VA Panel Addresses Human
Subject Protections
June 20, 2003 - The House Veterans Affairs Subcommittee
on Oversight and Investigations June 18 held a hearing
on the human subjects protections in the Department of Veterans
Affairs (VA) research program. The subcommittee also addressed
concerns that the research oversight office at VA should be
independent from the Office of Research and Development (ORD),
as proposed in legislation sponsored by Subcommittee Chairman
Steve Buyer (R-Ind.) (H.R.
1585).
The hearing was a follow-up to a September 2000 hearing,
at which the General Accounting Office (GAO) testified on
weaknesses in the VA's system for protecting human subjects.
At the June 18 hearing, GAO noted that VA "has not taken
sufficient action to strengthen protections for human subjects
since we made our recommendations nearly 3 years ago although
it has taken some important steps." In response to a
question from Chairman Buyer, the GAO representative recommended
that VA issue revised policy for implementing federal regulations
for the protection of human subjects, require recurring training,
and continue for-cause and prospective investigations.
Testifying on behalf of the VA, Under Secretary for Health
Robert Roswell, M.D., noted that VA has recently trained nearly
15,000 individuals involved in human subjects research, required
local leadership at each VA facility that conducts research
to certify that the local institutional review board (IRB)
oversees human studies effectively, and required credentialing
of all research personnel that have any degree of patient
contact. Dr. Roswell noted that he expects to publish revised
policy for implementing federal regulations as recommended
by GAO within 30 days.
Under recent reorganization at the VA, the new Office of
Research Oversight (ORO) effectively replaces the former Office
of Research Compliance and Assurance (ORCA). ORO will focus
exclusively on the oversight and investigative process; the
education activities formerly conducted by ORCA will be moved
under ORD because, as Chief Research and Development Officer
Nelda Wray, M.D., M.P.H. noted, "separation of the policing
and education functions is important." Dr. Wray also
noted that the IRB accreditation process with the National
Committee for Quality Assurance (NCQA) is back on track after
being temporarily discontinued while standards were being
revised.
Jonathan Fishburn, Director, Research, Education and Veterans' Legislative Affairs
AAMC Office of Governmental Relations
jfishburn@aamc.org
(202) 828-0525
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