[Federal Register Volume 63, Number 44 (Friday, March 6, 1998)]
[Rules and Regulations]
[Pages 11123-11124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5840]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AH68


Treatment of Research-Related Injuries to Human Subjects

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This final rule amends the Department of Veterans Affairs (VA) 
medical regulations to provide (or to pay for the provision of) 
necessary medical treatment to certain human subjects injured as a 
result of participation in VA research. Under the final rule all 
participants in research approved by a VA Research and Development 
Committee (regardless of source of funding), and conducted under the 
supervision of one or more VA employees, are eligible for treatment 
unless injuries are due to noncompliance by a research subject with 
study procedures. VA will provide medical care in those circumstances 
where VA has some responsibility for the need for medical care.

DATES: Effective Date: April 6, 1998.

FOR FURTHER INFORMATION CONTACT: David Thomas, Office of Research and 
Development (12B), Department of Veterans Affairs, 810 Vermont Avenue, 
NW., Washington, DC 20420, (202) 273-8284.

SUPPLEMENTARY INFORMATION: In a document published in the Federal 
Register on September 9, 1996 (61 FR 47469), VA proposed to provide (or 
to pay for the provision of) necessary medical treatment to certain 
human subjects injured as a result of participation in VA research. 
Based on the rationale set forth in the proposed rule and in this final 
rule, the provisions of the proposed rule are adopted as a final rule 
with changes discussed in this document.
    VA requested comments to be submitted on or before November 8, 
1996. Comments were received from six sources. These comments are 
discussed below.
    One commenter suggested that VA set forth the text of this final 
rule in a place in 38 CFR other than part 16. Part 16 consists of 
common rules applicable to a number of agencies. It was asserted that 
the provisions of the proposed rule are different because they are 
unique to VA. We agree with the suggestion and have included the text 
of the final rule in 38 CFR part 17.
    Proposed Sec. 16.125 (renumbered in the final rule as Sec. 17.85) 
provided, in part, that 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. One commenter 
asserted that the term ``VA employee'' should be narrowly construed and 
noted that this would lessen the amount of treatment that would need to 
be provided by VA. Another commenter asserted that medical treatment 
should be provided for injured subjects even if non-VA employees 
conducted the research. We believe VA should provide medical treatment 
to injured research subjects when individuals acting within their 
appointment as VA employees have supervisory responsibility over the 
conduct of the research. Consistent with this principle, the 
regulations are clarified to state that research subjects are eligible 
for medical treatment if injured during research conducted under the 
supervision of one or more VA employees. Further, to avoid confusion 
regarding who would be considered a VA employee, we have included in 
the final rule a definition of ``employee,'' which provides that `` `VA 
employee' means any person acting within an appointment by VA as an 
officer or employee.''
    Also, the proposed rule excluded the provision of medical treatment 
by VA for subjects injured as a result of research conducted for VA 
under a contract with a non-VA institution. One commenter argued 
against this exclusion. VA has retained the exclusion. The obligation 
to provide treatment under such circumstances

[[Page 11124]]

should rest with the contractor rather than VA because the contractor 
would have control over the actions of individuals involved in the 
research. Also, VA has clarified the exclusion to state that the 
exclusion covers contracts with individuals as well as non-VA 
institutions. The exclusion was intended to cover all contract research 
conducted by non-VA employees whether the contract was with an 
individual or an institution.
    The law directs VA to conduct a program of medical research in 
connection with caring for veterans. 38 U.S.C. 7303. VA includes 
nonveterans in VA research projects if there are not enough suitable 
veteran-patients and cares for them in VA hospitals as part of the 
research. 38 CFR 17.45 (1996). This final rule further implements 
Sec. 7303 to specify when and how VA gives free medical treatment to 
research subjects if their participation in the research adversely 
affects their health.
    Congress gives money to VA in appropriation accounts and restricts 
how VA may use the money in these accounts. VA pays for medical care 
and research out of different appropriation accounts. The law requires 
that, if VA medical care funds pay for the care of research subjects 
who are not otherwise eligible for VA care, VA research appropriation 
must reimburse VA medical care appropriation. 38 CFR 17.101(g).
    The Secretary hereby certifies that this final 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. This rule concerns individuals. It does not make changes 
applicable to small entities. Therefore, pursuant to 5 U.S.C. 605(b), 
this final rule is exempt from the initial and final regulatory 
flexibility analyses requirements of Secs. 603-604.
    There is no Catalogue of Federal Domestic Assistance Program 
Number.

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, Foreign relations, 
Government contracts, Grant programs-health, Grant programs-veterans, 
Health care, Health facilities, Health professions, Health records, 
Homeless, Medical and dental schools, Medical devices, Medical 
research, Mental health programs, Nursing homes, Philippines, Reporting 
and recordkeeping requirements, Scholarships and fellowships, Travel 
and transportation expenses, Veterans.

    Approved: February 26, 1998.
Togo D. West, Jr.,
Acting Secretary.
    For the reasons set out in the preamble, 38 CFR part 17 is amended 
as set forth below:

PART 17--MEDICAL

    1. The authority citation for part 17 continues to read as follows:

    Authority: 38 U.S.C. 501, 1721, unless otherwise noted.

    2. Section 17.85 and an undesignated center heading are added to 
read as follows:

Research-Related Injuries


Sec. 17.85  Treatment of research-related injuries to human subjects.

    (a) VA medical facilities shall provide necessary medical treatment 
to a research subject injured as a result of participation in a 
research project approved by a VA Research and Development Committee 
and conducted under the supervision of one or more VA employees. This 
section 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 an individual 
or a non-VA institution.

    Note to Sec. 17.85(a)(1) and (a)(2): 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 section 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 
section, 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 section, VA medical facility directors 
shall provide reasonable reimbursement for the emergency treatment in a 
non-VA facility.
    (c) For purposes of this section, ``VA employee'' means any person 
appointed by VA as an officer or employee and acting within the scope 
of his or her appointment (VA appoints officers and employees under 
title 5 and title 38 of the United States Code).

(Authority: 38 U.S.C. 501, 7303)

[FR Doc. 98-5840 Filed 3-5-98; 8:45 am]
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