[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Proposed Rules]
[Pages 47469-47470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22591]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 16
RIN 2900-AH68
Treatment of Research-Related Injuries to Human Subjects
AGENCY: Department of Veterans Affairs.
ACTION: Proposed rule.
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SUMMARY: The Department of Veterans Affairs (VA) proposes to amend its
regulations to provide (or to pay for the provision of) necessary
medical treatment to human subjects injured as a result of
participation in VA research. All participants in research approved by
a VA Research and Development Committee (regardless of source of
funding) and conducted by a VA employee would be eligible for such
treatment. Experience suggests the
[[Page 47470]]
incidence of research-related injury is low and, therefore, the
additional costs of this policy will be minimal.
DATES: Comments must be received on or before November 8, 1996.
ADDRESSES: Mail or hand deliver written comments to: Director, Office
of Regulations Management (02D), Department of Veterans Affairs, 810
Vermont Ave., NW, Room 1154, Washington, DC 20420. Comments should
indicate that they are submitted in response to ``RIN 2900-AH68''. All
written comments will be available for public inspection at the above
address in the Office of Regulations Management, Room 1158, between the
hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except
holidays).
FOR FURTHER INFORMATION CONTACT: Theodore W. Lorei, (202) 273-8285.
SUPPLEMENTARY INFORMATION: It is a commonly accepted ethical position
that research subjects deserve to receive free medical treatment if
their participation in the research results in unforeseen adverse
health effects. Although current VA regulations are silent regarding
this policy, the acceptance of this right in practice is suggested by
the inclusion of the following statement on the research consent form
(VA Form 10-1086): ``If any medical problems occur in connection with
this study, VA will provide emergency care''. It is important to
clarify this issue in regulation so that research participants can be
confidently informed of their rights and research administrators can
take appropriate action to provide such benefits when appropriate.
The Secretary hereby certifies that this rule will not have a
significant economic impact on a substantial number of small entities
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612.
There is no Catalog of Federal Domestic Assistance Program Number.
List of Subjects in 38 CFR Part 16
Human research subjects, reporting and record keeping requirements.
Approved: May 28, 1996.
Jesse Brown,
Secretary of Veterans Affairs.
For the reasons set out in the preamble, 38 CFR part 16 is proposed
to be amended as set forth below:
PART 16--PROTECTION OF HUMAN SUBJECTS
1. The authority citation for part 16 continues to read as follows:
Authority: 5 U.S.C. 301; 38 U.S.C. 501, 7331,7334; 42 U.S.C.
300v-1(b).
2. Section 16.125 is added to read as follows:
Sec. 16.125 Treatment of research-related injuries to human subjects.
(a) VA medical facilities shall provide necessary medical treatment
to research subjects who are injured as a result of participation in a
research project approved by a VA Research and Development Committee
and conducted by VA employees. This regulation does not apply to:
(1) Treatment for injuries due to noncompliance by a subject with
study procedures, or
(2) Research conducted for VA under a contract with a non-VA
institution.
Note: Veterans who are injured as a result of participation in
such research may be eligible for care from VA under other
provisions of this part.
(b) Except in the following situations, care for VA research
subjects under this regulation shall be provided in VA medical
facilities:
(1) If VA medical facilities are not capable of furnishing
economical care or are not capable of furnishing the care or services
required, VA medical facility directors shall contract for the needed
care.
(2) If inpatient care must be provided to a non-veteran under this
policy, VA medical facility directors may contract for such care.
(3) If a research subject needs treatment in a medical emergency
for a condition covered by this policy, VA medical facility directors
shall provide reasonable reimbursement for the emergency treatment in a
non-VA facility.
(Authority: 38 U.S.C. 501)
[FR Doc. 96-22591 Filed 9-6-96; 8:45 am]
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