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THE BELMONT REPORT

Page 8

Injustice may appear in the selection of subjects, even if individual subjects are selected fairly by investigators and treated fairly in the course of research. Thus injustice arises from social, racial, sexual and cultural biases institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although individual institutions or investigators may not be able to resolve a problem that is pervasive in their social setting, they can consider distributive justice in selecting

research subjects.

Some populations, especially institutionalized ones, are already

urd ed in many ways by their infirmities and environments. When research is proposed that involves risks and does not include a therapeutic component, other less burdened classes of persons should be called upon first to accept these risks of research, except where the research is directly related to the specific conditions of the class involved. Also, even though public funds for research may often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public health care constitute a pool of preferred research subjects if more advantaged populations are likely to

be the recipients of the benefits.

One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research suhjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition.

(FR Doc. 79-12065 Filed 4-17-79, 8:45 am)

Mr. VOLKMER. Without objection, Dr. McCarthy. Those regulations and the other documents will be made a part of the record at this point in the record.

We have a double vote-we're going to have two votes—but before we recess for that, since I reviewed your testimony, Dr. Levine—if you wish, you could proceed with that and we'll get that part out of the way, then we'll go vote and then I'll come back for Dr. Murray. So if you wish to- I believe you could complete yours in about 7 minutes; shall we say, 5 minutes?

Dr. LEVINE. I'll give it a try, sir.
Mr. VOLKMER. All right.

STATEMENT OF ROBERT J. LEVINE, M.D., DEPARTMENT OF IN

TERNAL MEDICINE, THE SCHOOL OF MEDICINE, YALE UNIVERSITY

Dr. LEVINE. In the course of my presentation I'm going to make frequent references to a book I wrote called "Ethics and Regulation of Clinical Research.” Unlike the book I referred to this morning, I have not had free copies distributed to members of the subcommittee.

Much of the early part of my written testimony consists of information that Dr. Blake reviewed quite adequately this morning, that in our view in general, after a patient or a subject abandons human materials, such as surgical specimens, or urine, for that matter, it's viewed as passing into the public domain. The individual loses all interest in it with one exception, and that's privacy.

I think all I want to say about that is adequately reflected in my written testimony without any need for me to review it here.

If the researcher wishes to remove human material primarily to serve research interests, the situation is very much different. In this case, full, informed consent is required. Dr. McCarthy has just reviewed the elements of informed consent, and I want to focus on two of them, the first being an explanation of the purposes of research and the second being a description of the benefits to the subject or to others which may reasonably be expected from the research.

In order to illustrate how such requirements are made operational in the practical arena, I want to consider the sort of consent form we might have prepared for Dr. Hagiwara's mother. I believe members of the subcommittee are familiar with the Hagiwara case.

Our IRB would have approved a consent form with the following statements of purpose and benefits:

The purpose of this research is to learn more than we now know about cancer of the cervix. In particular, we wish to learn whether cells like yours can be used to make antibodies to cancer cells. This research is not designed to bring any direct benefit to you. Rather, we hope that the knowledge developed in the course of this research will form the basis for developing improved treatments for future patients with cancer of the cervix.

In general, we ask researchers to tone down their usually overly exuberant statements of anticipated benefits. We do this in order to avoid creating the appearance of what the Nuremberg Code refers to as "deceit, duress, overreaching, or other ulterior form of constraint or coercion."

Should we go on to discuss the commercial implications of research? For the sake of this discussion, let us tentatively say “yes.” The statement of benefits may be expanded to read, "If we are successful, we may be able to develop a cure for cancer which, of course, would have enormous market value."

If we are to make such statements, to whom shall we make them? It's worth keeping in mind that most efforts of this sort fail. Researchers take cells from hundreds of people before they achieve success. Should such statements be made to all of these people? Are they all entitled to negotiate for a share of the proceeds? Or, instead, is this more like a lottery in which there will be but one winner?

It is commonplace that all scientists stand on the shoulders of their predecessors. They all draw on the work of those who have earlier discovered and published. Such is also the case for these research subjects. Should we have discussed the potential market value with all of the many men and women who donated their cells so that researchers could learn how to make hybridomas and monoclonal antibodies in the first place? If so, the number begins to loom large.

Much is made of our current capacity to make synthetic hormones using recombinant techniques. This capacity is totally contingent upon knowing the molecular structure of the hormone. In order to learn the structure of ACTH, Dr. Aaron Lerner and his colleagues had to first purify the hormone. This required taking pituitary glands from approximately 7,000 dead human beings. Are their estates entitled to a share in the proceeds?

I'll skip the next few paragraphs and say, I think not. I think that if the market value is to be disclosed, it should be at the stage of inevitability, the stage in applied research at which the development of a product that could have market value becomes inevitable. At this point, this fact could be disclosed to prospective subjects in order to give them an opportunity to accept or reject cooperating in the development of the product.

I agree with the intent of Congress expressed in the Organ Procurement and Transplantation Act in which it proscribes sale for valuable consideration of human organs. People should not be en

couraged to sell themselves or parts of themselves. I recognize that the Act excludes replenishable tissues, such as blood or sperm.

It may be somewhat hypocritical or evasive, but when we give people money in exchange for replenishable tissues we usually call it a payment for services rather than a purchase of tissue. The amounts of money that change hands in such transactions tend to be rather trivial; they pale into insignificance when compared with the amounts we are considering today.

With regard to research subjects, I think we should continue the prevailing practice of paying them for their time and inconvenience as suggested by the National Commission.

If we disclose potential market value at the stage of inevitability, no doubt some subjects will want to negotiate for a share in the proceeds. In general, they will find themselves in a very weak bargaining position. People eligible for this type of research are not unusual. Unfortunately, for example, many women have cancer of the cervix. Of course, there are some individuals who have very rare attributes; they, at first glance, might seem to be in a relative ly strong bargaining position

Mr. VOLKMER. Excuse me, Dr. Levine. I'm going to have to interrupt; rather than push you to finish it, I'm going to go vote and we'll recess for about 15 minutes.

Dr. LEVINE. Thank you.
[Short recess taken.)
Mr. VOLKMER. Dr. Levine, you may conclude your statement.
Dr. LEVINE. Thank you very much, sir.

There are some individuals who have very rare attributes. At first glance, they might seem to be in quite a strong bargaining position. For example, there are some who have rare diseases. In general, products that are developed as a result of research involving people with rare diseases do not have major commercial implications. This is among the reasons that Congress passed its act facilitating the development of orphan drugs.

Let's consider, finally, the possibility that some individual might have some truly unique attribute, one that could be exploited by researchers to create something having great market value. Quite frankly, I can't think of a real-world example, so let me suggest an analogy.

Suppose we had someone like Patrick Ewing. In the natural lottery a few people draw extraordinary numbers. Some have very rare, lethal diseases, and some grow to be over 7 feet tall with exceptional athletic skills. As we have noted with Patrick Ewing, they are truly in a most powerful bargaining position. Should Congress act to limit their bargaining power? Given the prevailing views held in the United States, the answer in the case of basketball is clearly "no." In the case of research, statutory constraints on such power might create problematic conflicts. If our Patrick Ewing refused to give a pint of blood for less than $1 million, and the research leading to a cure for AIDS was at the stage of inevitability, needing only that pint of blood for its completion, what would we do? Admittedly, the problem is very unlikely to come up.

In my judgment, it is equally unlikely that research designed to develop marketable products from human materials will present any problems that cannot be resolved within the framework of ex

isting informed consent regulations if they are interpreted intelli-
gently to meet the contingencies of specific programs in this field. I
believe this task can be accomplished by institutional review
boards within the framework of existing regulations.

Again, I thank you for the opportunity to present my views.
The prepared statement of Dr. Levine follows:

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I am Robert J. Levine, Professor of Medicine and Lecturer in Pharma

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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 sup

port from, among others, the National Institutes of Health and various drug

companies.

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