The first, held in May 1970, was devoted to the scientific aspects of prenatal diagnosis by amniocentesis and cytological or biochemical analysis of the amniotic fluid and amniotic fluid cells. The proceeding of that conference are about to be published.

The National Science Foundation recently awarded a $68,000 grant to the National Academy of Sciences to conduct a 1-year technology assessment in biological and medical science developments. A $1.5 million grant has been awarded by the NSF to the Center for Advanced Studies in the Behavioral Sciences to establish an integrated program of technology assessment, which will take into account the societal impacts of current and future developments in medicine and biology. The NSF expects that, as a result of these studies, there will be a more active concern within the academic community for the value questions associated with science research, and additional studies in the sciences and humanities.

It is also anticipated that within the next 1 to 2 years NSF-supported research will yield a major conceptual assessment and significant research plans for further work in societal impacts of biological and medical technology.

In the private sector, several distinguished groups already in existence have broad responsibilities in the areas outlined for the proposed Commission on Health Science and Society. These include the National Academy of Sciences, with its newly established Institute of Medicine, and its National Research Council; the American College of Surgeons, the National Academy of Engineering, the American Academy of Arts and Sciences, and the American Philosophical Society.

These prestigious organizations have taken very seriously the legal, social, and ethical implications of advances in the health sciences. Also in the private sector, the IBM Co. has funded a program on technology and society at Harvard University, which has produced a research review of the literature on the implications of biomedical technology, and the World Council of Churches has recently completed a conference on "Technology and the Future of Man and Society."

Finally, Mr. Chairman, a contribution to the public discussion of these questions has also been made by the Joseph P. Kennedy, Jr., Foundation at its recent symposium on human rights, research, and retardation, and by its funding of an institute at Georgetown University to consider the ethical and moral aspects of medical research.

This brings us to the critical decision points with respect to the proposed legislation. In the light of relevant activities already underway, and the number of existing institutions concerned on a continuing basis with issues raised by health research advances, is there a need for the National Commission proposed in Senate Joint Resolution 75? The issues are so complex and the underlying currents of change moving so swiftly that in our view no attempt to describe this particular healthscape at what would have to be a given moment of time could be definitive for long.

In other words, society might be better served by lower keyed but continuing efforts by the present variety of private and semipublic organizations and entities attempting to assess, rationalize, and explain. One cannot help but be impressed by the variety and quality of work already underway in this area, and the seriousness with which indivdiuals and institutions are attempting to deal with these matters.

Additional Federal support-apart from that already afforded through various means by such agencies as the National Institutes of Health and the National Science Foundation-does not appear to be an urgent need.

I am persuaded, too, of the appropriateness of a minimum overt role for the Federal Government in the debates and discussions taking places on these very fundamental issues. For these reasons, I cannot recommend enactment of Senate Joint Resolution 75.

Thank you, Mr. Chairman. I will be happy to answer any further questions you may have.

Senator KENNEDY. Thank you very much, Dr. Duval. As always, your testimony is extremely helpful.

I understand in 1968 the then Acting Secretary Cohen, Assistant Budget Director Cary, Surgeon General Steward, and NIH Director Shannon all looked favorably on such a Commission, and I understand your Department also reported favorably on the bill during the last Congress.

What has happened to change your mind on it?

Dr. DUVAL. I think, Senator, we can see that superb examples of advances have been made in the sectors that I referred to in the statement, and we believe that a single-shot approach by a commission with a 2-year life may not be as effective as the machinery that has already been established.

Senator KENNEDY. Of course, as I understand it, the commission is supposed to make recommendations to establish the institutional guidelines by which there would be an ongoing study and review of these problems. So rather than take a one-shot, 2-year approach as you have suggested, it would establish procedures by which there would be ongoing continuity, responsibility and information available.

It seems to me that all the things you have listed here have been pretty scatter-shot, haven't they? I mean, you have one group like IBM doing a study here, another group doing a study there, all of them on their own.

I don't yet see from what you have said this morning, that there is anything in your Department that is consolidating this, coordinating it, and able to give reliable information from time to time on what is happening.

You list various studies which are being done, all of which, I think, are extremely worthwhile, but you haven't told us what institutional apparatus has been set up so that there would be an ongoing, continuing setup either within NIH or some place in your Department— that would be responsible in this area.

Dr. DUVAL. The guidelines under which we operate through the research grant procedures at the NIH have to date, in our judgment, been very trustworthy.

We have had very few abuses under those guidelines when it comes to the use of public funds to support work in this area.

I would and in response to your opening comment, that the fact that the Commission may exist for 2 years, but lay down guidelines that will have a duration presumably greater than that

Senator KENNEDY. Of course, I don't understand that to be the necessary result of such a studv. They might say that what we ought to do is establish a group made up of different scientists, engineers,

theologians, ethicists, and various groups that would have an ongoing responsibility, and it might periodically report to the Congress as well as to the President; but at least, it would be an ongoing-type of existing institution. That might be the result.

They might have, as the special group suggested, a separate institution in terms of cancer. As I see it, they are wide open regarding the kinds of things that can be recommended, and I fail to see why you think the present situation-with all the uncoordinated studies that have been done-why that is a more satisfactory way of proceeding.

Dr. MARSTON. Senator Kennedy, I read the very, very valuable hearings of now almost 4 years ago, and I would only say that if the commission had been set up at that time and had completed its work 2 years ago, I think some of the points that you brought out in your opening statement would have been missed.

So, whatever the Congress eventually decides in this area, I think the point that I would like to emphasize along with Dr. Duval, and I gather with you, is that this is a dynamic field and that the most important thing is to have some mechanism periodically to bring before the American people and before the scientific community and the public, some of these very important questions.

Some of these, I think

Senator KENNEDY. How often? You mentioned "periodically." It seems to me it is being handled on a rather ad hoc basis now, isn't it? What group do you have within the Department which is thinking about this type of question all the time?

Dr. MARSTON. Could I go back

Senator KENNEDY. And you feel that it is of sufficient importance that you have people whose primary responsibility is to come in every day and think and work on these kinds of problems?

Dr. MARSTON. Yes, I think it is very important, and I think a question you raised during Dr. Duval's testimony deserves a little more exploration, and clarification of the problem. Could I take a couple of minutes to respond to that question?

Senator KENNEDY. All right.

Dr. MARSTON. Since the hearings of this committee last, I think the major change in the NIH position in the area of human experimentation has been to require greater evidence of institutional competence. As we started working in the area of protection of patients from adverse effects of human experimentation, it was first on the individual investigator, first on the peer review system, itself, and then the development of local committees to look at individual projects.

Now, as questions arise, we are looking at total institutions, universities, or teaching hosts, and their competence to cope with the question in the broader aspects of human experimentation, and here, I think, one can never be completely comfortable that we do have mechanisms that work on a day-by-day basis that call attention with every grant and every institution that receives a grant in this country.

Now, the areas in which we are far less comfortable are some that we are just beginning to go into at present, and this is where there is a true mixture of the problems of society and the problems of science. They extend to the question of the allocation of scarce resources, whether one is talking about the distribution of physicians on the one

hand or the allocation of expensive equipment, such as renal dialysis on the other.

They also cover areas such as our recent conference and the questions raised by new knowledge in genetics and also the one that the Kennedy Foundation covered.

Here, I think there is no answer, but there have been a significant number of serious attempts in a reasonably organized fashion. The Fogarty Center has set up a series of conferences on this. Others in the country have focused on it.

The more difficult problem, as I see it over time, is the changes that will result from advances in biomedical science and, if you will, man's image of himself. It makes a major difference in the whole area of how many children people plan for when the prospect is that few children will die of infectious diseases.

There is a great difference when an individual recovering from a previously fatal disease, whether it be cancer or a myocardial infarction, looked forward to an active life for a number of years.

And, of course, the whole question of prevention of illness through smoking being one that we know at present, the whole problem of diets, the large-scale clinical trials, and very difficult areas.

I think that this set of hearings of 4 years ago did a very good job in laying out the problems in the first two areas. I think we have made progress in a clearer understanding in this country at least that the boundaries and conditions of human experimentation. I think in the other two areas, we have fairly far to go, and need to seek a variety of mechanisms, not to find an answer, but to make progress in these life and death questions.

Senator KENNEDY. Say with respect to renal dialysis, do you have grants now directed at experimentation on that? Do you make such grants now?

Dr. MARSTON. Yes. We have a major target program to try to bring down the cost and try to improve the effectiveness of the machines themselves, the technology; and in addition, we have major programs to try to prevent the occurrence of renal dialysis.

Senator KENNEDY. What are your guidelines, say, as to who should get those machines?

Dr. MARSTON. As far as the question of the grants and accounts to work on the machines, it is a matter of who has the best ideas and what are the national needs for the development of the artificial process. We have at NIH no service programs that provide instruments to individuals for the treatment of patients.

Senator KENNEDY. When you OK a grant for experimenting with these machines, do you have any guidelines as to the kinds of people who ought to be benefiting from them? Or is that up to the local people? Dr. MARSTON. In the award of our grants for the support of renal dialysis centers, which tend to be different than some of the others, the first assessment is the likelihood that the proposal will give new knowledge which will improve the efficiency of the treatment of patients.

Beyond that, there is a requirement that there be an adequate selection process which focuses from the standpoint of the experiment largely on the protection of the patient and his suitability to meet the needs of the specific research protocol.

Senator KENNEDY. How do you define an adequate selection process and the patient's suitability?

Dr. MARSTON. If the purpose of the grant were to develop, for instance, a small unit that could be used perhaps at home, then one of the criteria would be to select an individual who could use it.

Senator KENNEDY. What do you recommend as to how they ought to select? Say there are four or five applications for that? Do you make any judgment about how to select them?

Dr. MARSTON. Again, for the purpose of our grants, it would be those situations that would generate the greatest scientific knowledge and the selection of those patients which would give the most useful information for the research protocol. This is quite different from the support of dialysis units for service purposes.

Senator KENNEDY. Say the city of Boston comes down to NIH, and we have, say, 25 machines and 100 different applications, and 75 people, 75 of those people, are going to die if they don't get the machines. We would like to know how we ought to select those people. What can you tell us about that?

Dr. DUVAL. Senator, I think Dr. Marston's point

Senator KENNEDY. No, I got his earlier point.

Dr. DUVAL. We understand this is different. This is not a function that we undertake at the National Institutes of Health.

Senator KENNEDY. What kind of help and assistance can you give the city of Boston on this?

Dr. DUVAL. In terms of guidelines?

Senator KENNEDY. Yes.

Dr. DUVAL. None.

Senator KENNEDY. What do you think you ought to do? Take a smaller community. Take Milford, Mass. They might have one or two. How are they going to be able to bring together the various different kinds of disciplines to make some kind of decision in terms of what they ought to do with that machine? I think one thing that we are seeing is that people in these communities who are trying to do it are throwing up their arms. They just don't want that responsibility. They set up some kind of ad hoc group at a hospital, which makes decisions that amount to playing God, and they don't want any part of it. They want some kind of help and assistance. They want to talk to people at the school of theology or the school of medicine or some other place, where they can get some guidance.

Dr. DUVAL. Yes, sir.

Senator KENNEDY. What they want is some place or someone who can help them. Not necessarily by saying "Here it is," or "This is it"; but at least some central place that can give them a range of alternatives, or a framework for their decisions.

I am just wondering. I don't know whether this study will lead to the recommendation that we should establish one place to resolve these questions, but at least the Commission could identify the kinds of alternatives which must be considered.

What are the people in those communities supposed to do? Where are they supposed to go; and if they come to HEW, what kind of answer or help can you give them?

Dr. DUVAL. May I say that you have expressed this dilemma extremely well, and we are all familiar with it.

We interpret our role as being that to provide such counsel and advice we can to persons who come forward with this kind of situa