Our next speaker will be Caroline Szetela, who is a medical ethicist and Ph.D. candidate at the University of Tennessee.

MS. SZETELA: Thank you. Good morning, I am again Caroline Szetela, I am a medical ethnics graduate student and getting my degree in Philosophy. What I want to talk about today insofar as I can, is how issues in biomedical ethics are solved. What mechanisms we have for the American public to be protected and perhaps represented in making decisions that are going to affect all of us.

I don=t want to claim to be an expert on this subject and have any ethical degrees, but I think I may be safe in saying that everybody in this room has a commitment, at least in principal, to two things, preservation of human dignity and prevention from suffering. That is two worthy goals. And when it comes to human subject research, we still have a lot of work to do in both of these areas.

The recommendations 9 through 15 which this panel is intended to address, has a lot of really positive suggestions in it. They are not yet implemented and most of those suggestions were deferred to the National Bioethical Advisory Committee or I hope, I can just abbreviate it as NBAC. And so we are naturally very concerned that NBAC is going to be responsive and have integrity in the process and in the solutions that it proposes.

I think many of us in here have very immediate experience from the past that informed consent has been inadequate. It remains inadequate and in my profession, most bioethicists, I think, concur that informed consent is very, very, very bad shape in some cases. We have a lot of opportunity for human suffering to be produced. We don=t have the appropriate checks and balances in the system that we need. And one thing that I think is germane to representing the American public, who are the subjects of research, is representation on committees who are making decisions about research protocols, not just on behalf of research institutions, but with a public advocacy sentiment. And that is, of course, built into the IRB system insofar as one lay member must be on any institutional review board. But, I have certainly seen lay members be ineffective members on IRBs. I have seen them be very effective as well. But, the system as it rests, needs a lot of improvement.

I want to suggest a couple of things. I think that in order to improve this problem, public representation needs to be on the committees at all levels, perhaps the National Bioethics Advisory Commission, certainly better membership on institutional review boards, so that the lay person on the board is not just a token member. And often they are not required to be present, if they are not comfortable showing up, they may not show up. If they show up, they may not feel comfortable advocating against majority who are very much pro-research, expedite the institution=s desires to go through with research.

I just want to address this book, which is a really fabulous book called ASociety=s Choices@. It was commissioned by the Federal Government to respond to the need for a National Bioethics Commission. And they made a number of very apropos recommendations. And I think that one is very relevant to today=s discussion. How can we get public representation on these committees? This one of the suggestions by the Institute of Medicine. And I will quote from this book. You will find it on both page 21 and it is also repeated word for word later in the book. It is regarding membership of committees. AEach national commission should have a diverse membership in order to represent the points of view of all of those concerned with or affected by the social and ethical issues to be considered. The composition of the body should enhance the qualities of impartiality.@ This is not something that we can be satisfied with at present. It needs to be implemented. And you will notice in this statement that it declares that public advocacy can be quite compatible with impartiality. And certainly is a necessary step towards and objective committee process, making these decisions for us in order to balance the over emphasis on committee memberships of hospital professionals, researchers and people who may have very subtle ideological desires to go through and which may jeopardize the public health.

I didn=t think I would go this fast, but I am ready to make a couple of conclusions. Again, we really need to make some serious improvements in the informed consent process. If you talk to clinicians, and I don=t mean to be a polemic or adversarial but, and Gary Ellis is right, we have some safeguards in place, when you talk to clinicians, one of their catch phrases that I often hear, without provoking them, it is a phrase that goes like this, AInformed consent is a joke.@ And I am not sure if this is written in some newsletters or what, but I hear these exact words repeated. And so, in order to make these, in order to clean up the system a little bit and protect ourselves, I would like to suggest two things.

I am very glad that the Interagency Working Group has suggested that the National Bioethics Advisory Commission address the problems of compensation in the future, when research subjects are harmed. I think we would do well to extend this principal back in time. And my proposals are these two. NBAC is a nice idea, but it is not nearly sufficient to solve the problems at present. And secondly, I would like to point out that a decent solution to the problems involving human subject research, must adequately deal with the suffering of past research victims as well.

And I made it within time. I am proud of myself.

MR. HOLLOWAY: Thank you very much.

Our next speaker is Jackie Kittrell, who comes from the American Environmental Health Studies Project.

MS. KITTRELL: Let me arrange my papers here.

My name is Jackie Kittrell, and I am from Knoxville, Tennessee, which is within 30 minutes of Oak Ridge, a large DOE facility. I am public interest attorney and my title is general counsel of a non-profit group called AAmerica Environmental Health Studies Project.@

As Carrie said, I feel like we are here on this panel to deal with recommendations from the Advisory Committee and also the Interagency Working Groups White Paper or implementation plans that they have given us recently. I am going to deal with recommendations nine through 16, actually. And it also includes the Advisory Committee findings 20 through 23. And within the White Paper, the Interagency Working Group=s staff preliminary draft response, the coverage is pages five through 14.

I was struck yesterday with something that may be really what is at issue here in how to move forward and how to handle, how to have adequate protection for human subjects now and in the future. And that is a contrast with how people in this room see how government works. I think there was a sentiment expressed at the end of the day by one of the experiment victims, that there is a belief that this government is still of the people, by the people and for the people. There is another kind of belief expressed by a lot of public servants in this room and out of this room and that is that they are the government and that we, as a constituency, as a clientele of theirs, and they are the profession, the professionals, we have to learn how to work with the government or work the government, I think as it was put yesterday. That is, you know, those two ideas of what government is, really clash when it comes to deciding how people can help their government. And what I am going to suggest is that the better way to look at this is the people in this room who have been through human research, have recently found out that they were human research subjects, have a whole lot of expertise. And their expertise is just as important as a more professional expertise in government public service.

I think that what I am going to suggest is that we need a more participatory style of working government. And one of the ways that we can do that is by figuring out how human subjects, human research subjects can provide expertise to the government in a very real way. One of the ways that comes to me as I read these recommendations is that really recommendations, recommendations 9, 10, 13, 14 and 15 all involve implementation plans by way of referring them to NBAC, or the National Bioethics Advisory Committee, that I understand is now in place, but hasn=t, the members haven=t been announced. I think that this almost brings forth the observation that there should be representation on NBAC by human experiment survivors.

It is possible, there are 15 members that are to be appointed to NBAC. The charter states that there should be one, at least one from five types of expert professions and three from the general public, with other expertise. They should be evenly balanced between scientific and non-scientific interests. The charter refers to experts and stakeholders, to a balance, to taking note of social and cultural morays of the times to establish a body sensitive to potential impact of its deliberations and recommendations. As I understand it, it is going to be dealing with things like an effort to ensure the centrality of ethics in human, in the oversight of human research, changes in the IRB regulations. Having a forum, a public forum for continuous interpretation of ethical rules. Implementation of the current federal systems for protecting rights and compensation for injury in the future.

So we are not even dealing with past injury here and there shouldn=t, and the expertise of the human radiation survivors or other human subject survivors should not be seen as in conflict with trying to figure out how to compensate those in the future.

I also think another really important reason why there ought to be an advocate of this sort on NBAC for human subjects, is the presence in the recommendations of recommendation 15 and even 16. Which deal with allowing secrecy still in classified human research to go on, both on individuals, specific individuals and on whole communities through the allowance of secret environmental releases. I think this makes it very clear to me that a strong advocate has to be on this NBAC.

There are other places in the recommendations that provide for ways that human subject advocates could be on other kinds of panels and other kinds of forums to advocate for the interest of the human subject. As I said recommendation 15 and 16 deal with secrecy and overseeing a secret classified kind of research. The Advisory Committee recommends an independent panel be formed on each of these matters to deal, I mean, maybe on one of these matters, on recommendation 15, to oversee the classification.

I don=t think the Interagency Working Group has taken up this recommendation, but I implore them to do so. That this is the perfect place to have an independent review panel made up of citizens and professionals to make sure that and I am not advocating secrecy in research at all, but if there is such, there really, really needs to be a check on it by having strong, strong, advocates for potential victims.

There are also many other places in the recommendations that agencies can use the expertise of the people in this room. Put them on institutional review boards. Take them to forums and have them speak as victims and say what they have been through and have them talk in a dialogue about how to prevent future harm. There is enough of them to go around. There is plenty of human subject victims that the Government has created. And I think part of their healing and part of the worth of their experience is to pass it onto you, so that it won=t happen again. I feel like the Government has been trying to with human subject research since, at least since 1972 in a public forthright way and hasn=t been very successful. And they need to include those most directly affected as required by the Federal Advisory Committee Act and the GSA regs.

MR. HOLLOWAY: Thank you very much.

Our next speaker is Sandra Reid from the Oak Ridge Health Liaison.

MS. REID: Good morning. I am going to comment on the, one of the last paragraph that raised great deal of concern for me, for my particular community, was when they were talking about the environmental laws and regulations and that this needs to be revisited. Particularly given that right now many of our environmental laws are under attack in Congress. I think this is a very, very important issue. This would allow them to still continue to a green run, that has happened both at Hanford and at Oak Ridge and at other sites. Laguna=s data is still classified.

I would also like to comment that I think that some of the problems that many of us have observed with the Advisory Committee, was because in spite of our many requests, we simply did not have adequate representation on this board. There were many times that we attempted to have our points of view addressed. It was not done. I think they had hoped to have a quick and dirty fix and sweep it under the rug. And this just could not be accomplished, given the complexity of this issue. I would recommend that in the future, that agencies ensure that at least one third of the board is comprised of people from these communities affected. And given the incredible complexity of this issue, that would bring people from many walks of life, who would speak actually to the issue and would be true advocates of the people within those communities. I think you will find that consensus can be achieved.

I also believe that a lot of the research that was done by the various students that came out, would have been more comprehensive and more adequate if the talents of these communities had been utilized. I am recent to this field. I have only worked in this a few years, but there are people who worked on this issue for more than 20 years. They have an enormous wealth of knowledge. And I think would have really directed a constructive and effective research into these areas and had those issues addressed in an open process, we would not now be facing this kind of antagonism towards the Administration that I am actually very proud to try to address this incredible difficult issue.

I want to point out that when Nixon came to power, he promised to deal with the Vietnam War, when he didn=t, it pissed everybody off so much, it became his problem. And I think many of us was so thrilled that President Clinton and Hazel O=Leary, tried to deal with this issue. It is an incredible complex and difficult issue. All of us who work in this, understand that. But, I can tell you that I believe that if it is not dealt with fairly and if it is not dealt with openly, it is going to become a problem for this Administration. And I think that would be an incredible pity.

I would like to say that what I feel that communities need besides these particular procedural guarantees, I am more of a pragmatist. I am a mother. I am registered nurse by training. I would like to remark that the Department of Energy is the only entity that right now has retained authority for all their radiology releases. In Oak Ridge, we still do not know what the atmospheric releases are of the radioactive, for the radioactivity in our community. It was only under legal pressure that they finally admitted that they could not account for 2.4 million pounds of mercury in 1984. Since then that mercury has become safe because it has converted suddenly into the safe substance, it is tightly bound up in the soil. And they can now sell homes in our community in a contaminated area of 300 parts per million, because they have established that it is safe. I am still a little confused about how that happened and it is because I obviously don=t have a strong science background, but it didn=t quite, it was never really made clear to me. And as a citizen, as a participant on the Citizens Advisory Board, the questions I asked were never adequately answered and the process was controlled. I am now on the Site Specific Advisory Board and that is a question that I am going forward to ask again. Why is this important? It is because the concern within our community is what I have heard from all of you today. How have these contaminants affected the health of us? The issue that is contentious, is not just the fact that we are in disbelief and dismay that the Government participated in something like this to its own people. And as a immigrant to your country, I can tell you that I was probably as outraged as many of you, particularly being a South African. I have lived in a police state. I know what goes on. And I can tell you that for me America was a beacon of light. I read your documents that said what the rights of man were. This had tremendous meaning for me. And in the years that I have come here and I have traveled across the states, I have recognized that the only people of the United States still maintain that independence and integrity, that they brought there from that bloody country over the water, where they forced ordinary people to cowtower to the aristocracy. Now what I want to know, is have we supplanted the aristocracy with the U.S. aristocracy here, who is telling us all what to do. Sorry, sorry, my little soapbox, I will get off of it.

I think we try and identify the problem, by developing a holistic environmental health plan. I wasn=t originally involved in this kind of jargon, but as I have worked amongst some of the communities in the Superfund, there are certain words as I started to interpret what they mean, really appeal to me. The holistic part means that it is going to work whatever is your particular community. And given the wide variety of people that we are, and the wonderful variety that is here in America, that is your strength. We should build upon that. It should not cause more division. We can use that as a way of identifying some of these problems. These projects must be defined, designed and shaped and governed by the affected populations. They must have the opportunity to bring their experts into address the problem. They must have people who are having dialogue within, that means a two way conversation, not a fraternalism little group, who are going to come in, who live thousand of miles away, who say AThis is what we are going to do@ and don=t understand that it cannot be done. It is simply isn=t possible given the way people live within that community.

We already actually have a successful example of these types of clinics. I actually worked within that system. Lyndon Johnson started the neighborhood clinics and for those of you who are not familiar with the medical system, this was when they went into communities and actually had the satellite clinics with a major center where people could be referred to. These projects or clinics would provide testing, diagnosis, treatment and treatment referral, the collecting of clinical data with of course the stringent protections for publishing, comparison of exposures, effectiveness of treatment, modalities, a registry and then a prevention development. It is important that we have education. Physicians and the medical field do not understand the complexity of the medical affects of these exposures. And we have to help them to learn how to identify the illnesses related to these exposures.

I am also concerned that we only look at the in point of cancer. As a nurse, that is rubbish. The pre cursors to that are more and varied. We are able to analyze them. They are auto immune diseases, in fact, I have found documents in the >40s and >50s that astounded me with what they actually knew then and what they were following in the work of health and safety data. And you all have got to realize, while I work, I live in Oak Ridge, I do not work at the facility, but it is the workers who have told me what I have to watch out for. It is the atomic vets who showed me documents to tell me what I needed to go for. As a nurse I am personally affronted by what happened to the Cincinnati people. And together we can support one another on this issue.

In Superfund we learned that the Department of Justice had told Barry Johnson not to deal with the issues of the clinics. This created an extremely chilling effect, none of us really understood what the hell was going on. And again from, coming from South African, I thought what the heck does this mean? Barry Johnson told us that they were not allowed to bring these clinics in, in spite of the fact that the mandate was to do that if there was, indeed, a health effect from a pollutant and there was justified reason to question it. Now, we are not dumb. We recognize that this could potentially cause liability for these communities, within these communities, however, my experience has been that if we help the people with regard to health, the liability issue is not as significant. I am not saying it is not there, but it is not as significant, the majority of people don=t want that. I have got zero minutes left, but please a little more.

There always going to be this tension. And I think that if we try and trace the toxic footprints, the way it is affecting people, we will get a better understanding of the medical effects so we can know exactly what it is that we need to deal with and people are not sitting there in suspicion and fear, which is what I see now.

With indulgence, I want to quote something from someone that I have grown to love and respect his writings. AAnother Distortion, the Technological Resolution@, is that instead of strengthening democracy at home, it has helped to eviscerate it. Giant industry and government woven into a increment computerized mechanism leave the person outside. The sense of participation is lost. The feeling that an ordinary influences important decisions vanishes. And the man becomes separated and diminished. When an individual is no longer a true participant, when he is no longer, when he no longer feels a sense of responsibility to his society, the content of democracy is emptied, the culture is degraded, and vulgarity enthroned. When the social system does not build security, but induces peril, inextricably, the individual is imperiled to pull away from the soloist society. This process produces alienation.

That was Martin Luther King in the >60s. Thank you.

MR. HOLLOWAY: Thank you very much.