[Federal Register Volume 79, Number 135 (Tuesday, July 15, 2014)]
[Notices]
[Pages 41291-41292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16492]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0031]


Draft Informed Consent Information Sheet: Guidance for 
Institutional Review Boards, Clinical Investigators, and Sponsors; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Informed Consent 
Information Sheet: Guidance for IRBs, Clinical Investigators, and 
Sponsors.'' The draft guidance announced in this notice is intended to 
assist institutional review boards (IRBs), clinical investigators, and 
sponsors involved in clinical investigations of FDA-regulated products 
in carrying out their responsibilities related to informed consent. The 
draft guidance provides the Agency's recommendations and requirements 
for informed consent to assure the protection of the rights and welfare 
of human subjects in clinical investigations.

DATES: Although comments on any guidance can be submitted at any time 
(see 21 CFR 10.115(g)(5)), to ensure that the Agency considers a 
comment on this draft guidance before it begins work on the final 
version of the guidance, electronic or written comments on the draft 
guidance should be submitted by September 15, 2014.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002 (1-
888-463-6332 or 301-796-3400); or the Office of Communication, Outreach 
and Development, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 
Silver Spring, MD 20993-0002 (1-800-835-4709 or 240-402-7800); or the 
Division of Industry and Consumer Education, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4622, Silver Spring, MD 20993 (1-800-638-2041 or 
301-796-7100). Send one self-addressed adhesive label to assist the 
office in processing your requests.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marsha Melvin, Office of Good Clinical 
Practice, Food and Drug Administration, 10903 New Hampshire Ave, 
Building 32, Silver Spring, MD 20993, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled: 
``Informed Consent Information Sheet: Guidance for IRBs, Clinical 
Investigators, and Sponsors.'' This draft guidance is intended to 
assist IRBs, clinical investigators, and sponsors involved in clinical 
investigations of FDA-regulated products in carrying out their 
responsibilities related to informed consent under 21 CFR part 50 by 
providing recommendations regarding the informed consent process, the 
elements of informed consent, and the documentation of informed consent 
to assure the protection of the rights and welfare of human subjects in 
clinical investigations. When finalized, this guidance will supersede 
the following Information Sheets: ``A Guide to Informed Consent'' and 
``Frequently Asked Questions'' (only the sections entitled ``Informed 
Consent Process'' and ``Informed Consent Document Content'') (September 
1998, Office of Health Affairs, Food and Drug Administration). To 
enhance human subject protection and reduce regulatory burden, the 
Department of Health and Human Services (HHS), Office for Human 
Research Protections (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 a part 
of these efforts.
    In addition, FDA acknowledges that HHS announced in 2011 that the 
Federal Government is contemplating various ways of enhancing the 
regulations overseeing research on human subjects. Before developing 
proposed changes to the regulations--which have been in place since 
1991 and are often referred to as the Common Rule--the Government 
issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking the 
public's input on an array of issues related to the ethics, safety, and 
oversight of human research. The changes under consideration can be 
found in the July 26, 2011, issue of the Federal Register in an ANPRM 
entitled ``Human Subjects Research Protections: Enhancing Protections 
for Research Subjects and Reducing Burden, Delay, and Ambiguity for 
Investigators'' (available at www.hhs.gov/ohrp/humansubjects/anprm2011page.html). FDA issues this draft guidance while the Agencies 
continue to explore potential changes to the Common Rule. To the extent 
that issues presented in this draft guidance intersect with the Common 
Rule, FDA plans to coordinate with other relevant Federal Agencies to 
facilitate consistency across policies.
    FDA is issuing this as a draft guidance because the Information 
Sheet entitled: ``A Guide to Informed Consent'' has been substantially 
revised due to changes in regulation/regulatory policy and in response 
to numerous questions about informed consent from subjects, subject 
advocates, and the research community. For example, the draft guidance 
includes a more detailed discussion of informed consent for non-English 
speaking subjects. In addition, new sections address the new element of 
informed consent for applicable clinical trials and discuss informed 
consent issues related to consent capacity, children as subjects, 
review of patient records, subjects with low literacy or numeracy, 
subjects participating in more than one clinical trial, and study 
suspension/termination. The draft guidance also explains the 
responsibilities of the IRB, investigator, sponsor, and FDA related to 
the development and review of informed consent documents.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance includes information collections provisions 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information referenced in this guidance that are related 
to IRB recordkeeping requirements under 21 CFR 56.115, which include 
the requirements for records related to informed consent, have been 
approved under OMB control number 0910-0130;

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the collections of information related to the elements of informed 
consent under 21 CFR 50.25, the documentation of informed consent under 
21 CFR 50.27, IRB written notification to approve or disapprove 
research under 21 CFR 56.109(e), and IRB continuing review under 21 CFR 
56.109(f) have been approved under OMB control number 0910-0755; the 
collection of information in 21 CFR part 312 have been approved under 
OMB control number 0910-0014; and the collections of information in 21 
CFR part 812 have been approved under OMB control number 0910-0078.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm.

    Dated: July 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16492 Filed 7-14-14; 8:45 am]
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