[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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