[Federal Register Volume 65, Number 62 (Thursday, March 30, 2000)]
[Notices]
[Pages 16923-16924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7778]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0805]


Draft Guidance for Institutional Review Boards, Clinical 
Investigators, and Sponsors: Exception From Informed Consent 
Requirements for Emergency Research; 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 document entitled ``Guidance for Institutional 
Review Boards, Clinical Investigators, and Sponsors: Exception from 
Informed Consent Requirements for Emergency Research.'' The draft 
guidance document provides guidance for developing and implementing 
research in emergency settings when an exception from the informed 
consent requirements is requested under the Food and Drug 
Administration's (FDA's) emergency research rule.

DATES: Written comments on the draft guidance document are to be 
submitted by May 30, 2000. General comments on the agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Institutional Review Boards, Clinical 
Investigators, and Sponsors: Exception from Informed Consent 
Requirements for Emergency Research'' to the Division of Compliance 
Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs 
(ORA), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857. Send one self-addressed adhesive label to assist the office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit written comments on the draft guidance document to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Bonnie M. Lee, Division of Compliance 
Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857,301-827-0415

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance document 
entitled ``Guidance for Institutional Review Boards, Clinical 
Investigators, and Sponsors: Exception from Informed Consent 
Requirements for Emergency Research.'' In the Federal Register of 
October 2, 1996 (61 FR 51498), FDA published regulations that provide a 
narrow exception to the requirement for obtaining and documenting 
informed consent from each human subject, or his or her legally 
authorized representative, prior to initiation of an experimental 
intervention (Sec. 50.24 (21 CFR 50.24) in part 50 (21 CFR part 50)). 
The exception

[[Page 16924]]

would apply to a limited class of research activities involving human 
subjects who are in need of emergency medical intervention but who 
cannot give informed consent because of their life-threatening medical 
condition, and who do not have a legally authorized person to represent 
them. The preamble to part 50 stated that the agency intends to monitor 
and evaluate the implementation of these regulations on an ongoing 
basis. Since the effective date of these emergency research regulations 
(November 1, 1996), FDA has reviewed the efforts of sponsors, 
Institutional Review Boards, and clinical investigators to interpret 
and comply with these regulations and has determined that guidance is 
needed.
    The draft guidance document, available for public comment, 
addresses issues pertinent to the implementation of FDA's emergency 
research regulations. The draft guidance document provides guidance on 
the development and conduct of community consultation and public 
disclosure activities; the establishment of informed consent procedures 
to be used when feasible; the need for the concurrence of a licensed 
physician; use of data monitoring committees; use of independent IRB's; 
documentation of efforts to contact a subject's legally authorized 
representative or family member regarding the subject's participation 
in the study; and other aspects of the emergency research regulations.
    This draft Level 1 guidance document is being issued consistent 
with FDA's Good Guidance Practices (62 FR 8961, February 27, 1997). It 
represents the agency's current thinking on ways to effectively 
implement its emergency research regulations in order to protect the 
rights and welfare of human subjects participating in that 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. As with other guidance documents, FDA does not intend 
this document to be all-inclusive and cautions that not all information 
contained in the guidance document may be applicable to all situations.

II. Request for Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance document. Two 
copies of any comments are to be submitted, except individuals may 
submit one copy. Comments are to be identified with the docket number 
found in the brackets in the heading of this document. A copy of the 
draft guidance document and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document using 
the Internet at http://www.fda.gov/ora/compliance__ref/bimo/
default.html.

    Dated: March 21, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-7778 Filed 3-29-00; 8:45 am]
BILLING CODE 4160-01-F