American Journal of Law & Medicine

Neither Moore nor the market: alternative models for compensating contributors of human tissue.


Parts and products of the human body are increasingly important to biomedical research. Tumors removed in surgery help researchers map the molecular progression of cancer. Blood samples matched to clinical profiles suggest the role of genes and other factors in disease. Both hospital patients and visitors to the World Wide Web (1) may be approached to provide tissues for study.

Sometimes this research results in commercial developments that produce substantial financial rewards for researchers, biotechnology companies and pharmaceutical or medical device makers. (2) Frequently, the use of human tissue is crucial to the scientific discoveries on which those products rely. (3) Yet, the individual sources of tissue seldom share in the ensuing profits.

The acceptability of this arrangement, often criticized as a double standard, has been scrutinized thoughtfully and vigorously in the literature of law and ethics for more than a decade. Debate was stimulated by a controversial 1990 decision in Moore v. Regents of the University of California. (4) In that case, a divided California Supreme Court rejected a patient's claim that his property fights had been violated when his doctor and others made highly profitable use of the patient's surgically excised spleen cells without obtaining his permission or sharing the commercial proceeds. (5) Since the Moore decision, commentators and the medical community have wrestled with the appropriate treatment of human tissue sources, whose contributions still tend to be handled as gifts. In twelve years of controversy, no professional consensus or concerted public policy response has emerged.

A central reason for the continuing policy impasse appears to lie in the difficulties associated with the only legal model seriously contemplated as an alternative to the status quo: the treatment of human biological materials as the salable private property of the persons from whom they are taken. (6) The creation of a market in human tissue, which appears to follow inevitably from a private property model, would entail its own formidable ethical and practical problems. Neither the Moore-based donation paradigm nor the market-based alternative is sufficiently satisfactory to quiet professional and social concerns.

Today, as will be detailed below, there are increasing domestic and international pressures to reconsider compensation for those who contribute human tissue for research. The situation demands a systematic response that comports with public values. Recently, in its report on research uses of human biological materials, the National Bioethics Advisory Commission (NBAC) deferred consideration of such a response, citing the need for fuller review of "conflicting religious and philosophical traditions" with respect to the treatment of the body as property. (7) It is important that further consideration of the issue take into account a broader range of possible approaches than the two extreme alternatives that have dominated the debate to date.

In particular, it is time to consider alternatives that represent a middle course between regimes of donation and private property. One such alternative would take a hybrid approach: maintain a general rule of donation for research tissue at the time it is acquired and provide an objective, non-market mechanism for compensation after research use for unusual cases in which samples prove to have significant commercial utility. This hybrid approach would draw from models of publicly mediated compensation in other areas of the law. Its implementation could be designed to take advantage of existing structures in the patent and drug approval processes.

To suggest such an intermediate course is not to presume that it, or any other compromise, can satisfy all of the objections raised to date with respect to both the donation paradigm and the market alternative. Yet, the proposal to be examined here can be tailored to a significant degree to address many of these objections. Its potential benefits and limitations warrant close examination. This article is a first step in that direction.

The discussion below attempts to make the case for an intermediate approach, then sketches the contours of one such model and assesses its adequacy. Section II summarizes the legal background for the question of compensation and highlights current practices and controversies that lend urgency to reconsideration of the question. The conclusion of that section reviews the major arguments raised by ethicists, judges and legal scholars in opposition to the prevalent regime of nonpayment. Section III presents the predominant objections to a market-based alternative. In the course of reviewing these objections, the article identifies ways of addressing the objections through the alternative approach to be proposed.

Section IV turns to existing models for post hoc, collectively determined compensation and situates these models in legal theory between a regime that prohibits payment and one that encourages a market exchange. The article seeks to explain why an intermediate approach may make the most sense for present purposes. The article then outlines a specific proposal embodying such an intermediate approach for human tissue transfers and suggests how it could be implemented in today's research environment. After noting some of the principal ethical and practical problems associated with the proposal, the article briefly considers its feasibility in international research. Finally, in Section V, the article identifies several areas for further study and suggests variations on the proposed model that might follow from this work.


For the majority of individuals who contribute tissue for research in the United States, the question of payment is guided--as a practical matter--by the Moore decision, (8) although it is legally binding only in California. The facts of the case highlight problems of consent and compensation that persist to a significant degree today, though usually in a less egregious form. Patient John Moore sued for a share in the proceeds, estimated by Moore at $3 billion, of the "Mo" cell line licensed commercially by the University of California, where Moore's physician both practiced medicine and conducted research. (9) The cell line had been established from Moore's diseased spleen tissue after it was surgically removed in connection with the treatment of his hairy cell leukemia. (10) Moore had no knowledge that his physician intended to use his removed tissue for commercial purposes, and on a consent form for the surgery Moore had expressly declined to relinquish all rights in potential products developed from his tissue. (11)

Moore's lack of awareness of researchers' plans for his tissue has remained typical for hospital patients in many settings. Failures of full disclosure are common even today. More often than not, consent forms given to hospital admittees--the primary source of existing tissue samples--have not disclosed the possibility of commercial use for tissue that is initially removed for diagnostic or therapeutic purposes. (12) Even when they acknowledge such uses, researchers seldom offer payment and patients rarely ask for it. (13)

This situation appears to be ripe for change. Amid professional calls for clearer disclosure of research prospects and (non)payment plans, (14) improved informed consent procedures can be expected to increase patients' awareness that their doctors or hospitals intend to use their tissue for research with potential commercial applications. Greater public attention may also be drawn to the issue by large-scale public solicitations of blood samples for genetic research.


In the Moore decision, the California Supreme Court recognized a right for Moore to seek redress for injuries, if any, that he had suffered as a patient, but not for injuries he might have suffered as a source of human tissue used in scientific research and commercial product development. The court found a duty on the part of physician-researchers to make fuller disclosure to patients than was made to Moore. (15) Doctors, the court said, must disclose financial or research interests that might affect their professional judgment in connection with procedures they recommend to patients. (16) But the justices declined to acknowledge a claim for unlawful taking or "conversion" of Moore's "property" under California law. (17)

In the majority opinion, which drew vigorous dissent, the Moore court took the position that societal interests in new medical products should trump the individual interests of tissue sources. The promising but fledgling biotechnology industry would suffer, it feared, if courts chose to "impose a tort duty on scientists to investigate the consensual pedigree of each human cell sample used in research." (18) The justices of the majority appeared to be influenced in part by the fact that Moore's specific legal theory--conversion--was a strict liability tort, which would apply to every party in possession of the cells, even those who had no responsibility for or knowledge of the deception. (19) The court suggested that the California legislature might recognize and delineate a more appropriate legal remedy for plaintiffs in Moore's position. (20)

The Moore case is widely known among professionals in bioethics and law, but as binding precedent it applies only in California. Federal laws do not generally forbid the payment of valuable consideration in the acquisition of human research materials, as they do in the procurement of organs for transplant. (21) Some state laws are more restrictive. (22) In much, if not most, of the United States, non-payment for research materials is a norm rather than a mandate.

Dissatisfaction with this norm is gaining increasing attention in the United States and the international community. Internationally, concern about exploitation of people in less developed communities has led to calls for benefit-sharing with groups participating in externally sponsored research, whether their participation involves enrollment in clinical trials or contribution of blood samples for studies of the human genome. (23) No consensus has been reached about exactly which parties (researchers, governments or companies) should be responsible to whom (individual subjects, their communities or host countries), or how specific obligations should be established and implemented. (24) The People's Republic of China has gone forward on its own, establishing a regulation to protect the country as a whole, rather than individual contributors, against uncompensated removal by outsiders of Chinese "human genetic resources." (25)

In the United States, some individuals, families and patient groups have begun to bargain with researchers in advance for the rights to use their tissue samples. (26) Other contributors of particularly valuable materials have reported feeling misled and betrayed when they discovered too late that researchers and companies expected to profit from what the contributors had offered with no strings attached. (27) Some have filed lawsuits, (28) although it is unclear exactly what legal remedies will be recognized to protect them after their tissue has been transferred.

The current state of affairs presents some of the least attractive features of a new and uncivilized frontier. Information is poorly distributed, if not concealed, and the failure to develop a social policy for the many is mitigated only by the self-help of the few--in particular, those few who are fittest for bargaining or litigation. When problems emerge in an activity so central to biomedical research, there is a public interest in promoting transparency and developing a rationally articulated policy for social, economic and professional responsibility.


Commentators have raised three principal objections to the outcome of the Moore case and the practice that has followed. The first alleges an injustice in allowing researchers and companies to benefit from commercialization of a person's tissue without requiring that financial proceeds derived from the tissue be shared with that person. The second emphasizes the offense to contributors' dignity, moral agency and equality caused by researchers' failure to disclose the possibility of commercial use. The third objection warns of the practical consequences, for both research and patient care, if people come to mistrust doctors and medical researchers because they feel they were deceived or treated unjustly. (29)

1. Injustice Between Researchers and Contributors

Dissenting from the majority opinion in the Moore case, California Supreme Court Justice Mosk argued that the law should at least recognize Moore's "right to do with his own tissue whatever the defendants [including his doctor and the University] did with it: i.e., he could have contracted with researchers and pharmaceutical companies to develop and exploit the vast commercial potential of his tissue and its products." (30) On this view, justice is a matter of equality: when researchers and companies are making profits from their contributions to research, the tissue contributors should not be left out. (31) The issue may also have been seen as one of reciprocity: the person from whose body the tissue is taken should share in the rewards resulting from his or her contribution. (32)

A contrary view might hold that, in an ideal world, equality would be furthered if individuals had no right to profit from their natural endowments--from the kind of "brute luck" that gave Moore a multi-million dollar spleen--but only from the "option luck" resulting from their voluntary choices. (33) In our present society, however, people can freely exploit their natural beauty, talent or scientific genius, and can even be paid for material contributions to a blood or sperm bank for purposes other than research. Unless current conditions change, an argument based on equality cannot justify denying payment to contributors of tissue samples for research.

More specifically, some have argued that the contributions of researchers, including labor and inventiveness, are more deserving of reward than the mere provision of the human biological materials with which researchers work. (34) Undeniably, it is important that innovation be encouraged and rewarded if we are to continue to reap the benefits of technological progress in biomedicine. The inventiveness argument, however, is most appropriately directed to questions of joint inventorship in the patent process. Human tissue, embodying both physiological properties and information often available from no other source, falls into a different category of value contributed. The proper question is one of proportionate allocation, rather than simple inclusion or exclusion.

In the absence of consensus regarding the appropriate substantive conception of justice that should guide public policy, it is important to turn our attention to procedural justice, to the means by which policy is made. Broadly defined, procedural justice in our liberal democracy requires that people have the ability, through their constitutional institutions or otherwise, to affect decision-making about the distribution of important social goods. (35) In this connection, there can be little dispute that justice is not being served. It is difficult to muster public deliberation about this matter, or even foster informed private behavior, when most deals are struck in obscurity. Most contributors are unaware of the likelihood that their tissue might be used in profit-making enterprises. The occasional lawsuit which seeks individual relief is unlikely to produce a coherent and predictable policy for the variety of circumstances in which samples are collected, distributed and used in biomedical research and development.

When "complicated uncertainties and tradeoffs" are involved, legislatures may be in the best position to design and institute appropriate remedies, as long as the interests of relatively vulnerable stakeholders are adequately represented. (36) The Moore court itself advocated such a solution: "Legislatures ... have the ability to gather empirical evidence, solicit the advice of experts, and hold hearings at which all interested parties present evidence and express their views." (37) As discussed below, a legislative remedy of a particular kind could offer significant advantages in accommodating both justice concerns and other considerations in the compensation of human tissue sources. (38)

One central but difficult issue in the political process would be the determination of standards by which appropriate compensation for use of a particular tissue sample should be calculated. (39) In that process, consideration should be given to a standard that would distinguish among materials based on their relative scientific and commercial utility in research and development. …

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