegation of research misconduct involving PHS
supported biomedical or behavioral research, research training or
activities related to that research or research training. The response
must consist of assessing the allegation to determine if the criteria
for initiating an inquiry are met and should consist of reasonable
efforts to obtain further information about the allegation. We do not
believe these are unreasonable burdens in response to oral allegations,
particularly since oral allegations can, and have conveyed information
leading to findings of research misconduct that have protected the
integrity of PHS supported research. We also note that the Offices of
the Inspector General at various Federal agencies routinely accept oral
and anonymous allegations in their pursuit of fraud, waste, and abuse.
D. Definition of Research Record, Sec. 93.226
We did not make any changes in this section in response to comments
that the inclusion of oral presentations will inhibit open scientific
discourse and objections to the interpretation of ``data and results''
to include computers and scientific equipment. The definition of
``research record'' is consistent with the definition of that term in
the OSTP Policy. Oral presentations are a widely accepted method of
conveying scientific information and research results. There is no
logical reason why scientists should be permitted to falsify,
fabricate, and plagiarize PHS supported biomedical and behavioral
research, research training and activities related to that research and
research training in oral presentations. The interpretation of the OSTP
definition to include computers and scientific instruments is
reasonable and consistent with the wording of the definition.
Laboratory records, ``both physical and electronic,'' are covered in
the OSTP definition. Computers and scientific instruments contain
electronic records. As explained above, we have made changes to clarify
that if those electronic records can be extracted from the computer or
instrument without change and recorded for later use, the computer or
instrument need not be retained as the repository of the record.
E. Definition of Retaliation, Sec. 93.226; Protection From Retaliation
Secs. 93.300(d) and 93.304(l)
One commentator recommended that the definition be amended to
include retaliation against the respondent for his/her efforts to
defend against the charges of research misconduct. The proposed
definition would not include action resulting from research misconduct
proceedings or personnel actions. It was also recommended that Secs.
93.300(d) and 93.304(l) be amended to require institutions to protect
respondents from retaliation by referring to ``all participants.''
The purpose of the retaliation provision is to encourage
researchers to come forward with good faith allegations of research
misconduct and to encourage good faith cooperation with a research
misconduct proceeding. In ORI's experience, there has been no showing
of a need to protect
[[Page 28378]]
respondents from retaliation in order to ensure they will take steps to
defend against an allegation of misconduct. In contrast, experience has
shown a need to restore the reputations of respondents where there is a
finding of no misconduct and Sec. 93.304(k) requires institutions to do
that. If a need to protect respondents from retaliation is shown,
institutions have broad discretion under the rule to address that
situation on a case-by-case basis or adopt a policy to remedy the
problem.
F. Responsibility of Institutions To Foster Responsible Conduct of
Research, Sec. 93.300(c)
Several commentators objected to the requirement that institutions
foster a research environment that promotes the responsible conduct of
research, arguing that it is beyond the scope of a regulation on
research misconduct. One letter, signed by four separate organizations,
stated: ``Though responsible conduct of research is clearly an
imperative that our institutions embrace, the nature of the general
research environment and the promotion of the responsible conduct of
research are not tied only to research misconduct as ORI staff have
asserted in many venues, and, as a consequence, should not be linked in
this particular policy.''
These commentators are reading too much into this provision. This
is not a requirement for institutions to establish a new program for
the responsible conduct of research. Rather, this provision
appropriately updates the language of the current regulation requiring
institutions to foster a research environment that discourages
misconduct in all research and deals forthrightly with possible
misconduct associated with research for which PHS funds have been
provided or requested (42 CFR 50.105). The new provision recognizes the
continuing importance of the responsible conduct of research to
competent research that is free of any research misconduct. As stated
by the Institute of Medicine (IOM) in its 2002 report, Integrity in
Scientific Research: Creating an Environment That Promotes Responsible
Conduct, ``instruction in the responsible conduct of research need not
be driven by federal mandates, for it derives from a premise
fundamental to doing science: the responsible conduct of research is
not distinct from research; on the contrary, competency in research
encompasses the responsible conduct of that research and the capacity
for ethical decisionmaking.'' (Report at p. 9). In the context of this
regulation, the directive in Sec. 93.300(c) to foster a research
environment that promotes the responsible conduct of research means an
environment that promotes competent, ethical research that is free of
misconduct. This is directly related to the purposes of the regulation
to establish the responsibilities of institutions in responding to
research misconduct issues and to promote the integrity of PHS
supported research and the research process (Sec. 93.101).
G. Responsibility for Maintenance of Research Records and Evidence,
Sec. 93.305
One commentator recommended that this section be amended to require
the prompt return to the respondent of records that, upon inventory,
are found not to be relevant to the misconduct proceeding. Paragraph
(a) of Sec. 93.305 requires the institution to obtain custody of all
records and evidence needed to conduct the research misconduct
proceeding. That requirement would not extend to records that are
reasonably determined by the institution not to be needed to conduct
the proceeding. We believe the imposition of an affirmative duty to
return records that are determined to be irrelevant could adversely
affect inquiries and investigations, because experience has shown that
research misconduct proceedings are better served by broadly securing
all records thought to be relevant. The respondent is protected by
paragraph (b) of Sec. 93.305 under which he/she may obtain copies of
the records or reasonable, supervised access.
H. Institutional Inquiry--Consideration of Honest Error or Difference
of Opinion, Sec. 93.307
Several commentators recommended amending this section to impose an
affirmative burden on institutions to assess whether honest error or
difference of opinion exempts the allegation from consideration as
research misconduct.
As noted earlier in this supplementary information, we have
concluded that honest error or difference of opinion is an affirmative
defense based on the statement in the preamble of the OSTP final rule
that institutions and agencies are not required to disprove possible
honest error or difference of opinion in order to make a finding of
research misconduct. However, because of the overlap between this
affirmative defense and the responsibility of institutions and HHS to
prove that the alleged research misconduct was committed intentionally,
knowingly, or recklessly, evidence of honest error or difference of
opinion is to be considered in determining whether the institutions and
HHS have met their burden of proving that element, a prerequisite to a
finding of research misconduct.
Under Sec. 93.307(c), the purpose of an inquiry is to conduct an
initial review of the evidence to determine if an investigation is
warranted. An investigation is warranted under Sec. 93.307(d) if: (1)
There is a reasonable basis for concluding that the allegation involves
PHS supported research, research training, or activities related to
that research or research training and falls within the definition of
research misconduct, and (2) preliminary information-gathering and
fact-finding from the inquiry indicates that the allegation may have
substance. It is important to note that possible honest error or
difference of opinion goes to the issue of whether the alleged research
misconduct was committed intentionally, knowingly, or recklessly, not
whether the allegation involves fabrication, falsification, or
plagiarism. A finding that the research misconduct is conducted
intentionally, knowingly, or reckless is necessary for a finding of
research misconduct; a finding that is not made until the investigation
is completed, absent an admission at an earlier stage.
Given this fact, and the preliminary nature of the fact finding at
the inquiry stage, it would be appropriate for the inquiry report to
note if there is possible evidence of honest error or difference of
opinion for consideration in the investigation, but it would be
inappropriate for the inquiry report to conclude, on the basis of an
initial review of the evidence of honest error or difference of
opinion, that the allegation should be dismissed. The determination of
whether the alleged misconduct is intentional, knowing, or reckless,
including consideration of evidence of honest error or difference of
opinion, should be made at the investigation stage, following a
complete review of the evidence. As noted in the preamble of the OSTP
final policy, institutions and HHS do not have the burden of disproving
possible honest error or differences of opinion.
I. Institutional Investigation, Sec. 93.310 and Investigation Time
Limits, Sec. 93.311
Some commentators recommended that complainants be given a right to
participate in the process. As explained in the preamble of the NPRM,
complainants are witnesses in that they do not control or direct the
process, do not have special access to evidence, except as determined
by the institution
[[Page 28379]]
or ORI, and do not act as decision makers. This ensures that the
institution will carry out its responsibility under Sec. 93.310(f) to
conduct investigations that are fair.
Other commentators felt that the respondent should have an explicit
right to review and comment on evidence and cross-examine witnesses at
the investigation stage, and the right to request an extension of time
for conducting the investigation. The proposed regulation requires
that: (1) Where appropriate, the respondent be given copies of, or
reasonable, supervised access to the research records secured by the
institution on or before the date it notifies the respondent of the
allegation, inquiry or investigation (Sec. 93.305(b)); (2) the
respondent be notified in writing of the allegations before the
investigation begins (Sec. 93.310(c)); (3) the institution interview
the respondent and any witnesses he/she identifies who may have
substantive information regarding any relevant aspects of the
investigation (Sec. 93.310(g)); and (4) the respondent be given 30 days
to review and comment on the investigation report (Sec. 93.312). These
provisions have been retained and, as noted above, we have added to
this final rule a requirement that respondent be given copies of, or
supervised access to the evidence supporting the investigation report,
concurrent with the period for comment. We believe these requirements
ensure that the respondent will have a fair opportunity to present
relevant evidence during the research misconduct proceeding,
particularly when viewed in the context of the respondent's right to
contest any HHS findings of research misconduct and proposed
administrative sanctions before an ALJ. It is important to note that
the final rule does not prohibit institutions from giving respondents
greater rights during the investigation, so long as they do not
contravene HHS requirements; the rule establishes a floor for their
participation.
J. Appointment of the ALJ and Scientific Expert, Sec. 93.502
Two scientific societies objected to the ALJ provision,
recommending that the current three member adjudication panel be
retained. Another scientific society raised concerns about the extent
to which scientists would be involved in the process, if they were not
part of the adjudication panel (these concerns have been addressed
through the changes in this section discussed above) and four
associations supported the ALJ provision, provided that scientific or
technical experts are required to participate in those cases involving
complex scientific, medical or technical issues. As stated in the
preamble of the NPRM, we believe that the change to a single
decisionmaker will substantially improve and simplify the process for
all parties. The change provides a process similar to Medicare and
State health care program exclusion cases brought by the Office of the
Inspector General (OIG), which have similar impacts on the reputations
of the respondents. This process is also consistent with Recommendation
92-7 of the Administrative Conference of the United States that ALJs
should hear and decide cases involving the imposition of sanctions
having a substantial economic effect. Use of an ALJ with ready access
to scientific and technical expertise, rather than multiple decision
makers, will streamline the process without compromising the quality of
decisions that are dependent upon resolution of scientific, medical, or
technical issues.
In addition to the comments recommending mandatory appointment of
an expert in complex cases, another commentator recommended that the
ALJ be required to appoint a scientific or technical expert to assist
the ALJ in every case, rather than the ALJ being authorized to appoint
such an expert and being required to appoint such an expert upon the
request of one of the parties, as proposed in the NPRM. We are not
changing the provision to require the appointment of an expert in every
case or in all cases involving complex issues. We believe that such a
rigid requirement is not needed to ensure fairness. In complex cases,
it will always be in the interest of at least one of the parties to
ensure that the ALJ fully understands the issues by requesting the
appointment of an expert. Upon such a request, the appointment of an
expert is mandatory. Furthermore, the ALJ, who is in the best position
to assess the complexity of the case in light of his/her own knowledge
and training, may appoint an expert in the absence of any motion by a
party. The self-interest of the parties and the duty of the ALJ to
exercise his/her discretion to provide a fair hearing should ensure
that an expert is appointed where necessary to ensure fairness. We will
closely monitor the appointment of experts in future hearings and, if
problems are apparent, consider amending the regulations to compel the
appointment of an expert in order to ensure that the ALJ will have the
benefit of expert advice in cases involving complex issues.
IV. General Issues and Requests for Clarification
Several general comments and requests for clarification are
addressed in the following question and answer format.
Q. Is the detail in the final rule contrary to the goal of the OSTP
Federal Policy on Research Misconduct to provide a more uniform
Federal-wide approach?
A. No, the final rule is consistent with the OSTP Federal Policy.
As stated elsewhere in this Supplementary Information we have made some
changes in order to adhere more closely to the Federal Policy and
refused to make other changes that would have been inconsistent with
the Federal Policy. The Supplementary Information section of the Notice
of Proposed Rulemaking (69 FR 20778, 20780 (April 16, 2004)) explained
that the proposed rule contained more detail than the existing rule
because institutions had over the years asked for more detailed
guidance and that detailed guidance would ensure thorough and fair
inquiries and investigations and greater accountability on the part of
all participants in research misconduct proceedings. Similarly, it was
explained that the more detailed hearing process was being proposed in
response to concerns that the current informal procedures lack the
consistency and clarity provided by binding rules of procedure for
other types of cases. Thus, the detail in the final rule is necessary
to ensure more uniformity among the various institutions that will be
conducting research misconduct proceedings and to ensure fair, uniform
procedures for the benefit of respondents. The detail in the proposed
rule, which is retained in this final rule, is entirely consistent with
the goals of the OSTP Federal Policy to provide for fair and timely
procedures and to strive for uniformity in implementation.
Q. How should institutions deal with bad faith allegations?
A. The final rule, Sec. 93.300(d), requires institutions to take
all reasonable and practical steps to protect the positions and
reputations of good faith complainants and protect them from
retaliation by respondents and other institutional members. By negative
implication, such steps are not required for bad faith complainants.
Bad faith complainants are those who, under the definition of ``good
faith'' in Sec. 93.210, do not have a belief in the truth of their
allegation that a reasonable person in the complainant's position could
have based on the information known to the complainant at the time.
[[Page 28380]]
We have determined there is no need for the final rule to further
address bad faith allegations, given that institutions may have
internal standards of conduct that address matters not addressed in the
final rule (Sec. 93.319). However, the definition of ``good faith''
provides important guidance for institutions because it makes clear
that an allegation can lack sufficient credibility and specificity so
that potential evidence of research misconduct cannot be identified
(Sec. 93.307(a)(3)), but still may not be a bad faith allegation. Thus,
if institutions exercise their discretion to adopt procedures
addressing bad faith allegations, we urge them to include fair
procedures for determining whether there has been a bad faith
allegation. ORI is prepared to work collaboratively with the research
community to develop guidance in this area if research institutions and
associations desire to do so.
Q. Will the final rule apply retroactively?
A. No, the final rule will become effective 30 days after the date
it is published in the Federal Register and will apply prospectively.
The effect of that prospective application will depend upon how the
provisions of the rule interact with the activities of the institution
and ORI. Upon the expiration of 30 days, the final rule will
immediately apply to institutions that are receiving PHS support for
research, research training or activities related to that research or
research training. For institutions not receiving such PHS support, the
regulation will not apply until they submit an application for that
support.
If an institution to which the final rule applies immediately has
completed an inquiry or investigation and reports to ORI after the
effective date of the final rule, ORI will take further action, make
findings, and provide an opportunity for a hearing in accordance with
the final rule. If a request for a hearing is received by the DAB Chair
after the effective date of the final rule, the hearing will be
conducted in accordance with the final rule. This will ensure that
respondents have the benefit of the detailed, fair hearing procedures
in the final rule. Because it is not possible to address every possible
scenario relating to the prospective application of the final rule,
institutions that have received allegations of misconduct, or have
ongoing inquiries or investigations upon the effective date of this
final rule should contact ORI to determine how the rule will apply to
those ongoing activities. ORI will make every effort to minimize
burdens and ensure that all parties are treated fairly. Generally, if
an institution has a research misconduct proceeding pending at the time
the new regulation becomes effective with respect to that institution,
ORI would expect the new procedural requirements to be applicable to
the institution's subsequent steps in that proceeding, unless the
institution or respondent would be unduly burdened or treated unfairly.
However, the definition of research misconduct that was in effect at
the time the misconduct occurred would apply.
Q. Should HHS take action to provide immunity from personal
liability for institutions, committee members, and witnesses who
participate in research misconduct proceedings?
A. As the commentator who raised this issue implied, a Federal
statute, rather than an HHS regulation, would be needed to provide this
immunity. Earlier attempts by HHS to develop legislation providing
immunity were unsuccessful. ORI does not currently have sufficient data
to make the case for Federal legislation. Interested parties are
encouraged to submit evidence that would help us in determining whether
there is a need for Federal legislation to provide immunity for
committee members and witnesses or to propose ways to provide such
protection in the absence of such legislation.
Q. Should HHS have primary responsibility for responding to
allegations of research misconduct at institutions that have repeatedly
failed to handle such allegations properly?
A. Under the final rule, HHS has the discretion to take
responsibility for responding to allegations of research misconduct at
institutions that are failing to handle such allegations properly.
Under Sec. 93.400, ORI may respond directly to any allegation of
research misconduct at any time before, during, or after an
institution's response to the matter. The ORI response may include, but
is not limited to, reviewing an institution's findings and process and
recommending that HHS perform an inquiry or investigation. In addition,
ORI may make findings and impose HHS administrative actions related to
an institution's compliance with the final rule. Where an institution
has failed in the past to respond promptly or properly to allegations
of research misconduct, ORI will monitor closely its subsequent
responses to allegations of research misconduct. However, ORI would
intervene only as it determines necessary and would first provide
advice and assistance to the institution. ORI would exercise its
discretion to respond directly to an allegation of research misconduct
only if the institution disregarded that advice or assistance or
otherwise continued to fail to properly carry out its responsibilities
under the final rule.
Q. Are sanctions required or available for imposition against those
who violate the confidentiality requirements in the final rule?
A. The final rule does not provide for specific sanctions against
those who violate the confidentiality protections in Sec. 93.108, but
an institution would be subject to the general sanctions for failure to
comply with the final rule and its assurance if it fails to comply with
Sec. 93.108. Section 93.300(e) requires institutions to provide
confidentiality to the extent required by Sec. 93.108, and Sec. 93.304
requires that an institution seeking an approved assurance have written
policies and procedures that, consistent with Sec. 93.108, provide for
protecting the confidentiality of respondents, complainants and
research subjects. The final rule does not impose, or require
institutions to impose sanctions against institutional members who
violate the confidentiality provisions of Sec. 93.108, but institutions
have the discretion to impose such sanctions by making compliance with
those provisions a condition of employment. Institutions may also wish
to develop specific policies addressing actions the institution may
take when institutional members violate the confidentiality
requirements.
Q. Does a respondent have a right to continue his/her research
after allegations of research misconduct have been made?
A. The final rule does not directly address the issue of whether
the respondent has a right to continue his/her research after an
allegation of research misconduct has been made. Section 93.305
requires the institution to: (1) promptly obtain custody of and
sequester all research records and evidence needed to conduct the
research misconduct proceeding; and (2) where appropriate, give the
respondent copies of, or reasonable, supervised access to the research
records. There are at least two reasons for providing such access: to
enable the respondent to prepare a defense against the allegation, and/
or to continue the research.
As proposed and adopted in this final rule, Sec. 93.305(b) requires
the institution to provide the respondent copies of, or supervised
access to the research records secured by the institution, unless that
would be inappropriate. The determination of when it would be
inappropriate to provide such copies or access is left to the
discretion of the institution. In exercising this discretion,
institutions
[[Page 28381]]
should consider separately the issues of whether the respondent should
continue the research and whether and under what circumstances the
respondent should be given copies of or access to the research records.
In considering the former issue, institutions should weigh, among other
factors, the special circumstances listed in Sec. 93.318, the
importance of continuing the research, and whether the expertise of the
respondent is unique. Institutions must also be cognizant of the
interests of the PHS funding agency and the need to confer with that
agency about suspension or discontinuation of the research or to obtain
approval if the Principal Investigator is being replaced. If the
respondent does not continue the research, it would be appropriate,
absent special circumstances, to give him/her a copy of the records, or
reasonable, supervised access to them for the purpose of preparing a
defense to the allegations. In order to ensure that the respondent has
this opportunity at the investigation stage, Sec. 93.312(a) requires
the institution to give the respondent a copy of, or supervised access
to the evidence upon which the draft investigation report is based
concurrently with the provision of the draft report for comment by the
respondent.
Q. Does the 120-day time limit for completing an investigation
include the 30-day period for respondent to review and comment on the
draft report?
A. Yes. Section 93.311 provides in pertinent part that an
institution must complete all aspects of an investigation within 120
days of beginning it, including providing the draft report for comment
in accordance with Sec. 93.312, and sending the final report to ORI
under Sec. 93.315. Under Sec. 93.313(g), the final report must include
and consider any comments made by the respondent or complainant on the
draft investigation report. If additional time is needed, the
institution can request reasonable extensions for completion of the
investigation.
Analysis of Impacts
As discussed in greater detail below, we have examined the
potential impact of this final rule as directed by Executive Orders
12866 and 13132, the Unfunded Mandates Act of 1995, the Regulatory
Flexibility Act, and the Paperwork Reduction Act of 1995.
We have also determined that this final rule will not: (1) Have an
impact on family well-being under section 654 of the Treasury and
General Government Appropriations Act of 1999; nor (2) have a
significant adverse effect on the supply, distribution, or use of
energy sources under Executive Order 13211.
A. Executive Order 12866
These final regulations have been drafted and reviewed in
accordance with Executive Order 12866 (58 FR 51735), section 1(b),
Principles of Regulation. The Department has determined that this final
rule is a ``significant regulatory action'' under Executive Order
12866, section 3(f), Regulatory Planning and Review because it will
materially alter the obligations of recipients of PHS biomedical and
behavioral research and research training grants. However, the final
regulation is not economically significant as defined in section
3(f)(1), because it will not have an annual effect on the economy of
$100 million or more or adversely affect in a material way the economy,
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities. Therefore, the information enumerated in
section 6(a)(3)(C) of the Executive Order is not required. The final
rule has been reviewed by the Office of Management and Budget (OMB)
under the terms of the Executive Order.
Recipients of PHS biomedical and behavioral research grants will
have to comply with the reporting and record keeping requirements in
the proposed regulation. As shown below in the Paperwork Reduction Act
analysis, those burdens encompass essentially all of the activities of
the institutions that are required under the proposed regulation. The
estimated total annual burden is 19,727.5 hours. The U.S. Department of
Labor, Bureau of Labor Statistics, sets the mean hourly wage for
Educational Administrators, Postsecondary at $ 36.12. The mean hourly
wage for lawyers is $ 51.56. The average hourly cost of benefits for
all civilian workers would add $ 7.40 to these amounts. In order to
ensure that all possible costs are included and to account for
potentially higher rates at some institutions, we estimated the cost
per burden hour at $ 100. This results in a total annual cost for all
institutions of $ 1,972,750.
B. The Unfunded Mandates Reform Act of 1995
Sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (2
U.S.C. 1532 and 1535) require that agencies prepare several analytic
statements before promulgating a rule that may result in annual
expenditures of State, local, and tribal governments, or by the private
sector, of $100 million or more in any one year. This final rule will
not result in expenditures of this magnitude, and thus the Secretary
certifies that such statements are not necessary.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (5 U.S.C. 601, et seq.) requires
agencies to prepare a regulatory flexibility analysis describing the
impact of the final rule on small entities, but also permits agency
heads to certify that the final rule will not, if promulgated, have a
significant economic impact on a substantial number of small entities.
The primary effect of this rule is to require covered institutions to
implement policies and procedures for responding to research misconduct
cases. The Department certifies that this rule will not have a
significant impact on a substantial number of small entities, as
defined by the Regulatory Flexibility Act, based on the following
facts.
Approximately 47 percent (1862) of the 4000 institutions that
currently have research misconduct assurances are small entities. The
primary impact of the final rule on covered institutions results from
the reporting and record keeping provisions which are analyzed in
detail under the heading, ``The Paperwork Reduction Act.'' Significant
annual burdens apply only if an institution learns of possible research
misconduct and begins an inquiry, investigation, or both. In 2001, 86
inquiries and 46 investigations were conducted among all the
institutions. No investigations were conducted by a small entity and
only one conducted an inquiry. Small entities would be able to avoid
entirely the potential burden of conducting an inquiry or investigation
by filing a Small Organization Statement under section 93.303. The
burden of filing this Statement is .5 hour. Thus, the significant
burden of conducting inquiries and investigations will not fall on a
substantial number of small entities.
A small organization that files the Small Organization Statement
must report allegations of research misconduct to ORI and comply with
all provisions of the proposed regulation other than those requiring
the conduct of inquiries and investigations. The total annual average
burden per response for creating written policies and procedures for
addressing research misconduct is approximately 16 hours. However,
approximately 99 percent of currently funded institutions already have
these policies and procedures in place and spend approximately .5 hour
updating
[[Page 28382]]
them. The most significant of the burdens that might fall on an entity
filing a Small Organization Statement is taking custody of research
records and evidence when there is an allegation of research
misconduct. The average burden per response is 35 hours, but based on
reports of research misconduct over the last three years, less than 5
small entities would have to incur that burden in any year.
Based on the forgoing analysis that was not commented upon when it
appeared in the Notice of Proposed Rulemaking, the Department concludes
that this final rule will not impose a significant burden on a
substantial number of small entities.
D. Executive Order 13132: Federalism
This final rule will not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Therefore, in accordance with section 6
of Executive Order 13132, we have determined that this rule does not
have sufficient federalism implications to warrant the preparation of a
federalism summary impact statement.
E. The Paperwork Reduction Act
Sections 300-305, 307-311, 313-318, and 413 of the rule contain
information collection requirements that are subject to review by the
OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et
seq.). The title, description, and respondent description of the
information collection requirements are shown below with an estimate of
the annual reporting burdens. Included in the estimates is the time for
reviewing instructions, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Public comments
on these estimates and other aspects of compliance with the Paperwork
Reduction Act were invited in the NPRM.
As indicated in the foregoing discussion of the comments, a number
of them addressed reporting and recordkeeping burdens. In response to
comments that the proposed reporting requirements in Secs. 93.300(a),
93.302(c) and 93.316 were subject to an overly broad interpretation, we
have made clarifying changes to limit their scope. This did not result
in any change in the burden estimates, because those estimates were
based upon a restrictive interpretation of the requirements. While
changes were made to make it easier for institutions to meet the
requirements in Secs. 93.305, 93.307, and 93.310 for securing records
contained in scientific instruments we do not believe that those
changes significantly affect the burden of the collection requirements.
As explained above, the addition of a relevancy standard to Sec.
93.317 and provisions for transferring the custody of records to HHS
will lessen the overall burden of retaining records of research
misconduct proceedings, although we have added a requirement that the
institutions document any determination that records are irrelevant. In
addition, we are adding an explanatory note to the burden estimate for
Sec. 93.317. This note explains that not all of the 53 respondents that
are expected to conduct research misconduct proceedings each year, on
average, will have to to retain the records of those proceedings for a
full seven years. If ORI determines that a thorough, complete
investigation has been conducted and finds that there was no research
misconduct or settles a case, it will notify the institution that it
does not have to retain the records of the research misconduct
proceeding, unless ORI is aware of an action by federal or state
government to which the records may pertain. Historically, about 60
percent of cases closed by ORI do not result in PHS misconduct findings
or PHS administrative actions. Thus, it is expected that in the
majority of cases ORI will notify the institutions that they do not
have to retain the records for the full seven-year period.
We have added a burden statement for the requirement in Sec.
93.302(a)(1) that institutions provide their policies and procedures on
research misconduct, upon request, to ORI, HHS, and members of the
public (this third item was added in response to comments). Based on
recent data, we have increased the number of respondents in the items
relating to the conduct of investigations by institutions. In addition,
we have made minor changes to account for the renumbering of sections
and paragraphs and to correct errors. With these changes, the estimates
published in the NPRM are adopted as the burden estimates of the final
rule. The information collection requirements in the final rule have
been submitted to OMB for review.
Title: Public Health Service Policies on Research Misconduct.
Description: This final rule revises the current regulation, 42 CFR
50.101, et seq., in three significant ways and will supersede the
current regulation. First, the proposed rule integrates the White House
Office of Science and Technology Policy's (OSTP) December 6, 2000,
government wide Federal Policy on Research Misconduct. Second, the
proposed rule incorporates the recommendations of the HHS Review Group
on Research Misconduct and Research Integrity that were approved by the
Secretary of HHS on August 25, 1999. Third, the proposed rule
integrates a decade's worth of experience and understanding since the
agency's first regulations were promulgated.
Description of Respondents: The ``respondents'' for the collection
of information described in this regulation are institutions that apply
for or receive PHS support through grants, contracts, or cooperative
agreements for any project or program that involves the conduct of
biomedical or behavioral research, biomedical or behavioral research
training, or activities related to that research or training (see
definition of ``Institution'' at Sec. 93.213).
Subpart C--Responsibilities of Institutions
Compliance and Assurances
Section 93.300(a)
See Sec. 93.304 for burden statement.
Section 93.300(c)
See Sec. 93.302(a)(2)(i) for burden statement.
Section 93.300(i)
See Sec. 93.301(a) for burden statement.
Section 93.301(a)
Covered institutions must provide ORI with an assurance either by
submitting the initial certification (500 institutions) or by
submitting an annual report (3500 institutions).
Number of Respondents--4000.
Number of Responses per Respondent--1.
Annual Average Burden per Response--.5 hour.
Total Annual Burden--2000 hours.
Section 93.302(a)(1)
Covered institutions must, upon request, provide their policies and
procedures on research misconduct to ORI, authorized HHS personnel, and
members of the public.
Number of Respondents--2000.
Number of Responses per Respondent--1.
Annual Average Burden per Response--.5 hour.
Total Annual Burden--1000 hours.
Section 93.302(a)(2)(i)
Each applicant institution must inform its research members
[[Page 28383]]
participating in or otherwise involved with PHS supported biomedical or
behavioral research, research training or activities related to that
research or research training, including those applying for PHS
support, of the institution's policies and procedures and emphasize the
importance of compliance with these policies and procedures.
Number of Respondents--4000.
Number of Responses per Respondent--1.
Annual Average Burden per Response--.5 hour.
Total Annual Burden--2000 hours.
Section 93.302(b)
See Sec. 93.301(a) for burden statement.
Section 93.302(c)
In addition to the annual report, covered institutions must submit
aggregated information to ORI on request regarding research misconduct
proceedings.
Number of Respondents--100.
Number of Responses per Respondent--1.
Annual Average Burden per Response--1 hour.
Total Annual Burden--100.
Section 93.303
Covered institutions that, due to their small size, lack the
resources to develop their own research misconduct policies and
procedures may elect to file a ``Small Organization Statement'' with
ORI.
Number of Respondents--75.
Number of Responses per Respondent--1.
Annual Average Burden per Response--.5 hour.
Total Annual Burden--37.5 hours.
Section 93.304
Covered institutions with active assurances must have written
policies and procedures for addressing research misconduct.
Approximately 3500 institutions already have these policies and
procedures in place in any given year and spend minimal time (.5 hour)
updating them. Approximately 500 institutions each year spend an
average of two days creating these policies and procedures for the
first time.
Number of Respondents--4000.
Number of Responses per Respondent--1.
Annual Average Burden per Response--2.5 hours.
Total Annual Burden--10,000 hours.
Section 93.305(a), (c), and (d)
When a covered institution learns of possible research misconduct,
it must promptly take custody of all research records and evidence and
then inventory and sequester them. Covered institutions must also take
custody of additional research records or evidence discovered during
the course of a research misconduct proceeding. Once the records are in
custody, the institutions must maintain them until ORI requests them,
HHS takes final action, or as required under Sec. 93.317.
Number of Respondents--53.
Number of Responses per Respondent--1.
Annual Average Burden per Response--35 hours.
Total Annual Burden--1855 hours.
Section 93.305(b)
Where appropriate, covered institutions must give the respondent
copies of or reasonable, supervised access to the research record.
Number of Respondents--53.
Number of Responses per Respondent--1.
Annual Average Burden per Response--5 hours.
Total Annual Burden--265 hours.
The Institutional Inquiry
Section 93.307(b)
At the time of or before beginning an inquiry, covered institutions
must notify the presumed respondent in writing.
Number of Respondents--53.
Number of Responses per Respondent--1.
Annual Average Burden per Response--1 hour.
Total Annual Burden--53 hours.
Section 93.307(e)
See Sec. 93.309 for burden statement.
Section 93.307(f)
Covered institutions must provide the respondent an opportunity to
review and comment on the inquiry report and attach any comments to the
report.
Number of Respondents--53.
Number of Responses per Respondent--1.
Annual Average Burden per Response--1 hour.
Total Annual Burden--53 hours.
Section 93.308(a)
Covered institutions must notify the respondent whether the inquiry
found that an investigation is warranted.
Number of Respondents--53.
Number of Responses per Respondent--1.
Annual Average Burden per Response--.5 hour.
Total Annual Burden--26.5 hours.
Section 93.309(a)
When a covered institution issues an inquiry report in which it
finds that an investigation is warranted, the institution must provide
ORI with a specified list of information within 30 days of the inquiry
report's issuance.
Number of Respondents--20.
Number of Responses per Respondent--1.
Annual Average Burden per Response--16 hours.
Total Annual Burden--320 hours.
Section 93.309(c)
Covered institutions must keep sufficiently detailed documentation
of inquiries to permit a later assessment by ORI of reasons why
decision was made to forego an investigation.
Number of Respondents--37.
Number of Responses per Respondent--1.
Annual Average Burden per Response--1 hour.
Total Annual Burden--37 hours.
The Institutional Investigation
Section 93.310(b)
See Sec. 93.309(a) for burden statement.
Section 93.310(c)
Covered institutions must notify the respondent of allegations of
research misconduct before beginning the investigation.
Number of Respondents--20.
Number of Responses per Respondent--1.
Annual Average Burden per Response--1.
Total Annual Burden--20 hours.
Section 93.310(d)
See Sec. 93.305(a), (c), and (d) for burden statement.
Section 93.310(g)
Covered institutions must record or transcribe all witness
interviews, provide the recording or transcript to the witness for
correction, and include the recording or transcript in the record of
the investigation.
Number of Respondents--20.
Number of Responses per Respondent--1.
Annual Average Burden per Response--15 hours.
Total Annual Burden--300 hours.
Section 93.311(b)
If unable to complete the investigation in 120 days, covered
institutions must submit a written request for an extension from ORI.
Number of Respondents--16.
[[Page 28384]]
Number of Responses per Respondent--1.
Annual Average Burden per Response--1 hour.
Total Annual Burden--16 hours.
Section 93.313
See Sec. 93.315 for burden statement.
Section 93.314(b)
If unable to complete any institutional appeals process relating to
the institutional finding of misconduct within 120 days from the
appeal's filing, covered institutions must request an extension in
writing and provide an explanation.
Number of Respondents--5.
Number of Responses per Respondent--1.
Annual Average Burden per Response--.5 hour.
Total Annual Burden--2.5 hours.
Section 93.315
At the conclusion of the institutional investigation process,
covered institutions must submit four items to ORI: the investigation
report (with attachments and appeals), final institutional actions, the
institutional finding, and any institutional administrative actions.
Number of Respondents--20.
Number of Responses per Respondent--1.
Annual Average Burden per Response--80 hours.
Total Annual Burden--1600 hours.
Section 93.316(a)
Covered institutions that plan to end an inquiry or investigation
before completion for any reason must contact ORI before closing the
case and submitting its final report.
Number of Respondents--10.
Number of Responses per Respondent--1.
Annual Average Burden per Response--2 hours.
Total Annual Burden--20 hours.
Other Institutional Responsibilities
Section 93.317(a) and (b)
See Sec. 93.305(a), (c), and (d), for burden statement. It is
expected that not all of the 53 respondents that learn of misconduct
will have to retain the records of their research misconduct
proceedings for seven years. If ORI determines that a thorough,
complete investigation has been conducted and finds that there was no
research misconduct, or settles the case, it will notify the
institution that it does not have to retain the records of the research
misconduct proceeding, unless ORI is aware of an action by federal or
state government to which the records pertain.
Section 93.318
Covered institutions must notify ORI immediately in the event of
any of an enumerated list of exigent circumstances.
Number of Respondents--2.
Number of Responses per Respondent--1.
Annual Average Burden per Response--1 hour.
Total Annual Burden--2 hours.
Subpart D--Responsibilities of the U.S. Department of Health and Human
Services Institutional Compliance Issues
Section 93.413(c)(6)
ORI may require noncompliant institutions to adopt institutional
integrity agreements.
Number of Respondents--1.
Number of Responses per Respondent--1.
Annual Average Burden per Response--20 hours.
Total Annual Burden--20 hours.
The Department has submitted a copy of this final rule to OMB for
its review of these information collection requirements under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Prior to the
effective date of this final rule, HHS will publish a notice in the
Federal Register announcing OMB's decision to approve, modify, or
disapprove the information collection provisions in this final rule. An
agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
List of Subjects
42 CFR Part 50
Administrative practice and procedure, Science and technology,
Reporting and recordkeeping requirements, Research, Government
contracts, Grant programs.
42 CFR Part 93
Administrative practice and procedure, Science and technology,
Reporting and recordkeeping requirements, Research, Government
contracts, Grant programs.
Dated: January 14, 2005.
Cristina V. Beato,
Acting Assistant Secretary for Health.
Dated: May 3, 2005.
Michael O. Leavitt,
Secretary of Health and Human Services.
0
Accordingly, under the authority of 42 U.S.C. 289b, HHS is amending 42
CFR parts 50 and 93 as follows:
PART 50--POLICIES OF GENERAL APPLICABILITY
0
1. The authority citation for 42 CFR part 50 continues to as follows:
Authority: Sec. 215, Public Health Service Act, 58 Stat. 690 (42
U.S.C. 216); Sec. 1006, Public Health Service Act, 84 Stat. 1507 (42
U.S.C. 300a-4), unless otherwise noted.
Subpart A [Removed]
0
2. Part 50, Subpart A (Sec. Sec. 50.101-50.105) is removed and
reserved.
0
3. A new Part 93, with subparts A, B, C, D and E is added to read as
follows:
PART 93--PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT
Sec.
93.25 Organization of this part.
93.50 Special terms.
Subpart A--General
93.100 General policy.
93.101 Purpose.
93.102 Applicability.
93.103 Research misconduct.
93.104 Requirements for findings of research misconduct.
93.105 Time limitations.
93.106 Evidentiary standards.
93.107 Rule of interpretation.
93.108 Confidentiality.
93.109 Coordination with other agencies.
Subpart B--Definitions
93.200 Administrative action.
93.201 Allegation.
93.202 Charge letter.
93.203 Complainant.
93.204 Contract.
93.205 Debarment or suspension.
93.206 Debarring official.
93.207 Departmental Appeals Board or DAB.
93.208 Evidence.
93.209 Funding component.
93.210 Good faith.
93.211 Hearing.
93.212 Inquiry.
93.213 Institution.
93.214 Institutional member
93.215 Investigation.
93.216 Notice.
93.217 Office of Research Integrity or ORI.
93.218 Person.
93.219 Preponderance of the evidence.
93.220 Public Health Service or PHS.
93.221 PHS support.
93.222 Research.
93.223 Research misconduct proceeding.
[[Page 28385]]
93.224 Research record.
93.225 Respondent.
93.226 Retaliation.
93.227 Secretary or HHS.
Subpart C--Responsibilities of Institutions
Compliance and Assurances
93.300 General responsibilities for compliance.
93.301 Institutional assurances.
93.302 Institutional compliance with assurances.
93.303 Assurances for small institutions.
93.304 Institutional policies and procedures.
93.305 Responsibility for maintenance and custody of research
records and evidence.
93.306 Using a consortium or person for research misconduct
proceedings.
The Institutional Inquiry
93.307 Institutional inquiry.
93.308 Notice of the results of the inquiry.
93.309 Reporting to ORI on the decision to initiate an
investigation.
The Institutional Investigation
93.310 Institutional investigation.
93.311 Investigation time limits.
93.312 Opportunity to comment on the investigation report.
93.313 Institutional investigation report.
93.314 Institutional appeals.
93.315 Notice to ORI of institutional findings and actions.
93.316 Completing the research misconduct process.
Other Institutional Responsibilities
93.317 Retention and custody of the research misconduct proceeding
record.
93.318 Notifying ORI of special circumstances.
93.319 Institutional standards.
Subpart D--Responsibilities of the U.S. Department of Health and Human
Services
General Information
93.400 General statement of ORI authority.
93.401 Interaction with other offices and interim actions.
Research Misconduct Issues
93.402 ORI allegation assessments.
93.403 ORI review of research misconduct proceedings.
93.404 Findings of research misconduct and proposed administrative
actions.
93.405 Notifying the respondent of findings of research misconduct
and HHS administrative actions.
93.406 Final HHS actions.
93.407 HHS administrative actions.
93.408 Mitigating and aggravating factors in HHS administrative
actions.
93.409 Settlement of research misconduct proceedings.
93.410 Final HHS action with no settlement or finding of research
misconduct.
93.411 Final HHS action with a settlement or finding of misconduct.
Institutional Compliance Issues
93.412 Making decisions on institutional noncompliance.
93.413 HHS compliance actions.
Disclosure of Information
93.414 Notice.
Subpart E--Opportunity to Contest ORI Findings of Research Misconduct
and HHS Administrative Actions
General Information
93.500 General policy.
93.501 Opportunity to contest findings of research misconduct and
administrative actions.
Hearing Process
93.502 Appointment of the Administrative Law Judge and scientific
expert.
93.503 Grounds for granting a hearing request.
93.504 Grounds for dismissal of a hearing request.
93.505 Rights of the parties.
93.506 Authority of the Administrative Law Judge.
93.507 Ex parte communications.
93.508 Filing, forms, and service.
93.509 Computation of time.
93.510 Filing motions.
93.511 Prehearing conferences.
93.512 Discovery.
93.513 Submission of witness lists, witness statements, and
exhibits.
93.514 Amendment to the charge letter.
93.515 Actions for violating an order or for disruptive conduct.
93.516 Standard and burden of proof.
93.517 The hearing.
93.518 Witnesses.
93.519 Admissibility of evidence.
93.520 The record.
93.521 Correction of the transcript.
93.522 Filing post-hearing briefs.
93.523 The Administrative Law Judge's ruling.
Authority: 42 U.S.C. 216, 241, and 289b.
Sec. 93.25 Organization of this part.
This part is subdivided into five subparts. Each subpart contains
information related to a broad topic or specific audience with special
responsibilities as shown in the following table.
------------------------------------------------------------------------
You will find provisions related to
In subpart . . . . . .
------------------------------------------------------------------------
A................................. General information about this rule.
B................................. Definitions of terms used in this
part.
C................................. Responsibilities of institutions
with PHS support.
D................................. Responsibilities of the U.S.
Department of Health and Human
Services and the Office of Research
Integrity.
E................................. Information on how to contest ORI
research misconduct findings and
HHS administrative actions.
------------------------------------------------------------------------
Sec. 93.50 Special terms.
This part uses terms throughout the text that have special meaning.
Those terms are defined in Subpart B of this part.
Subpart A--General
Sec. 93.100 General policy.
(a) Research misconduct involving PHS support is contrary to the
interests of the PHS and the Federal government and to the health and
safety of the public, to the integrity of research, and to the
conservation of public funds.
(b) The U.S. Department of Health and Human Services (HHS) and
institutions that apply for or receive Public Health Service (PHS)
support for biomedical or behavioral research, biomedical or behavioral
research training, or activities related to that research or research
training share responsibility for the integrity of the research
process. HHS has ultimate oversight authority for PHS supported
research, and for taking other actions as appropriate or necessary,
including the right to assess allegations and perform inquiries or
investigations at any time. Institutions and institutional members have
an affirmative duty to protect PHS funds from misuse by ensuring the
integrity of all PHS supported work, and primary responsibility for
responding to and reporting allegations of research misconduct, as
provided in this part.
Sec. 93.101 Purpose.
The purpose of this part is to--
(a) Establish the responsibilities of HHS, PHS, the Office of
Research Integrity (ORI), and institutions in responding to research
misconduct issues;
(b) Define what constitutes misconduct in PHS supported research;
(c) Define the general types of administrative actions HHS and the
PHS may take in response to research misconduct; and
(d) Require institutions to develop and implement policies and
procedures for--
(1) Reporting and responding to allegations of research misconduct
covered by this part;
(2) Providing HHS with the assurances necessary to permit the
institutions to participate in PHS supported research.
(e) Protect the health and safety of the public, promote the
integrity of PHS supported research and the research process, and
conserve public funds.
Sec. 93.102 Applicability.
(a) Each institution that applies for or receives PHS support for
biomedical or
[[Page 28386]]
behavioral research, research training or activities related to that
research or research training must comply with this part.
(b)(1) This part applies to allegations of research misconduct and
research misconduct involving:
(i) Applications or proposals for PHS support for biomedical or
behavioral extramural or intramural research, research training or
activities related to that research or research training, such as the
operation of tissue and data banks and the dissemination of research
information;
(ii) PHS supported biomedical or behavioral extramural or
intramural research;
(iii) PHS supported biomedical or behavioral extramural or
intramural research training programs;
(iv) PHS supported extramural or intramural activities that are
related to biomedical or behavioral research or research training, such
as the operation of tissue and data banks or the dissemination of
research information; and
(v) Plagiarism of research records produced in the course of PHS
supported research, research training or activities related to that
research or research training.
(2) This includes any research proposed, performed, reviewed, or
reported, or any research record generated from that research,
regardless of whether an application or proposal for PHS funds resulted
in a grant, contract, cooperative agreement, or other form of PHS
support.
(c) This part does not supersede or establish an alternative to any
existing regulations or procedures for handling fiscal improprieties,
the ethical treatment of human or animal subjects, criminal matters,
personnel actions against Federal employees, or actions taken under the
HHS debarment and suspension regulations at 45 CFR part 76 and 48 CFR
subparts 9.4 and 309.4.
(d) This part does not prohibit or otherwise limit how institutions
handle allegations of misconduct that do not fall within this part's
definition of research misconduct or that do not involve PHS support.
Sec. 93.103 Research misconduct.
Research misconduct means fabrication, falsification, or plagiarism
in proposing, performing, or reviewing research, or in reporting
research results.
(a) Fabrication is making up data or results and recording or
reporting them.
(b) Falsification is manipulating research materials, equipment, or
processes, or changing or omitting data or results such that the
research is not accurately represented in the research record.
(c) Plagiarism is the appropriation of another person's ideas,
processes, results, or words without giving appropriate credit.
(d) Research misconduct does not include honest error or
differences of opinion.
Sec. 93.104 Requirements for findings of research misconduct.
A finding of research misconduct made under this part requires
that--
(a) There be a significant departure from accepted practices of the
relevant research community; and
(b) The misconduct be committed intentionally, knowingly, or
recklessly; and
(c) The allegation be proven by a preponderance of the evidence.
Sec. 93.105 Time limitations.
(a) Six-year limitation. This part applies only to research
misconduct occurring within six years of the date HHS or an institution
receives an allegation of research misconduct.
(b) Exceptions to the six-year limitation. Paragraph (a) of this
section does not apply in the following instances:
(1) Subsequent use exception. The respondent continues or renews
any incident of alleged research misconduct that occurred before the
six-year limitation through the citation, republication or other use
for the potential benefit of the respondent of the research record that
is alleged to have been fabricated, falsified, or plagiarized.
(2) Health or safety of the public exception. If ORI or the
institution, following consultation with ORI, determines that the
alleged misconduct, if it occurred, would possibly have a substantial
adverse effect on the health or safety of the public.
(3) ``Grandfather'' exception. If HHS or an institution received
the allegation of research misconduct before the effective date of this
part.
Sec. 93.106 Evidentiary standards.
The following evidentiary standards apply to findings made under
this part.
(a) Standard of proof. An institutional or HHS finding of research
misconduct must be proved by a preponderance of the evidence.
(b) Burden of proof. (1) The institution or HHS has the burden of
proof for making a finding of research misconduct. The destruction,
absence of, or respondent's failure to provide research records
adequately documenting the questioned research is evidence of research
misconduct where the institution or HHS establishes by a preponderance
of the evidence that the respondent intentionally, knowingly, or
recklessly had research records and destroyed them, had the opportunity
to maintain the records but did not do so, or maintained the records
and failed to produce them in a timely manner and that the respondent's
conduct constitutes a significant departure from accepted practices of
the relevant research community.
(2) The respondent has the burden of going forward with and the
burden of proving, by a preponderance of the evidence, any and all
affirmative defenses raised. In determining whether HHS or the
institution has carried the burden of proof imposed by this part, the
finder of fact shall give due consideration to admissible, credible
evidence of honest error or difference of opinion presented by the
respondent.
(3) The respondent has the burden of going forward with and proving
by a preponderance of the evidence any mitigating factors that are
relevant to a decision to impose administrative actions following a
research misconduct proceeding.
Sec. 93.107 Rule of interpretation.
Any interpretation of this part must further the policy and purpose
of the HHS and the Federal government to protect the health and safety
of the public, to promote the integrity of research, and to conserve
public funds.
Sec. 93.108 Confidentiality.
(a) Disclosure of the identity of respondents and complainants in
research misconduct proceedings is limited, to the extent possible, to
those who need to know, consistent with a thorough, competent,
objective and fair research misconduct proceeding, and as allowed by
law. Provided, however, that:
(1) The institution must disclose the identity of respondents and
complainants to ORI pursuant to an ORI review of research misconduct
proceedings under Sec. 93.403.
(2) Under Sec. 93.517(g), HHS administrative hearings must be open
to the public.
(b) Except as may otherwise be prescribed by applicable law,
confidentiality must be maintained for any records or evidence from
which research subjects might be identified. Disclosure is limited to
those who have a need to know to carry out a research misconduct
proceeding.
[[Page 28387]]
Sec. 93.109 Coordination with other agencies.
(a) When more than one agency of the Federal government has
jurisdiction of the subject misconduct allegation, HHS will cooperate
in designating a lead agency to coordinate the response of the agencies
to the allegation. Where HHS is not the lead agency, it may, in
consultation with the lead agency, take appropriate action to protect
the health and safety of the public, promote the integrity of the PHS
supported research and research process and conserve public funds.
(b) In cases involving more than one agency, HHS may refer to
evidence or reports developed by that agency if HHS determines that the
evidence or reports will assist in resolving HHS issues. In appropriate
cases, HHS will seek to resolve allegations jointly with the other
agency or agencies.
Subpart B--Definitions
Sec. 93.200 Administrative action.
Administrative action means--
(a) An HHS action in response to a research misconduct proceeding
taken to protect the health and safety of the public, to promote the
integrity of PHS supported biomedical or behavioral research, research
training, or activities related to that research or research training
and to conserve public funds; or
(b) An HHS action in response either to a breach of a material
provision of a settlement agreement in a research misconduct proceeding
or to a breach of any HHS debarment or suspension.
Sec. 93.201 Allegation.
Allegation means a disclosure of possible research misconduct
through any means of communication. The disclosure may be by written or
oral statement or other communication to an institutional or HHS
official.
Sec. 93.202 Charge letter.
Charge letter means the written notice, as well as any amendments
to the notice, that are sent to the respondent stating the findings of
research misconduct and any HHS administrative actions. If the charge
letter includes a debarment or suspension action, it may be issued
jointly by the ORI and the debarring official.
Sec. 93.203 Complainant.
Complainant means a person who in good faith makes an allegation of
research misconduct.
Sec. 93.204 Contract.
Contract means an acquisition instrument awarded under the HHS
Federal Acquisition Regulation (FAR), 48 CFR Chapter 1, excluding any
small purchases awarded pursuant to FAR Part 13.
Sec. 93.205 Debarment or suspension.
Debarment or suspension means the Government wide exclusion,
whether temporary or for a set term, of a person from eligibility for
Federal grants, contracts, and cooperative agreements under the HHS
regulations at 45 CFR part 76 (nonprocurement) and 48 CFR subparts 9.4
and 309.4 (procurement).
Sec. 93.206 Debarring official.
Debarring official means an official authorized to impose debarment
or suspension. The HHS debarring official is either--
(a) The Secretary; or
(b) An official designated by the Secretary.
Sec. 93.207 Departmental Appeals Board or DAB.
Departmental Appeals Board or DAB means, depending on the context--
(a) The organization, within the Office of the Secretary,
established to conduct hearings and provide impartial review of
disputed decisions made by HHS operating components; or
(b) An Administrative Law Judge (ALJ) at the DAB.
Sec. 93.208 Evidence.
Evidence means any document, tangible item, or testimony offered or
obtained during a research misconduct proceeding that tends to prove or
disprove the existence of an alleged fact.
Sec. 93.209 Funding component.
Funding component means any organizational unit of the PHS
authorized to award grants, contracts, or cooperative agreements for
any activity that involves the conduct of biomedical or behavioral
research, research training or activities related to that research or
research training, e.g., agencies, bureaus, centers, institutes,
divisions, or offices and other awarding units within the PHS.
Sec. 93.210 Good faith.
Good faith as applied to a complainant or witness, means having a
belief in the truth of one's allegation or testimony that a reasonable
person in the complainant's or witness's position could have based on
the information known to the complainant or witness at the time. An
allegation or cooperation with a research misconduct proceeding is not
in good faith if made with knowing or reckless disregard for
information that would negate the allegation or testimony. Good faith
as applied to a committee member means cooperating with the research
misconduct proceeding by carrying out the duties assigned impartially
for the purpose of helping an institution meet its responsibilities
under this part. A committee member does not act in good faith if his/
her acts or omissions on the committee are dishonest or influenced by
personal, professional, or financial conflicts of interest with those
involved in the research misconduct proceeding.
Sec. 93.211 Hearing.
Hearing means that part of the research misconduct proceeding from
the time a respondent files a request for an administrative hearing to
contest ORI findings of research misconduct and HHS administrative
actions until the time the ALJ issues a recommended decision.
Sec. 93.212 Inquiry.
Inquiry means preliminary information-gathering and preliminary
fact-finding that meets the criteria and follows the procedures of
Sec. Sec. 93.307-93.309.
Sec. 93.213 Institution.
Institution means any individual or person that applies for or
receives PHS support for any activity or program that involves the
conduct of biomedical or behavioral research, biomedical or behavioral
research training, or activities related to that research or training.
This includes, but is not limited to colleges and universities, PHS
intramural biomedical or behavioral research laboratories, research and
development centers, national user facilities, industrial laboratories
or other research institutes, small research institutions, and
independent researchers.
Sec. 93.214 Institutional member.
Institutional member or members means a person who is employed by,
is an agent of, or is affiliated by contract or agreement with an
institution. Institutional members may include, but are not limited to,
officials, tenured and untenured faculty, teaching and support staff,
researchers, research coordinators, clinical technicians, postdoctoral
and other fellows, students, volunteers, agents, and contractors,
subcontractors, and subawardees, and their employees.
Sec. 93.215 Investigation.
Investigation means the formal development of a factual record and
the examination of that record leading to a decision not to make a
finding of research misconduct or to a recommendation for a finding of
research misconduct which may include
[[Page 28388]]
a recommendation for other appropriate actions, including
administrative actions.
Sec. 93.216 Notice.
Notice means a written communication served in person, sent by mail
or its equivalent to the last known street address, facsimile number or
e-mail address of the addressee. Several sections of Subpart E of this
part have special notice requirements.
Sec. 93.217 Office of Research Integrity or ORI.
Office of Research Integrity or ORI means the office to which the
HHS Secretary has delegated responsibility for addressing research
integrity and misconduct issues related to PHS supported activities.
Sec. 93.218 Person.
Person means any individual, corporation, partnership, institution,
association, unit of government, or legal entity, however organized.
Sec. 93.219 Preponderance of the evidence.
Preponderance of the evidence means proof by information that,
compared with that opposing it, leads to the conclusion that the fact
at issue is more probably true than not.
Sec. 93.220 Public Health Service or PHS.
Public Health Service or PHS means the unit within the Department
of Health and Human Services that includes the Office of Public Health
and Science and the following Operating Divisions: Agency for
Healthcare Research and Quality, Agency for Toxic Substances and
Disease Registry, Centers for Disease Control and Prevention, Food and
Drug Administration, Health Resources and Services Administration,
Indian Health Service, National Institutes of Health, and the Substance
Abuse and Mental Health Services Administration, and the offices of the
Regional Health Administrators.
Sec. 93.221 PHS support.
PHS support means PHS funding, or applications or proposals
therefor, for biomedical or behavioral research, biomedical or
behavioral research training, or activities related to that research or
training, that may be provided through: Funding for PHS intramural
research; PHS grants, cooperative agreements, or contracts or subgrants
or subcontracts under those PHS funding instruments; or salary or other
payments under PHS grants, cooperative agreements or contracts.
Sec. 93.222 Research.
Research means a systematic experiment, study, evaluation,
demonstration or survey designed to develop or contribute to general
knowledge (basic research) or specific knowledge (applied research)
relating broadly to public health by establishing, discovering,
developing, elucidating or confirming information about, or the
underlying mechanism relating to, biological causes, functions or
effects, diseases, treatments, or related matters to be studied.
Sec. 93.223 Research misconduct proceeding.
Research misconduct proceeding means any actions related to alleged
research misconduct taken under this part, including but not limited
to, allegation assessments, inquiries, investigations, ORI oversight
reviews, hearings, and administrative appeals.
Sec. 93.224 Research record.
Research record means the record of data or results that embody the
facts resulting from scientific inquiry, including but not limited to,
research proposals, laboratory records, both physical and electronic,
progress reports, abstracts, theses, oral presentations, internal
reports, journal articles, and any documents and materials provided to
HHS or an institutional official by a respondent in the course of the
research misconduct proceeding.
Sec. 93.225 Respondent.
Respondent means the person against whom an allegation of research
misconduct is directed or who is the subject of a research misconduct
proceeding.
Sec. 93.226 Retaliation.
Retaliation for the purpose of this part means an adverse action
taken against a complainant, witness, or committee member by an
institution or one of its members in response to--
(a) A good faith allegation of research misconduct; or
(b) Good faith cooperation with a research misconduct proceeding.
Sec. 93.227 Secretary or HHS.
Secretary or HHS means the Secretary of HHS or any other officer or
employee of the HHS to whom the Secretary delegates authority.
Subpart C--Responsibilities of Institutions
Compliance and Assurances
Sec. 93.300 General responsibilities for compliance.
Institutions under this part must--
(a) Have written policies and procedures for addressing allegations
of research misconduct that meet the requirements of this part;
(b) Respond to each allegation of research misconduct for which the
institution is responsible under this part in a thorough, competent,
objective and fair manner, including precautions to ensure that
individuals responsible for carrying out any part of the research
misconduct proceeding do not have unresolved personal, professional or
financial conflicts of interest with the complainant, respondent or
witnesses;
(c) Foster a research environment that promotes the responsible
conduct of research, research training, and activities related to that
research or research training, discourages research misconduct, and
deals promptly with allegations or evidence of possible research
misconduct;
(d) Take all reasonable and practical steps to protect the
positions and reputations of good faith complainants, witnesses and
committee members and protect them from retaliation by respondents and
other institutional members;
(e) Provide confidentiality to the extent required by Sec. 93.108
to all respondents, complainants, and research subjects identifiable
from research records or evidence;
(f) Take all reasonable and practical steps to ensure the
cooperation of respondents and other institutional members with
research misconduct proceedings, including, but not limited to, their
providing information, research records, and evidence;
(g) Cooperate with HHS during any research misconduct proceeding or
compliance review;
(h) Assist in administering and enforcing any HHS administrative
actions imposed on its institutional members; and
(i) Have an active assurance of compliance.
Sec. 93.301 Institutional assurances.
(a) General policy. An institution with PHS supported biomedical or
behavioral research, research training or activities related to that
research or research training must provide PHS with an assurance of
compliance with this part, satisfactory to the Secretary. PHS funding
components may authorize
[[Page 28389]]
funds for biomedical and behavioral research, research training, or
activities related to that research or research training only to
institutions that have approved assurances and required renewals on
file with ORI.
(b) Institutional Assurance. The responsible institutional official
must assure on behalf of the institution that the institution--
(1) Has written policies and procedures in compliance with this
part for inquiring into and investigating allegations of research
misconduct; and
(2) Complies with its own policies and procedures and the
requirements of this part.
Sec. 93.302 Institutional compliance with assurances.
(a) Compliance with assurance. ORI considers an institution in
compliance with its assurance if the institution--
(1) Establishes policies and procedures according to this part,
keeps them in compliance with this part, and upon request, provides
them to ORI, other HHS personnel, and members of the public;
(2) Takes all reasonable and practical specific steps to foster
research integrity consistent with Sec. 93.300, including--
(i) Informs the institution's research members participating in or
otherwise involved with PHS supported biomedical or behavioral
research, research training or activities related to that research or
research training, including those applying for support from any PHS
funding component, about its policies and procedures for responding to
allegations of research misconduct, and the institution's commitment to
compliance with the policies and procedures; and
(ii) Complies with its policies and procedures and each specific
provision of this part.
(b) Annual report. An institution must file an annual report with
ORI which contains information specified by ORI on the institution's
compliance with this part.
(c) Additional information. Along with its assurance or annual
report, an institution must send ORI such other aggregated information
as ORI may request on the institution's research misconduct proceedings
covered by this part and the institution's compliance with the
requirements of this part.
Sec. 93.303 Assurances for small institutions.
(a) If an institution is too small to handle research misconduct
proceedings, it may file a ``Small Organization Statement'' with ORI in
place of the formal institutional policies and procedures required by
Sec. Sec. 93.301 and 93.304.
(b) By submitting a Small Organization Statement, the institution
agrees to report all allegations of research misconduct to ORI. ORI or
another appropriate HHS office will work with the institution to
develop and implement a process for handling allegations of research
misconduct consistent with this part.
(c) The Small Organization Statement does not relieve the
institution from complying with any other provision of this part.
Sec. 93.304 Institutional policies and procedures.
Institutions seeking an approved assurance must have written
policies and procedures for addressing research misconduct that include
the following--
(a) Consistent with Sec. 93.108, protection of the confidentiality
of respondents, complainants, and research subjects identifiable from
research records or evidence;
(b) A thorough, competent, objective, and fair response to
allegations of research misconduct consistent with and within the time
limits of this part, including precautions to ensure that individuals
responsible for carrying out any part of the research misconduct
proceeding do not have unresolved personal, professional, or financial
conflicts of interest with the complainant, respondent, or witnesses;
(c) Notice to the respondent, consistent with and within the time
limits of this part;
(d) Written notice to ORI of any decision to open an investigation
on or before the date on which the investigation begins;
(e) Opportunity for the respondent to provide written comments on
the institution's inquiry report;
(f) Opportunity for the respondent to provide written comments on
the draft report of the investigation, and provisions for the
institutional investigation committee to consider and address the
comments before issuing the final report;
(g) Protocols for handling the research record and evidence,
including the requirements of Sec. 93.305;
(h) Appropriate interim institutional actions to protect public
health, Federal funds and equipment, and the integrity of the PHS
supported research process;
(i) Notice to ORI under Sec. 93.318 and notice of any facts that
may be relevant to protect public health, Federal funds and equipment,
and the integrity of the PHS supported research process;
(j) Institutional actions in response to final findings of research
misconduct;
(k) All reasonable and practical efforts, if requested and as
appropriate, to protect or restore the reputation of persons alleged to
have engaged in research misconduct but against whom no finding of
research misconduct is made;
(l) All reasonable and practical efforts to protect or restore the
position and reputation of any complainant, witness, or committee
member and to counter potential or actual retaliation against these
complainants, witnesses, and committee members; and
(m) Full and continuing cooperation with ORI during its oversight
review under Subpart D of this part or any subsequent administrative
hearings or appeals under Subpart E of this part. This includes
providing all research records and evidence under the institution's
control, custody, or possession and access to all persons within its
authority necessary to develop a complete record of relevant evidence.
Sec. 93.305 Responsibility for maintenance and custody of research
records and evidence.
An institution, as the responsible legal entity for the PHS
supported research, has a continuing obligation under this part to
ensure that it maintains adequate records for a research misconduct
proceeding. The institution must--
(a) Either before or when the institution notifies the respondent
of the allegation, inquiry or investigation, promptly take all
reasonable and practical steps to obtain custody of all the research
records and evidence needed to conduct the research misconduct
proceeding, inventory the records and evidence, and sequester them in a
secure manner, except that where the research records or evidence
encompass scientific instruments shared by a number of users, custody
may be limited to copies of the data or evidence on such instruments,
so long as those copies are substantially equivalent to the evidentiary
value of the instruments;
(b) Where appropriate, give the respondent copies of, or
reasonable, supervised access to the research records;
(c) Undertake all reasonable and practical efforts to take custody
of additional research records or evidence that is discovered during
the course of a research misconduct proceeding, except that where the
research records or evidence encompass scientific instruments shared by
a number of users, custody may be limited to copies of the data or
evidence on such instruments, so long as those copies are substantially
equivalent to the
[[Page 28390]]
evidentiary value of the instruments; and
(d) Maintain the research records and evidence as required by Sec.
93.317.
Sec. 93.306 Using a consortium or other person for research
misconduct proceedings.
(a) An institution may use the services of a consortium or person
that the institution reasonably determines to be qualified by practice
and experience to conduct research misconduct proceedings.
(b) A consortium may be a group of institutions, professional
organizations, or mixed groups which will conduct research misconduct
proceedings for other institutions.
(c) A consortium or person acting on behalf of an institution must
follow the requirements of this part in conducting research misconduct
proceedings.
The Institutional Inquiry
Sec. 93.307 Institutional inquiry.
(a) Criteria warranting an inquiry. An inquiry is warranted if the
allegation--
(1) Falls within the definition of research misconduct under this
part;
(2) Is within Sec. 93.102; and
(3) Is sufficiently credible and specific so that potential
evidence of research misconduct may be identified.
(b) Notice to respondent and custody of research records. At the
time of or before beginning an inquiry, an institution must make a good
faith effort to notify in writing the presumed respondent, if any. If
the inquiry subsequently identifies additional respondents, the
institution must notify them. To the extent it has not already done so
at the allegation stage, the institution must, on or before the date on
which the respondent is notified or the inquiry begins, whichever is
earlier, promptly take all reasonable and practical steps to obtain
custody of all the research records and evidence needed to conduct the
research misconduct proceeding, inventory the records and evidence, and
sequester them in a secure manner, except that where the research
records or evidence encompass scientific instruments shared by a number
of users, custody may be limited to copies of the data or evidence on
such instruments, so long as those copies are substantially equivalent
to the evidentiary value of the instruments.
(c) Review of evidence. The purpose of an inquiry is to conduct an
initial review of the evidence to determine whether to conduct an
investigation. Therefore, an inquiry does not require a full review of
all the evidence related to the allegation.
(d) Criteria warranting an investigation. An inquiry's purpose is
to decide if an allegation warrants an investigation. An investigation
is warranted if there is--
(1) A reasonable basis for concluding that the allegation falls
within the definition of research misconduct under this part and
involves PHS supported biomedical or behavioral research, research
training or activities related to that research or research training,
as provided in Sec. 93.102; and
(2) Preliminary information-gathering and preliminary fact-finding
from the inquiry indicates that the allegation may have substance.
(e) Inquiry report. The institution must prepare a written report
that meets the requirements of this section and Sec. 93.309.
(f) Opportunity to comment. The institution must provide the
respondent an opportunity to review and comment on the inquiry report
and attach any comments received to the report.
(g) Time for completion. The institution must complete the inquiry
within 60 calendar days of its initiation unless circumstances clearly
warrant a longer period. If the inquiry takes longer than 60 days to
complete, the inquiry record must include documentation of the reasons
for exceeding the 60-day period.
Sec. 93.308 Notice of the results of the inquiry.
(a) Notice to respondent. The institution must notify the
respondent whether the inquiry found that an investigation is
warranted. The notice must include a copy of the inquiry report and
include a copy of or refer to this part and the institution's policies
and procedures adopted under its assurance.
(b) Notice to complainants. The institution may notify the
complainant who made the allegation whether the inquiry found that an
investigation is warranted. The institution may provide relevant
portions of the report to the complainant for comment.
Sec. 93.309 Reporting to ORI on the decision to initiate an
investigation.
(a) Within 30 days of finding that an investigation is warranted,
the institution must provide ORI with the written finding by the
responsible institutional official and a copy of the inquiry report
which includes the following information--
(1) The name and position of the respondent;
(2) A description of the allegations of research misconduct;
(3) The PHS support, including, for example, grant numbers, grant
applications, contracts, and publications listing PHS support;
(4) The basis for recommending that the alleged actions warrant an
investigation; and
(5) Any comments on the report by the respondent or the
complainant.
(b) The institution must provide the following information to ORI
on request--
(1) The institutional policies and procedures under which the
inquiry was conducted;
(2) The research records and evidence reviewed, transcripts or
recordings of any interviews, and copies of all relevant documents; and
(3) The charges for the investigation to consider.
(c) Documentation of decision not to investigate. Institutions must
keep sufficiently detailed documentation of inquiries to permit a later
assessment by ORI of the reasons why the institution decided not to
conduct an investigation. Consistent with Sec. 93.317, institutions
must keep these records in a secure manner for at least 7 years after
the termination of the inquiry, and upon request, provide them to ORI
or other authorized HHS personnel.
(d) Notification of special circumstances. In accordance with Sec.
93.318, institutions must notify ORI and other PHS agencies, as
relevant, of any special circumstances that may exist.
The Institutional Investigation
Sec. 93.310 Institutional investigation.
Institutions conducting research misconduct investigations must:
(a) Time. Begin the investigation within 30 days after determining
that an investigation is warranted.
(b) Notice to ORI. Notify the ORI Director of the decision to begin
an investigation on or before the date the investigation begins and
provide an inquiry report that meets the requirements of Sec. 93.307
and Sec. 93.309.
(c) Notice to the respondent. Notify the respondent in writing of
the allegations within a reasonable amount of time after determining
that an investigation is warranted, but before the investigation
begins. The institution must give the respondent written notice of any
new allegations of research misconduct within a reasonable amount of
time of deciding to pursue allegations not addressed during the inquiry
or in the initial notice of investigation.
(d) Custody of the records. To the extent they have not already
done so at the allegation or inquiry stages, take all reasonable and
practical steps to obtain custody of all the research records and
[[Page 28391]]
evidence needed to conduct the research misconduct proceeding,
inventory the records and evidence, and sequester them in a secure
manner, except that where the research records or evidence encompass
scientific instruments shared by a number of users, custody may be
limited to copies of the data or evidence on such instruments, so long
as those copies are substantially equivalent to the evidentiary value
of the instruments. Whenever possible, the institution must take
custody of the records--
(1) Before or at the time the institution notifies the respondent;
and
(2) Whenever additional items become known or relevant to the
investigation.
(e) Documentation. Use diligent efforts to ensure that the
investigation is thorough and sufficiently documented and includes
examination of all research records and evidence relevant to reaching a
decision on the merits of the allegations.
(f) Ensuring a fair investigation. Take reasonable steps to ensure
an impartial and unbiased investigation to the maximum extent
practicable, including participation of persons with appropriate
scientific expertise who do not have unresolved personal, professional,
or financial conflicts of interest with those involved with the inquiry
or investigation.
(g) Interviews. Interview each respondent, complainant, and any
other available person who has been reasonably identified as having
information regarding any relevant aspects of the investigation,
including witnesses identified by the respondent, and record or
transcribe each interview, provide the recording or transcript to the
interviewee for correction, and include the recording or transcript in
the record of the investigation.
(h) Pursue leads. Pursue diligently all significant issues and
leads discovered that are determined relevant to the investigation,
including any evidence of additional instances of possible research
misconduct, and continue the investigation to completion.
Sec. 93.311 Investigation time limits.
(a) Time limit for completing an investigation. An institution must
complete all aspects of an investigation within 120 days of beginning
it, including conducting the investigation, preparing the report of
findings, providing the draft report for comment in accordance with
Sec. 93.312, and sending the final report to ORI under Sec. 93.315.
(b) Extension of time limit. If unable to complete the
investigation in 120 days, the institution must ask ORI for an
extension in writing.
(c) Progress reports. If ORI grants an extension, it may direct the
institution to file periodic progress reports.
Sec. 93.312 Opportunity to comment on the investigation report.
(a) The institution must give the respondent a copy of the draft
investigation report and, concurrently, a copy of, or supervised access
to, the evidence on which the report is based. The comments of the
respondent on the draft report, if any, must be submitted within 30
days of the date on which the respondent received the draft
investigation report.
(b) The institution may provide the complainant a copy of the draft
investigation report or relevant portions of that report. The comments
of the complainant, if any, must be submitted within 30 days of the
date on which the complainant received the draft investigation report
or relevant portions of it.
Sec. 93.313 Institutional investigation report.
The final institutional investigation report must be in writing and
include:
(a) Allegations. Describe the nature of the allegations of research
misconduct.
(b) PHS support. Describe and document the PHS support, including,
for example, any grant numbers, grant applications, contracts, and
publications listing PHS support.
(c) Institutional charge. Describe the specific allegations of
research misconduct for consideration in the investigation.
(d) Policies and procedures. If not already provided to ORI with
the inquiry report, include the institutional policies and procedures
under which the investigation was conducted.
(e) Research records and evidence. Identify and summarize the
research records and evidence reviewed, and identify any evidence taken
into custody but not reviewed.
(f) Statement of findings. For each separate allegation of research
misconduct identified during the investigation, provide a finding as to
whether research misconduct did or did not occur, and if so--
(1) Identify whether the research misconduct was falsification,
fabrication, or plagiarism, and if it was intentional, knowing, or in
reckless disregard;
(2) Summarize the facts and the analysis which support the
conclusion and consider the merits of any reasonable explanation by the
respondent;
(3) Identify the specific PHS support;
(4) Identify whether any publications need correction or
retraction;
(5) Identify the person(s) responsible for the misconduct; and
(6) List any current support or known applications or proposals for
support that the respondent has pending with non-PHS Federal agencies.
(g) Comments. Include and consider any comments made by the
respondent and complainant on the draft investigation report.
(h) Maintain and provide records. Maintain and provide to ORI upon
request all relevant research records and records of the institution's
research misconduct proceeding, including results of all interviews and
the transcripts or recordings of such interviews.
Sec. 93.314 Institutional appeals.
(a) While not required by this part, if the institution's
procedures provide for an appeal by the respondent that could result in
a reversal or modification of the findings of research misconduct in
the investigation report, the institution must complete any such appeal
within 120 days of its filing. Appeals from personnel or similar
actions that would not result in a reversal or modification of the
findings of research misconduct are excluded from the 120-day limit.
(b) If unable to complete any appeals within 120 days, the
institution must ask ORI for an extension in writing and provide an
explanation for the request.
(c) ORI may grant requests for extension for good cause. If ORI
grants an extension, it may direct the institution to file periodic
progress reports.
Sec. 93.315 Notice to ORI of institutional findings and actions.
The institution must give ORI the following:
(a) Investigation Report. Include a copy of the report, all
attachments, and any appeals.
(b) Final institutional action. State whether the institution found
research misconduct, and if so, who committed the misconduct.
(c) Findings. State whether the institution accepts the
investigation's findings.
(d) Institutional administrative actions. Describe any pending or
completed administrative actions against the respondent.
Sec. 93.316 Completing the research misconduct process.
(a) ORI expects institutions to carry inquiries and investigations
through to completion and to pursue diligently all significant issues.
An institution must
[[Page 28392]]
notify ORI in advance if the institution plans to close a case at the
inquiry, investigation, or appeal stage on the basis that the
respondent has admitted guilt, a settlement with the respondent has
been reached, or for any other reason, except the closing of a case at
the inquiry stage on the basis that an investigation is not warranted
or a finding of no misconduct at the investigation stage, which must be
reported to ORI under Sec. 93.315.
(b) After consulting with the institution on its basis for closing
a case under paragraph (a) of this section, ORI may conduct an
oversight review of the institution's handling of the case and take
appropriate action including:
(1) Approving or conditionally approving closure of the case;
(2) Directing the institution to complete its process;
(3) Referring the matter for further investigation by HHS; or,
(4) Taking a compliance action.
Other Institutional Responsibilities
Sec. 93.317 Retention and custody of the research misconduct
proceeding record.
(a) Definition of records of research misconduct proceedings. As
used in this section, the term ``records of research misconduct
proceedings'' includes:
(1) The records that the institution secures for the proceeding
pursuant to Sec. Sec. 93.305, 93.307(b) and 93.310(d), except to the
extent the institution subsequently determines and documents that those
records are not relevant to the proceeding or that the records
duplicate other records that are being retained;
(2) The documentation of the determination of irrelevant or
duplicate records; (3) The inquiry report and final documents (not
drafts) produced in the course of preparing that report, including the
documentation of any decision not to investigate as required by Sec.
93.309(d);
(4) The investigation report and all records (other than drafts of
the report) in support of that report, including the recordings or
transcriptions of each interview conducted pursuant to Sec. 93.310(g);
and
(5) The complete record of any institutional appeal covered by
Sec. 93.314.
(b) Maintenance of record. Unless custody has been transferred to
HHS under paragraph (c) of this section, or ORI has advised the
institution in writing that it no longer needs to retain the records,
an institution must maintain records of research misconduct proceedings
in a secure manner for 7 years after completion of the proceeding or
the completion of any PHS proceeding involving the research misconduct
allegation under subparts D and E of this part, whichever is later.
(c) Provision for HHS custody. On request, institutions must
transfer custody of or provide copies to HHS, of any institutional
record relevant to a research misconduct allegation covered by this
part, including the research records and evidence, to perform forensic
or other analyses or as otherwise needed to conduct an HHS inquiry or
investigation or for ORI to conduct its review or to present evidence
in any proceeding under subparts D and E of this part.
Sec. 93.318 Notifying ORI of special circumstances.
At any time during a research misconduct proceeding, as defined in
Sec. 93.223, an institution must notify ORI immediately if it has
reason to believe that any of the following conditions exist:
(a) Health or safety of the public is at risk, including an
immediate need to protect human or animal subjects.
(b) HHS resources or interests are threatened.
(c) Research activities should be suspended.
(d) There is reasonable indication of possible violations of civil
or criminal law.
(e) Federal action is required to protect the interests of those
involved in the research misconduct proceeding.
(f) The research institution believes the research misconduct
proceeding may be made public prematurely so that HHS may take
appropriate steps to safeguard evidence and protect the rights of those
involved.
(g) The research community or public should be informed.
Sec. 93.319 Institutional standards.
(a) Institutions may have internal standards of conduct different
from the HHS standards for research misconduct under this part.
Therefore, an institution may find conduct to be actionable under its
standards even if the action does not meet this part's definition of
research misconduct.
(b) An HHS finding or settlement does not affect institutional
findings or administrative actions based on an institution's internal
standards of conduct.
Subpart D--Responsibilities of the U.S. Department of Health and
Human Services
General Information
Sec. 93.400 General statement of ORI authority.
(a) ORI review. ORI may respond directly to any allegation of
research misconduct at any time before, during, or after an
institution's response to the matter. The ORI response may include, but
is not limited to--
(1) Conducting allegation assessments;
(2) Determining independently if jurisdiction exists under this
part in any matter;
(3) Forwarding allegations of research misconduct to the
appropriate institution or HHS component for inquiry or investigation;
(4) Recommending that HHS should perform an inquiry or
investigation or issue findings and taking all appropriate actions in
response to the inquiry, investigation, or findings;
(5) Notifying or requesting assistance and information from PHS
funding components or other affected Federal and state offices and
agencies or institutions;
(6) Reviewing an institution's findings and process;
(7) Making a finding of research misconduct; and
(8) Proposing administrative actions to HHS.
(b) Requests for information. ORI may request clarification or
additional information, documentation, research records, or evidence
from an institution or its members or other persons or sources to carry
out ORI's review.
(c) HHS administrative actions. (1) In response to a research
misconduct proceeding, ORI may propose administrative actions against
any person to the HHS and, upon HHS approval and final action in
accordance with this part, implement the actions.
(2) ORI may propose to the HHS debarring official that a person be
suspended or debarred from receiving Federal funds and may propose to
other appropriate PHS components the implementation of HHS
administrative actions within the components' authorities.
(d) ORI assistance to institutions. At any time, ORI may provide
information, technical assistance, and procedural advice to
institutional officials as needed regarding an institution's
participation in research misconduct proceedings.
(e) Review of institutional assurances. ORI may review
institutional assurances
[[Page 28393]]
and policies and procedures for compliance with this part.
(f) Institutional compliance. ORI may make findings and impose HHS
administrative actions related to an institution's compliance with this
part and with its policies and procedures, including an institution's
participation in research misconduct proceedings.
Sec. 93.401 Interaction with other offices and interim actions.
(a) ORI may notify and consult with other offices at any time if it
has reason to believe that a research misconduct proceeding may involve
that office. If ORI believes that a criminal or civil fraud violation
may have occurred, it shall promptly refer the matter to the Department
of Justice (DOJ), the HHS Inspector General (OIG), or other appropriate
investigative body. ORI may provide expertise and assistance to the
DOJ, OIG, PHS offices, other Federal offices, and state or local
offices involved in investigating or otherwise pursuing research
misconduct allegations or related matters.
(b) ORI may notify affected PHS offices and funding components at
any time to permit them to make appropriate interim responses to
protect the health and safety of the public, to promote the integrity
of the PHS supported research and research process, and to conserve
public funds.
(c) The information provided will not be disclosed as part of the
peer review and advisory committee review processes, but may be used by
the Secretary in making decisions about the award or continuation of
funding.
Research Misconduct Issues
Sec. 93.402 ORI allegation assessments.
(a) When ORI receives an allegation of research misconduct directly
or becomes aware of an allegation or apparent instance of research
misconduct, it may conduct an initial assessment or refer the matter to
the relevant institution for an assessment, inquiry, or other
appropriate actions.
(b) If ORI conducts an assessment, it considers whether the
allegation of research misconduct appears to fall within the definition
of research misconduct, appears to involve PHS supported biomedical or
behavior research, research training or activities related to that
research or research training, as provided in Sec. 93.102, and whether
it is sufficiently specific so that potential evidence may be
identified and sufficiently substantive to warrant an inquiry. ORI may
review all readily accessible, relevant information related to the
allegation.
(c) If ORI decides that an inquiry is warranted, it forwards the
matter to the appropriate institution or HHS component.
(d) If ORI decides that an inquiry is not warranted it will close
the case and forward the allegation in accordance with paragraph(e) of
this section.
(e) ORI may forward allegations that do not fall within the
jurisdiction of this part to the appropriate HHS component, Federal or
State agency, institution, or other appropriate entity.
Sec. 93.403 ORI review of research misconduct proceedings.
ORI may conduct reviews of research misconduct proceedings. In
conducting its review, ORI may--
(a) Determine whether there is HHS jurisdiction under this part;
(b) Consider any reports, institutional findings, research records,
and evidence;
(c) Determine if the institution conducted the proceedings in a
timely and fair manner in accordance with this part with sufficient
thoroughness, objectivity, and competence to support the conclusions;
(d) Obtain additional information or materials from the
institution, the respondent, complainants, or other persons or sources;
(e) Conduct additional analyses and develop evidence;
(f) Decide whether research misconduct occurred, and if so who
committed it;
(g) Make appropriate research misconduct findings and propose HHS
administrative actions; and
(h) Take any other actions necessary to complete HHS' review.
Sec. 93.404 Findings of research misconduct and proposed
administrative actions.
After completing its review, ORI either closes the case without a
finding of research misconduct or--
(a) Makes findings of research misconduct and proposes and obtains
HHS approval of administrative actions based on the record of the
research misconduct proceedings and any other information obtained by
ORI during its review; or
(b) Recommends that HHS seek to settle the case.
Sec. 93.405 Notifying the respondent of findings of research
misconduct and HHS administrative actions.
(a) When the ORI makes a finding of research misconduct or seeks to
impose or enforce HHS administrative actions, other than debarment or
suspension, it notifies the respondent in a charge letter. In cases
involving a debarment or suspension action, the HHS debarring official
issues a notice of proposed debarment or suspension to the respondent
as part of the charge letter. The charge letter includes the ORI
findings of research misconduct and the basis for them and any HHS
administrative actions. The letter also advises the respondent of the
opportunity to contest the findings and administrative actions under
Subpart E of this part.
(b) The ORI sends the charge letter by certified mail or a private
delivery service to the last known address of the respondent or the
last known principal place of business of the respondent's attorney.
Sec. 93.406 Final HHS actions.
Unless the respondent contests the charge letter within the 30-day
period prescribed in Sec. 93.501, the ORI finding of research
misconduct is the final HHS action on the research misconduct issues
and the HHS administrative actions become final and will be
implemented, except that the debarring official's decision is the final
HHS action on any debarment or suspension actions.
Sec. 93.407 HHS administrative actions.
(a) In response to a research misconduct proceeding, HHS may impose
HHS administrative actions that include but are not limited to:
(1) Clarification, correction, or retraction of the research
record.
(2) Letters of reprimand.
(3) Imposition of special certification or assurance requirements
to ensure compliance with applicable regulations or terms of PHS
grants, contracts, or cooperative agreements.
(4) Suspension or termination of a PHS grant, contract, or
cooperative agreement.
(5) Restriction on specific activities or expenditures under an
active PHS grant, contract, or cooperative agreement.
(6) Special review of all requests for PHS funding.
(7) Imposition of supervision requirements on a PHS grant,
contract, or cooperative agreement.
(8) Certification of attribution or authenticity in all requests
for support and reports to the PHS.
(9) No participation in any advisory capacity to the PHS.
(10) Adverse personnel action if the respondent is a Federal
employee, in compliance with relevant Federal personnel policies and
laws.
(11) Suspension or debarment under 45 CFR Part 76, 48 CFR Subparts
9.4 and 309.4, or both.
(b) In connection with findings of research misconduct, HHS also
may
[[Page 28394]]
seek to recover PHS funds spent in support of the activities that
involved research misconduct.
(c) Any authorized HHS component may impose, administer, or enforce
HHS administrative actions separately or in coordination with other HHS
components, including, but not limited to ORI, the Office of Inspector
General, the PHS funding component, and the debarring official.
Sec. 93.408 Mitigating and aggravating factors in HHS administrative
actions.
The purpose of HHS administrative actions is remedial. The
appropriate administrative action is commensurate with the seriousness
of the misconduct, and the need to protect the health and safety of the
public, promote the integrity of the PHS supported research and
research process, and conserve public funds. HHS considers aggravating
and mitigating factors in determining appropriate HHS administrative
actions and their terms. HHS may consider other factors as appropriate
in each case. The existence or nonexistence of any factor is not
determinative:
(a) Knowing, intentional, or reckless. Were the respondent's
actions knowing or intentional or was the conduct reckless?
(b) Pattern. Was the research misconduct an isolated event or part
of a continuing or prior pattern of dishonest conduct?
(c) Impact. Did the misconduct have significant impact on the
proposed or reported research record, research subjects, other
researchers, institutions, or the public health or welfare?
(d) Acceptance of responsibility. Has the respondent accepted
responsibility for the misconduct by--
(1) Admitting the conduct;
(2) Cooperating with the research misconduct proceedings;
(3) Demonstrating remorse and awareness of the significance and
seriousness of the research misconduct; and
(4) Taking steps to correct or prevent the recurrence of the
research misconduct.
(e) Failure to accept responsibility. Does the respondent blame
others rather than accepting responsibility for the actions?
(f) Retaliation. Did the respondent retaliate against complainants,
witnesses, committee members, or other persons?
(g) Present responsibility. Is the respondent presently responsible
to conduct PHS supported research?
(h) Other factors. Other factors appropriate to the circumstances
of a particular case.
Sec. 93.409 Settlement of research misconduct proceedings.
(a) HHS may settle a research misconduct proceeding at any time it
concludes that settlement is in the best interests of the Federal
government and the public health or welfare.
(b) Settlement agreements are publicly available, regardless of
whether the ORI made a finding of research misconduct.
Sec. 93.410 Final HHS action with no settlement or finding of
research misconduct.
When the final HHS action does not result in a settlement or
finding of research misconduct, ORI may:
(a) Provide written notice to the respondent, the relevant
institution, the complainant, and HHS officials.
(b) Take any other actions authorized by law.
Sec. 93.411 Final HHS action with settlement or finding of research
misconduct.
When a final HHS action results in a settlement or research
misconduct finding, ORI may:
(a) Provide final notification of any research misconduct findings
and HHS administrative actions to the respondent, the relevant
institution, the complainant, and HHS officials. The debarring official
may provide a separate notice of final HHS action on any debarment or
suspension actions.
(b) Identify publications which require correction or retraction
and prepare and send a notice to the relevant journal.
(c) Publish notice of the research misconduct findings.
(d) Notify the respondent's current employer.
(e) Take any other actions authorized by law.
Institutional Compliance Issues
Sec. 93.412 Making decisions on institutional noncompliance.
(a) Institutions must foster a research environment that
discourages misconduct in all research and that deals forthrightly with
possible misconduct associated with PHS supported research.
(b) ORI may decide that an institution is not compliant with this
part if the institution shows a disregard for, or inability or
unwillingness to implement and follow the requirements of this part and
its assurance. In making this decision, ORI may consider, but is not
limited to the following factors--
(1) Failure to establish and comply with policies and procedures
under this part;
(2) Failure to respond appropriately when allegations of research
misconduct arise;
(3) Failure to report to ORI all investigations and findings of
research misconduct under this part;
(4) Failure to cooperate with ORI's review of research misconduct
proceedings; or
(5) Other actions or omissions that have a material, adverse effect
on reporting and responding to allegations of research misconduct.
Sec. 93.413 HHS compliance actions.
(a) An institution's failure to comply with its assurance and the
requirements of this part may result in enforcement action against the
institution.
(b) ORI may address institutional deficiencies through technical
assistance if the deficiencies do not substantially affect compliance
with this part.
(c) If an institution fails to comply with its assurance and the
requirements of this part, HHS may take some or all of the following
compliance actions:
(1) Issue a letter of reprimand.
(2) Direct that research misconduct proceedings be handled by HHS.
(3) Place the institution on special review status.
(4) Place information on the institutional noncompliance on the ORI
Web site.
(5) Require the institution to take corrective actions.
(6) Require the institution to adopt and implement an institutional
integrity agreement.
(7) Recommend that HHS debar or suspend the entity.
(8) Any other action appropriate to the circumstances.
(d) If the institution's actions constitute a substantial or
recurrent failure to comply with this part, ORI may also revoke the
institution's assurance under Sec. Sec. 93.301 or 93.303.
(e) ORI may make public any findings of institutional noncompliance
and HHS compliance actions.
Disclosure of Information
Sec. 93.414 Notice.
(a) ORI may disclose information to other persons for the purpose
of providing or obtaining information about research misconduct as
permitted under the Privacy Act, 5 U.S.C. 552a.
(b) ORI may publish a notice of final agency findings of research
misconduct, settlements, and HHS administrative actions and release and
withhold information as permitted by the Privacy Act and the Freedom of
Information Act, 5 U.S.C. 552.
[[Page 28395]]
Subpart E--Opportunity To Contest ORI Findings of Research
Misconduct and HHS Administrative Actions
General Information
Sec. 93.500 General policy.
(a) This subpart provides a respondent an opportunity to contest
ORI findings of research misconduct and HHS administrative actions,
including debarment or suspension, arising under 42 U.S.C. 289b in
connection with PHS supported biomedical and behavioral research,
research training, or activities related to that research or research
training.
(b) A respondent has an opportunity to contest ORI research
misconduct findings and HHS administrative actions under this part,
including debarment or suspension, by requesting an administrative
hearing before an Administrative Law Judge (ALJ) affiliated with the
HHS DAB, when--
(1) ORI has made a finding of research misconduct against a
respondent; and
(2) The respondent has been notified of those findings and any
proposed HHS administrative actions, including debarment or suspension,
in accordance with this part.
(c) The ALJ's ruling on the merits of the ORI research misconduct
findings and the HHS administrative actions is subject to review by the
Assistant Secretary for Health in accordance with Sec. 93.523. The
decision made under that section is the final HHS action, unless that
decision results in a recommendation for debarment or suspension. In
that case, the decision under Sec. 93.523 shall constitute findings of
fact to the debarring official in accordance with 45 CFR 76.845(c).
(d) Where a proposed debarment or suspension action is based upon
an ORI finding of research misconduct, the procedures in this part
provide the notification, opportunity to contest, and fact-finding
required under the HHS debarment and suspension regulations at 45 CFR
part 76, subparts H and G, respectively, and 48 CFR Subparts 9.4 and
309.4.
Sec. 93.501 Opportunity to contest findings of research misconduct
and administrative actions.
(a) Opportunity to contest. A respondent may contest ORI findings
of research misconduct and HHS administrative actions, including any
debarment or suspension action, by requesting a hearing within 30 days
of receipt of the charge letter or other written notice provided under
Sec. 93.405.
(b) Form of a request for hearing. The respondent's request for a
hearing must be--
(1) In writing;
(2) Signed by the respondent or by the respondent's attorney; and
(3) Sent by certified mail, or other equivalent (i.e., with a
verified method of delivery), to the DAB Chair and ORI.
(c) Contents of a request for hearing. The request for a hearing
must--
(1) Admit or deny each finding of research misconduct and each
factual assertion made in support of the finding;
(2) Accept or challenge each proposed HHS administrative action;
(3) Provide detailed, substantive reasons for each denial or
challenge;
(4) Identify any legal issues or defenses that the respondent
intends to raise during the proceeding; and
(5) Identify any mitigating factors that the respondent intends to
prove.
(d) Extension for good cause to supplement the hearing request. (1)
After receiving notification of the appointment of the ALJ, the
respondent has 10 days to submit a written request to the ALJ for
supplementation of the hearing request to comply fully with the
requirements of paragraph (c) of this section. The written request must
show good cause in accordance with paragraph (d)(2) of this section and
set forth the proposed supplementation of the hearing request. The ALJ
may permit the proposed supplementation of the hearing request in whole
or in part upon a finding of good cause.
(2) Good cause means circumstances beyond the control of the
respondent or respondent's representative and not attributable to
neglect or administrative inadequacy.
Hearing Process
Sec. 93.502 Appointment of the Administrative Law Judge and
scientific expert.
(a) Within 30 days of receiving a request for a hearing, the DAB
Chair, in consultation with the Chief Administrative Law Judge, must
designate an Administrative Law Judge (ALJ) to determine whether the
hearing request should be granted and, if the hearing request is
granted, to make recommended findings in the case after a hearing or
review of the administrative record in accordance with this part.
(b) The ALJ may retain one or more persons with appropriate
scientific or technical expertise to assist the ALJ in evaluating
scientific or technical issues related to the findings of research
misconduct.
(1) On the ALJ's or a party's motion to appoint an expert, the ALJ
must give the parties an opportunity to submit nominations. If such a
motion is made by a party, the ALJ must appoint an expert, either:
(i) The expert, if any, who is agreed upon by both parties and
found to be qualified by the ALJ; or,
(ii) If the parties cannot agree upon an expert, the expert chosen
by the ALJ.
(2) The ALJ may seek advice from the expert(s) at any time during
the discovery and hearing phases of the proceeding. The expert(s) shall
provide advice to the ALJ in the form of a written report or reports
that will be served upon the parties within 10 days of submission to
the ALJ. That report must contain a statement of the expert's
background and qualifications. Any comment on or response to a report
by a party, which may include comments on the expert's qualifications,
must be submitted to the ALJ in accordance with Sec. 93.510(c). The
written reports and any comment on, or response to them are part of the
record. Expert witnesses of the parties may testify on the reports and
any comments or responses at the hearing, unless the ALJ determines
such testimony to be inadmissible in accordance with Sec. 93.519, or
that such testimony would unduly delay the proceeding.
(c) No ALJ, or person hired or appointed to assist the ALJ, may
serve in any proceeding under this subpart if he or she has any real or
apparent conflict of interest, bias, or prejudice that might reasonably
impair his or her objectivity in the proceeding.
(d) Any party to the proceeding may request the ALJ or scientific
expert to withdraw from the proceeding because of a real or apparent
conflict of interest, bias, or prejudice under paragraph (c) of this
section. The motion to disqualify must be timely and state with
particularity the grounds for disqualification. The ALJ may rule upon
the motion or certify it to the Chief ALJ for decision. If the ALJ
rules upon the motion, either party may appeal the decision to the
Chief ALJ.
(e) An ALJ must withdraw from any proceeding for any reason found
by the ALJ or Chief ALJ to be disqualifying.
Sec. 93.503 Grounds for granting a hearing request.
(a) The ALJ must grant a respondent's hearing request if the ALJ
determines there is a genuine dispute over facts material to the
findings of research misconduct or proposed administrative actions,
including any debarment or suspension action. The respondent's general
denial or assertion of error for each finding of research misconduct,
and any basis for the finding, or for the proposed HHS administrative
actions in
[[Page 28396]]
the charge letter, is not sufficient to establish a genuine dispute.
(b) The hearing request must specifically deny each finding of
research misconduct in the charge letter, each basis for the finding
and each HHS administrative action in the charge letter, or it is
considered an admission by the respondent. If the hearing request does
not specifically dispute the HHS administrative actions, including any
debarment or suspension actions, they are considered accepted by the
respondent.
(c) If the respondent does not request a hearing within the 30-day
time period prescribed in Sec. 93.501(a), the finding(s) and any
administrative action(s), other than debarment or suspension actions,
become final agency actions at the expiration of the 30-day period.
Where there is a proposal for debarment or suspension, after the
expiration of the 30-day time period the official record is closed and
forwarded to the debarring official for a final decision.
(d) If the ALJ grants the hearing request, the respondent may waive
the opportunity for any in-person proceeding, and the ALJ may review
and decide the case on the basis of the administrative record. The ALJ
may grant a respondent's request that waiver of the in-person
proceeding be conditioned upon the opportunity for respondent to file
additional pleadings and documentation. ORI may also supplement the
administrative record through pleadings, documents, in-person or
telephonic testimony, and oral presentations.
Sec. 93.504 Grounds for dismissal of a hearing request.
(a) The ALJ must dismiss a hearing request if the respondent--
(1) Does not file the request within 30 days after receiving the
charge letter;
(2) Does not raise a genuine dispute over facts or law material to
the findings of research misconduct and any administrative actions,
including debarment and suspension actions, in the hearing request or
in any extension to supplement granted by the ALJ under Sec.
93.501(d);
(3) Does not raise any issue which may properly be addressed in a
hearing;
(4) Withdraws or abandons the hearing request; or
(b) The ALJ may dismiss a hearing request if the respondent fails
to provide ORI with notice in the form and manner required by Sec.
93.501.
Sec. 93.505 Rights of the parties.
(a) The parties to the hearing are the respondent and ORI. The
investigating institution is not a party to the case, unless it is a
respondent.
(b) Except as otherwise limited by this subpart, the parties may--
(1) Be accompanied, represented, and advised by an attorney;
(2) Participate in any case-related conference held by the ALJ;
(3) Conduct discovery of documents and other tangible items;
(4) Agree to stipulations of fact or law that must be made part of
the record;
(5) File motions in writing before the ALJ;
(6) Present evidence relevant to the issues at the hearing;
(7) Present and cross-examine witnesses;
(8) Present oral arguments;
(9) Submit written post-hearing briefs, proposed findings of fact
and conclusions of law, and reply briefs within reasonable time frames
agreed upon by the parties or established by the ALJ as provided in
Sec. 93.522; and
(10) Submit materials to the ALJ and other parties under seal, or
in redacted form, when necessary, to protect the confidentiality of any
information contained in them consistent with this part, the Privacy
Act, the Freedom of Information Act, or other Federal law or
regulation.
Sec. 93.506 Authority of the Administrative Law Judge.
(a) The ALJ assigned to the case must conduct a fair and impartial
hearing, avoid unnecessary delay, maintain order, and assure that a
complete and accurate record of the proceeding is properly made. The
ALJ is bound by all Federal statutes and regulations, Secretarial
delegations of authority, and applicable HHS policies and may not
refuse to follow them or find them invalid, as provided in paragraph
(c)(4) of this section. The ALJ has the authorities set forth in this
part.
(b) Subject to review as provided elsewhere in this subpart, the
ALJ may--
(1) Set and change the date, time, schedule, and place of the
hearing upon reasonable notice to the parties;
(2) Continue or recess the hearing in whole or in part for a
reasonable period of time;
(3) Hold conferences with the parties to identify or simplify the
issues, or to consider other matters that may aid in the prompt
disposition of the proceeding;
(4) Administer oaths and affirmations;
(5) Require the attendance of witnesses at a hearing;
(6) Rule on motions and other procedural matters;
(7) Require the production of documents and regulate the scope and
timing of documentary discovery as permitted by this part;
(8) Require each party before the hearing to provide the other
party and the ALJ with copies of any exhibits that the party intends to
introduce into evidence;
(9) Issue a ruling, after an in camera inspection if necessary, to
address the disclosure of any evidence or portion of evidence for which
confidentiality is requested under this part or other Federal law or
regulation, or which a party submitted under seal;
(10) Regulate the course of the hearing and the conduct of
representatives, parties, and witnesses;
(11) Examine witnesses and receive evidence presented at the
hearing;
(12) Admit, exclude, or limit evidence offered by a party;
(13) Hear oral arguments on facts or law during or after the
hearing;
(14) Upon motion of a party, take judicial notice of facts;
(15) Upon motion of a party, decide cases, in whole or in part, by
summary judgment where there is no disputed issue of material fact;
(16) Conduct any conference or oral argument in person, by
telephone, or by audio-visual communication;
(17) Take action against any party for failing to follow an order
or procedure or for disruptive conduct.
(c) The ALJ does not have the authority to--
(1) Enter an order in the nature of a directed verdict;
(2) Compel settlement negotiations;
(3) Enjoin any act of the Secretary; or
(4) Find invalid or refuse to follow Federal statutes or
regulations, Secretarial delegations of authority, or HHS policies.
Sec. 93.507 Ex parte communications.
(a) No party, attorney, or other party representative may
communicate ex parte with the ALJ on any matter at issue in a case,
unless both parties have notice and an opportunity to participate in
the communication. However, a party, attorney, or other party
representative may communicate with DAB staff about administrative or
procedural matters.
(b) If an ex parte communication occurs, the ALJ will disclose it
to the other party and make it part of the record after the other party
has an opportunity to comment.
(c) The provisions of this section do not apply to communications
between an employee or contractor of the DAB and the ALJ.
Sec. 93.508 Filing, forms, and service.
(a) Filing. (1) Unless the ALJ provides otherwise, all submissions
required or authorized to be filed in the proceeding must be filed with
the ALJ.
[[Page 28397]]
(2) Submissions are considered filed when they are placed in the
mail, transmitted to a private delivery service for the purpose of
delivering the item to the ALJ, or submitted in another manner
authorized by the ALJ.
(b) Forms. (1) Unless the ALJ provides otherwise, all submissions
filed in the proceeding must include an original and two copies. The
ALJ may designate the format for copies of nondocumentary materials
such as videotapes, computer disks, or physical evidence. This
provision does not apply to the charge letter or other written notice
provided under Sec. 93.405.
(2) Every submission filed in the proceeding must include the title
of the case, the docket number, and a designation of the nature of the
submission, such as a ``Motion to Compel the Production of Documents''
or ``Respondent's Proposed Exhibits.''
(3) Every submission filed in the proceeding must be signed by and
contain the address and telephone number of the party on whose behalf
the document or paper was filed, or the attorney of record for the
party.
(c) Service. A party filing a submission with the ALJ must, at the
time of filing, serve a copy on the other party. Service may be made
either to the last known principal place of business of the party's
attorney if the party is represented by an attorney, or, if not, to the
party's last known address. Service may be made by--
(1) Certified mail;
(2) First-class postage prepaid U.S. Mail;
(3) A private delivery service;
(4) Hand-delivery; or
(5) Facsimile or other electronic means if permitted by the ALJ.
(d) Proof of service. Each party filing a document or paper with
the ALJ must also provide proof of service at the time of the filing.
Any of the following items may constitute proof of service:
(1) A certified mail receipt returned by the postal service with a
signature;
(2) An official record of the postal service or private delivery
service;
(3) A certificate of service stating the method, place, date of
service, and person served that is signed by an individual with
personal knowledge of these facts; or
(4) Other proof authorized by the ALJ.
Sec. 93.509 Computation of time.
(a) In computing any period of time under this part for filing and
service or for responding to an order issued by the ALJ, the
computation begins with the day following the act or event, and
includes the last day of the period unless that day is a Saturday,
Sunday, or legal holiday observed by the Federal government, in which
case it includes the next business day.
(b) When the period of time allowed is less than 7 days,
intermediate Saturdays, Sundays, and legal holidays observed by the
Federal government must be excluded from the computation.
(c) Where a document has been filed by placing it in the mail, an
additional 5 days must be added to the time permitted for any response.
This paragraph does not apply to a respondent's request for hearing
under Sec. 93.501.
(d) Except for the respondent's request for a hearing, the ALJ may
modify the time for the filing of any document or paper required or
authorized under the rules in this part to be filed for good cause
shown. When time permits, notice of a party's request for extension of
the time and an opportunity to respond must be provided to the other
party.
Sec. 93.510 Filing motions.
(a) Parties must file all motions and requests for an order or
ruling with the ALJ, serve them on the other party, state the nature of
the relief requested, provide the legal authority relied upon, and
state the facts alleged.
(b) All motions must be in writing except for those made during a
prehearing conference or at the hearing.
(c) Within 10 days after being served with a motion, or other time
as set by the ALJ, a party may file a response to the motion. The
moving party may not file a reply to the responsive pleading unless
allowed by the ALJ.
(d) The ALJ may not grant a motion before the time for filing a
response has expired, except with the parties' consent or after a
hearing on the motion. However, the ALJ may overrule or deny any motion
without awaiting a response.
(e) The ALJ must make a reasonable effort to dispose of all motions
promptly, and, whenever possible, dispose of all outstanding motions
before the hearing.
Sec. 93.511 Prehearing conferences.
(a) The ALJ must schedule an initial prehearing conference with the
parties within 30 days of the DAB Chair's assignment of the case.
(b) The ALJ may use the initial prehearing conference to discuss--
(1) Identification and simplification of the issues, specification
of disputes of fact and their materiality to the ORI findings of
research misconduct and any HHS administrative actions, and amendments
to the pleadings, including any need for a more definite statement;
(2) Stipulations and admissions of fact including the contents,
relevancy, and authenticity of documents;
(3) Respondent's waiver of an administrative hearing, if any, and
submission of the case on the basis of the administrative record as
provided in Sec. 93.503(d);
(4) Identification of legal issues and any need for briefing before
the hearing;
(5) Identification of evidence, pleadings, and other materials, if
any, that the parties should exchange before the hearing;
(6) Identification of the parties' witnesses, the general nature of
their testimony, and the limitation on the number of witnesses and the
scope of their testimony;
(7) Scheduling dates such as the filing of briefs on legal issues
identified in the charge letter or the respondent's request for
hearing, the exchange of witness lists, witness statements, proposed
exhibits, requests for the production of documents, and objections to
proposed witnesses and documents;
(8) Scheduling the time, place, and anticipated length of the
hearing; and
(9) Other matters that may encourage the fair, just, and prompt
disposition of the proceedings.
(c) The ALJ may schedule additional prehearing conferences as
appropriate, upon reasonable notice to or request of the parties.
(d) All prehearing conferences will be audio-taped with copies
provided to the parties upon request.
(e) Whenever possible, the ALJ must memorialize in writing any oral
rulings within 10 days after the prehearing conference.
(f) By 15 days before the scheduled hearing date, the ALJ must hold
a final prehearing conference to resolve to the maximum extent possible
all outstanding issues about evidence, witnesses, stipulations, motions
and all other matters that may encourage the fair, just, and prompt
disposition of the proceedings.
Sec. 93.512 Discovery.
(a) Request to provide documents. A party may only request another
party to produce documents or other tangible items for inspection and
copying that are relevant and material to the issues identified in the
charge letter and in the respondent's request for hearing.
(b) Meaning of documents. For purposes of this subpart, the term
documents includes information, reports, answers, records, accounts,
papers, tangible items, and other data and documentary evidence. This
subpart does not require the creation of any document. However,
requested data
[[Page 28398]]
stored in an electronic data storage system must be produced in a form
reasonably accessible to the requesting party.
(c) Nondisclosable items. This section does not authorize the
disclosure of--
(1) Interview reports or statements obtained by any party, or on
behalf of any party, of persons whom the party will not call as witness
in its case-in-chief;
(2) Analyses and summaries prepared in conjunction with the
inquiry, investigation, ORI oversight review, or litigation of the
case; or
(3) Any privileged documents, including but not limited to those
protected by the attorney-client privilege, attorney-work product
doctrine, or Federal law or regulation.
(d) Responses to a discovery request. Within 30 days of receiving a
request for the production of documents, a party must either fully
respond to the request, submit a written objection to the discovery
request, or seek a protective order from the ALJ. If a party objects to
a request for the production of documents, the party must identify each
document or item subject to the scope of the request and state the
basis of the objection for each document, or any part that the party
does not produce.
(1) Within 30 days of receiving any objections, the party seeking
production may file a motion to compel the production of the requested
documents.
(2) The ALJ may order a party to produce the requested documents
for in camera inspection to evaluate the merits of a motion to compel
or for a protective order.
(3) The ALJ must compel the production of a requested document and
deny a motion for a protective order, unless the requested document
is--
(i) Not relevant or material to the issues identified in the charge
letter or the respondent's request for hearing;
(ii) Unduly costly or burdensome to produce;
(iii) Likely to unduly delay the proceeding or substantially
prejudice a party;
(iv) Privileged, including but not limited to documents protected
by the attorney-client privilege, attorney-work product doctrine, or
Federal law or regulation; or
(v) Collateral to issues to be decided at the hearing.
(4) If any part of a document is protected from disclosure under
paragraph (d)(3) of this section, the ALJ must redact the protected
portion of a document before giving it to the requesting party.
(5) The party seeking discovery has the burden of showing that the
ALJ should allow it.
(e) Refusal to produce items. If a party refuses to provide
requested documents when ordered by the ALJ, the ALJ may take
corrective action, including but not limited to, ordering the
noncompliant party to submit written answers under oath to written
interrogatories posed by the other party or taking any of the actions
at Sec. 93.515.
Sec. 93.513 Submission of witness lists, witness statements, and
exhibits.
(a) By 60 days before the scheduled hearing date, each party must
give the ALJ a list of witnesses to be offered during the hearing and a
statement describing the substance of their proposed testimony, copies
of any prior written statements or transcribed testimony of proposed
witnesses, a written report of each expert witness to be called to
testify that meets the requirements of Federal Rule of Civil Procedure
26(a)(2)(B), and copies of proposed hearing exhibits, including copies
of any written statements that a party intends to offer instead of live
direct testimony. If there are no prior written statements or
transcribed testimony of a proffered witness, the party must submit a
detailed factual affidavit of the proposed testimony.
(b) A party may supplement its submission under paragraph (a) of
this section until 30 days before the scheduled hearing date if the ALJ
determines:
(1) There are extraordinary circumstances; and
(2) There is no substantial prejudice to the objecting party.
(c) The parties must have an opportunity to object to the admission
of evidence submitted under paragraph (a) of this section under a
schedule set by the ALJ. However, the parties must file all objections
before the final prehearing conference.
(d) If a party tries to introduce evidence after the deadlines in
paragraph (a) of this section, the ALJ must exclude the offered
evidence from the party's case-in-chief unless the conditions of
paragraph (b) of this section are met. If the ALJ admits evidence under
paragraph (b) of this section, the objecting party may file a motion to
postpone all or part of the hearing to allow sufficient time to prepare
and respond to the evidence. The ALJ may not unreasonably deny that
motion.
(e) If a party fails to object within the time set by the ALJ and
before the final prehearing conference, evidence exchanged under
paragraph (a) of this section is considered authentic, relevant and
material for the purpose of admissibility at the hearing.
Sec. 93.514 Amendment to the charge letter.
(a) The ORI may amend the findings of research misconduct up to 30
days before the scheduled hearing.
(b) The ALJ may not unreasonably deny a respondent's motion to
postpone all or part of the hearing to allow sufficient time to prepare
and respond to the amended findings.
Sec. 93.515 Actions for violating an order or for disruptive conduct.
(a) The ALJ may take action against any party in the proceeding for
violating an order or procedure or for other conduct that interferes
with the prompt, orderly, or fair conduct of the hearing. Any action
imposed upon a party must reasonably relate to the severity and nature
of the violation or disruptive conduct.
(b) The actions may include--
(1) Prohibiting a party from introducing certain evidence or
otherwise supporting a particular claim or defense;
(2) Striking pleadings, in whole or in part;
(3) Staying the proceedings;
(4) Entering a decision by default;
(5) Refusing to consider any motion or other action not timely
filed; or
(6) Drawing the inference that spoliated evidence was unfavorable
to the party responsible for its spoliation.
Sec. 93.516 Standard and burden of proof.
(a) Standard of proof. The standard of proof is the preponderance
of the evidence.
(b) Burden of proof. (1) ORI bears the burden of proving the
findings of research misconduct. The destruction, absence of, or
respondent's failure to provide research records adequately documenting
the questioned research is evidence of research misconduct where ORI
establishes by a preponderance of the evidence that the respondent
intentionally, knowingly, or recklessly had research records and
destroyed them, had the opportunity to maintain the records but did not
do so, or maintained the records and failed to produce them in a timely
manner and the respondent's conduct constitutes a significant departure
from accepted practices of the relevant research community.
(2) The respondent has the burden of going forward with and the
burden of proving, by a preponderance of the evidence, any and all
affirmative defenses raised. In determining whether ORI has carried the
burden of proof
[[Page 28399]]
imposed by this part, the ALJ shall give due consideration to
admissible, credible evidence of honest error or difference of opinion
presented by the respondent.
(3) ORI bears the burden of proving that the proposed HHS
administrative actions are reasonable under the circumstances of the
case. The respondent has the burden of going forward with and proving
by a preponderance of the evidence any mitigating factors that are
relevant to a decision to impose HHS administrative actions following a
research misconduct proceeding.
Sec. 93.517 The hearing.
(a) The ALJ will conduct an in-person hearing to decide if the
respondent committed research misconduct and if the HHS administrative
actions, including any debarment or suspension actions, are
appropriate.
(b) The ALJ provides an independent de novo review of the ORI
findings of research misconduct and the proposed HHS administrative
actions. The ALJ does not review the institution's procedures or
misconduct findings or ORI's research misconduct proceedings.
(c) A hearing under this subpart is not limited to specific
findings and evidence set forth in the charge letter or the
respondent's request for hearing. Additional evidence and information
may be offered by either party during its case-in-chief unless the
offered evidence is--
(1) Privileged, including but not limited to those protected by the
attorney-client privilege, attorney-work product doctrine, or Federal
law or regulation.
(2) Otherwise inadmissible under Sec. Sec. 93.515 or 93.519.
(3) Not offered within the times or terms of Sec. Sec. 93.512 and
93.513.
(d) ORI proceeds first in its presentation of evidence at the
hearing.
(e) After both parties have presented their cases-in-chief, the
parties may offer rebuttal evidence even if not exchanged earlier under
Sec. Sec. 93.512 and 93.513.
(f) Except as provided in Sec. 93.518(c), the parties may appear
at the hearing in person or by an attorney of record in the proceeding.
(g) The hearing must be open to the public, unless the ALJ orders
otherwise for good cause shown. However, even if the hearing is closed
to the public, the ALJ may not exclude a party or party representative,
persons whose presence a party shows to be essential to the
presentation of its case, or expert witnesses.
Sec. 93.518 Witnesses.
(a) Except as provided in paragraph (b) of this section, witnesses
must give testimony at the hearing under oath or affirmation.
(b) The ALJ may admit written testimony if the witness is available
for cross-examination, including prior sworn testimony of witnesses
that has been subject to cross-examination. These written statements
must be provided to all other parties under Sec. 93.513.
(c) The parties may conduct direct witness examination and cross-
examination in person, by telephone, or by audio-visual communication
as permitted by the ALJ. However, a respondent must always appear in-
person to present testimony and for cross-examination.
(d) The ALJ may exercise reasonable control over the mode and order
of questioning witnesses and presenting evidence to--
(1) Make the witness questioning and presentation relevant to
deciding the truth of the matter; and
(2) Avoid undue repetition or needless consumption of time.
(e) The ALJ must permit the parties to conduct cross-examination of
witnesses.
(f) Upon request of a party, the ALJ may exclude a witness from the
hearing before the witness' own testimony. However, the ALJ may not
exclude--
(1) A party or party representative;
(2) Persons whose presence is shown by a party to be essential to
the presentation of its case; or
(3) Expert witnesses.
Sec. 93.519 Admissibility of evidence.
(a) The ALJ decides the admissibility of evidence offered at the
hearing.
(b) Except as provided in this part, the ALJ is not bound by the
Federal Rules of Evidence (FRE). However, the ALJ may apply the FRE
where appropriate (e.g., to exclude unreliable evidence).
(c) The ALJ must admit evidence unless it is clearly irrelevant,
immaterial, or unduly repetitious. However, the ALJ may exclude
relevant and material evidence if its probative value is substantially
outweighed by the danger of unfair prejudice, confusion of the issues,
or by considerations of undue delay or needless presentation of
cumulative evidence under FRE 401-403.
(d) The ALJ must exclude relevant and material evidence if it is
privileged, including but not limited to evidence protected by the
attorney-client privilege, the attorney-work product doctrine, or
Federal law or regulation.
(e) The ALJ may take judicial notice of matters upon the ALJ's own
initiative or upon motion by a party as permitted under FRE 201
(Judicial Notice of Adjudicative Facts).
(1) The ALJ may take judicial notice of any other matter of
technical, scientific, or commercial fact of established character.
(2) The ALJ must give the parties adequate notice of matters
subject to judicial notice and adequate opportunity to show that the
ALJ erroneously noticed the matters.
(f) Evidence of crimes, wrongs, or acts other than those at issue
in the hearing is admissible only as permitted under FRE 404(b)
(Character Evidence not Admissible to Prove Conduct; Exceptions, Other
Crimes).
(g) Methods of proving character are admissible only as permitted
under FRE 405 (Methods of Proving Character).
(h) Evidence related to the character and conduct of witnesses is
admissible only as permitted under FRE Rule 608 (Evidence of Character
and Conduct of Witness).
(i) Evidence about offers of compromise or settlement made in this
action is inadmissible as provided in FRE 408 (Compromise and Offers to
Compromise).
(j) The ALJ must admit relevant and material hearsay evidence,
unless an objecting party shows that the offered hearsay evidence is
not reliable.
(k) The parties may introduce witnesses and evidence on rebuttal.
(l) All documents and other evidence offered or admitted into the
record must be open to examination by both parties, unless otherwise
ordered by the ALJ for good cause shown.
(m) Whenever the ALJ excludes evidence, the party offering the
evidence may make an offer of proof, and the ALJ must include the offer
in the transcript or recording of the hearing in full. The offer of
proof should consist of a brief oral statement describing the evidence
excluded. If the offered evidence consists of an exhibit, the ALJ must
mark it for identification and place it in the hearing record. However,
the ALJ may rely upon the offered evidence in reaching the decision on
the case only if the ALJ admits it.
Sec. 93.520 The record.
(a) HHS will record and transcribe the hearing, and if requested,
provide a transcript to the parties at HHS' expense.
(b) The exhibits, transcripts of testimony, any other evidence
admitted at the hearing, and all papers and requests filed in the
proceeding constitute the record for the decision by the ALJ.
[[Page 28400]]
(c) For good cause shown, the ALJ may order appropriate redactions
made to the record at any time.
(d) The DAB may return original research records and other similar
items to the parties or awardee institution upon request after final
HHS action, unless under judicial review.
Sec. 93.521 Correction of the transcript.
(a) At any time, but not later than the time set for the parties to
file their post-hearing briefs, any party may file a motion proposing
material corrections to the transcript or recording.
(b) At any time before the filing of the ALJ's decision and after
consideration of any corrections proposed by the parties, the ALJ may
issue an order making any requested corrections in the transcript or
recording.
Sec. 93.522 Filing post-hearing briefs.
(a) After the hearing and under a schedule set by the ALJ , the
parties may file post-hearing briefs, and the ALJ may allow the parties
to file reply briefs.
(b) The parties may include proposed findings of fact and
conclusions of law in their post-hearing briefs.
Sec. 93.523 The Administrative Law Judge's ruling.
(a) The ALJ shall issue a ruling in writing setting forth proposed
findings of fact and any conclusions of law within 60 days after the
last submission by the parties in the case. If unable to meet the 60-
day deadline, the ALJ must set a new deadline and promptly notify the
parties, the Assistant Secretary for Health and the debarring official,
if debarment or suspension is under review. The ALJ shall serve a copy
of the ruling upon the parties and the Assistant Secretary for Health.
(b) The ruling of the ALJ constitutes a recommended decision to the
Assistant Secretary for Health. The Assistant Secretary for Health may
review the ALJ's recommended decision and modify or reject it in whole
or in part after determining it, or the part modified or rejected, to
be arbitrary and capricious or clearly erroneous. The Assistant
Secretary for Health shall notify the parties of an intention to review
the ALJ's recommended decision within 30 days after service of the
recommended decision. If that notification is not provided within the
30-day period, the ALJ's recommended decision shall become final. An
ALJ decision that becomes final in that manner or a decision by the
Assistant Secretary for Health modifying or rejecting the ALJ's
recommended decision in whole or in part is the final HHS action,
unless debarment or suspension is an administrative action recommended
in the decision.
(c) If a decision under Sec. 93.523(b) results in a recommendation
for debarment or suspension, the Assistant Secretary for Health shall
serve a copy of the decision upon the debarring official and the
decision shall constitute findings of fact to the debarring official in
accordance with 45 CFR 76.845(c). The decision of the debarring
official on debarment or suspension is the final HHS decision on those
administrative actions.
[FR Doc. 05-9643 Filed 5-16-05; 8:45 am]
BILLING CODE 4150-31-P
