[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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finalizes the draft guidance entitled, ``Guidance on Important 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received comments on the draft guidance document from 30 individuals 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]
BILLING CODE 4150-36-P