2011-22883. 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of the Assistant Secretary for Health and the Food and Drug Administration (FDA), are announcing the availability of a draft guidance entitled, “Guidance on Exculpatory Language in Informed Consent.” The draft guidance, when finalized, will represent OHRP's and FDA's current thinking on this topic and will supersede OHRP's November 15, 1996 guidance document entitled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 The draft guidance is intended primarily for institutional review boards (IRBs), investigators, sponsors, and funding agencies that may be responsible for the review, conduct, or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Submit written requests for copies of the draft Guidance on Exculpatory Language in Informed Consent document to the Division of Policy and Assurances, Office for Human Research Protections, 1101 Wootton Parkway,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 See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance document.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 [e-mail] 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 [e-mail].

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.

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.