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doing. The issue before us today revolves around veterans given informed consent before participating in medical research. Without informed consent, no veteran can properly be a research subject. The concerns about informed consent go straight back to the awful things the Nazis did to people during the holocaust, and called it medical research. The civilized world vowed that it would never happen again, and in 1949 made a statement on the Nuremberg code to establish ethical guidelines for human medical research. I am deeply disturbed, and appalled by the report that four veterans at West Los Angeles VA were the victims of medical research without consent whatsoever. One of the veterans even refused consent. These veterans, who will not be publicly identified, were old and sick, and three out of four had psychiatric conditions. They were particularly vulnerable, and a VA doctor took advantage of them. Their faces are the faces of veterans in the VA hospitals across the country. The subcommittee demanded an explanation, and accountability. These outrageous crimes against our veterans must not happen again.

Our witnesses today are from HHS Office for Protection from Research Risks, from the VA's Washington office, and from the West Los Angeles VA. Also, we have a panel of experts in medical research anxious to give us their evaluation. At this time, I will recognize the distinguished Chairman of the Subcommittee for Health, Mr. Stearns.

OPENING STATEMENT OF HON. CLIFF STEARNS, CHAIRMAN, SUBCOMMITTEE ON HEALTH

Mr. STEARNS. Good morning, and thank you, Mr. Chairman. I think you have outlined the position of our two joint committees this morning. For many of us, it has been quite a disappointment to understand this because the VA has long prided itself on the quality of its medical research program. In fact, a few of us went over to tour the Washington Veterans' Hospital here, and met with the Assistant Chief of Staff for Research, Dr. Levine, and many of us felt there was a lot of good research being done there. But, of course, the revelations leading to today's hearing raise some very, very troubling questions.

It is natural to ask whether attention to patient protection is as lax at other VA centers as, apparently, it was at West Los Angeles. We don't know the answer to that question because for too long it appears research has operated under a so-called trust relationship. Obviously, this trust relationship broke down at one hospital that we know of.

VA officials have been on notice, though, of the potential for this problem. So, this should not be totally a surprise to them. A retired NIH official appearing before our committee in a 1994 hearing on VA radiation research testified to VA's very limited oversight of patient protections. Let me quote to you this morning, Mr. Chairman, what he said. "In the Department of Veterans Affairs, you have one part-time official who looks after the implementation of the regulations in all of the VA hospitals. That man works nights; he works weekends, but that is not enough. He needs a staff. There is no trained investigator in the Department of Veterans Affairs to inves

tigate complaints. We only have two in the Department of Health and Human Services."

Dr. Kizer has devoted considerable attention, during his tenure, to the issue of patient safety in VA facilities. So, many of us will be very anxious to hear from Dr. Kizer on the third panel.

Research, as all of us know, is a key VA mission, but obviously we need to safeguard the patients and make sure these safeguards are in place so that all patients are protected against undue risks in research.

So, Mr. Chairman, together with my staff, we commend you for this hearing, and we look forward to hearing from all the panelists. Thank you.

Mr. EVERETT. Thank you. I now recognize the ranking member of our Oversight and Investigations Subcommittee, Ms. Corrine Brown for any opening remarks she may have.

OPENING STATEMENT OF HON. CORRINE BROWN

Ms. BROWN. Thank you, Chairman Everett, and members of the committee. We all know that VA research has made major contributions to healthcare for veterans, and to healthcare in general. VA medical care, supplemented by VA research, is a significant part of any intelligent discussion of healthcare in America. VA research has produced major breakthroughs, including the pacemaker, the first kidney transplant in the United States, the CAT scan, and the MRI scan, the vaccination for hepatitis, the first successful drug treatment for TB, high blood pressure, and schizophrenia, lighter and more responsive prostheses for amputees, kidney, and home dialysis techniques. These are medical advances the whole world needs to be using today. There will be more.

Congress has faith in VA research. However, veterans check into the VA for care, not to give scientists help with experiments. When veterans at the VA agree to take part in experiments, the veterans should be helped. They must be the right subject, not merely the most convenient ones. Research at the West LA VA Medical Center appears to have crossed the line set forth in law and regulation. Congress will not tolerate this.

In addition, whenever an urban hospital performs life-endangering procedures on its patients without the consent, Congress must ask very serious questions. I am concerned that patients who are poor, who have no other recourse for medical treatment, and are heavily weighted toward minority population have become too available for experiments that may serve science, but not the veterans who have already given more than this Nation asked for.

The purpose of this hearing is to learn from what has happened in West LA and the rest of the Greater Los Angeles system-is West LA an exception or is it a glaring example of a system-wide problem? What assurances can VA give us that the situation in West LA is being corrected, and that requirements set forth in law and regulations are applied and enforced throughout the VA network? I believe these issues before us boil down to two questions: Are current research rules adequate for protecting veterans, including older and mentally ill veterans, and are the rules seriously in force? I look forward to getting some answers this morning. Thank

Mr. EVERETT. Thank the gentle lady. Now, I recognize the ranking Democrat on the Health Subcommittee, Mr. Gutierrez, for any opening remarks he may have.

OPENING STATEMENT OF HON. LUIS V. GUTIERREZ

Mr. GUTIERREZ. Thank you, Mr. Chairman. I would like to thank the witnesses for being today, and I hope this hearing will give us the opportunity to find out what transpired at the Veterans Affairs Medical Center in West Los Angeles and Sepulveda.

I am deeply disturbed that the reports of veterans being exploited by staff at VA hospitals for research purposes. These are very serious allegations which suggest that doctors put aside their consciences and medical responsibilities to achieve personal gain. Thousands of veterans in this country rely on the VA for medical care and treatment. I recognize that many important medical advances have come from VA research. Many veterans welcome the opportunity to participate in medical research programs that offer them the most advanced treatment available. But if informed consent requirements for veteran patients are not respected, and researchers are not held accountable for their unethical research practices, VA research should cease to continue.

Much to my dismay, I believe the VA is in crisis, and that the problems identified at West Los Angeles and Sepulveda reflect larger problems, Mr. Chairman. As we know the Department of Veterans Affairs is facing a severe budget constraint. The lack of proper funding has led to the reduction of medical staff at VA hospitals by the thousands, and are projected in the coming year to be 7,500. It is not uncommon for a veteran to wait months to see a doctor for an examination or over a year to get treatment.

I also understand that some VA hospital administrators are receiving bonuses, Mr. Chairman, in their contracts, bonuses which are directly related to eliminating nurses, physician assistants, and medical staff because they are meeting the goals of cutting costs. I am very concerned that the severe budget crisis the VA is facing is responsible for creating a system where mistakes, abuse, and consistent inadequate care is the norm for our veterans.

In this specific case, if we find the patients were, in fact, used for research purposes by their doctors without consent, or in violation of strict medical regulations, we must hold those doctors accountable. We must also make every effort to ensure that if illegal and unethical violations were committed by medical staff, such crimes I underscore the word "crimes," must never occur again at any VA facility. But the work must not stop there.

Patient care should be our most important priority. Mr. Chairman, the VA has many doctors and nurses who are dedicated to their jobs, and the patients they serve. Perhaps these men and women do not receive the recognition they deserve. However, this specific case should serve as a wake-up call for the entire system. Our VA healthcare system is failing our veterans. More funding, more programs, more oversight, and more dedication to our veterans is desperately needed. Thank you, Mr. Chairman.

Mr. EVERETT. Thank you. Dr. Snyder, any remarks you may have? If you care to submit something for the record, please do so.

Because of the nature of some of today's testimony, the witness panels will be sworn in for their testimony. I ask witnesses to please limit their oral testimony to 5 minutes. Your complete written statement will be made part of the official hearing record. I also ask that we hold all questions until the entire panel has testified.

At this time, I would like to recognize Panel I: Dr. Tom Puglisi, Director, Division of Human Subject Protections, Office for Protection from Research Risks, National Institute of Health in the Department of Health and Human Services, and ask him to please introduce his staff.

TESTIMONY OF J. THOMAS PUGLISI, DIRECTOR, DIVISION OF HUMAN SUBJECT PROTECTIONS, OFFICE FOR PROTECTION FROM RESEARCH RISKS, NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES; ACCOMPANIED BY GARY B. ELLIS, DIRECTOR, OFFICE FOR PROTECTION FROM RESEARCH RISKS, NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

TESTIMONY OF J. THOMAS PUGLISI

Mr. PUGLISI. Mr. Chairman and members of the subcommittees, I am Tom Puglisi, Director of the Division of Human Subject Protections in NIH's Office for Protection from Research Risks, OPRR. I am accompanied by Gary B. Ellis, OPRR's director. Dr. Ellis chairs the Inter-Agency Human Subjects Committee of which the VA is an active member, in the person of Dr. Tim Gerrity, whom you will hear from later this morning.

Mr. EVERETT. Dr. Puglisi, will you please repeat after me? [Witness sworn.]

Mr. EVERETT. Thank you. Please go ahead.

Mr. PUGLISI. This spring marks the 25th anniversary of the 1994 Department of Health and Human Services Regulations for Protection of Human Subjects. In 1991, the core HHS regulations were adopted by other departments and agencies, including the Department of Veterans Affairs, as the Federal Policy, Common Rule, for the protection of human subjects. Today the Common Rule is shared by 17 departments and agencies covering most, but not all, Federally-sponsored human subjects research.

The Common Rule provides three key protections for human subjects: First, research must be reviewed and approved by a duly constituted Institutional Review Board. Second, researcher must obtain and document subjects' informed consent. Federal regulations require that informed consent include eight specific elements of information. Any researcher who recruit a subject without conveying all eight of these required elements is not obtaining informed consent. Third, research institutions must provide the Federal Government with a satisfactory Assurance of Compliance. An Assurance is a written commitment to adhere to basic ethical principles, and to the requirements of the Human Subjects regulations. Under the Common Rule, OPRR has authority to approve Assurances for Federal-wide use. Other Common Rule departments or agencies may approve Assurances for research that they themselves support.

From 1987 to 1998, the VA West Los Angeles and the VA Sepulveda held separate Federal-wide Assurances approved by OPRR. Upon their merger, OPRR approved a new Assurance for the VA Greater Los Angeles Health Care System which includes both facilities.

On March 22 of this year, OPRR deactivated that Assurance. What led to OPRR's action? In 1993, OPRR received an allegation that informed consent procedures for psychiatric research at West Los Angeles failed to meet regulatory standards. OPRR found numerous informed consent documents lacking basic required information, and ordered correction of these deficiencies.

In January 1995, I led a follow-up site visit to the West Los Angeles facility. The site visit revealed a number of serious deficiencies in the Institutional Review Board's operating procedures. OPRR required additional corrective actions. In April 1998, OPRR requested updated documentation regarding these required actions. Review of this information revealed continuing serious deficiencies in human subject protection procedures.

As a result, OPRR deactivated the VA Greater Los Angeles Health Care System Assurance. This action removed the Assurance required for conduct of Federally-supported human subjects research. HHS supported human subjects research may resume at the VA Greater Los Angeles Health Care System only under new Assurance mechanisms that entail more stringent oversight by OPRR.

As I indicated previously, OPRR has_authority under the Common Rule for approving Assurances at HHS-supported institutions for Federal-wide use. At present, 41 VA facilities hold Assurances that are approved by OPRR for Federal-wide use. Some 50 VA facilities are covered under other Assurance mechanisms that are limited to specific categories of HHS-supported research.

OPRR is currently conducting three compliance investigations that involve other VA facilities, specifically the James A. Haley VA Hospital which is conducting research in association with the University of South Florida in Tampa, the Philadelphia VA Medical Center, and the Cincinnati VA Medical Center which is conducting research in association with the University of Cincinnati. I am not able to comment further on these ongoing investigations because OPRR has not yet reached any determinations of fact in these

cases.

OPRR recently completed a complex investigation of several HHS-supported psychiatric research projects at the VA Medical Center in the Bronx, New York, research that was conducted with the Mt. Sinai Medical Center. Although deficiencies were identified, OPRR has now determined that appropriate corrective actions have been implemented for current and future research. OPRR has neither an immediate nor an historical basis for distinguishing compliance of VA medical centers as a class from that of other biomedical and behavioral research institutions.

It is clear, however, that VA medical centers have a profound obligation to ensure that our Nation's veterans are afforded the highest levels of protection when they become human subjects. To the extent that any VA research involves any veteran subject who may be vulnerable for any reason-for example, because of illness, eco

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