SOME “NEW MEN OF POWER’: THE CASE OF BIOMEDICAL RESEARCH SCIENTISTS

Bernard Barber, Ph.D.

Barnard College, Columbia University, New York, N . Y

From time to time, the distribution of relative amounts of power in a society changes. Different groups become more and less powerful as the various sources of their relative power increase or decrease. When a certain group undergoes one of these relative increases in power, we may call them “new men of power,” to use a phrase that my late Columbia colleague, C. Wright Mills, used in 1948 to describe American labor leaders, a group that had risen to power in the late 1930’s and 1940’s. Businessmen were “new men of power” in the late 19th and early 20th centuries, as were atomic scientists starting with the Second World War. Lately we have heard about another constellation of “new men of power,” those who are in the military-industrial complex. I want to talk about some problems connected with a very recently risen set of “new men of power,” the biomedical research scientists in our universities, our government clinical research centers, and our drug-industry laboratories.

The sources of new power for biomedical research scientists are quite obvi- ous. They are rooted in the fundamental scientific discoveries that biological science has made in the last 25 years and in the many technological discoveries that sometimes combine with these scientific discoveries to produce the greatly increased therapeutic power of the medical profession. Biomedical research scientists now have a whole new magnitude of power to d o good, and also a whole new magnitude of power to d o harm, which we saw in the teratogenic consequences of thalidomide.

How have the biomedical research scientists used their great new power? Whenever some new set of “new men of power” arise, there are those who fear that they will become the “new irresponsibles.” Is this true of the biomedical research scientists? I think not. I think that, on the whole, though with some unevennesses, they have acted fairly responsibly. They have tried to d o as much good as possible and to forestall as much harm as possible. Where harm has been done, it has often been done accidentally, despite reasonable self-controls. Furthermore, biomedical scientists have been quick to learn from such mistakes and to correct them.

And yet, there remains the charge by knowledgeable and reasonable men that too many biomedical research scientists have acted only on what I have called “mediocre ethics.” Taking evidence from the biomedical science journals themselves, men like Beecher, in this country, and Pappworth, in Britain, have documented the evidence for this charge of mediocre ethics. This is a serious charge, not because it says that there is a great deal of poor ethical practice in human experimentation. It does not say that at all. It says only that some small but significant proportion of biomedical research scientists are using mediocre ethics. And that is a serious charge in a situation where the very highest ethical standards are supposed to be followed by everyone in every situation involving the use of human subjects.

If there is, then, some apparent need for ethical improvement in this area, what are some of the operating mechanisms of personal and social control that

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operate fairly effectively when we take them as a whole group but that also require some improvement, both severally and overall? Before I consider some of these mechanisms, though, let me repeat that I am talking about raising already fairly high standards-I am not attacking any total moral inadequacy. If we are not clear on this point, we cannot know what we need to do. As a result of the Southam “live cancer cell” case and of the Public Health Service regulation of 1966 that all grantee institutions must have ethical peer review for all funded research, biomedical research institutions now have more peer review committees and more stringent review than they have ever had before. I am convinced that in these last few years we have already made some considerable improvement in ethical standards for human experimentation. It is on this understanding that I am considering the various mechanisms of social and personal control over ethical behavior.

I shall discuss, briefly, six of these. I should like to remind you that the order in which I discuss them is not an order of their importance. Please do not commit the fallacy of the list here. These six mechanisms often work all together, or some subset of them do, to produce satisfactory ethical behavior.

First, there is the general ethical training that all members of a society receive. I am persuaded, despite the harsh views that many of our moralists take of our society, that the general ethical training that members of Western society receive is an indispensable ingredient of good ethical practice in human experimentation. We do, in some considerable measure, try to treat our fellows as we would have them treat us. We do try to have a special compassion for the weak, the sick, the disadvantaged.

But note, these are very general ethical maxims and therefore very difficult to apply in the particular, specific cases that confront the biomedical research scientist. This problem of the need for greater ethical specificity is one of the key problems for all ethical behavior, I do not believe in any radical situational ethics. I am simply insisting that moral absolutes can be applied sensibly only in very specific situations and with very specific factual knowledge about those situations.

Second, for many, though not all, biomedical research scientists, there is the ethical training they may receive in medical schools and in internships and residencies. I regret to say that it is my impression that this training seems to be unsatisfactory in the few places where it occurs and is almost totally lacking in most places. But there are some signs pointing to improvement. At the Yale Medical School, for example, Dr. Jay Katz, who has given a scholarly interest to ethical problems of human experimentation, presents seminars in this area to at least some specially interested students. Also, at the Mount Sinai School of Medicine, Dr. Jack Green, in the process of discussing a whole series of prob- lems connected with drugs in our society, gives special attention to ethical problems of human experimentation.

Third, there are the general ethical codes for medical practice and research. If you examine such codes as the Hippocratic Oath, Sir Thomas Percival on Ethics, the Nuremberg Code, and the Declaration of Helsinki, you will find that as you proceed from earlier to later codes, from the former to the latter, they become both more concerned with the ethics of human experimentation and more specific in the prescriptions and proscriptions they contain. But even the latest of these codes, the Declaration of Helsinki, can carry a conscientious researcher only part of the way. It covers many problems, but many remain,

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and researchers often need much more specific guidance than any general code can give them.

Fourth, there is informal peer learning and control. Researchers often informally consult with their peers; they compare cases, get new perspectives, and search for the endless compromises that have to be made if the inherent dilemma of risk to the subject and joy of discovery to the investigator is to be satisfactorily resolved in every specific case. But informal peer consultation has its limitations. It may be too personal; friends may hesitate to speak out against one another’s moral lapses, however small. And there is the danger of mutual blindness; the members of a single, ingrown informal group may all have the same perspectives, the same heedlessness of what some subjects and other researchers may consider important.

Fifth, there are formal review committees, more impersonally constituted than a set of informal colleagues. In the last five years, as I have said, there has been a great increase in the number of these committees, chiefly because since 1966 they have been mandated by the Public Health Service for all its grantee institutions. As a result of some current research sponsored by the Russell Sage Foundation which Dr. John Lally, Mr. Daniel Sullivan and I now have under way, we hope to learn some basic facts about these committees: when they were first organized and why; whether they consider all research or only that which is PHS-funded; how many members they have, who these members are, and how often they meet. We want to know if these committees have outsiders on them, and who these outsiders are. We want to know something of the mecha- nisms involved in the decision-making process of these committees.

All of these matters are interesting, but the matter of outsiders is one that I consider particularly important. One of the possible defects of formal review committees is that even they, like informal groups, are too ingrown, too particu- laristic, too narrow in their perspectives, to function as well as they might. In view of these possibilities, I should like to see two kinds of outsiders mandated as members of all review committees. One kind is relevant biomedical research experts from institutions other than the one where the review committee func- tions. Such expert outsiders would carry from Harvard to Texas, or from Kansas to Cornell, for instance, a different perspective and an impersonal objec- tivity that is harder to provide from the inside. A second kind of outsider should be the sociological-legal-ethical expert, fairly knowledgeable about biomedical research, but, rather, an expert in such problems as the nature of social norms, the problems of fair or judicial procedure, and the relevance of public feelings, values, and knowledge to the ethical matter in hand. Indeed, with this kind of outsider in wind, I foresee a whole new social role, one in which people with various kinds of social science and legal training undergo further formal and on-the-job training to qualify themselves to serve on ethical review committees in biomedical research institutions. It is not sufficient to have a slightly trained person in this role. Some members of the clergy can fill it, but not all, and even those who are suited should have further training. Some members of the general public might fill it, but, once again, only if they have special sociological-legal skills and further training.

Sixth, and finally, there is the control mechanism of legislation. I think no one knows better than I, after years of dealing with very able and very ethical biomedical research scientists, that they usually share the anti-law attitudes that many members of our society have. Too many of these men tend to think of law as necessarily and only negative, restrictive, and punitive. They do not see

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law for what it also often is, indeed usually is perhaps, a creative force for social and ethical innovation. In this area of ethical experimentation, I am convinced, some broad and tentative legislation could be a great creative social force. For example, the present PHS regulation about ethical review committees is an administrative regulation, without explicit statutory enactment. I would con- sider it desirable to have a uniform statute enacted by all the states requiring such ethical review committees of peers to pass on all research involving human experimentation, no matter what the source of funding of the research. As was the case with other uniform statutes such as that which was recently drawn up for Anatomical Gifts and which will be discussed later by the Sadler brothers, any statute of this kind should be the result of intensive legal research and of close cooperation between legal scholars, sociologists, and biomedical research scientists. I would note that fair laws protect all the parties at interest, and I think a fair law about human experimentation, drawn up as I have suggested, would protect not only subjects of such experimentation, but the careful and conscientious experimenter himself. Without such a law, the inevitable acci- dental misadventures of research using humans can become the focus of unrea- sonable and even malicious attacks on biomedical research scientists. The Uni- form Anatomical Gift Act, which has already been adopted by almost forty states in the short space of two years, does indeed protect both physicians and donors.

Furthermore, given the great concern of the general public and their various elected and self-appointed representatives in these matters, I suggest that it is no longer a question of law or no law in this area. It is inevitable that there will be legislation. Indeed, at least two proposals were introduced before the New York State Legislature in its recent session. The question now is whether bio- medical science is going to get a “good” law or a “bad” law for human experi- mentation. I should hope that we could take action to get a good law before the threat of a bad law is upon us. We should endeavor to set up some model good laws in advance of such threats. I might note that the Association of the Bar of New York is concerning itself presently in this matter, though with not as much speed as one might wish, and action by this distinguished and able body would be very valuable for the goal that I have suggested. Professor Frank Grad (this monograph) of the Columbia Law School has drawn up a model statute that will be a valuable focus for further discussion in this area.

In conclusion, let me say that I am optimistic for a future in which, by a variety of means, we shall be able to raise our ethical standards for biomedical research on human beings still higher than they now are. But such optimism rests on the assumption that there will be much more reasonable cooperation among the interested parties and much more necessary research on the actual facts of the case than there now is. I think there is good ground for believing that this assumption will be realized.