[Federal Register Volume 73, Number 231 (Monday, December 1, 2008)]
[Notices]
[Pages 72804-72805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28369]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Draft Guidance on Important Considerations for When Participation 
of Human Subjects in Research Is Discontinued

AGENCY: Department of Health and Human Services, Office of the 
Secretary, Office of Public Health and Science, Office for Human 
Research Protections.

ACTION: Notice.

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SUMMARY: The Office for Human Research Protections (OHRP), Office of 
Public Health and Science, is announcing the availability of a draft 
guidance document entitled, ``Guidance on Important Considerations for 
When Participation of Human Subjects in Research is Discontinued,'' and 
is seeking comment on the draft guidance. The draft guidance document, 
when finalized, would provide OHRP's first formal guidance on this 
topic. The draft document, which is available on the OHRP Web site at 
http://www.hhs.gov/ohrp/requests/, is intended primarily for 
institutional review boards (IRBs), investigators, and funding agencies 
that may be responsible for the review or oversight of human subject 
research conducted or supported by the Department of Health and Human 
Services (HHS). OHRP will consider comments received before issuing the 
final guidance document.

DATES: Submit written comments by January 30, 2009.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled, ``Guidance on Important Considerations for 
When Participation of Human Subjects in Research is Discontinued,'' to 
the Division of Policy and Assurances, Office for Human Research 
Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Send 
one self-addressed adhesive label to assist that office in processing 
your request, or fax your request to 301-402-2071. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the draft guidance document.
    You may submit comments by any of the following methods:
     E-mail: discontinueparticipation@hhs.gov. Include 
``Guidance on Discontinuation of Subject Participation'' in the subject 
line.
     Fax: 301-402-2071.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Michael A. Carome, M.D., Captain, U.S. Public Health 
Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
    Comments received within the public comment period, including any 
personal information, will be made available to the public upon 
request.

FOR FURTHER INFORMATION CONTACT: Michael A. Carome, M.D., Captain, U.S. 
Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, 
Rockville, MD 20852, 240-453-6900; e-mail Michael.Carome@hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The OHRP, Office of Public Health and Science, is announcing the 
availability of a draft guidance document entitled, ``Guidance on 
Important Considerations for When Participation of Human Subjects in 
Research is Discontinued.'' The draft guidance document, when 
finalized, would provide OHRP's first formal guidance on this topic. 
The draft document is intended primarily for IRBs, investigators, and 
funding agencies that may be responsible for the review or oversight of 
human subject research conducted or supported by HHS.
    The proposed guidance document would apply to non-exempt human 
subjects research conducted or supported by HHS. It would provide 
guidance on important considerations for when participation of human 
subjects in research is discontinued, either because a subject 
voluntarily chooses to discontinue participation during the course of 
the research, or because an investigator terminates a subject's 
participation in the research without regard to the subject's consent. 
In particular, the proposed guidance addresses the following topics:
    (1) What does the word participation, as used in HHS regulations at 
45 CFR part 46, subpart A, mean?
    (2) What does discontinuation of a subject's participation in 
research mean?
    (3) The distinction between a complete versus a partial 
discontinuation of a subject's participation in research.
    (4) Clarification that investigators may continue to analyze 
already collected individually identifiable private information about a 
subject even when the subject's participation has been completely 
discontinued.
    (5) Considerations regarding the discontinuation of a subject's 
participation in emergency research for which the requirements for 
obtaining informed consent were waived by the IRB.
    (6) Clarification that research can continue to involve human 
subjects even when the participation of all subjects has been completed 
or discontinued.
    (7) Recommendations for documenting the discontinuation of 
subjects' participation in research.
    OHRP notes that the Food and Drug Administration (FDA) is 
publishing elsewhere in this issue a notice announcing the availability 
of a final guidance document entitled ``Guidance for Sponsors, Clinical 
Investigators, and IRBs: Data Retention When Subjects Withdraw from 
FDA-Regulated Clinical Trials.'' OHRP believes the interpretations 
provided in the proposed draft guidance are harmonious with those 
provided in FDA's final guidance document. In particular, FDA's 
guidance document explains that under applicable FDA law and 
regulations, data collected on study subjects enrolled in an FDA-
regulated clinical trial up to the time of subject withdrawal must 
remain in the trial database in order for the study to be 
scientifically valid. Likewise, OHRP's proposed draft guidance 
clarifies that when a subject informs an investigator of his/her 
decision to discontinue participation in research, or an investigator 
decides to terminate a subject's participation regardless of the 
subject's consent, the investigator may continue to analyze already 
collected individually identifiable private information about that 
subject. In addition, OHRP believes that its proposed draft guidance 
document is consistent with the HIPAA Privacy Rule (45 CFR part 160 and 
Subparts A and E of 56 CFR part 164), where applicable. The Privacy 
Rule gives an individual the right to revoke Authorization in writing, 
except to the extent a covered entity has taken action in reliance on 
the Authorization. In the context of research, this reliance exception 
permits the continued use and disclosure of protected health 
information already obtained pursuant to the Authorization prior to its 
revocation, to the extent necessary to protect the integrity of the 
research study.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
document on OHRP's Web site at http://www.hhs.gov/ohrp/requests/.

[[Page 72805]]

III. Request for Comments

    OHRP is making its draft guidance document available for public 
comment. OHRP's guidance document will be finalized and issued after 
the public comments have been considered.

    Dated: November 21, 2008.
Melody H. Lin,
Deputy Director, Office for Human Research Protections.
 [FR Doc. E8-28369 Filed 11-28-08; 8:45 am]
BILLING CODE 4150-36-P