the human subject protection system are likely to be under funded because administrators usually don't see it as their most pressing concern. To the extent that VA Medical Centers are under funded, I think it is safe to assume that the human subject protection system is also under funded. Very few institutions fund their IRB, their human subject protection process first. Most of the time, human subject protections are at the end of the pecking order, not at the beginning.

Mr. BUYER. I want to pick up off something that the ranking member brought up about this serving of the greater good. Is it within now-help me understand part of the cultural justifications within the research community. Do they, somehow, sort of justify that they can go beyond the consent because they are serving the greater good? How is it they justify such actions?

Mr. ELLIS. I think there is a failure to distinguish between treating a patient, and pursuing new knowledge for the greater good. Patients need treatment; that is healthcare. Ordinarily, people don't need to be research subjects. They may wish to be for a variety of reasons, and that is fine. People may wish to take risks, that's an option on their part, and they have to know what they are getting into. It is the failure to distinguish treatment from research that is at the basis of some physician researchers going wrong here.

Mr. BUYER. Thank you. I yield back.

Mr. EVERETT. Thank you. Mr. Rodriguez?

Mr. RODRIGUEZ. Thank you, Mr. Chairman. Regarding NIH, and I realize we are talking about the VA. But, I also have had some concerns with NIH, and I just sent a letter about the fact that, aside from some of its ways of funding, and I recognize there is a process to try to allow so it is research oriented and it is research guided. But, there have been some concerns, at least I have some concerns that I have already indicated to Secretary Shalala regarding NIH, and that is its lack of connectiveness to the community, and there is a lack of impact from the community as to where they should be doing research or in what areas. I was wondering if you want to make any comments in that area because I know that I have had some problems from that perspective with NIH? I have had my problems with VA, but I am referring now to NIH.

Mr. ELLIS. I think it is a very timely comment. I know the NIH director is thinking along the same lines, and by coincidence today in Bethesda, he is chairing the first meeting of his newly appointed Council of Public Representatives. So, this is a group that was just named this week, it met yesterday for orientation, meeting in full session today. So, these are the type of individuals you describe, call them ordinary citizens, they are each, actually, extraordinary individuals. But, this is a new group to meet twice a year to advise the NIH Director on just the sort of issues you are raising.

Mr. RODRIGUEZ. I would ask that you send me a copy of those individuals that are participating in that process, if you can? Mr. ELLIS. I would be pleased to do it.

Mr. RODRIGUEZ. And, I was wondering if you have any obligations from your role to make any recommendations regarding NIH? Mr. ELLIS. I don't hold

Mr. RODRIGUEZ. Holding NIH responsible and accountable for what it funds or doesn't fund, or what it does and doesn't do?

Mr. ELLIS. Well, as you know, our office is part of NIH. We are not, however, involved in identifying specific subject matter to be supported for research. It is just beyond our office's purview.

Mr. RODRIGUEZ. Is there anything within NIH that assesses that?

Mr. ELLIS. NIH has a very well developed system of peer review, scientific review to select among the many opportunities for research in biomedicine and behavior.

I am just suggesting your question may be misdirected to our of fice, that is all.

Mr. PUGLISI. I think, relative to what our office does, we have encouraged institutions to place community members on their institutional review boards in numbers far greater than the minimal regulatory requirement. We believe that it is very, very important for representatives of the community in which research is going to be conducted to take a role in evaluating the propriety of that research. Some institutions have followed our guidance, other institutions have not. Some members of the scientific community seem to be uncomfortable with opening up the IRB process to greater numbers of community members. Other members of the scientific community embrace it.

Mr. ELLIS. We have addressed this in additional ways as well. I can tell you we met with the American Legion this week, and we had a very constructive meeting. We said, "Look, the Legion has members in all 50 States and territories around the country; these are potential institutional review board members." I think that that is the kind of involvement in this oversight process that we want to foster.

Mr. RODRIGUEZ. But, as you well indicated, when you have too many, you might have none.

Mr. ELLIS. We need to increase, incrementally, the lay involvement, the community involvement in the process of oversight of research. The regulations describe minimal participation. So, that is the only tool we have. There has got to be one non-affiliated member on the Institutional Review Board, meaning not affiliated with the institution. There has got to be one non-scientist. That can be the same individual, actually, the non-scientist who is not affiliated. That is the minimum requirement. We like to see institutions go beyond that.

Mr. EVERETT. Gentlemen, I want to thank you. I couldn't help but pick up on your comment of the culture of non-compliance. This committee has been faced with a cultural problem in the VA for a number of years to include sexual harassment, the mismanagement of millions of dollars, attempted coverup, in my opinion, of 40 deaths at Columbia, Missouri hospital. As a matter of fact, I could take more time than we have got to continue this. We made it well known to the VA that we feel like that culture that exists in the VA must change or VA won't survive it.

Thank you very much for your testimony today.

Mr. PUGLISI/ELLIS. Thank you, Mr. Chairman.

Mr. EVERETT. I would like to call up Panel II. Dean Norman, Acting Chief of Staff, West Los Angeles VA Medical Center; Stephen

Pandol, Former Director of Research and Development, West Los Angeles VA Medical Center; Ken Clark, Chief Network Officer at the Department of Veterans Affairs, and the Former Director of the West Los Angeles VA Medical Center; and, Ron Norby, Clinical Manager and Deputy Network Director of VISN 22.

Would you all rise, please?

[Witnesses sworn.]

Mr. EVERETT. Thank you very much. Please be seated.

Dr. Pandol, I understand you are the only one who will make a statement today. If you will, please proceed. I am going to ask you, please, limit your statement to 5 minutes. Your complete statement will be made a part of the record. The members have already read it. Unfortunately, we just really can't take more than 5 minutes on these statements. If you will limit to 5 minutes, and please proceed.

TESTIMONY OF STEPHEN PANDOL, FORMER DIRECTOR, RESEARCH AND DEVELOPMENT, WEST LOS ANGELES VA MEDICAL CENTER, DEPARTMENT OF VETERANS AFFAIRS; ACCOMPANIED BY DEAN NORMAN, ACTING CHIEF OF STAFF, WEST LOS ANGELES VA MEDICAL CENTER, DEPARTMENT OF VETERANS AFFAIRS; KENNETH CLARK, CHIEF NETWORK OF. FICER AND FORMER DIRECTOR, WEST LOS ANGELES VA MEDICAL CENTER, DEPARTMENT OF VETERANS AFFAIRS, AND RONALD NORBY, CLINICAL MANAGER AND DEPUTY NETWORK DIRECTOR, VETERANS INTEGRATED SERVICE NETWORK 22

TESTIMONY OF STEPHEN PANDOL

Dr. PANDOL. Thank you, Mr. Chairman.

Mr. EVERETT. Would you have your attorney identify himself for the record, please?

Mr. KRANE. My name is David Krane of the law firm of Krane, Lowell and Ingrim.

Mr. EVERETT. Thank you. Please proceed.

Dr. PANDOL. Thank you, Mr. Chairman, ladies and gentlemen. My name is Stephen Pandol, M.D. There have been innumerable allegations made toward the research administration of the West Los Angeles VA Medical Center. My purpose today is to provide important factual information and to submit to you suggestions that may be useful in improving the performance and safety of our human research in the Department of Veterans Affairs.

The concern that the members of your subcommittee have expressed about the issue of safety and human research at our facility is exactly the concern I had 3 years ago when I took my position. Within days of arriving, I was informed of problems in cardiology and cardiology human research. There had been an investigation of the problems, but some individuals came to me and told me that the investigation was a white wash. I stopped the research of three medical investigators, and demanded of the chief of staff that a more exhaustive investigation of the problems take place.

The ensuing board of investigation lasted approximately 6 months. The Chief of Staff requested that I not be a member. As a result of that investigation and because of other observations, re

search administration took a hard look at the issues surrounding safety and oversight of human research projects. The measures we instituted have had significant impact on improving safety and oversight. I firmly believe that these activities serve as a model for ensuring safety of human research. I urge you to ask questions about what we have done.

Although we made substantial improvements in human research oversight, our efforts were thwarted by severe financial problems we inherited, and extreme difficulty in obtaining resources to provide adequate staffing. The VA research appropriation only provides research administrative support funds for grants funded by the VA. Only 25 percent of our research portfolio was VA-funded. About one-half of our research administrative costs were related to non-VA projects which included those from our own non-profit research corporation, UCLA, and the National Institute of Drug Abuse, nor NIDA. Administrative services for these projects were provided without compensation.

Our research portfolio is one of the largest in the Nation, so the ramifications of this dilemma were profound. My research staff began to develop creative ways to reimburse for our services. Basically, we were using VA research funds to provide services for other organizations, agencies and companies. Even attempts to rectify this situation with our own non-profit research corporation with its corporate contracts were met with severe obstacles from VA management and our legal department. We received no support from UCLA, and the National Institute of Drug Abuse, or NIDA, argued vehemently over issues surrounding administrative support. NIDA, I might add, even strongly argued against allowing our research department oversight function over major a cocaine project that was in place on our campus. I urge you to ask questions about this.

Finally, I had no success in urging management to use resources provided in the medical care appropriation for research support to address the desperate needs of research. I estimated that annually our medical center used only about one half of the $20 million in this category that it receives to support research. Our research facilities are the worst in the Nation.

The issue that has most recently focused your attention on safety and oversight in human research revolves around the shut-down of research at West LA. Within 24 hours of our notification of the action, the research staff provided a point-by-point response to all issues delineated by OPRR. Our report indicated that the action to rescind the multiple project assurance status was based on misinterpreted and out of date information. I am not sure that this report was ever brought forward by management.

As delineated in my written statement, OPRR did not communicate with West LA for over 2 years. Neither my superiors, my predecessors, nor VA headquarters ever informed me of the OPRŘ restriction. Once we learned of the restriction, we attempted to address all outstanding issues, and provide materials to OPRR. OPRR made the decision to rescind our MPA without a site visit or without any telephone calls or dialogue with the research department. Lessons learned from the VA Medical Center should, hopefully, result in facilitating the dedication of effort and resources to pro

mote the development of a safer and more enlightened and productive system of human research. The conduct of action to halt all research at the VA Medical Center, and to rescind the MPA status only served to punish one organization whose difficulties are merely a reflection of those that permeate our IRBs and research departments nationally.

George Grob, in his report entitled, "Institution Review Boards, a Time for Reform," states that the oversight process should focus less on mere compliance matters, and more on performance issues. Be assured we do care deeply about veterans and public health, and we hope it becomes apparent that we did markedly improve human research safety at West LA. Furthermore, as several of you have indicated, the research we do provides significant advances in health to our veterans and our Nation. Thank you.

[The prepared statement of Dr. Pandol appears on p. 105.]

Mr. EVERETT. Thank you. I am informed the rest of the panel will rely on the official VA statement, is that correct?

Dr. PANDOL. Yes.

Mr. EVERETT. Dr. Pandol, I know there is a lot at stake for you today, but let me get a couple of things straight.

You seem to believe that the suspension of research at West VA was not justified. But, you also say that you were not getting the support you needed from your supervisors, is that correct?

Dr. PANDOL. Yes, to be really clear, there are some issues with the OPRR report that I think are incorrect, and that they need dialogue and discussion. That hasn't been done. But, you are right, the support was meager.

Mr. EVERETT. And, those issues of OPRR are pointed out in your statement, which I have read.

Doctor, you have been reassigned from your duties as Director of Research at West LA. I am not aware that anyone else above you has been reassigned. Do you believe you are being made a scapegoat?

Dr. PANDOL. I think it is a possibility. I think, as we are learning today, and I have tried to explain-this is an extremely complex problem with a lot of issues involved. I am an easy target.

Mr. EVERETT. Who is in the chain of command above you?

Dr. PANDOL. My supervisor was Dr. Dean Norman, Chief of Staff. Mr. EVERETT. Has anything happened to Dr.-

Dr. PANDOL. I don't know. He would have to answer that.

Mr. EVERETT. Is it correct that the National Association of Veterans' Research and Education Foundation offered you any kind of services and administrative support for the West VA research service, but not actual funding, and you did decline the offer?

Dr. PANDOL. That is not true.

As I alluded to in my talk, and also in my prepared testimony, we had an argument over approximately 2 years on funding for one aspect of human research oversight. That was the oversight that was required for the contracts and grants that went to our research non-profit corporation. Over 2 years, we received gifts of approximately $200,000 each year. I must say that the money used to come at the end of the year or into the following year, and it made it extremely difficult for us to have stable staffing. So, at the end of 1998, we made an arrangement so that we could have stable