HONORABLE TERRY EVERETT, CHAIRMAN

Hearing II on Human Subject Medical Research in the VA

September 28, 2000

OPENING STATEMENT

The hearing will come to order.

Good morning! This subcommittee's second hearing on VA research will follow-up on what progress the VA has made in protecting veterans volunteering in its medical research programs since the suspension of all medical research at the West Los Angeles VA medical facilities eighteen months ago.

Chairman Cliff Stearns of the Health Subcommittee, and Ranking Democratic Member Corrine Brown of the Oversight and Investigations Subcommittee and I were extremely concerned with what we heard last April. VA obviously failed to protect our veterans at the West Los Angeles medical research facility.

After the hearing, I asked the GAO to investigate whether the research violations at the West LA VA were isolated incidents or whether this lack of protections for human subjects could be widespread in VA medical research.

The General Accounting Office’s written statement today describes a "disturbing pattern of noncompliance" at eight VA medical centers in ensuring the protection of human research subjects. I will ask GAO what the implications of this finding are system-wide for VA facilities engaged in medical research and what should be done.

We will hear from the Department of Health and Human Services’ new Office of Human Research Protections which is now responsible for overseeing protection of human subjects in research throughout the federal government.

And, finally, we will hear from the VA. I had hoped that the last eighteen months would allow the department to proactively identify and correct all the serious violations discovered at West Los Angeles or anywhere else they might be occurring in the VA. The VA did announce the creation of its own research compliance organization called the Office of Research Compliance and Assurance (ORCA). I would like to note that this was announced one day before this Subcommittee's hearing last April.

I certainly expect that the VA will tell this Committee that it is truly committed to the safety and welfare of veterans participating in medical research. These veterans are one of the most vulnerable populations in all of human medical research. Their protection must be a top priority of the Department.

So what has the VA actually done? That’s what counts. The VA should have the specifics with definite completion dates for every initiative that isn’t already completed, and be able to convince us that ORCA will be an effective watchdog.

What I have seen so far leaves me skeptical about how aggressive the VA has been, so I look forward to hearing today’s testimony and the answers of our witnesses to the Subcommittee’s questions.

Back to Witness List