Bill Introduced to Make ORCA Independent of VA

Bill Introduced to Make ORCA Independent of VA

Thu, 10 Apr 2003

Anyone who is even slightly familiar with the problems undermining the safety of human subjects in clinical research knows that conflicts of interest and the absence of independent oversight are at the root of most problems.

The Veterans Administration research facilities have a history of ethical research violations. A major public scandal involving serious human subjects violations at the West Los Angeles VA led to the first shut down of clinical trials in 1999. Administrators of the VA then told Congress that the VA would establish an internal, independent watchdog oversight entity for its human subjects, animal welfare and researcher safety (bio-safety).

The Office of Research Compliance and Assurance (ORCA) was thus established to ensure that research conducted at VA facilities follow ethical and safety standards.

But in January 2003, the VA decided to merge ORCA into its Office of Research and Development (ORD). This is a clear conflict of interest: ORD’s mission is to attract research grants, ORCA was established to oversee the research activities of ORD.

In response to concerns about the safety of veterans, Congress has just introduced a bill, HR 1585, to codify into legislation the independence of ORCA. Essentially the bill requires the VA to maintain the integrity of ORCA, the office it had established in 1999. Representative Steve Buyer R-Ind. who introduced the bill along with 16 co-sponsors said: “My colleagues and I want to insure that oversight of human subjects is truly independent.”

The bill has been referred to the House Committee on Veteran Affairs (HCVA) and additional information can be obtained from Peter Dickerson, Communications Director, HCVA, 202 225-3527.

Letters of support for this legislation to Representative Steve Buyer and the following would be appreciated.

The Honorable Steve Buyer,
Chair, Subcommittee on Oversight and Investigations,
House Committee on Veterans Affairs,
U.S. House of Representatives
Canon Office Building, Room 335,
Washington DC, 20515
FAX: 202-225-2267

The Honorable Christopher Smith,
Chairman, House Committee of Veterans Affairs
U.S. House of Representatives
Canon Office Building, Room 335,
Washington DC, 20515
fax 202-225-7768

The Honorable Lane Evans,
Ranking Minority, House Committee of Veterans Affairs
U.S. House of Representatives
Canon Office Building, Room 333,
Washington DC, 20515
E-MAIL: lane.evans@mail.house.gov

Secretary Anthony J. Principi
Secretary, (00)
Department of Veterans Affairs
810, Vermont Avenue, N.W.,
Washington DC, 20420

Robert H. Roswell, MD
Undersecretary for Health (10), DVA,
810, Vermont Avenue, N.W.,
Washington DC, 20420
FAX 202 273 5787
robert.roswell@mail.va.gov