59 FR 36717 (FINAL RULE) SORN 09-37-0021

Federal Register

Department of Health and Human Services (HHS)

Office of the Secretary of Health and Human Services

45 CFR Part 5b
Privacy Act; Exempt System

Date: July 19, 1994

Action: Final rule.

Summary: The Department of Health and Human Services (HHS) is exempting a proposed system of records, 09-37-0021, "Public Health Service Records Related to Investigations of Scientific Misconduct, HHS/OASH/ORI," from certain requirements of the Privacy Act to protect records compiled during investigations of scientific misconduct and other related decision records leading to the investigation and to protect the identity of confidential sources in such investigations.

Effective Date: August 18, 1994.

For Further Information Contact: Barbara Bullman, J.D. (301) 443-5300.

Supplementary Information: In 1989, the Public Health Service (PHS) established two offices, the Office of Scientific Integrity Review (OSIR) and the Office of Scientific Integrity (OSI), to address matters relating to scientific misconduct in the course of research funded by the Public Health Service (54 FR 11080, March 16, 1989). The OSIR and OSI were abolished recently and their functions transferred to the Office of Research Integrity (ORI) (57 FR 24262-3, June 8, 1992).

The records in the ORI contain information obtained prior to, during, and following investigations of scientific misconduct. The records are located in the ORI, in the PHS Agency Misconduct Program Officers' files and in PHS Agency senior intramural research managers' offices. The system also contains records that were transferred to ORI from the other offices which had primary responsibility for misconduct functions prior to ORI's establishment. The PHS is preparing to organize and operate these records as a "system of records" as defined by the Privacy Act. This system will be published so that the system becomes final on or after the date this rule becomes final.

Section 552a(k)(2) of the Privacy Act provides that an agency head may exempt a system of records from certain provisions of the Act, if the system of records contains investigatory material compiled for law enforcement purposes. If the records result in a denial of any right, privilege, or benefit to an individual, that individual would be entitled by Federal law to access the file, except for that information which would reveal a confidential source who was provided information under an express promise of confidentiality. Further, section 552a(k)(5) permits an agency to exempt a system of records which is comprised of investigatory material for use in determining suitability, eligibility, or qualifications for Federal civilian employment or financial assistance, but only to the extent that the exemption is required to prevent revealing a confidential source.

On June 12, 1992, the Secretary published a proposed rule in the Federal Register to exempt the ORI-related system of records from certain provisions of the Privacy Act (57 FR 25005). The comment period was open through July 13, 1992. Three responses were received that addressed the exemptions. The comments were from one institutional representative and two representatives of professional associations. PHS has also considered comments received from members of the PHS Advisory Committee on Scientific Integrity.

In general, these comments opposed withholding from the respondent the identity of individuals who provide information on allegations of misconduct under an express promise of confidentiality pursuant to exemptions (k)(5) and (k)(2). The comments indicated that the accused had a right to know the identity and source of the accusations and that this right outweighed the need to protect the identity of the individuals providing such information. In addition, one of the commenters believed that the subject of an investigation should have access to all the records in the file prior to a determination of misconduct.

After considering the comments, PHS believes that the exemptions are necessary to carry out its responsibilities effectively. It is essential to the credibility and effectiveness of the ORI that ORI be able to maintain the confidentiality of individuals providing information pertinent to scientific misconduct cases. In certain instances, sources of information necessary for a thorough investigation may be reluctant to provide sensitive information unless they can be assured that their identities will not be revealed. In addition, the exemptions are necessary to prevent premature disclosure of records which may impede the investigation. In practice, the respondent during the course of the investigation has an opportunity to be interviewed by ORI on matters related to the alleged or apparent incidents of research misconduct. The interviews are transcribed and a copy provided to the respondent. In addition, the respondent may have (1) Reasonable access to copies of any research data under review and (2) an opportunity to submit information and evidence and obtain a copy of the draft investigative report to comment on.

Other Federal agencies that conduct investigations into violations of law or regulations have established systems that are exempt from the access, amendment and certain other provisions permitted by the exemption provisions of the Privacy Act. PHS believes that the (k)(2) and (k)(5) exemptions are essential to assure that the investigative files will not be disclosed inappropriately. Except for information that would reveal the identity of a confidential source, the exemptions will not prohibit a respondent from having a reasonable opportunity of obtaining access to his or her file in those cases in which a finding of scientific misconduct has become final and an administrative action has been imposed.

There is no substantive difference between the proposed rule and the final rule. Accordingly, the Department is exempting this system under paragraphs (k)(2) and (k)(5) of the Privacy Act from the notification, access, correction, and amendment provisions of the Privacy Act (paragraphs (c)(3), (d), (e)(4) (G) and (H), and (f)). However, consideration will be given on a case-by-case basis to requests for access, notification, and corrections which are addressed to the system manager.

Impact Analyses

The Department has determined that the amendment to exempt a system of records from certain requirements of the Privacy Act is not a major rule within the meaning of Executive Order 12291 and it will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act. The rule affects only a small number of research grants funded by the PHS as compared to the total number awarded annually. Finally, this rule does not impose any new information collection requirement under the Paperwork Reduction Act.

List of Subjects in 45 CFR Part 5b


For the reasons set out in the preamble, title 45, part 5b is amended as set forth below:

Dated: June 30, 1994.
Assistant Secretary for Health.

Approved: July 5, 1994.
Secretary, Health and Human Services.

Part 5b-Privacy Act Regulations

1. The authority citation for part 5b is unchanged and reads as follows:

Authority: 5 U.S.C. 301, 5 U.S.C. 552a.

2. In part 5b, § 5b.11 is amended by adding paragraph (b)(2)(vii) as follows:

§ 5b.11 -- Exempt systems.

* * * * *

(b) * * *

(2) * * *

(vii) Pursuant to subsections (k)(2) and (k)(5) of the Act:

Public Health Service Records Related to Investigations of Scientific Misconduct, HHS/OASH/ORI.

[FR Doc. 94-17482 Filed 7-18-94; 8:45 am]
Billing Code 4160-17-M

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