[Federal Register Volume 75, Number 182 (Tuesday, September 21, 2010)]
[Notices]
[Pages 57469-57470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23517]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Guidance on Withdrawal of Subjects From Research: Data Retention
and Other Related Issues
AGENCY: Office for Human Research Protections, Office of the Assistant
Secretary for Health, Office of the Secretary, Department of Health and
Human Services.
ACTION: Notice.
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SUMMARY: The Office for Human Research Protections (OHRP), within the
Office of the Assistant Secretary for Health, is announcing the
availability of a guidance document entitled, ``Guidance on Withdrawal
of Subjects From Research: Data Retention and Other Related Issues.''
The guidance document provides OHRP's first formal guidance on this
topic. The document, which is available on the OHRP Web site at http://www.hhs.gov/ohrp/policy/subjectwithdrawal.html or http://www.hhs.gov/ohrp/policy/subjectwithdrawal.pdf, 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). The guidance document announced in this notice
finalizes the draft guidance entitled, ``Guidance on Important
Considerations for When Participation of Human Subjects in Research is
Discontinued,'' that was made available for public comment through a
notice in the Federal Register on December 1, 2008 (73 FR 72804). OHRP
received comments on the draft guidance document from 30 individuals
and organizations, and those comments were considered as the guidance
was finalized.
DATES: Comments on OHRP guidance documents are welcome at any time.
ADDRESSES: Submit written requests for a single copy of the guidance
document entitled, ``Guidance on Withdrawal of Subjects From Research:
Data Retention and Other Related Issues,'' 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 guidance document.
Submit written comments to COMMENTS ON SUBJECT WITHDRAWAL GUIDANCE,
Office for Human Research Protections, 1101 Wootton Parkway, Suite 200,
Rockville, MD 20852. Comments also may be sent via e-mail to
[email protected] or via facsimile at 240-402-2071.
FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, PhD, Office for
Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville,
MD 20852, 240-453-6900; e-mail [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
OHRP, Office of the Assistant Secretary for Health, is announcing
the availability of a guidance document entitled, ``Guidance on
Withdrawal of Subjects From Research: Data Retention and Other Related
Issues.'' The guidance document provides OHRP's first formal guidance
on this topic. The 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 guidance document applies to non-exempt human subjects research
conducted or supported by HHS. The guidance addresses the following six
topics:
(1) What does it mean when a subject withdraws from a research
study?
[[Page 57470]]
(2) May an investigator retain and analyze already collected data
about a subject who withdraws from the research or whose participation
is terminated by the investigator?
(3) Can investigators honor subjects' requests to have their data
destroyed or excluded from any analysis?
(4) Should the withdrawal of a subject from a research study be
documented?
(5) What is the relationship of this guidance to FDA's guidance on
this issue and to the HIPAA Privacy Rule?
(6) When seeking the informed consent of subjects, what should
investigators tell subjects about data retention in the event the
subjects withdraw?
Of particular importance, the guidance document clarifies that when
a subject chooses to withdraw from (i.e., discontinue his or her
participation in) an ongoing research study, or when an investigator
terminates a subject's participation in such a research study without
regard to the subject's consent, the investigator may retain and
analyze already collected data relating to that subject, even if that
data includes identifiable private information about the subject.
The guidance document announced in this notice finalizes the draft
guidance entitled, ``Guidance on Important Considerations for When
Participation of Human Subjects in Research is Discontinued,'' that was
made available for public comment through a notice in the Federal
Register on December 1, 2008 (73 FR 72804). OHRP received comments on
the draft guidance document from 30 individuals and organizations, and
those comments were considered as the guidance was finalized.
In addition to the change in the title, the final guidance document
differs from the draft guidance document that was made available for
public comment in the following three key ways:
(1) All content regarding biospecimens that was included in the
draft guidance document has been removed from the final guidance
document. This change makes the final guidance document more harmonious
with the Food and Drug Administration's (FDA's) corresponding guidance
entitled, ``Guidance for Sponsors, Clinical Investigators, and IRBs:
Data Retention When Subjects Withdraw from FDA-Regulated Clinical
Trials,'' which also focuses on data retention when subjects withdraw
from research and is silent on issues related to biospecimens.
Furthermore, research involving the banking and use of biospecimens for
research purposes is a complex, evolving area of research. OHRP
believes that guidance on the use of biospecimens obtained from
subjects who subsequently withdraw from research should be addressed in
the future by a more comprehensive guidance document that addresses
more broadly research involving biospecimens. In the meantime,
individuals with questions regarding how to handle biospecimens
obtained from subjects who subsequently withdraw from a research study
should contact OHRP by telephone at 240-453-6900 or 866-447-4777 or by
e-mail at [email protected].
(2) The final guidance document includes more examples of social
and behavioral research activities in order to emphasize that the
guidance applies to such research, in addition to its applicability to
biomedical research.
(3) The final guidance includes a recommendation that investigators
plan for the possibility that subjects will withdraw from research and
that they include a discussion of what withdrawal will mean and how it
will be handled in their research protocols and informed consent
documents. Furthermore, the final guidance addresses the question of
what investigators, when seeking the informed consent of subjects,
should tell the subjects about data retention in the event the subjects
withdraw.
For HHS-conducted or supported research that is regulated by FDA,
FDA's guidance on this issue also should be consulted. FDA's guidance
entitled, ``Guidance for Sponsors, Clinical Investigators, and IRBs:
Data Retention When Subjects Withdraw from FDA-Regulated Clinical
Trials'' can be found at http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0576-gdl.pdf.
II. Electronic Access
Persons with access to the Internet may obtain the guidance
document on OHRP's Web site at http://www.hhs.gov/ohrp/policy/subjectwithdrawal.html or http://www.hhs.gov/ohrp/policy/subjectwithdrawal.pdf.
III. Comments
Interested persons may submit comments regarding this guidance
document to OHRP at any time. Please see the ADDRESSES section for
information on where to submit written comments.
Dated: September 15, 2010.
Jerry Menikoff,
Director, Office for Human Research Protections.
[FR Doc. 2010-23517 Filed 9-20-10; 8:45 am]
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