[Federal Register: May 18, 1994]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Office of the Assistant Secretary for Health; Privacy Act of 1974;
Altered System of Records
AGENCY: Public Health Service, HHS.
ACTION: Notification of an altered system of records.

SUMMARY: In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing a notice of a proposal to alter system of records 09-37-0151, Public Health Service ALERT Records Concerning Individuals Found to Have Committed Scientific Misconduct in PHS Sponsored Research, HHS/OASH/ORI. This system of records has been transferred from the National Institutes of Health to the Office of Research Integrity, Office of the Assistant Secretary for Health, Public Health Service.

The purpose of altering this system of records is to automate the system of records so that storage will be on computer disks as well as hard copy. In addition, ORI is proposing to maintain the social security numbers of the individuals in the system of records solely to confirm the identify of the subjects of the records.

DATES: PHS invites interested persons to submit comments on the proposed alterations on or before June 27, 1994. PHS has sent a Report of Altered System to the Congress and to the Office of Management and Budget on May 6, 1994. The alteration of this system of records will be effective 60 days from the date submitted to OMB, unless PHS receives comments which result in a contrary determination.

ADDRESS: Comments should be addressed to the ORI Privacy Act Officer at the address listed below. Comments received will be available for inspection from 9 a.m. to 3 p.m.

FOR FURTHER INFORMATION CONTACT:

Privacy Act Officer, Office of Research Integrity, Rockwall II, suite 700,
5515 Security Lane, Rockville, MD 20852.

SUPPLEMENTARY INFORMATION: PHS proposes to alter this system of  records, 09-37-0151, ALERT Records Concerning Individuals Found to Have Committed Scientific Misconduct in PHS Sponsored Research, HHS/OASH/ORI, principally by changing the method of Storage of the records from hard copy to one that includes storage on computer disks.

This system was maintained by NIH. The system name has been changed to more accurately describe the records in the system. The number and title has been changed from 09-25-0151, Administration: ALERT Records Concerning Individuals under Investigation for Possible Misconduct in Science or Subject to Sanction for Such Misconduct to "09-37-0151. ALERT Records Concerning Individuals Found to Have Committed Scientific Misconduct in PHS Sponsored Research."

PHS also proposes to maintain the Social Security numbers of the subjects of the records. The character, scope and operation of the system will remain the same. The Division of Policy and Education, ORI will continue to maintain this system of records and will control disclosures, as appropriate.

The change in the method of storage will provide a more effective way for ORI to perform its responsibilities in the award of funds for scientific research and development. Automating the system will provide more effective means of communicating necessary information between agencies. Social Security numbers will be used solely for the purpose of correctly identifying the subjects of the investigation. In those instances when the SSN is not available, the date of birth will be utilized.

This system has had minor modifications since the last publication of the system notice. These changes were to the System Name and Number, Categories of Individuals Covered by the System, Categories of Records in the System, Purposes of the System, Safeguards, System Manager(s) and Address. They are as follows:

The change in the System Number and Name described above was made to more accurately describe the records in the system.

The Categories of Individuals covered by the system has been narrowed. The PHS ALERT no longer contains the names of individuals who are subject to an investigation of scientific misconduct or where there has been a determination that misappropriation of federal research funds had occurred.

Individuals may be the subject of the records if they fall within the following categories:

(1) ORI has made a finding of scientific misconduct concerning the individual; (2) the individual is the subject of an administrative action imposed as a result of a determination that scientific misconduct has occurred; (3) the Individual has agreed to voluntary corrective action as result of an investigation of scientific misconduct; (4) ORI has received a report of an investigation by an institution in which there was a finding of scientific misconduct concerning the individual and ORI has determined that PHS has jurisdiction; (5) FDA has determined that there is sufficient reason to believe that official action is warranted against the individual for violation of an FDA regulation governing research.

In addition, the following changes have been made to the system of records:

The Categories of Records in the system has been changed to more accurately reflect the information that is maintained in the system.

The Purpose section has been changed in a way that it remains compatible with the previous published purposes. We have added a section that deals with those instances in which the information in the system may be used.

The Safeguards section has been altered as necessary to assure that the records are maintained in a secure manner compatible with their content and purposes.

The System Manager and address section has been changed to reflect changes in the internal organizational structure of the ORI and its procedures.

Additionally, PHS has made a number of editorial changes throughout the system notice to clarify and to accommodate normal updating changes.

The four routine uses for this system are compatible with the stated purposes of the system. The first routine use allows referral to the appropriate official(s) of the awardee institution or organization when in connection with an ORI review of an institution's investigation or finding of scientific misconduct by an individual employed by or affiliated with the institution or organization, a PHS agency is taking an action affecting research and research training awards to that institution or organization. The second routine use proposed for this system permits disclosure to a congressional office to allow the subject individuals to obtain assistance from their representatives in Congress, should they so desire. Such disclosure would be made only pursuant to a request from the subject of the record. The third routine use allows disclosure to the Department of Justice, a court, or administrative tribunal in the event of litigation. The fourth routine use allows disclosure by way of an electronic bulletin board to outside organizations and institutions of investigative findings and administrative actions when scientific misconduct is found. This disclosure will provide information that will enable the institutions and organizations to enforce PHS administrative actions within their institution or organization.

This system notice is written in the present, rather than the future tense, to avoid the unnecessary expenditure of public funds to republish the notice after the notice becomes effective.

Dated: May 9, 1994.

Wilford J. Forbush, Director, Office of Management.
09-37-0151

Public Health Service ALERT Records Concerning Individuals Found to Have Committed Scientific Misconduct in PHS Sponsored Research, HHS/OASH/ORI.

None.

Office of Research Integrity, Public Health Service, Rockwall II, suite 700, 5515 Security Lane, Rockville, Maryland 20852.

Subjects may include (1) researchers currently or formerly employed by the Federal Government; (2) individuals being considered for appointment to Public Health Service (PHS) advisory committees; (3) investigators on research grants, fellowships, cooperative agreements, or contracts awarded by any PHS agency, ("Investigators" may include principal investigators, co-investigators, program directors, trainees, recipients of career awards or fellowships, or other individuals who conduct or are responsible for research or research training funded by PHS); (4) research investigators, such as guest workers, not employed by PHS but who conduct research in PHS facilities or are closely associated with research conducted by PHS; (5) other individuals, such as subgrantees, subcontractors or assistants on research or research training grants, contracts or cooperative agreements, who by training, experience, occupation or other qualifications are potential candidates for research or research training grants, contracts, cooperative agreements or other benefits.

Such individuals would be subjects of records in this system if they fall within the following categories:

(1) ORI has made a finding of scientific misconduct concerning the individual; 

(2) The individual is the subject of administrative actions imposed as a result of a determination that scientific misconduct has occurred. Such administrative actions include but are not limited to: (a) Restrictions on specific activities or expenditures under an active award, (b) a requirement for special reviews of all requests for funding; (C) actions affecting eligibility for appointment as an individual or member of a committee providing advice to PHS; (d) debarment from participation in covered transactions which may include grants, contracts, and cooperative agreements; (e) suspension or termination of an active award; (f) special restrictions on regulated research, such as disqualification by the Food and Drug Administration (FDA) from use of investigational drugs or other products, or other restrictions place on such use; and (g) termination of employment or other disciplinary action against an employee of PHS.

(3) The individual has agreed to a voluntary corrective action as a result of an investigation of scientific misconduct.

(4) ORI has received a report of an investigation by an institution in which there is a finding of scientific misconduct concerning the individual and ORI has determined that PHS has jurisdiction.

(5) The FDA has determined after an investigation that there is sufficient reason to believe that official action is warranted against the individual for violation of FDA regulations governing research.

This system contains records relating to findings of scientific misconduct and to actions that PHS has taken in connection with such findings including voluntary exclusion agreements. This information is limited to (1) the ORI Case Reference number, (2) the name of the subject of the investigation, (3) the individual's social security number, (4) the date of birth of the individual, (5) the type of misconduct, (6) the institution that conducted the investigation, (7) a summary of the administrative actions imposed as a result of the misconduct and the effective and expiration dates, (8) the involved PHS support and the involved PHS agencies or funding components including identification of the specific office responsible for the investigation, (9) the record creation date, and (10) the last entry date. Scientific misconduct is defined as fabrication, falsification, plagiarism or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting or reporting research. It does not include honest error or differences in interpretations or judgement of data.

Authority for this system comes from the legislation which authorizes PHS to make awards for biomedical and behavioral research and research training, and from PHS's concomitant responsibility to assure both that funds disbursed under awards are spent for authorized purposes and that recipients of such funds conform to all appropriate laws and regulations. (5 U.S.C. 301; 29 U.S.C. 669; 42 U.S.C. 241, 242b, 242c, 2421, 242m, 247c, 281-289h, 285n, 285n-2, 285o, 285o-2, 300a-2, 300b-1-b-3, 300c-12, 300z-7, as these provisions relate to biomedical and behavioral research and research training).

This system of records enables PHS agencies to discharge effectively their responsibilities in the award and administration of research and training grants, cooperative agreements and contracts, while protecting the privacy and other rights of individuals. The PHS ALERT system is used to collect, control and disseminate to PHS agency officials on a need-to-know basis information that: (1) The PHS has made a finding of scientific misconduct or (2) the PHS has imposed administrative action(s) at the conclusion of an investigation for scientific misconduct; or (3) has received a report of an investigation by an institution in which there is a fining of scientific misconduct and ORI has determined that the PHS has jurisdiction, or (4) the FDA has determined after an investigation that there is sufficient reason to believe that official action is warranted against such persons for violation of FDA regulations governing research or (5) an individual has agreed to a voluntary corrective action relative to findings of scientific misconduct.

Specifically,

(1) PHS records the existence of such administrative actions in the system so that PHS agencies can track and implement the administrative actions, for example by refusing to accept an application or proposal from a debarred person. In addition, PHS informs members of technical merit review groups of actions taken if the disclosure is necessary to ensure an unbiased review by providing an accurate account of the case, for example, when information concerning the conduct investigated has been disclosed by other sources, such as the press or other communications media.

(2) The ORI will transmit the names and, if available, the SSN or date of birth of those individuals against whom there was a finding of scientific misconduct and administrative action(s) to the Division of Research Grants (DRG), National Institutes of Health (NIH) and to other appropriate officials within the PHS. DRG will use this file to screen automatically PHS research contract and grant award records; applications for PHS funding of research grants, fellowships and cooperative agreements; and nominations/appointments to PHS advisory committees.

(3) If the ORI's review of the institutional investigation findings or the Departmental Appeals Board (DAB) hearing on the findings fail to confirm misconduct (a) the individual's name is removed from the PHS ALERT system of records and the individual is notified in writing; (b) responsible PHS agency officials are notified of the outcome; (c) if any interim administrative actions had been imposed, they are withdrawn.

(4) Appropriate agency officials are notified of additions to the PHS ALERT for the purpose of communicating and disseminating information about scientific misconduct.

(5) PHS Committee Management Officers are notified of administrative actions restricting or prohibiting PHS advisory service in order to assist in the appointment of candidates for the advisory committees.

(6) Upon request, the System Manager may disclose information to PHS agency officials who are considering hiring a subject individual.

(7) Upon request, the System Manager may disclose information in the PHS ALERT to contracting officers in order to assist them in the award of a contract.

1. PHS may notify responsible officials of the awardee institutions or organizations when, in connection with an ORI review of an institution's investigation or a finding of scientific misconduct by an individual employed by or affiliated with the institution or organization, a PHS agency takes an action affecting research and research training awards to the institution or organization. Information disclosed will be limited to the name of the subject individual, description of the action and the reason for it.

2. Disclosure may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of that individual.

3. Disclosure may be made from this system of records to the Department of Justice, or to a court or other tribunal, when (a) HHS, or any component thereof; or (b) any HHS employee in his or her official capacity or (c) any HHS employee in his or here individual capacity where the Department of Justice, (or HHS, where it is authorized to do so) has agreed to represent the employee; or (d) the United States or any agency thereof where HHS determines that the litigation is likely to affect HHS or any of its components is a party to litigation, and HHS determines that the use of such records by the Department of Justice, court or other tribunal is relevant and necessary to the litigation and would help in the effective representation of the governmental party, provided, however, that in each case, HHS determines that such disclosure is compatible with the purpose for which the records were collected.

4. Disclosure may be made via an electronic bulletin board to institutions, organizations and persons connected to the electronic bulletin boards outside the DHHS and components within the DHHS of the names of individuals against whom there was a finding of scientific misconduct and an imposition of administrative actions including voluntary exclusion agreements. The information will enable applicant institutions to enforce PHS administrative actions within their institutions.

Records are stored in file folders and computer disks.

Records are retrieved by name of the individual who is the subject of an ORI investigation or review of an institution's investigation or subject to an administrative action.

1. Authorized users: Records are available only to the system manager, Director of Division of Policy and Education (DPE), ORI, or designee. Any disclosure to other individuals must be authorized by the Director, DPE.

2. Procedural safeguards: Access to records is strictly controlled by the system manager and the officials specified under "Authorized Users." Individuals who receive disclosures from this system before there is a final agency finding, are informed that the information is confidential.

3. Physical safeguards: Sensitive records stored in file folder and on computer discs are kept in locked file cabinets in areas which are locked when not in use. Special measures, commensurate with the sensitivity of the records, are taken to prevent unauthorized copying or disclosure of records.

These practices are in compliance with the standards of chapter 45-13 of the HHS General Administration Manual, "Safeguarding Records contained in Systems of Records," supplementary Chapter PHS hf: 45-13, and the Department's Automated Information System Security Handbook.

Records are retained and disposed of in accordance with the OASH Records Control Schedule. If an institutional finding of scientific misconduct is reversed by ORI or DAB, the PHS ALERT records are destroyed. If an investigation results in an official administrative action or voluntary exclusion agreements, a record of such administrative action is maintained for the duration of the administrative action and then destroyed.

PHS ALERT System Manager, Division of Policy and Education, Office of Research Integrity, Rockwall II, suite 700, 5515 Security Lane, Rockville, MD 20852.

Individuals are routinely notified in writing when they become the subject of a record in this system, unless a law enforcement agency has instructed PHS not to do so. Subject individuals are also informed routinely when their records are deleted from the system.

Individuals may write to the system manager at the address above and provide their full name and the name of this Privacy Act system of records to request a copy of the record. Requesters should also reasonably specify the record contents being sought. Individuals may also request a listings of accountable disclosures that have been made of theirrecords, if any.

Individuals may write to the system manager and reasonably identify the record and the information being contested; and state the reasons for requesting the change, along with supporting information to show that the record is untimely, incomplete, irrelevant, or inaccurate. The right to contest records is limited to information which is incomplete, irrelevant, incorrect or untimely (obsolete).

Information in these records is obtained from awardee institutions or organizations, and PHS agencies and organizations responsible for investigations.