[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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