[Federal Register Volume 60, Number 143 (Wednesday, July 26, 1995)]
[Notices]
[Pages 38353-38354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18334]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service


Action Related to Emergency Research Activity

agency: Public Health Service, HHS.

action: Notice.

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summary: The Public Health Service is announcing an action related to 
the applicability of the Title 45 CFR Part 46 (protection of human 
subjects) requirement for obtaining and documenting informed consent 
for a specific research activity. The purpose of this action is to 
invoke 45 CFR 46.101(i) related to an NIH funded research project: 
``National Acute Brain Injury Study: Hypothermia.'' This important and 
necessary research needs to be carried out in human subjects who 
require emergency therapy and for whom, because of the subjects' 
medical condition and the unavailability of legally authorized 
representatives of the subjects, no legally effective informed consent 
can be obtained.

for further information contact: F. William Dommel, Jr., J.D., Senior 
Policy Advisor, Office for Protection from Research Risks, 6100 
Executive Boulevard, Suite 3B01J, National Institutes of Health, MSC 
7507, Rockville, MD 20892-7507. Telephone (301) 496--7005 ext. 203 (not 
a toll-free number).

SUPPLEMENTARY INFORMATION:

Waiver

    Pursuant to Section 46.101(i) of Title 45 of the Code of Federal 
Regulations, the Secretary of Health and Human Services, has waived the 
general requirements for informed consent at 45 CFR 46.116 and 46.117 
for the specific research activity known as the ``National Acute Brain 
Injury Study: Hypothermia'' and funded by the National Institutes of 
Health (NIH) grant number R01 NS 32786 under the following strictly 
limited circumstances:

    In the course of the conduct of the research funded under NIH 
grant number R01 NS 32786, human research subjects may be included 
without seeking informed consent as otherwise required by 45 CFR 
46.116 and 46.117 if the proposed research involves the study of 
activities which would be carried out on persons who are in need of 
emergency treatment and the IRB(s) responsible for the review, 
approval, and continuing review of the research approve(s) that 
research without requiring that legally effective informed consent 
be obtained and the IRB(s) find(s), document(s), and report(s) to 
the Office for Protection from Research Risks (OPRR), NIH, that the 
research is approved in the absence of a requirement for obtaining 
informed consent for the following reasons:
    (i) The opportunity for the subjects to participate in the 
research is in the health interest of the subjects;
    (ii) The waiver of consent will not adversely affect the rights 
and welfare of the subjects;
    (iii) Additional appropriate protections of the rights and 
welfare of the subjects will be 

[[Page 38354]]
provided, including , but not limited to, consultation (which may 
include consultation carried out by the IRB itself) with 
representatives of the communities from which the subjects will be 
drawn;
    (iv) The research could not practicably be carried out without 
the waiver; and
    (v) Whenever appropriate, the subjects will be provided with 
additional pertinent information after participation.

Background

    The NIH, through its National Institute of Neurological Disorders 
and Stroke, has funded a research project entitled, ``National Acute 
Brain Injury Study: Hypothermia,'' which is a study of the treatment 
with hypothermia of severe head injury. This important and necessary 
research needs to be carried out in human subjects who, because of 
their injuries, are not conscious and cannot, therefore, consent to 
their participation. In some instances, but not always, consent from a 
legally authorized representative can be sought and obtained. 
Nevertheless, the unavailability of such representatives in many cases 
is impeding the progress of the research to such an extent, that the 
NIH determined that the research cannot go forward in the context of 
the current Department of Health and Human Services (HHS) regulations 
for the protection of human subjects (45 CFR Part 46) unless certain 
informed consent requirements of those regulations are waived by the 
Secretary, HHS in accord with the waiver provisions provided at 45 CFR 
46.101(i). A request for consideration of such a waiver was received 
from the Institutional Review Board, University of Texas Health Science 
Center, Houston, on July 12, 1995.
    Current HHS regulations permit IRBs acting in accord with an 
Assurance of Compliance with 45 CFR Part 46, to waive the requirement 
for obtaining informed consent under the following stringently applied 
conditions found at 45 CFR 46.116(d).
    The IRB must find and document that:
     The research involves no more than minimal risk to the 
subjects;
     The waiver * * * will not adversely affect the rights and 
welfare of the subjects;
     The research could not practicably be carried out without 
the waiver * * *; and,
     Whenever appropriate, the subjects will be provided with 
additional pertinent information after participation.
    However, the waiver of informed consent requirements now being 
authorized under Sec. 46.101(i) could not previously have been approved 
by an IRB, acting independently of the Sec. 46.101(i) waiver, because 
the risk involved in this emergency treatment activity is greater than 
minimal and therefore the ``minimal risk'' requirement for the exercise 
of an IRB waiver of informed consent could not be met.
    NIH notes that testimonies to this effect, in regard to similar 
research activities, were delivered to (i) the Subcommittee on 
Regulation, Business Opportunities, and Technology, Committee on Small 
Business, U.S. House of Representatives (Washington, DC, May 23, 1994); 
(ii) the Coalition Conference of Acute Resuscitation Researchers 
(Washington, DC, October 25, 1994); (iii) the meeting of Applied 
Research Ethics National Association (Boston, MA, October 30, 1994); 
(iv) the meeting of Public Responsibility in Medicine & Research 
(Boston, MA, November 1, 1994); and (v) the Food and Drug 
Administration/National Institutes of Health Public Forum on Informed 
Consent in Clinical Research Conducted in Emergency Circumstances 
(Rockville, MD, January 9-10, 1995).
    Therefore, the issue for decision by the Secretary was whether this 
particular research activity, involving greater than minimal risk to 
the subjects, should be permitted to go forward in the absence of 
legally effective informed consent. The decision is that under certain 
strictly limited circumstances such permission is appropriate.

Periodic Review

    A periodic review of the implementation by IRBs of this waiver will 
be conducted by OPRR to determine its adequacy in meeting its intended 
need or if adjustments to the waiver might be necessary and 
appropriate.

    Dated: July 19, 1995.
Philip R. Lee,
Assistant Secretary for Health.
[FR Doc. 95-18334 Filed 7-25-95; 8:45 am]
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