[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Draft Guidance on Important Considerations for When Participation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Public Health and Science, is announcing the availability of a draft
guidance document entitled, ``Guidance on Important Considerations for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is seeking comment on the draft guidance. The draft guidance document,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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled, ``Guidance on Important Considerations for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to the draft guidance document.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: [email protected]. 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 [email protected].
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]
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