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 relatively 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. 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 intelligently 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:] my own. 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 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. Afternoon panel: What is the responsibility of the researcher to the patient or subject in cases in which human organs, tissues, cells, or body fluids (henceforth called "human materials") are used in research that might lead to the development of products that might have market value? Before I respond to this question I wish to consider briefly the point at which persons lose their "interests" in materials that once were part of their bodies. In this discussion I shall make frequent reference to my book, Ethics and Regulation of Clinical Research, Urban & Schwarzenberg, Baltimore, 1981. - in After a person abandons human material in order to serve his or her personal good, he or she loses all but one interest in it; that interest is privacy. Common ways in which this is accomplished range from urination to surgical removal of a diseased organ (e.g., the gallbladder). These materials should be seen as passing into the public domain after the urine has been flushed or after the gallbladder has been examined by a surgical pathologist and is destined for its usual disposition cineration. After the surgical pathologist has completed his or her examination of the gallbladder, we permit researchers to use this organ for their own purposes as long as the patient's privacy interests are protected properly. Usually this is accomplished by not letting the researcher know whose gallbladder it was. Thus, in the development of something like the HeLa cell line, which, of course, has considerable commercial value, the modern researcher usually does not know who "Helen Lane" is. Helen Lane is the fictitious name of the woman from whom the original cervical cancer cells were taken to establish the HeLa cell line. We do not use informed consent in such cases. a "right of notice" (Levine, pp.111-113). Rather, we recognize The customary practices of the hospital are made explicit on the forms used to authorize surgery or autopsy. The surgical permission form, for example, states that it is customary to deliver the removed part to the surgical pathologist for diagnostic examination and that in some cases it might be retained for research or teaching purposes before it is destroyed. In the event the researcher must know the name of the patient in order to accomplish the purposes of the research, additional procedural protections are involved. In some cases, in order to protect privacy interests, it is necessary to negotiate full informed consent with the patient (Levine, pp.112-113). Such procedures are also used for "leftover" blood, urine, spinal fluid, and so on, collected for diagnostic purposes. If the researcher wishes to remove human material primarily to serve research interests, the situation is different. In this case, full informed consent is required ethically as well as by the regulations of DHHS and FDA. are: ་ Among the elements of informed consent defined in federal regulations an explanation of the purposes of the research..." and "A description of any benefits to the subjects 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, let us consider the consent form we might have prepared for Dr. Hagiwara's mother (Royston, I.: Cell Lines From Human Patients: Who Owns Them? A Case Report. Clinical Research 33:442-443, 1985). In order to make this discussion less compli |