[Federal Register Volume 71, Number 167 (Tuesday, August 29, 2006)]
[Notices]
[Pages 51198-51199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14262]
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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Draft Guidance for Institutional Review Boards, Clinical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availability of a draft guidance entitled ``Guidance for Institutional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 This draft
guidance, when finalized, is intended to assist Institutional Review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and conduct of emergency research.The draft guidance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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Policy (HF-11), Office of the Commissioner,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 Submit written comments on the draft guidance to the Division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://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INFORMATION section for electronic access to the draft guidance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FDA is announcing the availability of a draft guidance entitled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://www.fda.gov/cder/guidance/index.htm or 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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