It would be unfortunate indeed if the exciting advances being made in the field of biotechnology as it relates to human health were to be dampened by a national sense that researchers and universities were profiting from the donations of research materials obtained deceptively from volunteers. While I believe that the current regulations governing informed consent should provide adequate protection, I also believe that the academic community needs to be totally open and honest about these matters. In the final analysis it is the public trust that matters most. I thank the subcommittee for giving me this opportunity to encourage that trust.

Mr. VOLKMER. Thank you very much, Dr. Blake.
Dr. Levine.

STATEMENT OF DR. ROBERT E. LEVINE, CHAIRMAN, INSTITUTIONAL REVIEW BOARD, YALE SCHOOL OF MEDICINE, NEW HAVEN, CT

Dr. LEVINE. I want to thank you for giving me the opportunity to present my views on the matters that you are considering.

In my presentation I shall draw liberally on the 1984 report of the 20th century fund task force on the commercialization of scientific research. I have had several copies of this report sent to your staff, and I hope you will have access to them.

As a member of that task force I had the opportunity to participate in their extensive study of the problems presented by relationships between industry and academia. The report focuses on molecular biology as its model.

Before I get into the specifics, let me consider some of the fundamental values of the university, particularly those values that may be threatened by the relationship with industry. Here are the ones identified by the task force:

First, there should be a free exchange of information and ideas within the university community. Students and faculty should all have access to these ideas and information.

Second, there should be a freedom to pursue knowledge for its own sake.

Third, there should be an appropriate balance within the university of efforts devoted to sciences, arts, and the humanities.

Fourth and last, the members of the faculty should be available to provide disinterested advice to Federal, State, and local governments on public policy issues.

These are ideals. They are not norms. We do not pretend to live in perfect harmony with these ideals. What they do is serve as reminders for us of what we should be striving for. As we in the university consider new relationships or policies, we should keep in

mind that we should resist those that threaten our efforts to aspire to these ideals.

Now, before I go on, I want to address the sentimental notion that the university is an ivory tower, a place where scholars pursue the development of new knowledge and its transmission to the next generation unburdened by the cares of the real world. It is, in part, that, but it is not only that. It is also a marketplace. We compete for recognition by students and by colleagues. We compete for laboratory space, for tenure, and so on. These are among the traditional coins of the academic realm. I am sure you have heard our metaphor or slogan, "Publish or perish." In our divinity school, it is, "Publish or parish." We also compete for money, and in the medical school, it is, "Publish or practice.'

We also compete for money in such forms as grants and contracts from the Federal Government, and we compete for patronage from philanthropists and from industry. We compete in the real world for consulting fees, for professional fees, and through marketing of our patented inventions.

We have some fear that, as has happened so often in the past, the will of the patron will dominate the art and the science. After he left his post as Assistant Secretary of Health, Dr. Theodore Cooper, now executive vice president of the Upjohn Corp., gave a speech to academic physicians and scientists. In this, he pointed out the perils of patronage.

As he pointed out, the Federal Government began by patronizing research and education and then went on to dictate medical school admissions policies and curriculum content. Although medical schools were quite delighted with the early patronage, they were perturbed, to say the least, by the later developments. He warned us that the same thing could happen if industry became the dominant patron.

Let me turn now to the 20th century fund observations. Ties between the scientific community and corporations and between corporations and universities are not, of course, new. Such ties are one reason for the continued supremacy of American science. The task force calls attention to the fact that the problems presented by such ties have been the subject of various summit meetings among university leaders.

In addition, various new guidelines have been proposed by groups such as the National Academy of Sciences, the American Association of University Professors, and the American Civil Liberties Union.

The task force concluded that radical changes are not called for. Rather, they formulated a number of policies that they consider both flexible enough and resilient enough to protect the independence and freedom of the scientific and academic communities in dealing with Government and corporate enterprise. Let me emphasize, both Government and industry. The task force saw the very same problems in the universities' relationships with both Government and industry.

The key recommendations of the task force focus on disclosure; for example, disclosure of relevant commercial connections to department chairmen or other designated officials. They also call for disclosure of outside sponsorships to students-those students who

are directly involved in research projects with professors having these commercial connections.

Furthermore-and this is very important-the professors must define for their students procedures that will be used to determine who will be named inventors on the patents that may result from the research.

There are other specific recommendations addressed to specific threats. Some of these are quoted in my written testimony.

Now I want to turn to some specific questions that were put to me by your staff.

First, do such relations inhibit the flow of information within the university? Yes, they may. But as the task force observed, Government contracts also place conditions on the disclosure of discoveries. Just as research projects supported by industry can be classified for proprietary reasons, projects supported by Government can be classified for security reasons.

Not too long ago, the Department of Defense floated the idea that in the future it would have to give approval before the findings of research it had sponsored could be published in journals. A possible consequence might be that a graduate student might not know whether his or her thesis research could be published, a situation that students and universities would find intolerable.

So it is not only industry that calls for secrecy within the university environment. Moreover, the Department of Defense is not the only Federal agency that may call for secrecy. Many universities, including Yale, have policies prohibiting research sponsorship by any agency that requires curtailment of publication. These delays up to, say, 45 or 90 days are tolerated so that the sponsors may review for prospective-review for the possibility of patentable inventions. Veto power is generally precluded.

University policies notwithstanding, there is still secrecy in the academic environment with or without outside sponsorship. You can find ample evidence of this in Watson's book, "Double Helix." In the academic marketplace, scientists often keep their ideas secret so that they may be accorded the recognition usually associated with being the first to publish a new idea or discovery.

Second, do collaborations between academia and industry change the nature of research? Does availability of money change the objectives of research? Again, I must answer, "Yes."

This matter was also addressed by the task force. I quote:

The contract research portion of Federal grants, which is usually not subject to peer review, can be as restrictive in terms of the intellectual freedom accorded the individual scientist as industrial contracts. In such contract research grants, the research objective is specified by the Government agency rather than by the university.

I continue to quote:

Other restrictions also arise. For example, NIH provides most of the money made available for biomedical research. The priorities of the NIH, which is subject to political pressures to cure cancer or treat epidemics, influence the priorities of the scientific community.

I ask you to recall the "war on cancer" that was declared in the early 1970's and the later very high priority accorded to research and service in the field of mental health.

Third, does industry disrupt research programs by suddenly withdrawing support? Again, the answer is, "Yes." Again I must say that in this respect, industry does not differ essentially from the Government. For various reasons, research sponsors may lose interest in certain fields of research. In developmental and applied research, it seems to me that industry and Government are about equally likely to withdraw support unexpectedly.

In basic research, on the other hand, industry seems to me to be much more patient and stable in its support of research. Unexpected Governmental actions may threaten the stability of entire fields of research or, for that matter, the entire research community. Consider, for example, the impoundment of research funds in the early 1970's. More recently, biomedical researchers have felt profoundly threatened by directives issued by OMB to NIH.

In summary, the university in its evolving relationships with industry is not presented with any challenges that differ qualitatively from those with which it has had a good deal of experience. Some of the current turmoil reflects the fact that universities are beginning to see the Federal Government as an increasingly unpredictable patron.

In their search for stability they are turning to industry and attempting to negotiate long-term support. Is this bad? I don't know.

I am inclined to agree with Leon Kass, the distinguished physician-philosopher from the University of Chicago. I would have chosen a different metaphor, but I cannot express my overall attitude more concisely than he did:

Academic sciences have for years played upon the public's utilitarian concerns and always promised and even emphasized the probable long-run practical benefits when seeking congressional support to satisfy their private curiosity. Science, even university science, is, to some extent, a kept woman, and the question sometimes seems to be only who shall keep her and what is her price. Her virtue and her fruitfulness may not suffer from wedding herself to industry.

If you think the wedding to industry is bad, then in my view the best way to avoid it is to stabilize Federal support for academic research. However, if you decide there are specific problems requiring legislative remedy, I urge you to identify the problems you wish to fix rather than the wrong-doers you wish to constrain.

For example, if you wish to prohibit conduct of secret or classified research in universities, by all means do so, but do so consistently. Proscribe all such research, whether it be sponsored by industry, Government, or others. Such an approach would be consistent with the doctrine of equal protection of the law than would be the alternative approach, to develop legislation governing the conduct of industry in order to foreclose classified research in the university.

Thank you.

[The prepared statement of Dr. Levine follows:]

I am Robert J. Levine, Professor of Medicine and Lecturer in Pharmacology at Yale University School of Medicine; I also chair its Institutional Review Board. I am very pleased that you have invited me to appear before you today. In this appearance I represent no interests other than my own. My relevant professional interests are identified in my curriculum vitae, copies of which I provided for your colleagues on the staff. My primary scholarly and teaching interests over the past twelve years have been in the field of medical ethics. Previously, I was Chief of the Section of Clinical Pharmacology at Yale University School of Medicine doing clinical research as well as basic laboratory ("bench") research with financial support from, among others, the National Institutes of Health and various drug companies.