[Federal Register: August 29, 2006 (Volume 71, Number 167)]
[Notices]               
[Page 51198-51199]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au06-48]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0331]

 
Draft Guidance for Institutional Review Boards, Clinical 
Investigators, and Sponsors; Exception from Informed Consent 
Requirements for Emergency Research

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availability of a draft guidance entitled ``Guidance for Institutional 
Review Boards, Clinical Investigators, and Sponsors; Exception from 
Informed Consent Requirements for Emergency Research.'' This draft 
guidance, when finalized, is intended to assist Institutional Review 
Boards (IRBs), clinical investigators, and sponsors in the development 
and conduct of emergency research.The draft guidance

[[Page 51199]]

also describes the additional specific human subject protection 
requirements for emergency research. Elsewhere in this issue of the 
Federal Register, FDA is announcing a public hearing on emergency 
research conducted without informed consent under FDA regulations.

DATES: Submit written or electronic comments on the draft guidance by 
October 30, 2006. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Policy (HF-11), Office of the Commissioner, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. Submit phone requests to 800-835-4709 or 301-
827-1800. Submit written comments on the draft guidance to the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 

INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Carolyn Hommel, Good Clinical Practice 
Program (HF-34), Food and Drug Administration, 5600 Fishers Lane 
Rockville, MD 20857, 301-827-3340.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Guidance for Institutional Review Boards, Clinical Investigators, and 
Sponsors; Exception from Informed Consent Requirements for Emergency 
Research.'' This draft guidance was developed to assist IRBs, clinical 
investigators, and sponsors in the development and conduct of emergency 
research, that is, research in emergency settings when an exception 
from the informed consent requirements is requested under FDA's 
emergency research regulation. Further, the draft guidance describes 
the additional specific human subject protection requirements for 
emergency research, such as community consultation and public 
disclosure activities, the need for the concurrence of a licensed 
physician, use of data monitoring committees, use of independent IRBs, 
and the documentation of efforts to contact a subject's legally 
authorized representative or family member regarding the subject's 
participation in the study.
    In addition to the draft guidance, FDA is holding a public hearing 
on emergency research conducted without informed consent under FDA 
regulations. The public hearing is designed to solicit the views of 
individuals and groups affected by challenges encountered in the 
conduct of emergency research in the absence of informed consent, 
including patient advocacy groups, individuals who have participated in 
clinical trials, IRB members, sponsors, clinical investigators, medical 
societies, ethicists, and other interested parties. FDA will consider 
comments and suggestions received at the hearing together with any 
comments received on the draft guidance to determine whether the 
current framework is adequate for the ethical conduct of emergency 
research, or whether modifications would be appropriate.
    Under the regulations in 21 CFR 50.24, and the conforming 
amendments contained in 21 CFR parts 56, 312, 314, 601, 812, and 814, 
an exception may be requested from the requirement to obtain informed 
consent from each subject, or the subject's legally authorized 
representative, prior to enrollment in a clinical investigation. The 
narrow exception applies to emergency research for which, among other 
things, the following conditions exist: (1) An investigational new drug 
application (IND) or investigational device exemption application (IDE) 
is required; (2) that involves human subjects who have a life-
threatening medical condition (for which available treatments are 
unproven or unsatisfactory); (3) that involves subjects who because of 
their medical condition (e.g., unconsciousness) cannot give informed 
consent; and (4) where, to be effective, the intervention must be 
administered before informed consent from the subjects' legally 
authorized representative is feasible. Studies involving an exception 
from the general requirement of informed consent may proceed only after 
a sponsor has received prior written permission from FDA, and the IRB 
has found and documented that specific conditions have been met.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on the 
exception from informed consent requirements for emergency research. 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 refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 in part 56 (21 CFR part 56) have been 
approved under OMB control number 0910-0130, the collections of 
information in part 312 (21 CFR part 312) have been approved under OMB 
control number 0910-0014, and the collections of information in part 
812 (21 CFR part 812) have been approved under OMB control number 0910-
0078. Modifications to these approved information collection 
requirements are underway or will be made at the time that each 
information collection is renewed. The agency believes that this is 
appropriate because this guidance has only a minor impact on these 
existing collections of information.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www
.fda.gov/ohrms/dockets/default.htm.

    Dated: August 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14262 Filed 8-25-06; 8:45 am]

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