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TREATMENT OF RESEARCH-RELATED INJURIES
Effective April 6, 1998, VA will provide
necessary treatment to patients injured as a result of participating in
research studies approved by a VA Research and Development Committee and
conducted under the supervision of VA employees regardless of the source
of funding for the study. The final rule was published in the March 6,
1998, Federal Register and is provided below.
[Federal Register: March 6, 1998 (Volume
63, Number 44)]
[Rules and Regulations]
[Page 11123-11124]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06mr98-17]
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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.
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
- The authority citation for part 17
continues to read as follows:
Authority: 38 U.S.C. 501, 1721, unless otherwise noted.
- 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]
BILLING CODE 8320-01-P
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