[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Notices]
[Pages 55390-55391]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22883]



[[Page 55390]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. HHS-OPHS-2011-0014]


Guidance on Exculpatory Language in Informed Consent, Draft

AGENCY: Office for Human Research Protections, Office of the Assistant 
Secretary for Health, Office of the Secretary, and the Food and Drug 
Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Office for Human Research Protections (OHRP), Office of 
the Assistant Secretary for Health and the Food and Drug Administration 
(FDA), are announcing the availability of a draft guidance entitled, 
``Guidance on Exculpatory Language in Informed Consent.'' The draft 
guidance, when finalized, will represent OHRP's and FDA's current 
thinking on this topic and will supersede OHRP's November 15, 1996 
guidance document entitled ```Exculpatory Language' in Informed 
Consent'' and question number 52 in FDA's January 1998 guidance 
entitled, ``Institutional Review Boards Frequently Asked Questions--
Information Sheet Guidance for Institutional Review Boards and Clinical 
Investigators.'' The draft guidance is intended primarily for 
institutional review boards (IRBs), investigators, sponsors, and 
funding agencies that may be responsible for the review, conduct, or 
oversight of human subject research conducted or supported by HHS or 
regulated by FDA.

DATES: Submit written comments by November 7, 2011.

ADDRESSES: Submit written requests for copies of the draft Guidance on 
Exculpatory Language in Informed Consent document 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INFORMATION section for information on electronic access to the draft 
guidance document.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 identified by docket ID number HHS-OPHS-
2011-0014, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Enter the above docket ID number in the ``Enter Keyword or ID field and 
click on ``Search.'' On the next page, click the ``Submit a Comment'' 
action and follow the instructions.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Irene Stith-Coleman, PhD., Office for Human Research 
Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
    Comments received, including any personal information, will be 
posted without change to http://www.regulations.gov.

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 Irene.StithColeman@hhs.gov or Sara 
Goldkind, M.D., Office of Good Clinical Practice, 10903 New Hampshire 
Ave., WO32-5110, Silver Spring, MD 20993, 301-796-8342; e-mail 
Sara.Goldkind@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    OHRP and FDA are announcing the availability of a draft guidance 
entitled, ``Guidance on Exculpatory Language in Informed Consent.'' The 
draft guidance is intended primarily for institutional review boards 
(IRBs), investigators, sponsors, and funding agencies that may be 
responsible for the review, conduct, or oversight of human subject 
research conducted or supported by HHS or regulated by FDA. This 
guidance, which is available on the OHRP Web site at http://www.hhs.gov/ohrp/newsroom/rfc/index.html and the FDA Web site at http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm, is intended to assist IRBs in making the required 
regulatory determinations when reviewing research under 21 CFR 50.20 
and 45 CFR 46.116 by providing recommendations regarding what language 
is considered to be exculpatory under HHS and FDA regulations, and thus 
inappropriate to include in informed consent. The draft guidance should 
also help clinical investigators and sponsors better understand the 
regulatory requirements as to what language is permissible to include 
in informed consent. The draft guidance, when finalized, will represent 
OHRP's and FDA's current thinking on this topic and will supersede 
OHRP's November 15, 1996 guidance document entitled, `` `Exculpatory 
Language' in Informed Consent'' and question number 52 in FDA's January 
1998 guidance entitled, ``Institutional Review Boards Frequently Asked 
Questions--Information Sheet Guidance for Institutional Review Boards 
and Clinical Investigators.''
    To enhance human subject protection and reduce regulatory burden, 
OHRP and FDA have been actively working to harmonize the agencies' 
regulatory requirements and guidance for human subject research. This 
draft guidance document was developed as part of these efforts. OHRP 
and FDA believe that it will be most helpful to the regulated community 
to issue a joint guidance document which will clearly demonstrate the 
agencies' harmonious approach to the topic of what language could be 
considered exculpatory and thus prohibited in informed consent versus 
what language could be acceptable in informed consent.
    OHRP and FDA are issuing this as draft guidance because the 
agencies have revised and clarified what constitutes exculpatory 
language in informed consent and therefore prohibited under 21 CFR 
50.20 and 45 CFR 46.116 in response to numerous questions and comments 
from the IRB and research communities. The draft guidance includes a 
detailed discussion about what OHRP and FDA consider to be exculpatory 
language, examples of informed consent language that OHRP and FDA would 
consider to be acceptable, and examples of informed consent language 
that OHRP and FDA would consider to be exculpatory.
    This draft guidance is part of the Information Sheet Guidance 
Initiative, announced in the Federal Register of February 3, 2006 (71 
FR 5861), which describes FDA's intention to update the process for 
developing, issuing, and making available guidances intended for IRBs, 
clinical investigators, and sponsors. Known as ``Information Sheets,'' 
these guidances have provided recommendations to IRBs, clinical 
investigators, and sponsors to help them fulfill their responsibilities 
to protect human subjects who participate in research regulated by the 
FDA. The Information Sheet Guidance Initiative is intended to ensure 
that the Information Sheets are updated, consistent with the FDA's good 
guidance practices (GGPs). As part of the initiative, which will be 
ongoing, the agency plans to rescind Information Sheets that are 
obsolete, revise and reissue guidances that address current issues, and 
develop new guidance documents as needed.
    The draft guidance is being issued consistent with FDA's GGPs 
regulation (21 CFR 10.115). The draft guidance, when finalized, will 
represent OHRP's and FDA's current thinking on this topic. It does not 
create or confer any rights for or on any person and does not operate 
to bind OHRP or FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

[[Page 55391]]

II. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.regulations.gov, http://www.hhs.gov/ohrp/newsroom/rfc/index.html, or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.

III. Request for Comments

    OHRP and FDA are making their joint draft guidance document 
available for public comment. The guidance document will be finalized 
and issued after the public comments have been considered.

    Dated: September 1, 2011.
Jerry Menikoff,
Director, Office for Human Research Protections.
David Dorsey,
Acting Associate Commissioner for Policy and Planning, U.S. Food and 
Drug Administration.
[FR Doc. 2011-22883 Filed 9-6-11; 8:45 am]
BILLING CODE 4150-36-P