ORI Responses to Issues Arising from Inquiries and Investigations
- Categories of Personnel Covered
- Confessions/Negotiated Pleas
- Good Faith Complainants
- Ownership and Retention of Data
- Institutional vs PHS Standards
- Credentials and Publications
- Training Foreign Students
- Provision of Counsel
- Complainant as a Witness
- Release of Case Information
- When ORI Notification Is Required
- Administrative Actions Requiring Documentation
- ORI Jurisdiction on Non-PHS Issues
- Various Ways of "Reporting" Research Results
- Avoiding Conflicts of Interest
- Needed Corrections in Cases
- "Gag" Provisions Are Contrary to Responsibilities and Laws
- PHS Funding Jurisdiction in Research Misconduct Cases Explained
- When Institutions Mistakenly Report "Admissions" to ORI
- Inquiry vs Investigation Stages in Research Misconduct Cases
- Concerns about Using Set-Up Experiments in Institutional Investigations
- Assessing Research Misconduct Allegations Involving Clinical Research
A variety of important issues have arisen in the course of inquiries and investigations conducted by extramural institutions into allegations of research misconduct. The Office of Research Integrity (ORI) presents its position on 24 significant issues. For areas of conduct not covered by the PHS definition of research misconduct, the statutory mandate and regulations do not replace the authority of extramural institutions to establish their own professional norms on the responsible conduct of research.
(1) Categories of Personnel Covered - Inquiries and investigations required by the ORI assurance program must be conducted on allegations of research misconduct brought against any individual involved in PHS-supported research. This includes postdoctoral fellows, residents, graduate students, undergraduate students, nurses, technicians, and other staff members. Institutional policies and procedures may not be limited only to faculty and professional staff. Policies and procedures which do not apply to all individuals engaged in the research enterprise do not meet the requirements of either the institution's assurance to ORI or the Federal regulation at 42 C.F.R. Part 93 and may place the institution's assurance in jeopardy.
(2) Confessions and Negotiated Pleas - Occasionally, institutions have accepted a "confession" or admission of misconduct in lieu of a full investigation, especially when the respondent has left or offered to leave the institution as part of a negotiated settlement. However, respondents sometimes withdraw or explain away their "confession" after the institutional report is sent to ORI. Consequently, ORI requests that confessions be fully documented in the record using the terms of the research misconduct definition (falsification, fabrication, or plagiarism) and acknowledging that the action constitutes research misconduct. Pursuant to 42 C.F.R.§ 93.316, the institution is required to notify ORI in advance if the institution intends to close the case at any stage on the basis that the respondent has admitted guilt. If the confession or admission does not provide a sufficient basis for closing the case, ORI may request the institution to complete its investigation. Institutions and respondents may not enter into settlements in PHS research misconduct cases that require the parties to keep the matter confidential (i.e. not notify ORI) or that "settle" the inquiry or investigation without an appropriate finding.
(3) Good Faith Complainants - The question of what constitutes a good faith allegation of research misconduct continues to cause concern and confusion among institutions. Under the regulation, institutions must protect the positions and reputations of those persons who, in good faith, make allegations of research misconduct. 42 C.F.R. § 93.210. A "good faith" allegation means that the complainant made the allegation with a belief in the truth of the allegation which a reasonable person in the complainant's position could have based upon the information know to the complainant at the time the allegation was made. Thus, an allegation may be made in good faith even if an investigation subsequently does not support a finding of misconduct, or even if the allegation was made for personal reasons, such as dislike of a colleague. However, an allegation is not in good faith if made with knowing or reckless disregard for information that would disprove the allegation. A complainant may not be retaliated against for making a good faith allegation.
(4) Ownership and Retention of Data - Research data generated under PHS funding generally is owned by the grantee institution, not the principal investigator or the researcher producing the data. The institution is the grantee and assumes legal and financial accountability for the awarded funds. See 42 C.F.R. § 52.2. Therefore, a grantee institution has not only the right, but the obligation to require a researcher to produce accurate supporting data not only for funded programs but also for grant applications. Additionally, NIH grant regulations require an institution to retain records for specific lengths of time and to provide records on request to support a grant project. 45 C.F.R. § 74.53. Some institutions have also developed specific internal procedures defining the types of research records that must be kept, their form, and the length of time they must be retained. In conjunction with the regulations, policies such as these help to protect both institutions and responsible researchers in the event of an allegation of research misconduct.
(5) Institutional Versus PHS Standards - Research misconduct under the PHS standards must meet certain legal requirements which may be greater, lesser, or different from an institution's own internal standards. Therefore, in the course of an investigation, an institution may find conduct to be actionable under its own standards, even though the action does not meet the PHS definition of research misconduct. If ORI reaches a determination that a particular action does not fall within the PHS definition of research misconduct (as opposed to whether the action actually occurred), this PHS finding should not affect the institution's internal finding or any administrative actions that it imposes.
(6) Credentials and Publications - Falsification or fabrication of a researcher's credentials and publication list in an application for PHS funds can result in a finding of research misconduct. A review of credentials and publications during the peer review process may be critical to determining if an individual is capable of performing the proposed research. Some researchers have listed degrees they did not have or positions they have not held. Therefore, fabrication or falsification of credentials or manuscripts can, in some circumstances, be considered research misconduct.
(7) Training Foreign Students - Foreign students and postdoctoral fellows involved in inquiries and investigations of research misconduct have told ORI that certain research policies in the U.S. are different from those in their home countries. They have noted that no one ever discussed these differences with them or told them that they were performing research in what was considered to be an inappropriate manner. It is possible that some allegations of misconduct could be avoided if these individuals received training in biomedical research ethics, and if their mentors and fellow researchers made a point of helping them to understand the appropriate research methods and practices.
(8) Provision of Counsel - ORI permits, but neither requires nor provides counsel for respondents, complainants, and other participants in misconduct proceedings. An institution must decide to whom it should provide counsel, and if counsel should be provided. Some institutions routinely provide counsel for all or some parties, while others provide none. If counsel is provided, care should be taken to prevent any potential conflicts of interest between the needs of the institution and that of the individual being provided with representation. For example, if an institution decides to provide a respondent with counsel, the institution's obligation to comply with the regulation and to cooperate with ORI investigations must not be compromised. ORI strongly recommends that outside counsel be provided in this instance. Also, while parties may arrange for their own counsel, reimbursement is not available from the Federal government under the Equal Access to Justice Act in hearings before the Departmental Appeals Board.
(9) Complainant As a Witness - Once a complainant has made a formal allegation of research misconduct, the person must be treated as any other witness in the proceeding. The complainant is not a "party," does not control nor direct the process, act as a decision maker, nor have unqualified access to the available evidence. While ORI encourages complainants to cooperate fully with ORI and institutions, the investigating body, not the complainant has the responsibility to ensure that the allegation is thoroughly and competently investigated to resolution. For the full text of the ORI policy on "The Complainant's Role in an Inquiry, Investigation, or Hearing," see ORI Newsletter, Vol. 8, No. 1, p.8.
(10) Release of Case Information - The PHS regulation requires that disclosure of the identify of affected individuals, to the extent possible, be limited to those with a need to know. 42 C.F.R. § 93.108. However, this does not create an absolute bar to disclosure and relates only to the regulatory "research misconduct" investigation and reporting requirements mandated by the PHS Act and Federal regulations. It would not preclude an institution from disclosing information regarding actions that it may have taken under the institution's internal procedures, if the disclosure of those actions is not otherwise prohibited. For example, if an institution determines that it needs to disclose some information related to actions taken under its internal standards, it may do so if it doesn't disclose the PHS component of the investigation.
(11) When ORI Notification Is Required - Extramural institutions are required to notify ORI of research misconduct cases if an institution concludes that an investigation is warranted (42 C.F.R. § 93.309). The only time ORI need not be notified is when an inquiry committee finds insufficient evidence of possible misconduct to warrant further investigation. However many institutions remain confused about when a misconduct proceeding may be stopped at the inquiry stage without notification and when it must proceed to a conclusion. In the usual situation, the inquiry committee's responsibility is to determine whether there was sufficient evidence to warrant an investigation, not to determine whether there was misconduct and "resolve" the issue. Even if the respondent admits to misconduct at the inquiry stage and the institution believes that no further investigation is necessary, the institution must report its misconduct finding to ORI and state why it believes further investigation is unnecessary. See 42 C.F.R. § 93.316.
(12) Debarments/Exclusions - Debarments and exclusions are actions taken by the Federal government to protect itself and to ensure that it deals only with responsible persons. Persons may be debarred or voluntarily exclude themselves for several reasons, including a criminal conviction, fraud, or a history of unsatisfactory performance. Once debarred or excluded, a person may not participate in "covered transactions" with the Federal government for a set period of time, usually three years (as defined in 45 C.F.R. Part 76). In this section, ORI answers some commonly asked questions regarding debarment and what an institution can do to protect itself when dealing with debarred persons. However, this is only a general discussion, and institutions and individuals should consult counsel with respect to the particulars of any debarment or exclusion. For debarments based on findings of research misconduct, questions may also be directed to ORI counsel at (301) 443-3466. The applicable nonprocurement debarment regulation can be found at 45 C.F.R. Part 76. For simplicity, we've used the term "debarment" to include any actions, including voluntary exclusions, which are listed in the General Services Administration's Excluded Parties LIst System (EPLS).
Who can be debarred?
Both individuals and entities may be subject to debarment. In the area of grant and cooperative agreement supported research, this includes anyone who participates in the research: the principal investigators, researchers, contractors, students, and technical and support staff. To date, all ORI debarments have involved individuals, not institutions or other entities.
What types of nonprocurement transactions are barred?
With some exceptions, because debarments are government-wide, debarred persons may not participate in any Federal nonprocurement or procurement (contract) transactions. Nonprocurement transactions include, but are not limited to, grants, cooperative agreements, subsidies, contracts, subcontracts, scholarships, fellowships, loans, and other forms of Federal funding. For example, debarred persons may not be listed on a grant application for direct receipt of financial assistance in the form of a salary. Also, a debarred researcher may not receive nonfinancial assistance by being allowed to use federally funded equipment, laboratory space, office personnel, and other resources. Physicians excluded under Medicare and Medicaid provisions are also considered to be debarred. However, since some debarments and exclusions are limited in scope or effect, an institution should check the actual terms of an exclusion.
How long is a debarment?
The usual term is three years. However, debarments may be for longer periods depending on the seriousness of the debarred person's actions and any aggravating or mitigating circumstances.
What work can the debarred person do?
Many areas of employment are unaffected by debarment. For example, debarred persons may work as Federal government employees. They may work for state or local governments, universities, professional and trade organizations, or in the private sector as long as none of the assistance, benefits, or contracts they receive originates with Federal monies. Debarred researchers may continue to receive research grant support from nonfederal sources.
Is an institution that receives Federal funding required to discharge a debarred person?
No. Debarred persons are only prevented from participating in covered transactions. Therefore, they can still participate in any nonfederally funded activities. Upon request, ORI will review the proposed or current work of researchers who have been debarred for research misconduct
May an institution be held responsible for the conduct of its debarred employees?
Yes. An institution cannot knowingly allow a debarred person to participate in federally funded projects without obtaining an exception from the HHS debarring official. See 45 C.F.R. § 76.400.
How can an institution know whether a person has been debarred?
All debarred persons are listed in the EPLS, which is available at http://epls.arnet.gov
More specific information on why individuals have been debarred may be found in summaries published by ORI in the Federal Register, the ORI Newsletter and in the NIH Guide for Grants and Contracts.
(13) Administrative Actions Requiring Documentation - This covers situations where administrative actions imposed on respondents in research misconduct cases require institutions and/or individuals to submit specified documents to PHS funding agencies and copies of those documents to ORI.
When a certification of data requirement is imposed on a respondent, the employing institution must certify that the data provided by the respondent are based on actual experiments or are otherwise legitimately derived, and that the data, procedures, and methodology are accurately reported in the grant application or report submitted to the agency. The statement of certification must accompany the grant application or report; a copy of the statement must be sent to ORI by the institution..
When a plan of supervision is imposed on a respondent, the institution which submits an application for PHS support for a research project on which the individual's participation is proposed or which uses the individual in any capacity on PHS-supported research, must submit with the grant application a plan of supervision that will ensure the scientific integrity of the individual's research contribution. ORI retains the right to review and determine whether the supervision plan crafted by the respondent and the institution is acceptable to ORI based upon the scope of the misconduct previously committed. A copy of the plan must be submitted to ORI by the institution.
When a respondent is required to submit a retraction or a correction of an article, the respondent must also send a copy of the retraction or correction letter to ORI. The respondent remains in the ALERT system until the letter is received even if the term of other administrative actions has expired. ORI may also send a letter to the journal.
When a certification of sources requirement is imposed on a respondent, the respondent must submit with each application or report a statement of certification, endorsed by an institutional official, that all contributors to the application or report are properly cited or otherwise acknowledged. A copy of the statement must be sent to ORI by the institution.
(14) ORI Jurisdiction on Non-PHS Issues - ORI does not have jurisdiction to review a research misconduct investigation or a compliance or a retaliation issue related to non-PHS funded research. ORI jurisdiction only extends to projects for which PHS funds are requested or provided; the existence of an assurance does not give ORI authority over non-PHS matters. (42 U.S.C. § 289b(b), 42 C.F.R.§ 93.102.)
Nor does an institution's use of ORI-approved policies and procedures for non-PHS matters extend ORI's authority to these issues. Some have argued that any institution that accepts PHS support receives indirect costs to support its research infrastructure, and therefore all research conducted at the institution should be considered to fall under ORI's authority. However, this would subject all research at the PHS-funded institution to ORI jurisdiction, extending ORI authority beyond that which is granted in the statute and the regulation.
If an institution's report contains both PHS and non-PHS issues, ORI conducts its oversight only on those issues that fall within ORI's jurisdiction. Although ORI may consider non-PHS issues as relevant to demonstrating a larger pattern of conduct or in support of a Government-wide debarment, it will make research misconduct findings only on the PHS issue(s). Therefore, even if ORI initially accepts a case, if it subsequently determines that there is no PHS funding jurisdiction, ORI will administratively close the case and take no further action except a referral to another agency, if warranted.
(15) Various Ways of "Reporting" Research Results - The PHS definition defines research misconduct as fabrication, falsification, or plagiarism in "proposing, performing, or reviewing research, or in reporting research results." 42 C.F.R. § 93.103. Research results do not need to be published before they fall within the PHS definition.
ORI considers the following to be examples of "reported" research:
Data presented in manuscripts or theses or given to a mentor or lab chief as representing the results of experiments;
Reports submitted to PHS such as progress reports in competing renewal applications (Type 2), applications for continuing years of an approved project (Type 5), and preliminary data in new grant applications (Type 1);
Abstracts, posters, oral presentations, and preliminary reports presented at scientific meetings or records of these presentations; Data reported to central databases, such as multi-center clinical trials or epidemiological research; and Patent applications.
(16) Avoiding Conflicts of Interest - In responding to allegations, institutions need to select committee members and experts who are free from bias and have no real or apparent conflicts of interest either with the parties involved or the subject matter. Consequently, these individuals should be free of professional, financial, personal, or other substantial ties to the accused and the complainant.
Generally, it is the responsibility of the institution's Research Integrity Officer (RIO) to select committee members who have the necessary expertise to evaluate the evidence and issues related to the allegations. The RIO needs to notify the respondent of the proposed committee membership and the respondent should have the opportunity to submit a written objection to any appointed member of the investigation committee or expert based on bias or conflict. The RIO then determines whether the challenged member or expert should be replaced with a qualified substitute.
The institution may use either outside researchers or its own scientists as experts but should not select persons who are directly responsible for the laboratory or research project where the misconduct is alleged to have occurred. These individuals have conflicts of interest as mentors, co-authors, and/or supervisors of the respondent that may compromise their objectivity in reviewing the allegations. For more details on this issue, see ORI Newsletter, Vol. 6, No. 3, p. 6.
(17) Needed Corrections in Cases - Institutions need to consider all the forms of research reporting that must be corrected or retracted after a finding of research misconduct. In addition to correcting or retracting any scientific publications containing fabricated or falsified data, in some cases, nucleotide sequences submitted to a national database may need to be retracted as well.
(18) "Gag" Provisions Are Contrary to Responsibilities & Laws - ORI's position is that "gag" provisions in institutional settlement agreements are contrary to the institution's responsibilities to report misconduct under the Public Health Service (PHS) Act, 42 U.S.C. § 289b, and the regulatory complainant protection provision, Section 93.300(d) of the Public Health Service Policies on Research Misconduct. The PHS research misconduct policies require institutions to notify ORI of the outcome of misconduct investigations and, under certain circumstances, of alleged misconduct before concluding an investigation. Contracting to conceal misconduct would violate the institution's obligation to disclose misconduct to ORI.
Furthermore, courts have held that similar "gag" provisions violate complainant protection laws. See e.g., Connecticut Light & Power v. U.S. Dept. of Labor, 85 F.3d 89 (2d Cir. 1996); EEOC v. Cosmair, Inc., 821 F.2d 1085, 1089 (5th Cir. 1987).
(19) PHS Funding Jurisdiction in Research Misconduct Cases Explained - An important preliminary issue in research misconduct cases is whether there is Public Health Service (PHS) funding jurisdiction that would allow ORI to exercise its oversight responsibilities. Although there are many possible funding and misconduct scenarios, the general principles discussed below may provide valuable guidance for institutions and individuals alike.
In most cases the PHS funding agency is the National Institutes of Health, but it may be any of the seven other PHS agencies: Center for Disease Control and Prevention, Food and Drug Administration, Substance Abuse and Mental Health Services Administration, Health Resources and Services Administration, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, and the Indian Health Service. Under the PHS Policies on Research Misconduct, ORI's authority extends to "PHS supported biomedical or behavioral extramural or intramural research; PHS supported biomedical or behavioral extramural or intramural research training programs; 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; plagiarism of research records produced in the course of PHS supported research, research training or activities related to that research or research training. 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. 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. 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." Section 93.102.
The following are examples of situations where ORI would have jurisdiction in a misconduct case:
- Research funded by PHS grants, contracts, and cooperative agreements.
- Applications for PHS-funded grants, whether or not the grants are funded.
- Applications for PHS-funded grants that are withdrawn either before or after funding.
- Research data submitted in progress or final reports on funded grants.
- Materials submitted by a respondent during an inquiry or investigation that are falsified or fabricated even if no research misconduct is ultimately found in the underlying research.
- Research not conducted with PHS funds if the data from that research are then used in or referenced in PHS-related grant applications or progress or final reports.
- Research data included in publications that cite PHS support.
Another closely related issue is who makes the decision on PHS funding jurisdiction. Initially, the institution has the responsibility to make an independent determination of PHS funding jurisdiction that does not rely solely on the representations of either the respondent or the complainant. While complainants are often in a good position to provide helpful information to the institution regarding the existence of PHS funding, and should always make an effort to assist in the determination, they are not required to prove this issue. However, a respondent who affirmatively claims that the subject matter of the alleged research misconduct does not involve any PHS funding should be required to establish this claim.
An institution's decision regarding PHS jurisdiction, however, is not determinative of the issue nor is it binding on ORI. As part of ORI's responsibility for determining whether an institution is complying with its assurance, ORI may request, and the institution is obligated to provide, reasonable evidence that PHS funding jurisdiction is or is not involved in any particular case. ORI is authorized to and does review the institution's conclusion regarding the involvement of PHS support. Section 93.400(a)(2).
Any party or institution with questions about a PHS funding issue may contact ORI's Division of Investigative Oversight for further assistance.
(20) When Institutions Mistakenly Report "Admissions" to ORI - ORI has found that failure to follow an appropriate investigation process led to reaching incorrect conclusions in two different cases. In one case, institutional officials informed ORI that they were closing the case because the respondent had made an "admission" of research misconduct. In another case, officials said they were closing the case because a former employee was probably responsible for the alleged misconduct.
In these cases, initial conclusions by research staff, principal investigators (PIs), and/or institutional officials that the respondents had made "admissions" or were "responsible for misconduct" were largely undocumented and ultimately were found to be unsupportable. In each case, ORI asked the institutions to provide a more formal investigative process to address the questions raised during ORI's oversight review.
To concur with an institution's finding of research misconduct, that is based on an "admission," ORI not only needs a well-documented (preferably written or transcribed) admission containing language such as "I falsified results" or "I admit to research misconduct," but also sufficient substantive evidence to support the admission. In addition, the PHS regulation requires that the respondent be notified of the allegations and findings and be allowed to respond to them, or to waive that opportunity under the institution's policies for investigations. Section 93.312
A research manager for a behavioral research study found discrepancies in records by a staff interviewer. The manager checked with a few of the research subjects, who said they did not remember getting any calls in the past year. When the principal investigator (PI) confronted the interviewer, he denied any wrongdoing and subsequently resigned without explanation. The institutional officials then notified ORI that the interviewer had "committed" research misconduct.
As part of it's oversight process, however, ORI required the institution to notify the respondent of the proposed findings and offer him the opportunity for an interview with an inquiry committee. During the respondent's interview, he again denied any falsification of data, stating that he had called the subjects from home, as allowed by the protocol. The respondent told the committee that he had resigned simply because he thought the PI no longer trusted him. The committee ultimately found there was insufficient documentary evidence to warrant an investigation or a finding of research misconduct.
An institution investigated allegations that a PI had falsified research records in a clinical trial. The committee exonerated the PI, but its report found the nurse coordinator to be the most likely person responsible for the discrepancies (possible falsifications) between the primary records and those sent to the trial's data coordinating center. However, the institution had closed the case without contacting the nurse coordinator, who had left the institution.
ORI required the institution to open a new investigation with the nurse coordinator as respondent in this case. While the nurse coordinator was not available for an interview, she provided written comments. After interviewing several witnesses and reviewing the records, the new investigation committee found one change in the data was not significant. For the other discrepancies, the committee found insufficient evidence that the respondent had changed the records. Thus, the institution made no finding of misconduct in this case.
(21) Inquiry Versus Investigation Stages in Research Misconduct Cases - When examining allegations of research misconduct, institutions have an obligation to conduct an initial inquiry, and, if warranted, a thorough investigation in accordance with PHS Policies on Research Misconduct. 42 C.F.R. Part 93. This article discusses some procedural and substantive considerations in examining allegations of research misconduct in inquiries and investigations.
After receiving a good faith allegation of research misconduct, an institution will usually open an inquiry to gather general information and make initial findings of fact to determine whether the allegation has substance and there is sufficient evidence to warrant an investigation. Sometimes, however, when there is sufficient evidence already at hand, for example as the result of an audit of a clinical trial, the institution may move directly to the investigation stage. If the inquiry uncovers evidence of "fabrication, falsification or plagiarism," an investigation is warranted. Section 93.307 (d). In general, absent full admissions, inquiries should not be used to make findings on whether research misconduct in fact occurred.
On occasion, ORI receives an inquiry report in which either the committee has conducted the equivalent of an investigation and made specific findings, or which is obviously the result of a negotiated agreement. These reports may violate the PHS regulation and cause substantial difficulties for ORI's oversight. Findings made at the inquiry stage are all too frequently incomplete because the record has not been fully developed, and negotiated agreements violate the PHS regulation, if made without advance notice to ORI. Both instances may deprive ORI of the facts necessary to determine whether there has been an adverse effect on the PHS sponsored research, and the institution may be required to reopen its case and initiate an investigation.
Instead of short circuiting the process, once an institution has determined that there is some evidence of possible misconduct, a thorough investigation should be conducted in accordance with the requirements explained in Section 93.310. Only after this process is complete should the investigation committee turn to an analysis of whether the charges have been proven by a preponderance of the evidence.
Even if the record is relatively complete at the inquiry stage, the PHS regulation gives respondents the opportunity to have a full investigation unless they admit misconduct and waive the investigation. This multiple stage process has also been endorsed by the Federal Office of Science and Technology Policy which has stated that the investigation is "the formal examination and evaluation of the relevant facts leading either to dismissal of the case or a recommendation for a finding of research misconduct or other appropriate remedies." Federal Policy on Research Misconduct, 65 Fed. Reg. 76260-76263 (December 6, 2000).
(22) Concerns about Using Set-up Experiments in Institutional Investigations - Several investigation reports transmitted to ORI from research institutions in recent years have included descriptions of experiments that were set up to try to detect additional fabrication or falsification of research results by the respondents. The set-up experiments (S-UEs) were arranged by complainants or institutional officials. Setting up experiments or asking respondents to repeat the experiments resulted in misconduct findings in the first three case examples given here. However, in other cases, the S-UEs failed to include safeguards, so the results were not useful in supporting an ORI finding of research misconduct. Furthermore, "repeating" the originally-claimed results in an experiment does not alone disprove an allegation that the original work was fabricated.
Most findings of research misconduct are not based on the implementation of S-UEs and S-UEs are not necessary to confirm research misconduct. The results of S-UEs will not be useful in confirming misconduct unless adequate safeguards are imposed to monitor the situation and document any evidence.
An M.D./Ph.D. graduate student was suspected of fabricating data on experiments over several years. When asked to return to the laboratory to repeat the work on blinded samples, the student repeated the results in the presence of a coworker. However, when the laboratory director evaluated the materials used in the repeat experiments, the director found changes indicating the student had surreptitiously determined the contents of the "blinded" tubes before doing the new experiments. The student admitted doing so when challenged, and ORI obtained a debarment of the respondent from receiving Federal funds.
A postdoctoral fellow was observed pipetting material into labeled scintillation vials before conducting an experiment. The complainant secretly counted the vials and found they had been "spiked" with radioactive material. The respondent apparently was conducting the research with unlabeled cells and discarding them. The complainant went to the laboratory director, who set up experiments with animals deliberately mis-identified as being transgenic, but the fellow got the results that he had predicted if they were transgenic. The institution found research misconduct in this case and retracted four papers. Based on the institution's report, ORI obtained a debarment agreement.
The institution found substantial evidence of falsification of data by a graduate student who had finished a doctoral thesis. The officials delayed awarding the degree, but allowed the student a year to try to repeat the allegedly falsified results in another laboratory. ORI informed the institution that getting the expected results would not constitute proof that the original experiments were actually done, since the student might have correctly predicted the results without actually conducting the original experiments. But the institution insisted that the student have the opportunity to repeat the protocol. However, the student ultimately was unable to do so (there was evidence the student had changed the labels on the new materials, too). ORI found sufficient evidence of multiple falsifications in the student's original research to warrant debarment.
A group of postdoctoral and graduate students had individually raised concerns about some of the work that their professor did to complete the assays and report the results of the experiments that the students had initiated. So the students set up several experiments in which the biological samples were non-positive controls, but they told the professor that they were actual test samples. The professor got results that were consistent with those predicted by his theoretical model, but were impossible to achieve based on the actual samples. Unfortunately, the students did not inform the chairman, dean, or counsel in advance, and they could not prove later what the samples had contained. Although the evidence of other falsifications by the professor was sufficient for ORI to get a debarment agreement, ORI was not able to use the results of the S-UE to confirm research misconduct.
A professor and a senior scientist suspected that a graduate student had spiked biological samples before testing, to guarantee achieving the predicted results. They notified university officials, and they arranged for the student to return to their laboratory to conduct controlled, blinded experiments under their close supervision. However, because they learned later that the student could have had overnight access to the room with the "blinded" samples, the student could have tested and decoded the samples before the supervised runs. In the end, the institution found that the evidence was insufficient to conclude that the student had committed research misconduct, and ORI agreed.
A postdoctoral fellow was accused of manipulating instruments to get results that were "almost perfect" in physiological experiments on patient tissues. The laboratory chief set up experiments in which water was substituted for the biological agent in the solution that he planned for the fellow to use. When the new results came out as expected, he accused the fellow of falsifying all the results, and the fellow left the laboratory without responding. However, the investigation committee found that none of the new stock solution, made up to a standard volume, appeared to have been used. The fellow's notebooks indicated that a new vial of agent had been prepared, and the fellow testified that this new solution had been used for the repeat experiments. The institution found insufficient evidence of misconduct, and ORI agreed.
ORI concludes from these examples that set-up experiments have sometimes been problematic, especially when the members of the laboratory conducting the S-UEs have not sufficiently documented the evidence or informed institutional officials who could independently monitor or confirm the actions. However, in other cases, the S-UEs have been used successfully to confirm suspicions about research misconduct and to obtain an admission from the respondent.
(23) Assessing Research Misconduct Allegations Involving Clinical Research
An allegation of wrongdoing in research involving human subjects must be assessed to determine under which Public Health Service (PHS) regulation or policy it should be handled. For ORI, the question is whether it is an allegation of research misconduct that falls under the PHS definition in Section 93.103. The following are examples of falsification and fabrication that have formed the basis for PHS findings of research misconduct in clinical research. Generally, these incidents occurred in the context of conducting clinical research or reporting data (internally or externally), publishing data or results, or including data or research records in grant applications or progress reports.
- substituting one subject's record for that of another subject;
- falsely reporting to a data coordinating center that certain clinical trial staff, who were certified to perform the procedures on the subjects, had done so, when they had not;
- altering the dates and results from subjects' eligibility visits;
- altering the dates on patient screening logs and/or submitting the same log with altered dates on multiple occasions;
- failing to update the patient's status and representing data from prior contacts as being current;
- altering the results of particular tests on blood samples to show that the test accurately predicted a disease or relapse;
- backdating follow-up interviews to fit the time window determined by the study protocol; and
- falsifying the times that blood samples were drawn from human subjects.
- creating records of interviews of subjects that were never performed;
- making up progress notes for patient visits that never took place and inserting them into the medical record to support published and unpublished research reports; and
- preparing records for calls and follow-up contacts to subjects who had already died.