Pseudoxanthoma elasticum

I. Introduction

In the past, one would have expected families afflicted by a degenerative and fatal disease to rejoice at medical researchers' development of reliable carrier and prenatal screening to detect the genetic mutation causing the condition.1 However, a recent legal action, initiated by families suffering from a rare genetic disorder known as Canavan disease2 against the researchers who isolated the gene associated with this condition, illustrates the complexities inherent in the relationships among human research participants and medical researchers in our current era of genomic exploration and commercialization. In that case, Greenberg v. Miami Children's Hospital Research Institute, Inc. ,3 the plaintiffs included a group of parents who gave birth to children afflicted with Canavan disease4 and also three nonprofit community groups dedicated to assisting those affected by this condition.5 All plaintiffs supplied some combination of tissue, autopsy, blood, urine, and other pathology samples, personal data, funding, and other resources in order to advance medical research of Canavan disease.6 The plaintiffs alleged that the defendants, a scientific researcher and a hospital,7 breached both their duty of informed consent and their fiduciary duty when they failed to disclose to the plaintiffs their intention to patent the gene and diagnostic test for Canavan disease.8 In addition, the plaintiffs asserted that the defendants wrongfully converted the plaintiffs' property by using the plaintiffs' contributions to reap personal economic benefit rather than to promote widely affordable and accessible carrier and prenatal testing for Canavan disease in accordance with the plaintiffs' goals.9 According to the plaintiffs, had they known of the defendants' intention to patent the gene associated with Canavan disease, they either would have imposed restrictions on the researchers' use of their genetic material in order to avoid commercialization of the Canavan disease gene or, instead, would have chosen to donate their samples to researchers who pursued objectives compatible with their own.10 Based upon these same facts, the plaintiffs also asserted claims of unjust enrichment," fraudulent concealment,12 and misappropriation of trade secrets.13 On May 29, 2003, Judge Federico A. Moreno of the United States District Court for the Southern District of Florida dismissed five of the plaintiffs' six claims pursuant to Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim upon which relief may be granted. He did, however, hold that only the plaintiffs' unjust enrichment cause of action survived the motion.14

Among the myriad ethical and legal issues raised, but not resolved, by the Greenberg action is the optimal means of distribution among biomedical researchers and their research participants15 of any rights in commercial products and revenues derived from human tissue.16 In the case that has addressed this question most squarely, Moore v. Regents of the University of California,17 the Supreme Court of California held in 1990 that plaintiff John Moore, a patient undergoing treatment for cancer, did not possess property rights in the commercial products that his physician-researcher developed from his excised tissue.18 The Moore majority based its holding in large measure on its belief that judicial extension of the conversion doctrine would hinder the growth of the fledgling biotechnology19 industry by making each cell sample "the potential subject matter of a lawsuit."20 The Moore majority also found that the plaintiff s rights were protected adequately under the theories of breach of fiduciary duty and lack of informed consent, claims that the court decided in Mr. Moore's favor.21 Although Moore constitutes binding precedent only in California, this decision is extremely influential in shaping the public policy debate regarding research participants' property rights in their bodily tissue.22 Indeed, the Florida federal court that decided Greenberg cited Moore for the proposition that the law does not recognize a property interest in excised biological materials for the purposes of a conversion claim.23

While the judicial precedent established by the Moore and Greenberg courts seems to suggest that research participants lack property rights in their tissue,24 the experiences of another group of research participants provide striking evidence to the contrary. In 2001, PXE International, a patient group that represents the interests of individuals afflicted with pseudoxanthoma elasticum (PXE), a genetic disease that causes calcification of the connective tissue of the skin, eyes, and arteries,25 successfully negotiated for a share in the patent rights obtained by researchers who identified and filed a patent application for the gene associated with the disorder.26 These rights include royalties from any diagnostic test or marketable product resulting from the discovery of the gene, as well as the authority to control licensing of such genetic tests. PXE International negotiated for these rights in exchange for its contributions to the research effort, which included help in identifying and soliciting participation on the part of affected families, setting up a tissue repository, and raising money to support scientific investigation.27 Like the plaintiffs in Greenberg, PXE International sought to ensure broad and affordable availability of the test for their disease, as well as any downstream developments.28 Unlike the Greenberg plaintiffs, however, PXE International negotiated directly with the scientists to whom they gave research support and materials in exchange for these rights.

Presently, because neither the members of PXE International nor the researchers who identified the gene associated with PXE disease have raised a legal challenge to their agreement, no court has considered the enforceability of this contract. However, the very existence of their agreement invites consideration of how a court would rule if the researchers were to bring a suit alleging that their contract with PXE International is void as against public policy on the grounds that research participants cannot possess property rights in their tissue pursuant to Moore. Certainly, it would be surprising if the court were to strike this agreement, which was the product of free and full negotiation among the parties.29 Adherence to a market-inalienability model,30 which posits that human research participants do not possess property rights in their tissue, invites increased scrutiny in an era marked by dramatic commercial gains from biomedicine.

A comparison of the Moore case, which denied the plaintiff a share in the profits resulting from the commercialization of his bodily tissue, and the PXE agreement, which suggests that research participants are permitted to negotiate for such rights, reveals a fundamental inconsistency. Of course, one key distinction between the Moore case and the PXE example is that plaintiff John Moore did not bargain for any ownership interest, while PXE International did negotiate expressly for property rights in order to protect the interests of its members. This distinction fails to justify the disparate treatment accorded to the research participants in these examples, however, when one considers that Mr. Moore's physician engaged in deception by denying his intention to conduct research upon Mr. Moore's tissue.31 Certainly, if the courts do recognize the right of savvy research participants such as the members of PXE International to negotiate for property rights in the commercial products developed from their tissue, it is not only illogical, but also unjust, to deny any property rights whatsoever to the Moore and Greenberg plaintiffs, from whom researchers withheld critical information about their designs to commercialize their scientific findings.32

In light of the Moore majority's rejection of the plaintiffs conversion claim, other courts likely will hold, in the absence of any contractual provisions to the contrary, that research participants possess no property rights in their body tissue. Clearly, any broad judicial recognition of property rights in human tissue used for research would raise many vexing ethical and policy questions upon which courts generally prefer to defer to the legislature.33 Thus far, however, the United States Congress has declined to address this policy debate.34

This Article proposes that Congress enact legislation permitting and regulating the sale of human tissue used for research purposes,35 and establish a tort of conversion in the event that a scientific researcher wrongfully exercises dominion over a research participant's tissue. Uniform national legislation is essential because scientists typically obtain the tissue upon which they experiment from research participants, tissue banks, and repositories throughout the United States, and from other nations as well.36

In advocating for congressionally mandated recognition of property rights in human tissue used for genetic research, this Article begins in Part II with a critique of the market-inalienability approach. Although the Moore court did not advocate strictly for this model,37 the majority decision nonetheless did present the primary policy arguments advanced in support of the normative view that human research participants lack property rights in their tissue. Part II thus begins with a discussion of the facts of the Moore case before proceeding to a detailed analysis of the shortcomings of the marketinalienability model. This part also refutes the Moore majority's assertion that the doctrines of fiduciary duty and lack of informed consent are sufficient to protect individuals' rights to control the research use of their tissue.

Part III then considers the property model,38 as demonstrated by PXE International, a patient advocacy group that negotiated successfully with scientists for a share in the commercial products developed from its group members' tissue. This Part analyzes both the advantages and drawbacks of this approach to apportioning the profits of biotechnological innovation among scientists and research participants.

Notwithstanding the merits of the property model, it is clear that reliance on a property model alone proves insufficient, in light of the fact that many research participants do not negotiate for property rights in their tissue because they lack (and, indeed, have often been denied by the researchers) significant information, both in terms of the tissue removed from their bodies and the potential value of that material. Part IV examines one such instance, the pending Greenberg proceeding, which is the latest legal action to raise the issue of research participants' rights in commercial products developed from their genetic material.

Part V then proposes a hybrid model, which invokes both a property rule and, when necessary, a liability rule39 in the form of an action for conversion. Such an approach is essential because recourse to the property rights model becomes impossible once tissue has been taken and developed into a commercial product.40 It is simply inconsistent to recognize research participants' property rights in their tissue only so long as those rights have been negotiated in advance, but then to deny recovery under a liability rule to other research participants who were denied full information regarding the commercialization of their tissue.

Part V considers some alternative approaches, including a hybrid model combining the donative and liability regimes, as proposed by one commentator. In her article, Charlotte Harrison advocates a ban on private sales of tissue from the original source and instead calls for a statutorily established tribunal or administrative agency to compensate tissue contributors after the fact according to statutory criteria.41 This model proves inadequate, however, because it denies research participants the opportunity to bargain autonomously, and also threatens to strip power from patient advocacy groups such as PXE International that have been so effective in advancing the rights of their members. Part V also briefly examines the creation of a federal tissue trust, concluding that the implementation of such a system is unlikely, as a practical matter.

II. The Market-Inalienability Model

A. Moore v. Regents of the University of California

The normative view that research participants possess no property rights in their tissue or the commercial products developed therefrom finds its underpinnings in the 1990 California Supreme Court decision Moore v. Regents of the University of California.42 Pursuant to the Moore marketinalienability model, researchers generally treat their research participants as donors unentitled to any remuneration for their tissue and other bodily material.43 Moreover, as stated by Professor Mahoney, "[a] substantial amount of the tissue used in biotechnology research is extracted in the course of medical treatment" from an individual "who is often-at least at the time of the extraction-unaware that her medical waste carries any potential economic returns."44

Plaintiff John Moore was among those individuals from whom scientists harvested tissue for research use without first obtaining informed consent. Mr. Moore first sought treatment at the Medical Center at the University of California at Los Angeles (UCLA Medical Center) in October 1976, shortly after learning that he had hairy-cell leukemia.45 Mr. Moore's attending physician, Dr. David W. Golde,46 confirmed Mr. Moore's diagnosis and recommended removal of his spleen for therapeutic purposes.47 Surgeons at UCLA Medical Center performed the splenectomy in October 1976.48

Unbeknownst to Mr. Moore, before his operation, Dr. Golde, his attending physician, and Shirley Quan, a UCLA researcher,49 arranged for further scientific study of the spleen tissue removed from Mr. Moore's body.50 This tissue particularly interested researchers because its tendency to overproduce certain proteins, called lymphokines, rendered it especially useful in locating the gene responsible for creating those proteins. Some lymphokines possess therapeutic value, and knowledge of the genetic material associated with their production in the body could enable researchers to manufacture large quantities of lymphokines through recombinant DNA techniques.51 This research had no relation to Mr. Moore's medical care, and neither Dr. Golde nor Ms. Quan ever informed Moore of their research plans for this tissue or requested his consent.52

Dr. Golde and Ms. Quan continued their research on Mr. Moore for several years, causing him great inconvenience and expense. Mr. Moore returned to the UCLA Medical Center from his home in Seattle approximately twelve times between 1976 and 1983 at the direction of Dr. Golde, who misled Mr. Moore by misrepresenting to him that such visits were in the interest of his health.53 During these visits, Dr. Golde drew additional samples of blood, blood serum, skin, bone marrow aspirate, and sperm.54 Not until 1983, about seven years after the initial surgery and after they had already filed a patent application,55 did the researchers inform Mr. Moore that they were engaged in medical experimentation,56 and even then the defendants assured him that this research was purely scientific rather than commercial. Mr. Moore further asserted that, despite his express inquiries about the potential financial benefits flowing from their research, defendants repeatedly denied that his biological materials possessed any commercial value.57

Notwithstanding their disavowals of any financial interests in Mr. Moore's tissue, Dr. Golde had succeeded, sometime before August 1979, in developing a cell line from it.58 On January 30, 1981, the Regents of the University of California (Regents)59 applied for a patent on the cell line, and the patent issued on March 20, 1984, naming Dr. Golde and Ms. Quan as the inventors of the cell line and the Regents as the assignee of the patent.60 The patent also covered various methods for using the cell line to produce lymphokines.61 With the Regents' assistance, Dr. Golde negotiated license agreements for commercial development of the cell line and corresponding products with two pharmaceutical firms, Genetics Institute, Inc. and Sandoz Pharmaceuticals Corporation (Sandoz).62

John Moore learned of the patent on the so-called Mo cell line63 only because he had become suspicious of his doctor's insistence upon conducting so many tests after the curative splenectomy, and also of the doctor's refusal to have a doctor in Seattle perform the supposedly necessary tests. An attorney hired by Mr. Moore, Jonathan Zackey, located online a scholarly scientific article in which the coauthors, including Dr. Golde, described their research upon the tissue of an unnamed "37-year-old white male from Seattle, Washington,"64 who proved to be John Moore.65

In September 1984, Mr. Moore initiated a lawsuit against Dr. Golde, Ms. Quan, the Regents of the University of California, Genetics Institute, and Sandoz, alleging, among other things, conversion,66 lack of informed consent, and breach of fiduciary duty.67 For his conversion claim, plaintiffs theory of recovery was that the tissue removed from his body was his tangible personal property, at least in the sense that he was entitled to direct its use, and that he never consented to its use in commercial research.68 According to this theory, the unauthorized use of his cells constituted conversion, and Mr. Moore therefore claimed a proprietary interest in each of the products that the defendants developed from his cells or the patented cell line.69 In his complaint, Mr. Moore sought a share in the proceeds of the products from that cell line, which he estimated at over $3 billion by 1990.70 Even today, the American Type Culture Collection (ATCC)71 continues to sell Mr. Moore's cells.72

In its five-to-two majority opinion in Moore, the Supreme Court of California declined to acknowledge a claim for conversion of Mr. Moore's property under California law.73 In deciding this issue of first impression, the court took the position that society's need for new medical products must outweigh the interests of research participants, or else the fledgling biotechnology industry would suffer.74 Moreover, the court stated that it did not need to expand the tort doctrine of conversion because the legal theories of breach of fiduciary duty and lack of informed consent adequately protected the plaintiff's interests.75 Specifically, the court recognized a duty on the part of a physician-researcher to "disclose personal interests unrelated to the patient's health, whether research or economic, that may affect his medical judgment" in connection with procedures he recommends to patients.76 Finally, the justices were especially mindful that the conversion theory relied on by Mr. Moore is a strict liability tort, meaning that liability would attach to every party in possession of the cells, even those who had no responsibility for or knowledge of the deception.77 The court declared that "[i]f the scientific users of human cells are to be held liable for failing to investigate the consensual pedigree of their raw materials, we believe the Legislature should make that decision."78

In fact, the California legislature did not enact legislation invalidating Moore,79 nor has any other legislature enacted a statute expressly according research participants the right to sell their tissue for research purposes.80 In examining whether the United States Congress ought to recognize such a right, it is necessary to consider the policy arguments set forth in Moore. As stated previously, the California Supreme Court did not go so far as to declare that human tissue could never be considered property for any purpose whatsoever.81 Nevertheless, the Moore opinion does indeed rely upon the three major arguments proffered by advocates of the market-inalienability model. First, according to this view, granting research participants property rights in their tissue will hinder investment in the biotechnology industry and, concomitantly, the advancement of public health. second, as a related principle, research participants do not merit property rights because, unlike scientific researchers, they perform no innovative or creative work. Third, the commodification of the human body is immoral and unethical. In addition, commentators concerned about the protection of human health offer two additional arguments, which were not discussed in the Moore opinion, in support of the market-inalienability model. They fear that widespread pecuniary compensation for human research participants will permit scientists to lure participants with false or misguided promises of profits and also induce individuals to risk their physical health in exchange for financial gain. Moreover, they assert that the promise of profits will lead to a decline in gratuitous donation of human tissue for research purposes.

B. Analysis of the Policy Considerations Underlying the MarketInalienability Model

1. According Research Participants Property Rights in Their Tissue Will Not Impede Investment in the Biotechnology Industry or the Advancement of Public Health

Absent a clear legislative command, the California Supreme Court in Moore declined to extend the tort of conversion so as to grant a research participant property rights in the products derived from his tissue.82 The Moore majority emphasized that the primary policy reason underlying its decision was the need to facilitate research scientists' access to human tissue, and thereby foster public health.83 Thus, the Moore majority embraced the Kaldor-Hicks model of efficiency,84 which prescribes that:

[A] proposal for increasing aggregate economic welfare ought to be adopted if, in consequence, gainers could, in concept, have sufficient gain to compensate losers and be left with a net gain. Whether compensation is actually given, however, is not a matter of relevance to the economic analysis of the implementation decision. As Kaldor put it, "this is a political question."

The Moore court's application of the Kaldor-Hicks model in this policy area raises the question of whether that court correctly assessed the effects upon the biotechnology industry of according human research participants property rights in their tissue.

Because biomedical research is a costly and financially risky endeavor,86 Congress must consider carefully whether according human research participants property rights in their tissue will diminish the incentives to invest in this industry. Certainly, if research participants were to enjoy property rights in their tissue, biomedical scientists would face a significant increase in their transaction costs. First, scientists would be obliged to compensate research participants for their genetic material, whether pursuant to a contract negotiated at the inception of the research or pursuant to a liability rule after the fact. This obligation to remunerate research participants presents a particular risk to scientists in the nonprofit sector, who do not necessarily plan to commercialize their findings.87 Second, researchers would face significant transaction costs88 in locating and then negotiating compensation arrangements with each individual participant involved in a given research effort, and research institutions would incur considerable monitoring and enforcement costs in ensuring the compliance of their staff. Because many biotechnological research studies involve numerous tissue samples from individuals worldwide,89 such negotiations could prove quite complex and protracted. Furthermore, bargaining among scientists and research participants could prove impossible in cases where the identities of these participants are unknown, either because researchers obtained the tissue from another scientist, a tissue bank, or a repository without the tissue's identifying information,90 or because the participants remain anonymous.91 Third, the problems of increased financial and transaction costs reach their apex in the case of the potential holdout who refuses to participate in research unless she is compensated at a very high rate.92 Finally, recognizing the research participant's right to share in the revenues may imply some right to control the products of that research; for example, research participants may demand widespread and affordable licensing of the intellectual property developed from their tissue, thereby further decreasing the scientists' profits.93 All of these factors combined would present significant disincentives to researchers, who presumably would encounter these impediments well before they could ascertain the profitability of their research enterprise. On the other hand, countervailing arguments support the notion that compensating research participants might stimulate innovation.

a. An Analysis of the Economic and Transaction Costs Involved in Compensating Research Participants and the Importance of Compensation in Terms of Stimulating Participation

While a legal regime that accords research participants property rights in their tissue arguably threatens to increase to some degree the economic and transaction costs facing researchers, thereby negatively affecting scientific innovation, commentators have warned that failure to recognize such rights entails costs of its own. For example, some altruistic individuals who ordinarily would contribute their tissue for biomedical research may decline to participate if they feel exploited because everyone else involved in researching their genes, aside from them, is making a profit.94 In addition, less selfless individuals might refuse to undergo the inconvenience, medical risks, loss of privacy, and possibility of genetic discrimination associated with biomedical research without legal protection of their right to remuneration, thereby decreasing the supply of tissue available for research.95

What is more, a system that assures compensation for research participants encourages individuals to propose research that scientists might not have conceived on their own, thereby stimulating biotechnological research. For instance, in 1988, Mr. Erich Karl Fuchs, a gay man who had been exposed to the HIV virus on many occasions, began to suspect that he was unusually resistant to it. He continually contacted researchers over a period of six years to suggest that they study his genetic material, and, in 1994, scientists eventually agreed to study Mr. Fuchs and another man exhibiting similar resistance to the virus, Mr. Steve Crohn. Ultimately, researchers were able to isolate the gene responsible for immunity to the HIV virus and to patent a test to identify others with a similar genetic makeup.96 As this example illustrates, individuals affected by a medical condition are often among the first to note scientifically significant phenomena within themselves.97 On the other hand, potential research participants, motivated by the promise of material gain, might distort the information they provide to researchers in order to increase their value as research participants. Such behavior could detract from the quality of the research results, and even endanger the health of the research participant and others in the study.98 Scientists can minimize this problem, however, by screening potential research participants to determine whether they meet eligibility criteria before disclosing the possibility of commercial benefits flowing from the study."

While researchers already can choose to encourage participation in biomedical research by voluntarily offering compensation to research participants, assuming that the contractual PXE model withstands judicial scrutiny in the years to come,100 this model fails to provide a complete solution. Researchers may hesitate to compensate one research participant when others are donating their tissue, lest donors feel exploited and come to expect payment.101 Moreover, the pure property rights approach does not protect research participants against scientists with whom they did not deal directly. Consider, for example, a situation where a research participant permits one researcher to use her tissue for a particular purpose, in exchange for compensation. This researcher then sells the tissue to a second scientist who lacks any contact with the research participant, and this second scientist uses the tissue without the knowledge of its source. Under the current law as set forth in Moore, the legal theories available to the research participant, namely the doctrines of breach of informed consent and of fiduciary duty, are most likely ineffective against that second scientist. After all, the second scientist owes the research participant no duties, and therefore would not be liable for the first researcher's wrongful sale of the tissue according to dicta set forth by the Moore majority.102 Faced with this possibility, potential research participants might decline to participate at all. Congressional recognition of property rights in human tissue would encourage the research participant's involvement by offering her a remedy for unauthorized use of her tissue by strangers.

Another potential problem raised by recognition of research participants' rights in their tissue, quite apart from the financial costs of compensating them for the tissue itself, is the issue of transaction costs. Indeed, one United States government report stated that "[t]he actual compensation to the human sources of original tissues and cells is unlikely to have a large economic impact on the use of human biological materials, but transaction costs are likely to dwarf the costs of payments to these individuals."103 One can argue, however, that pursuant to Moore, the duty of informed consent already requires physician-researchers to communicate their financial interests to the research participants with whom they deal directly.104 This duty must surely extend as well to scientists engaged in primarily research-oriented, as opposed to therapeutic, relationships with their research participants. Courts have held that researchers, as compared to treating physicians, must be held to a higher duty of disclosure vis-a-vis their research participants because research participants stand to reap little or no personal benefit from their involvement in biomedical experimentation.105 As stated in one government report, "[s]ince greater disclosure is usually required in a research setting, it would follow that disclosure of potential commercial gain would be required there as well."106 The report added: "It should not be assumed that all persons, upon learning that they carry a unique cell strain or other type of biological material, will agree to its commercial marketing as a developed cell line. Some people may be opposed to such use . . . ."107

Thus, in light of the generally recognized principle that research scientists who deal directly with a research participant owe a duty of informed consent, which would include the duty to reveal their economic interests in the research,108 the only scientists who would face an entirely new duty if Congress were to recognize a federal tort of conversion of body tissue would be (1) those who obtain the tissue from other researchers, tissue banks, or repositories109 and (2) those who conceive of a research use for tissue after having obtained it from the research participant.110 Both of these groups presently may be free of any duty of informed consent under federal or state law.111 The exemption of such researchers from the requirements of informed consent is quite controversial, and in recent years has generated vigorous debate among, and proposals for reform by, government officials, industry leaders, policy makers, and scholars.112

In deciding whether to extend the law of informed consent to apply to researchers who obtain tissue from other researchers, tissue banks, or repositories, it is worth noting that, as a practical matter, a system that exempts researchers from obtaining informed consent if they procure tissue from anyone other than the research participant might slow the pace of biomedical research by encouraging scientists to leave the tissue collection to others rather than risk incurring the duty of informed consent. Moreover, "[t]he fundamental principle underlying the need for consent for medical or research purposes is respect for personal autonomy,"113 and strict adherence to this principle militates against exempting such researchers from the duty of informed consent. Because research participants can refuse involvement altogether,114 they ought to have access to information about all research uses of their tissue.115 This logic applies equally to anonymized tissue samples,116 even though federal regulations do not require informed consent for research on them.117 As stated in a report of the National Bioethics Advisory Commission (NBAC):

[I]t is incorrect to assume that because the sources cannot be identified they cannot be harmed or wronged. Some interests of the sample sources may be harmed even if they are not completely identifiable, and interests of others also may be at risk. For example, there may be group or family interests that could be revealed or placed at risk because of research that is conducted on a class of similar, albeit individually unidentifiable, samples. Individuals have an interest in avoiding uses of their tissues that they regard as morally impermissible or objectionable. Thus, were their materials to be used in research that they would consider objectionable, it is possible that some individuals could be wronged, if not harmed.118

In order to assist researchers in tracking whether informed consent was given for the use of tissue obtained from tissue banks and repositories, federal legislation could require these institutions to retain informed consent documents and contact information relating to the suppliers of its tissue samples.

In terms of the application of the law of informed consent in cases where later research uses are conceived for previously collected tissue, it is clear that both federal and state law recognize the importance of a continuing duty of informed consent on the part of researchers.119 According to a government report, "[i]t can be argued that the discovery in a subject's body of a unique cell line that may be commercially valuable constitutes a significant new finding" that "could influence a subject in deciding whether or not to continue his role in the research project," and therefore must be disclosed to the research participant.120

Another set of transaction costs faced by researchers required to compensate their research participants involves record-keeping. Professor Heidt states that "researchers would need to keep track of patients, cell lines, the patient's contribution to each cell line, [and] the role of each cell line in developing the end products" and that "[s]tudies involving the development of cell lines can takes years to complete and commercial application even longer."121 There is good reason, however, to require researchers to keep careful track of human tissue, whether used separately or in combination with the tissue of others. The Moore majority itself acknowledged the importance of keeping biological materials in safe hands, as the cell line derived from Mr. Moore's body contained genetic material capable of reproducing a harmful virus.122 Certainly, the current fear in the United States regarding the possibility of bioterrorism, as demonstrated by recent concern about anthrax, has highlighted the importance of monitoring closely the exchange of potentially hazardous biological materials.123 Such record keeping to track the use of each biological sample surely would not prove unduly burdensome in light of "the meticulous care and planning necessary in serious modern medical research."124

Another transaction cost facing researchers obliged to compensate their research participants is the problem of the potential holdout who refuses to supply tissue unless his price is met. Some courts and scholars reject the notion that a research participant is entitled to determine the amount of consideration tendered for his tissue, arguing that such behavior by research participants smacks of inappropriate profiteering by individuals seeking a windfall from the research efforts of others.125 On the other hand, the principle of informed consent enshrined in both state and federal law already recognizes the right of research participants to refuse involvement in biomedical research on moral, ethical, religious, health, privacy, or any other personal grounds.126 While some may contend that widespread acceptance of the notion that research participants merit compensation will discourage altruism on the part of certain individuals who otherwise would donate their tissue gratuitously, it is already the case that research participants can negotiate with researchers for a share in the profits from commercial products developed from their tissue.127 Federal codification of this right would merely ensure that even those research participants denied informed consent would receive compensation, alongside their counterparts who had bargained for remuneration.

As a practical matter, it is difficult for biomedical researchers to determine the terms of compensation for their various research participants in light of the fact that only rarely is the tissue "provided by any single (or very few) individual(s) potentially profit-yielding to the research community because the [tissue] is both commercially useful and rare."128 Instead, "[r]esearch results are typically a series of several joint efforts with specimens provided by several individuals,"129 and "many laboratory transformations over a long period of time separate the original extraction from the end product."130 Ultimately, however, researchers would adapt to a legal regime that accords research participants property rights in their tissue by negotiating with each putative participant in advance,131 thereby strengthening the law of informed consent.132 Furthermore, should judicial calculation of damages prove necessary pursuant to a liability rule, "mere difficulty in ascertaining damages is not a basis for denying them," as explained by a federal court that awarded a researcher both compensatory and punitive damages on his conversion claim after a rival scientist destroyed his cell line, which was part of a valuable research project.133

Speaking purely in terms of economic efficiency, facilitating the ability of research participants to negotiate for compensation in exchange for their tissue might actually stimulate more productive biomedical research. Our current system, which permits many researchers to obtain biological materials for nominal cost, fails to allocate these materials to the highest bidder, who presumably would put them to their most efficient use.134 While Professor Gold argues persuasively that market analysis proves an inappropriate means of valuing human tissue because of the significant nonmarket value inhering in such material from the perspective of the research participant,135 this analysis does not settle the question. It is clear that at present the biomedical industry rests firmly upon free market principles,136 and that the creation of a nonprofit, nongovernmental organization to control valuable tissue, as envisaged by Professor Gold,137 is unlikely.138 Thus, in allocating property rights among researchers, it is logical to rely upon the market system in order to ensure that the tissue goes to the user who values it most highly and will, it is hoped, use it most productively.

b. The Issue of Shared Control over the Products of Biomedical Research

Critics of any system that accords research participants property rights in their tissue also fear that research participants will wish to control the licensing of the intellectual property created using their tissue, thereby leading to suboptimal use of the technology. This argument conflates, however, the notions of property rights in human tissue and ownership of the intellectual property developed from that tissue. Pursuant to federal patent law, only the person holding the patent possesses the exclusive right to make, use, or sell the invention,139 or to license that property to others.140 Implementation of a law according research participants a property interest in their tissue would not ipso facto supplant federal patent law. Indeed, absent any finding of joint inventorship,141 a research participant has no more right to control the intellectual property developed from her tissue than would the person who supplied chemical reagents to the researchers. Rather, federal law would simply recognize the research participant's right to negotiate for compensation for her tissue, and also her right to receive remuneration under a liability rule where she has neither negotiated for nor expressly or impliedly waived her rights to payment. In such liability cases, damages would depend upon the characteristics of the tissue, the profit earned by researchers, and whether the researchers acted in good faith, as opposed to concealing information from the research participant.142 With respect to the right to control the intellectual property developed from human tissue, however, Congress could provide that a research participant must negotiate directly for such rights with her biomedical researchers, as PXE International has done.143

Notably, more than one commentator has expressed concern that research participants might condition their consent to research upon scientists' promise that "the patient's cells only be used in research designed to benefit certain races" or social groups.144 This argument is not compelling, however, because not only research participants, but also scientists themselves, might exhibit such prejudices. Moreover, federal antidiscrimination law is the appropriate means for dealing with such issues if they arise, and could be amended, if necessary, for this purpose.

As demonstrated by the foregoing discussion, proponents of the market-inalienability model overestimate the negative impact that recognition of the property rights of human research participants would have on biomedical research. In addition, they fail to consider fully that research participants contribute considerable value to the research process, and therefore merit compensation.

2. Considerations of Equity Militate in Favor of a System That Compensates Research Participants for Their Involvement in Furthering Biomedicine

Another principle underlying the market-inalienability model is the notion that the biotechnology industry is entitled to reap all of the pecuniary rewards flowing from its inventive work, because its endeavors require significant investment of capital, labor, and time, and offer only a small likelihood of success.145 In Moore, for example, the Supreme Court of California held that the plaintiff did not possess any property interest in the patented cell line and the products derived therefrom because the patent awarded by the United States Patent and Trademark Office (PTO) demonstrated that the cell line was the product of invention created by the researchers alone.146 According to this view, research participants do not merit any share in the wealth because they simply supply the naturally occurring raw materials. By contrast, researchers employ skill and ingenuity to transform these materials into marketable products.

While it is true that research participants do not fit within the definition of a joint inventor,147 this fact should not operate to deprive them of any property rights whatsoever in the valuable raw materials that they supply. As Justice Mosk observed in his vigorous dissent in Moore:

[N]o one can question Moore's crucial contribution to the invention-an invention named, ironically, after him: but for the cells of Moore's body taken by defendants, there would have been no Mo cell line . . . . [F]or all their expertise, defendants do not claim they could have extracted the Mo cell line out of thin air.148

Because human tissue is just as indispensable in the research process as chemical reagents and other equipment used in scientific research, research participants are no less deserving of compensation than the suppliers of these materials.149 In fact, researchers' obligation to remunerate their research participants arises at the moment when the researchers begin to use that tissue, even if a patent is never issued. In the Moore case, for example, where researchers put Mr. Moore's tissue to productive use for more than seven years before their patent was issued, the patent should not be understood to "operate retroactively to immunize defendants from accountability for conduct occurring long before the patent was granted."150 Surely, as stated by Justice Mosk, "a patent is not a license to defraud."151

In cases where a research participant sues for conversion, federal law should provide that the fact-finder consider researchers' skill and efforts in altering and enhancing the value of the tissue in calculating the damages, if any, owed to the plaintiff. This approach is more equitable than denying research participants any share whatsoever in the profits from the commercial products developed from their tissue.152 Ultimately, the development of a market in human tissue would see the emergence of market prices for various human tissues.

Those who oppose compensation of research participants for their tissue also contend that it is unfair for an individual to enjoy a windfall simply because he happens to possess tissue that is valuable to researchers, especially when the health of all members of society depends upon biomedical innovations developed through the use of such tissue. Property rights already inhere, however, in that which we did not earn. As explained by one commentator:

In our present society . . . 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.153

Research participants also merit property rights in their genetic material because, like the scientists themselves, participants face risks associated with biomedical research. While the scientists' risks are primarily financial, research participants must contend with the potential for harm resulting from the medical procedures they undergo in the experimentation process, the loss of privacy, the dangers of negative consequences from the release of their medical information, and the risk of learning emotionally disturbing information about their health.154

While research participants may garner some benefit from their scientific participation, this is not reason enough to exclude them from any share in the profits from products created from their tissue. The notion that research participants merit no compensation other than the chance to consume the diagnostics and therapeutics developed from research on their tissue found expression in the comments of Fima Lifshitz, chief of medical staff at Miami Children's Hospital, who was quoted as declaring, in response to the lawsuit initiated by the Greenberg plaintiffs, that "[t]he issue should be quenched [sic] at once because these people are going to derive a great deal of benefit from this. They shouldn't be complaining."155 The reality, of course, is that research participants often do not derive direct benefit from the experimentation on their tissue, either because such research does not lead to a successful product; because medical advances arrive too late to help individuals who had participated in the research at an earlier stage, as was the case for many of those who contributed tissue to the Canavan research effort; or because the research participants are not directly affected by the disease being studied but, instead, simply wish to assist a research effort for which their tissue could be useful. Moreover, the potential for medical benefit from research is not reason enough to deny any compensation whatsoever to research participants who contribute valuable tissue to medical research. Just as a research scientist might derive both professional prestige and pecuniary gain from a patented product, so might a research participant benefit both financially and physically from her research contributions.

The issue of the equitable distribution of the profits from biomedical products developed through the use of human tissue has practical as well as moral consequences. Widespread public perception that the current system is unfair will not only lead to mistrust between patients and doctors156 and a general decrease in research participation,157 but could also cause an overall decline in public and, therefore, government, support of such research.158 Thus, considerations of equity militate in favor of acknowledging a research participant's property rights in her tissue. Nevertheless, such an approach raises complex moral, ethical, and religious questions about commodification of the human body.

3. Recognition of Property Rights in Human Tissue Would Neither Commodity Human Beings nor Erode Notions of Community

While the Moore majority did not address the moral, ethical, and religious issues raised by a potential property interest in the human body, Justice Arabian did do so in his separate concurring opinion. In rejecting Mr. Moore's claim, Justice Arabian declared:

Plaintiff has asked us to recognize and enforce a right to sell one's own body tissue for profit. He entreats us to regard the human vessel-the single most venerated and protected subject in any civilized society-as equal with the basest commercial commodity. He urges us to commingle the sacred with the profane. He asks much.159

Justice Arabian did not, however, assert that under no circumstances should the law recognize a property right in human tissue. Rather, he even spoke approvingly of a "licensing scheme" establishing "a fixed rate of profit sharing" between researcher and participant, and suggested that the legislature is the proper forum for consideration of such a regime.160

Some commentators warn, however, that legislative recognition of the property rights of individual research participants in their tissue would both commercialize and commodity the human body.161 Professors Andrews and Nelkin suggest chilling possibilities, such as a man being denied welfare because of the value of his kidney, or a woman's eggs being harvested to pay for her hospital bill.162 Professor Radin raises the specter of the government exercising its power of eminent domain to declare certain organs public property.163 Congress also has evinced concern about the commercialization of human body parts through enactment of federal legislation prohibiting the purchase and sale of human organs for transplantation.164

Professor Mahoney responds that such arguments regarding the dangers of commercialization of human tissue fail to consider that "[p]roperty is a flexible concept, not an all-or-nothing one,"165 and that the existence of heavily regulated markets such as the one in securities demonstrates that "the choice is not between a completely unrestricted exchange system on the one hand and a total absence of commercial activity in human tissue on the other."166 The sale and purchase of human tissue for research would be appropriate for regulation by federal agencies such as the Department of Health and Human Services and Food and Drug Administration. What is more, federal law could be formulated to provide that an individual who declares bankruptcy is entitled to retain his biological property if he chooses, much as the bankruptcy laws in many states permit a debtor to retain his Bible and other family treasure as well as the tools of his trade, in recognition of their uniqueness.167

Furthermore, warnings about the dangers of recognizing a property interest in human tissue presuppose that such tissue is not yet commodified. It is clear, however, that biomedical advances have already resulted in unprecedented commercialization of the human body, and both researchers and shareholders in biotech firms routinely profit from this process. In the Moore case, for example, where the plaintiff alleged that the defendants could expect profits of over three billion dollars from their research on his tissue,168 the appellate court declared that the researchers' position that "plaintiff cannot own his tissue, but that they can, is fraught with irony."169 Indeed, human tissue provided gratuitously can be exploited for its financial value once it has been taken from the donor and stored in a secondary repository.170 In addition, a thriving commercial market already exists in blood and gametes.171

In any event, the mere fact that markets do exist for various types of human biological materials does not dictate that market prices are the only measure of their worth. It is possible to place a price tag on something without that price being the only measure of its value. According to Professor Maguire Shultz:

Many things that partake of the monetary economy also involve aspects of life that are deeply revered. We buy a wedding ring or a home but its personal worth is not equated with its price. Doctors deal with the creation, sustenance and termination of life. We do not expect the fees we pay them to capture all of their meaning and importance to us. Neither do we deny them the capacity to get monetary recognition for their work. Similarly, we appraise a couple's ability to sustain the costs of raising a child when we decide whether they are fit adoptive parents. We award child support when a divorce occurs; we assess damages for the costs of raising a child born because of a negligent diagnostic test, or for an untimely death in a wrongful death action. We are not confused about whether these financial representations adequately sum the value of the lives or relationships in question. We simply say that money is one dimension of human interaction and valuing. The critical issue is not whether something involves monetary exchange as one of its aspects, but whether it is treated as reducible solely to its monetary features.172

Analogously, life insurance "initially provoked condemnation but has come to enjoy broad social acceptance."173 This perspective challenges the Kantian notion that pricelessness is the hallmark of dignity.174

Indeed, fixing a price for human tissue might actually enhance its dignity.175 As Professor Maguire Shultz stated in advocating for the rights of private parties to contract for maternal surrogacy services:

Efforts sharply to segregate money and values are frequently regressive in effect. "Either/or" thinking rarely captures the complexity or nuance of human reality. Nor does experience suggest that the more we value something, the less we entangle it with money. In fact, there is a strongly competing truism suggesting that that which we reward with money is that which we value.176

In addition, it is overly simplistic to conceive of the recognition of the property rights of research participants as commodification of the human body. Courts and scholars have noted that the concept of property law actually rests upon the notion of a "bundle of rights," including the rights to "possess, to use, to exclude, to profit, and to dispose."177 Thus, according to Professors Litman and Robertson, the issue of property rights in human tissue ought to be framed in terms of control:

[I]f property is viewed more accurately, in terms of control over one's body, these criticisms [regarding commodification of the human body] may be inapt. If property confers exclusive control to people over their own bodies, then their dignity is enhanced, not diminished. Indeed, as a general proposition, the greater the control conferred on individuals in relation to their bodies, the greater the respect that is being accorded to individuals.178

Justice Broussard emphasized in his separate opinion this right of control, suggesting that the "pertinent inquiry is not whether a patient generally retains an ownership interest in a body part after its removal from his body, but rather whether a patient has a right to determine, before a body part is removed, the use to which the part will be put after removal."179

Certainly, if we assume that human tissue will generate profit in our society, then our notions of individual autonomy militate in favor of according the individual the power to control what becomes of that tissue. As the lower court emphasized in Moore, to decide otherwise "would open the door to a massive invasion of human privacy and dignity in the name of medical progress."180 This is especially true when the parties possess unequal bargaining power, a circumstance recognized by the courts.181 Biomedical researchers possess scientific information about the value of body tissue and their designs to obtain a patent that their research participants do not possess. Moreover, research participants are often concerned about a disease affecting themselves or their loved ones and therefore may feel particularly vulnerable during the bargaining process.182

Some contend that research participants can receive adequate protection of their dignitary interests under the Moore holding, which provides that physician-researchers who take an economic interest in their patients are subject to a duty of informed consent and also a fiduciary duty to disclose this information.183 Nevertheless, these common law doctrines prove insufficient in several respects to protect the autonomy and dignity of research participants.

4. The Doctrines of Informed Consent and Breach of Fiduciary Duty Prove Inadequate to Protect Research Participants' Interests in Dignity and Autonomy

The doctrines of informed consent and breach of fiduciary duty, as they have been interpreted traditionally and were set forth in Moore, prove inadequate in four major respects to protect research participants' interests in their autonomy and dignity. This statement would prove true even if the Supreme Court of California's decision in Moore, which is binding precedent only in California, were to be adopted on a national scale.184

First, the Moore court itself undermined its holding by stating that "[i]n some cases, . . . a physician's research interest might play such an insignificant role in the decision to recommend a medically indicated procedure that disclosure should not be required because the interest is not material."185 As noted by one commentator, this qualification by the Moore court "abolishes a uniform standard of disclosure" by introducing an ambiguous "materiality" standard and then fails to specify whose definition of materiality will apply.186

Second, the doctrines of informed consent and breach of fiduciary duty protect only those research participants involved in a physician-patient relationship with the researchers. As stated by Professors Alpers and Lo:

[T]he Moore decision leaves large groups of patients unprotected and large groups of profit-makers unregulated. The doctrines of informed consent and fiduciary obligation operate only within the confines of the physician-patient relationship. While informed consent is required in research on human subjects, the relationship between the researcher and subject is not a fiduciary one. The researcher need not be a physician, and even if he is, he has no fiduciary responsibility if the research subject is not his patient in the clinical sense. Furthermore, the requirements of informed consent and fiduciary responsibility, which infuse the culture of clinicians, have no sway over the activities of corporate entities engaged in biotechnological research. These requirements leave completely unregulated commercial entities which may exploit research materials for a profit.187

Thus, while the doctrines of informed consent and breach of fiduciary duty required Mr. Moore's treating physician to inform Mr. Moore of the physician's economic interests in his tissue, the researchers and biotech firms with whom Mr. Moore had no therapeutic relationship faced no similar obligation.188

Third, even in cases involving physician-researchers, the amount of damages available under the theories of lack of informed consent and breach of fiduciary duty will not motivate them to disclose their financial interests. As indicated by Justice Mosk in his Moore dissent, in order to recover under these doctrines, which sound in negligence rather than battery, the plaintiff must prove a "causal relationship between the physician's failure to inform and the injury to the plaintiff," a connection that arises "only if it is established that had revelation been made consent to treatment would not have been given."189 The reason for this requirement is that the two doctrines aim to prevent physicians' pecuniary interests from clouding their professional judgment concerning the treatment of their patients, not at protecting patients' dignitary or financial interests or their personal autonomy.190 The Moore majority took care to emphasize this point, declaring that "[a] physician is not the patient's financial adviser," and "the reason why a physician must disclose possible conflicts is not because he has a duty to protect his patient's financial interests, but because certain personal interests may affect his professional judgment."191

Three years after Moore, the California Supreme Court clarified in Arato v. Avedon192 its narrow view of the scope of a physician's duty of informed consent.193 In Arato, family members brought an informed consent action against the decedent's physicians, alleging that the physicians' failure to disclose statistical mortality information affected the decedent's nonmedical interests. The family contended that, if the physicians had made decedent aware of his short life expectancy, he would have put his business and investment affairs in order.194 The court rejected this argument, noting that:

[A]lthough an aspect of personal autonomy, the conditions for the exercise of the patient's right of self-decision presuppose a therapeutic focus . . . . The fact that a physician has "fiducial obligations" . . . which . . . prohibit misrepresenting the nature of the patient's medical condition, does not mean that he or she is under a duty, the scope of which is undefined, to disclose every contingency that might affect the patient's nonmedical "rights and interests."195

According to Professor Krause, "[b]y focusing exclusively on medical interests, the Arato court limited Moore in a way that may exacerbate the problems inherent in traditional informed consent law: where a patient's health is improved at the expense of his 'non-medical' dignity interests, Moore will not provide relief."196 Thus, the doctrines of lack of informed consent and breach of fiduciary duty are inadequate to protect the interests of research participants facing situations similar to those encountered by Mr. Moore and the Greenberg plaintiffs. Arguably, research participants will be left without a remedy, because the harm they suffered affected not their medical interests, but rather their dignity and autonomy.197

In response to Justice Mosk's contention in his dissent in Moore that the remedies afforded under the theories of breach of fiduciary duty and lack of informed consent are "largely illusory" and therefore insufficient to protect the interests of research participants,198 Justice Broussard suggested that, at least in a therapeutic context where treatment is successful, such as the Moore case, a plaintiff who did not give informed consent to research "should not be required to establish that he would not have proceeded with the medical treatment in question if his physician had made full disclosure, but only that the doctor's wrongful failure to disclose information proximately caused the plaintiff some type of compensable damage."199 Thus, because the harm Mr. Moore alleged arose from the use of his cells without his permission and not from his splenectomy itself, the court should require him to prove only that he would have refused research on his tissue, not that he would have declined surgical treatment for his life-threatening leukemia.200 Noting that the Moore majority did not identify the damages Mr. Moore could recover in an action for breach of fiduciary duty, Justice Broussard indicated in his separate opinion his belief that "in appropriate circumstances, punitive as well as compensatory damages would clearly be recoverable in such an action."201

Nevertheless, it remains doubtful whether courts and juries would award the damages contemplated by Justice Broussard and, if so, fix such damages at a dollar amount high enough to deter physician-researchers from breaching their duty of informed consent and their fiduciary obligation. If not, many physician-researchers simply would make the rational, albeit immoral, economic choice to use human tissue to develop commercially lucrative biotechnology products without first obtaining informed consent, rather than negotiating with research participants in advance. Certainly, without recognition of a property right in human tissue, it would not be surprising if courts and juries awarded relatively low compensatory and punitive damages, particularly when the plaintiff suffered no physical injury.202 In addressing the adequacy of damages in cases such as Moore, Professor Bobinski has proposed more explicit reliance on the principle of unjust enrichment enshrined in fiduciary law, explaining:

If the key to the claim is the impermissible benefit to the physician rather than the actualization of risk for the patient, then unjust enrichment principles might supply the measure of damages . . . . A breach of fiduciary duty, for example, could be remedied by requiring that the fiduciary disgorge profits from an undisclosed transaction, even if the transaction also presented benefits to the entrustor.203

A significant shortcoming of this approach, however, is that the plaintiffs damages likely will prove to be quite small if a third party, such as a biotech firm, rather than the research participant's physician-researcher, reaped the bulk of the profits from the tissue studied. This issue is hardly a purely academic one, because many physician-researchers transfer their patent rights to third parties who then commercialize the patented innovations on a large scale.204 As noted above, these third parties owe no fiduciary duty or duty of informed consent to the research participants.205 Explicit recognition of individuals' property rights in their tissue avoids this problem, and is consistent with society's acceptance of the right of scientists to profit from their research on human tissue.

For the reasons set forth above, the doctrines of lack of informed consent and breach of fiduciary duty are of limited use in protecting research participants' autonomy and right to control the use of their tissue. As stated in one government report, "[t]he propriety of researchers achieving financial success from manipulating human specimens in their research is an issue best handled under other legal theories and principles," including "provisions in research contracts [and] property law."206 Professor Epstein concurs, stating that even though punitive damages could be assessed, thereby assuring plaintiffs in a breach of duty to disclose case damages equal to what they would win in a conversion action, a conversion action is preferable "because it creates cleaner property rights in those cases in which individuals do enter into various kinds of business transactions."207

5. Concerns About Scientists Luring Research Participants with Promises of False Profits and Participants Elevating Financial Concerns over Health Concerns Do Not Furnish Sufficient Reason to Deny Research Participants an Ownership Interest in Their Tissue

Those opposed to recognizing research participants' property rights in their tissue often express concern that scientists will induce research participation with false or misguided promises of profits.208 Professors Knoppers and Laberge warn that researchers might lure participants with promises of "ultimately fictitious percentages of far-off royalties."209 Individuals with limited education and financial resources are particularly vulnerable to such offers.210 Moreover, even those researchers wishing to deal honestly with their research participants might find themselves unable to estimate accurately the potential commercial value of particular tissue specimens, and would therefore offer unintentionally misleading information.211 However, a legal system that refuses to recognize research participants' property interest in their tissue does not forestall these problems.

First, it is already "common practice for sponsors and even research institutions to compensate subjects for participating in research."212 Thus, even without legal recognition of individuals' property rights in their tissue, scientists presently induce research participation with financial remuneration. On the other hand, it is clear that widespread expectation that a research participant can claim financial compensation, whether through a contractual arrangement or a liability rule, could encourage even more research participation by individuals willing to risk their health in the hope of pecuniary gain.

There are several arguments in response to this concern. First, as a practical matter, there is much to recommend in a legal system that increases the supply of human tissue for research.213 Second, while the law must guard against situations where researchers make false or inaccurate promises in order to secure the involvement of research participants or cases where individuals facing financial hardship agree out of desperation to participate in research, the doctrine of informed consent is specifically designed for just this problem.214 Indeed, if we deem these participants so vulnerable that they merit protection from unscrupulous researchers, it is illogical to maintain the current system, which denies effective recovery to the most vulnerable research participants of all, those who were not even aware of their research participation or of their researchers' plans to commercialize their tissue.215 Third, with respect to the concern that research participants will risk their health for the speculative promise of profit, it is arguably excessively paternalistic to protect potential research participants from their own desire to contribute tissue for scientific experimentation in exchange for valuable consideration. Moreover, as Professor Mahoney emphasized:

[P]reventing excessive risktaking by banning payments, instead of through the regulation of collection procedures and required disclosure of relevant hazards, is a curious strategy. When a conclusion is reached that workers are exposing themselves to excessive risks, the usual response is to alter workplace conditions to reduce the risk, not to forbid payments for the work while suggesting that altruistically minded volunteers perform the work for free.

It should be acknowledged, however, that widespread societal acceptance of the notion that research participants possess a property interest in their tissue will lead individuals to expect compensation for their research participation.217 This problem leads many commentators to express concern that such a system would erode notions of community and discourage altruistic donation not just of tissue for research purposes, but also inhibit gratuitous donation of organs and blood.218

6. Recognition of Research Participants' Property Rights in Their Tissue Will Neither Erode Appreciably Notions of Community nor Discourage Altruism

Denying research participants property rights in their tissue does not necessarily foster notions of community or disseminate widely the fruits of biotech research. Instead, the tissue taken from research participants without compensation is used by researchers and biotech firms to develop commercial products, some of which may be priced beyond the reach of most consumers.219 Our legal and economic systems are premised upon the notion that promise of reward for individual effort, not communitarian ideals, will stimulate biomedical research and innovation that will redound to the benefit of society.

Nonetheless, some commentators fear that recognition of property rights in human tissue ultimately will discourage altruism in other areas where it is typically practiced, such as gratuitous donation of organs220 and blood221 to human recipients. With respect to organ donation in particular, it is important to recall that federal law already prohibits the sale of human organs for transplant.222 There are several policy reasons why federal law defensibly could continue to encourage altruistic transfer of human organs for transplant but nonetheless recognize property rights in human tissue that is either (1) regenerative; (2) not vital for the healthy functioning of the human body; or (3) required to be removed for purposes of diagnosis or treatment.223

With respect to other types of tissue, where donative and sales regimes exist side by side, such as blood and plasma, there is no evidence that a commercial market decreases charitable donations, as theorized by Richard Titmuss, a leading British social policy analyst.224 As explained by one commentator, "[t]he legality of a market in blood for transfusion in the United States has far from eliminated the donation of blood for that purpose."225 Even if one accepts the notion that overall blood donations have declined since the implementation of a commercial regime,226 it is not clear that a causal relationship exists between these two factors. In response to Professor Titmuss, Professor Kenneth Arrow, an American Nobel Laureate in Economics, has offered an alternative explanation: that the United States instituted a system of monetary compensation for blood in response to the inadequacy of an entirely donative system.227 Thus, any shortage in the nation's blood supply may result simply from the American public's disinclination to behave altruistically,228 as opposed to the availability of payment for their blood and plasma.

Because so little is understood about the causes of altruistic behavior,229 "[i]t is uncertain whether the existence of payments will cause individuals who would have acted altruistically to instead opt to receive compensation."230 What is clear is that individuals are highly motivated to pursue their selfinterest, as demonstrated by the actions of the patient advocacy group PXE International.

III. The PXE Contractual Property Rights Model

While the Moore case posits the altruistic donation of tissue by human research participants, patient advocacy groups such as PXE International are contracting around this decision in order to establish property rights in tissue used by researchers, in what this Article will refer to as the contractual property rights model. Specifically, this grassroots group, which represents the interests of individuals afflicted with pseudoxanthoma elasticum (PXE), a genetic disorder causing calcification of elastic tissue, has negotiated directly with researchers for a share in the profits from any gene patent that might arise.231 Sharon Terry, president of PXE International and the mother of two children afflicted with PXE, has indicated that the group is motivated by its desire to ensure affordable and widely available genetic tests for the disorder.232

Ms. Terry and her husband began in 1995 to organize families affected by PXE, shortly after her two children were diagnosed with the disease.233 After it became clear to them that researchers with whom the Terry family had banked blood were not willing to share it with other scientists, Ms. Terry realized that, in her words, "the research community was not set up to work together."234 Moreover, those scientists studying the disease had located only about four or five families to study, and therefore could not expect to achieve progress as quickly as they would with more research participants.235 Indeed, PXE International estimates that the disease affects only about one in 25,000 births, and thus qualifies as a so-called orphan disease of little interest to pharmaceutical companies because even a successful treatment would hold little prospect of generating large revenues.236

A. Formation and Terms of the Contract Between PXE International and PXE Researchers

The Terry family realized that they could steer researchers toward PXE disease by collecting blood and tissue samples and providing funding, and also that they could maintain some control over the research by exchanging this valuable property only in exchange for consideration.237 Although neither Sharon Terry, an educator, nor her husband, Patrick, a construction manager, had prior experience in organizing a foundation or in directing biotechnological research,238 within four years of their children's diagnoses they had located "2,000 people with the disease, set up a repository to store tissue samples, and began raising money for research."239 During that time, Ms. Terry also engaged pro bono legal help to incorporate PXE International, Inc. as a nonprofit organization and to provide counsel about acquiring samples for the bank.240

According to Ms. Terry, because PXE International had done so much of the work of procuring patients and funding, the group had no trouble partnering with many research teams eager to study the organization's collection of samples and willing to agree to the group's terms.241 She also noted that, in light of the Greenberg action that was filed around this time,242 researchers were particularly concerned about avoiding negative publicity,243 and, presumably, potential litigation. According to the contract between the researchers and PXE International, the latter was entitled to retain ownership rights in any patent applications arising from the research, thereby enabling the foundation to share in any revenue from the discoveries, to ensure broad and affordable availability of genetic tests, and to influence future licensing of the intellectual property.244 This marked the first time that researchers who isolated a gene had filed a joint patent application with a patient advocacy group.245

In February 2000, University of Hawaii pathobiologist Charles Boyd isolated the gene associated with PXE.246 While Dr. Boyd listed Ms. Terry on the patent applications as part of the research team247 and also signed the standard PXE International contract, his agreement with the University of Hawaii actually granted the university the rights to his inventions.248 Although the university had not focused on these conflicting contracts at the time when Dr. Boyd began working with PXE International in the mid-1990s, because the prospect of licensing seemed unlikely for a disease as rare as PXE,249 this had changed by the time Dr. Boyd had isolated the gene associated with PXE in 2000. The university balked at giving total control over the licensing rights to PXE International, since the foundation's goals were incompatible with its own. While the University of Hawaii sought lucrative licensing arrangements, PXE International's aim was to ensure that any available medications would be affordable for its members. Ultimately, the parties reached an agreement in 2001.250 The university accorded to PXE International the right to make the licensing decisions, and the parties agreed to split equally the royalties deriving from any diagnostic test or marketable product.251

While PXE International's contract with researchers is unprecedented, commentators expect others patient groups to follow suit. This trend has already been observed by executives with Genetic Alliance, a Washington, D.C.-based advocacy group that assisted PXE International in drafting its contract with researchers.252 Patient groups such as Cure Autism Now and the Juvenile Diabetes Research Foundation International have pooled members' specimens to create biorepositories, and one Genetic Alliance vice president has indicated that these groups inform her that the terms for access to these repositories would address intellectual property considerations.253 These patient groups are likely to be able to exert a great deal of leverage, since researchers will prefer tissue from these biorepositories, which comes replete with individual health histories and symptom descriptions, to the millions of specimens already stored in the U.S.254

The necessity of collaboration among research participants, patient advocacy groups, and scientists has been recognized by organizations such as the American Society of Human Genetics (ASHG), a professional association of human geneticists, including researchers, academicians, clinicians, laboratory practice professionals, genetic counselors, and nurses.255 The ASHG emphasizes that these patient groups contribute to biomedical research by encouraging the participation of their members and creating blood and tissue banks, raising funds, educating research participants and scientists about the nature and expectations of the research, as well as the consent process, and bridging cultural gaps between researchers and participants.256 In light of the importance of these groups, it is critical to examine the ramifications of the contractual property rights model they are embracing.

B. The Advantages of the PXE Contractual Property Rights Approach

One of the main benefits flowing from patient groups' claims to property rights in the tissue of their members is the potential for enhanced public access to diagnostic tests and therapeutics for the treatment of disease, to the extent that these groups demand some control over the licensing of the products developed from such tissue. Many scholars have written extensively about the problems that arise when researchers who obtain patents on human genes enter into exclusive licensing agreements, license their intellectual property to a very limited number of downstream users, or charge particularly high fees for these products. These practices maximize the profits enjoyed by scientists, the institutions that employ them, and biotechnology firms, while simultaneously limiting consumers' access to diagnostic tests and therapeutic treatments.257 While the promise of profits is of course necessary to foster innovation, patient advocacy groups can help to balance the need to stimulate profits with the goal of promoting public health. Indeed, PXE International has emphasized repeatedly that its aim is to promote access to diagnostics and therapeutics, not only for its own members, but also for others suffering from disease.258

Patient advocacy groups also contribute to the advancement of research in various ways. These groups help to identify and recruit research participants,259 formulate informed consent policies,260 engage in efforts to increase public awareness of their disease and funding for medical research,261 and even become so knowledgeable about their disease that they offer researchers significant medical insights.262

Furthermore, assuming that it becomes more common for patient advocacy groups to negotiate for property rights in their members' tissue,263 these groups avoid some of the practical and ethical problems raised by this practice. First, these groups overcome the fact that "individual sources are rarely substantially responsible for products of commercial value."264 For example, Professor Greely suggests:

[I]n research conducted with users of the Veterans Administration system, some share of any commercial value could be dedicated to improving the lives of those in Veterans Administration hospitals. Similar kinds of collective benefits could be foreseen when doing research with members of other kinds of health systems, such as health maintenance organizations, or in geographically or culturally-defined communities.265

Second, as noted by Professor Greely, patient advocacy groups also overcome the problem that the prospect of a share in the profits might "operate as an undue inducement to someone to participate in research,"266 because the profits would flow to the group rather than the individual research participants. Moreover, group ownership of the commercial profits flowing from the tissue, vested in the foundation, would avoid the appearance of profiting from one's disease, which strikes some as unseemly,267 and also strengthens notions of community so highly prized by scholars such as Titmuss.268

C. The Drawbacks of the PXE Contractual Property Rights Approach

Notwithstanding the many advantages offered by the patient advocacy groups, it is clear that they do not provide the only or even the best means of protecting the rights of research participants. For this reason, it is essential that the United States Congress recognize the right of each individual research participant to claim a property interest in his tissue.

Among the most obvious limitations of the group rights approach is that not all patients will locate a patient advocacy group or have easy access to such a group even if one exists. Some individuals may prefer not to participate in such groups, either because they suffer a negative psychological impact from associating with others with their disease or they may fear genetic discrimination if they are linked with such a group.269 Moreover, some patient groups may not represent individual patients as they would prefer.270 Thus, individuals should enjoy the legal right to negotiate on their own behalf with biomedical researchers.

Even for a patient with access to and the desire to join an advocacy group, it is not clear that such groups always advance scientific research. Professor Eisenberg has warned that the presence of more parties at the bargaining table hinders the ability of pharmaceutical firms to negotiate the licensing agreements necessary to pursue planned drug development initiatives.271 Moreover, a patient group that exerts control over scientists' research agendas because of its ownership of scientifically valuable tissue may choose to pursue research strategies of dubious scientific merit, thereby slowing the pace of biotechnological progress.272

Even if a patient group ultimately does negotiate successfully with researchers for the implementation of scientifically sound research projects, there is some concern that the group might exercise control over the discoveries in such a way as to maximize the group's profits, while simultaneously limiting access to people afflicted by other diseases. For example, there is evidence that the gene associated with PXE might also relate to hypertension and cardiovascular disease research. As president of PXE International, Ms. Terry has asserted that her group will resist bettering their own fortunes at the expense of other disease sufferers, stating that although "[i]t's been suggested that we could make a killing because who cares if we're making the costs of cardiovascular treatment huge," PXE International does not "just represent people with PXE, we represent anybody who has anything."273 As a practical matter, of course, she acknowledges that the group would insist upon licensing deals that would maximize the access of PXE patients to a future diagnostic test or treatment.274 Third parties could hardly fault PXE International for protecting its members above all, in light of the fact that these members incurred the inconvenience and risk of research participation. What is more, it is quite rational for PXE International to guard its discoveries closely and to optimize its profits from them, given that orphan diseases such as PXE garner little direct federal funding.275

If profits from biotechnological products were to flow to the individual members of a disease advocacy group, as opposed to the foundation as a whole, however, this would belie the notion that patient advocacy groups are necessarily communitarian in perspective. Clearly, the existence of a foundation does not preclude the possibility of personal profit, as noted by the attorney who drafted the patent application for PXE International and PXE researchers. He stated that: "[T]he awards of group ownership could include dividends from royalties, despite risking the appearance of getting paid for their disease. After all, . . . the costs of a lifetime of treating a chronic disease add up."276 The payment of such dividends undoubtedly would provoke an outcry from commentators who accept commercialization by a community group, but not by an individual.277

Even those who support the property rights model, however, acknowledge that this approach is insufficient to protect the rights of research participants who did not negotiate with their researchers, such as those involved in the Greenberg litigation discussed immediately above. For reasons that will be examined below, it is critical that federal law mandate that research participants in this predicament have recourse to a liability model.

IV, Greenberg v. Miami Children's Hospital Research Institute, Inc.

The recent action, Greenberg v. Miami Children's Hospital Research Institute, Inc.,278 represents the dangers of relying solely upon either the present market-inalienability or the pure property rights model. It is critical to resolve this issue because we can expect lawsuits such as Greenberg to prove more common in light of scientists' enhanced ability to locate the genetic markers for various diseases. Ultimately, individuals will tend to refuse to participate in scientific studies if they perceive the law as unfair to the plaintiff research participants.

A. The Scientific and Legal Background of the Greenberg Action279

1. The Research Relating to Canavan Disease

In 1981, Chicago residents Daniel and Debbie Greenberg gave birth to their first child, Jonathan.280 While Jonathan seemed normal at birth, his parents observed problems with his motor skills during his first year, and a neurologist ultimately diagnosed the child with Canavan disease.281 Tragically, the Greenberg's second child, Amy, born in 1983, also suffered from the disease.282 In 1987, Daniel Greenberg approached a medical researcher, Dr. Reuben Matalon, who had never previously studied Canavan, and requested his involvement in such research. At that time, Dr. Matalon directed a laboratory that performed clinical testing and research of phenylketonuria (PKU) and other familial disorders at the University of Illinois in Chicago.283

Dr. Matalon's research proceeded in two major stages. First, by 1988, he and his team determined that the deficiency of a certain enzyme, aspartoacylase, caused Canavan disease. Dr. Matalon achieved this insight by using blood, urine, and tissue samples provided by the Greenbergs and one other family, as well as money provided by a nonprofit organization. Armed with knowledge of the cause of Canavan disease, Dr. Matalon and his team were able to design a prenatal screening test. From 1988 to 1990, at least twenty couples, including the Greenbergs, benefited from prenatal testing developed by Dr. Matalon's lab.284

In the second stage of his research, Dr. Matalon began to search for the gene associated with Canavan disease, both in order to develop a more reliable prenatal test and to perform carrier screening.285 By this time, Dr. Matalon was conducting his research in Miami, where he had been recruited by Miami Children's Hospital (MCH) to establish and direct a center for research on genetic diseases, the Miami Children's Hospital Research Institute (MCH Research Institute).286 This phase of the research relied upon the contributions of thousands of individual research participants.287 As asserted in the Greenberg Complaint, the plaintiffs288 provided the researchers with a combination of blood, tissue, autopsy, and other samples, confidential medical information, and funding.289 By early 1993, a graduate student on Dr. Matalon's team succeeded in cloning the gene associated with Canavan disease.290

2. The Patenting of the Gene Associated with Canavan Disease and the Licensing Process

Shortly after researchers isolated the gene associated with Canavan disease, the Canavan Foundation and the National Tay-Sachs and Allied Diseases Association (NTSAD) began working with local and national groups to promote Canavan disease testing. The plaintiffs viewed their collaboration with researchers as a "partnership," and alleged in their complaint that, "[c]onsistent with their understanding that affordable and accessible testing was a 'partnership' goal," in spring 1996 the Canavan Foundation had established a free testing program at Mount Sinai Hospital in New York City.291 By November 1998, the plaintiffs Canavan Foundation and NTSAD had persuaded the American College of Obstetricians and Gynecologists to issue guidelines recommending carrier screening of Ashkenazi couples.292

Unbeknownst to plaintiffs, however, MCH Research Institute had filed a patent application for the gene associated with Canavan disease and related applications, including carrier and prenatal testing, in September 1994.293 The United States Patent and Trademark Office issued U.S. Patent No. 5,679,635 to the MCH Research Institute in October 1997.294 As plaintiffs explained in their complaint:

Through patenting, Defendants acquired the ability to restrict any activity related to the Canavan disease gene, including without limitation: carrier and prenatal testing, gene therapy and other treatments for Canavan disease and research involving the gene and its mutations. The patent enabled Defendants to prevent doctors from testing or examining patients for the Canavan disease gene, even though the doctors could do so using traditional medical practices and such testing or examination would not require the use of any product or device invented by Defendants.295

The plaintiffs allege that it was around 1994 that the defendants first presented them with a written consent form, at the plaintiffs' suggestion.296 They contend that this form was inadequate, for its description of the defendants' purpose as "identify[ing] mutations in the Canavan gene which may lead to carrier detection within my family" was woefully incomplete in that it failed to reveal the researchers' commercial aims.297

Shortly after their 1997 receipt of the patent, of which the plaintiffs remained unaware, MCH began working with a patent consultant on a marketing plan.298 In late 1998, MCH and MCH Research Institute began sending letters to clinical laboratories engaged in Canavan testing and to the plaintiffs, informing them of the patent and the hospital's plans for commercializing the test.299 These letters indicated the defendants' intent "to enforce vigorously [their] intellectual property rights relating to carrier and patient DNA tests for Canavan Disease mutations."300 Through these letters, the plaintiffs learned for the first time, indirectly, of the defendants' patent and their concomitant ability to earn royalties from the research in which the plaintiffs had participated with the goal of ensuring affordable and accessible carrier and prenatal screening and, ultimately, contributing to a treatment or cure for Canavan disease.301

The parties differ in their views of MCH's marketing plan. According to Professor Merz, whose involvement the plaintiffs requested in their negotiations with MCH,302 there were to be two stages of licensing.303 First, "a limited number of academic laboratories (likely to be a subset of the many already performing the testing) would be granted nonexclusive licenses to perform an annually limited number of tests" for a "fixed $12.50 per test royalty."304 During the second phase, "a large commercial laboratory would be licensed as a 'market leader' with what would be, in effect, an exclusive license to the remainder of the testing volume."305

Professor Merz sharply criticizes both the substance of MCH's negotiation demands and its negotiation strategy. With respect to the substance, he refutes what he terms MCH's "justification" for exclusive licensing, namely that "a large reference laboratory would be able to spend the resources for outreach and education needed to ensure screening and testing of all couples at risk."306 Professor Merz notes that testing for Tay-Sachs disease is widespread even though testing methods "have never been restricted," and attributes this success to community groups such as NTSAD and Dor Yeshorim, which "stand as testaments to the ability of community-based organizations to develop and carry out population education and screening."307 With respect to MCH's negotiation strategy, Professor Merz contends that the hospital unfairly established a set of rules that imposed a gag on participants to the negotiation, and acted vengefully by prohibiting physicians at his institution, the University of Pennsylvania School of Medicine (Penn), from sending samples to any licensed lab for Canavan disease testing so long as MCH and Penn were unable to reach a licensing agreement.308 What is more, once MCH refused to license Penn, the hospital callously disregarded human health in its pursuit of profits, according to Professor Merz, by withholding information from physicians at Penn as to which labs were licensed to perform the testing, simply because MCH intended soon to grant one exclusive license and terminate the limited licenses it had granted to academic labs.309

MCH maintains that, while it had initially "considered donating the gene patent to the public and forgoing royalties on any test," it eventually declined to do so out of fear that, because "there were so few people who needed the test that laboratories would not bother to publicize it."310 Thus, according to MCH, after months of deliberations and negotiations with academic and commercial laboratories, MCH decided to charge a royalty fee of $12.50 per test.311 This money would be used to defray MCH's costs in funding Dr. Matalon's research, and some of it would be devoted to publicizing the test.312

In April 2000, MCH offered the plaintiffs approximately $20,000 per year of the estimated $375,000 in annual royalties, with such funds intended to educate the public about Canavan disease and to subsidize the cost of testing for qualifying families.313 MCH also abandoned its plans to implement exclusive licensing.314 Nonetheless, the parties failed to reach an agreement, in large part because MCH's offer of funding was conditioned upon the plaintiffs' promise that they would cease public criticism of the hospital's licensing program and royalty fees, a requirement that the plaintiffs refused to accept.315

3. The Legal Proceedings in Greenberg v. Miami Children's Hospital Research Institute, Inc.

In October 2002, Daniel Greenberg, along with his coplaintiffs,316 filed a lawsuit in the United States District Court for the Northern District of Illinois against defendants MCH, MCH Research Institute, and Dr. Reuben Matalon.317 The six counts of the complaint included lack of informed consent,318 breach of fiduciary duty,319 unjust enrichment,320 fraudulent concealment,321 conversion,322 and misappropriation of trade secrets.323

The gravamen of the Greenberg plaintiffs' complaint was that they were not informed of, and did not consent to, the patenting of the gene associated with Canavan disease and the commercialization of carrier and prenatal tests.324 When they furnished researchers with tissue, autopsy, blood, urine, and other pathology samples, as well as personal familial data and funding, the plaintiffs expected Canavan research to remain in the public domain in order to facilitate the development of a cure for the disease, and they also intended for carrier and prenatal testing to be affordable and accessible to as many families as possible.325 According to the plaintiffs, they would have refused to participate in the research had they known of the defendants' "true intentions to commercialize their genetic material through patenting and restrictive licensing,"326 or else would have "imposed conditions . . . to avoid commercialization of the Canavan disease gene or opted to donate their samples to other researchers who shared their common goals of accessible and affordable testing."327

The plaintiffs also alleged conversion, claiming a "property interest in their blood, tissue, urine and autopsy samples and those of their minor children, and in the genetic information contained therein,"328 as well as in the "Canavan Registry," a compendium of contact information and medical data about families worldwide afflicted with Canavan Disease compiled by Daniel Greenberg in conjunction with the NTSAD.329 Plaintiffs contended that their purpose in contributing their bodily materials was to promote the "good of the public at large,"330 and that the defendants wrongfully converted their plaintiffs' property for "their exclusive economic benefit."331

B. Analysis of the Greenberg Decision

Given the parallels between the Greenberg and Moore actions, the court alluded to the latter case when deciding the former, though declining to follow it in some respects.332 Ultimately, the Greenberg court dismissed with prejudice five of the six claims brought by the plaintiffs, permitting only the unjust enrichment cause of action to survive.333 Although the court considered the issues in the context of a Rule 12(b)(6) motion to dismiss for failure to state a claim upon which relief may be granted,334 as opposed to a full trial on the merits, the Greenberg holding provides a telling example of how courts will adjudicate cases involving research participants. This decision clearly demonstrates the necessity for a federally recognized property right inhering in research participants with respect to their tissue.

1. Lack of Informed Consent

The Greenberg court dismissed the plaintiffs' first claim, lack of informed consent, based on several grounds.335 First, the court questioned whether researchers who lack a therapeutic relationship with the research participant even owe that individual a duty of informed consent.336 Assuming arguendo that researchers do owe such a duty,337 the court declined in the instant action to extend this obligation to include disclosure of a researcher's economic interests, stating that this requirement "has no support in established law, and more ominously, . . . would have pernicious effects over medical research, as it would give each donor complete control over how medical research is used and who benefits from that research."338 The court emphasized, in response to plaintiffs' citations of cases that support the notion that a researcher must disclose economic interests, such as Moore339 and Grimes v. Kennedy Krieger Institute, Inc.,340 that those cases from other jurisdictions were not controlling authority in Florida.341 Most of all, the court was persuaded by "the practical implications of retroactively imposing a duty" of informed consent, namely that such an obligation would "chill medical research as it would mandate that researchers constantly evaluate whether a discloseable event has occurred" and would give research participants too much control over medical research.342

There are several significant critiques of the Greenberg court's rejection of plaintiffs' claim of lack of informed consent. First, as explained above, courts have recognized that, even more so than a treating physician, a researcher owes a duty of informed consent to a research participant.343 Second, given the fact that most scientific research is commercial in nature,344 it is critical to extend this duty of informed consent to include researchers' economic interests, in order to preserve the autonomy of research participants.345 As the plaintiffs noted, the defendants, in failing to reveal their commercial interests, treated the research participants like "treasure troves."346 Third, the court drew a specious distinction between Mr. Moore, who was an unwitting research participant, and the Greenberg plaintiffs, who were aware that they were participating in research. By classifying the latter plaintiffs as willing donors, the court misses an important point: A research participant can be a voluntary donor for one purpose (that is, noncommercial research), but not for another (that is, commercial research). To hold otherwise would be to encourage scientific researchers to overstep the bounds of their described research agenda to conduct upon research participants additional experiments to which they had not consented.

2. Breach of Fiduciary Duty

The Greenberg court also dismissed the plaintiffs' second cause of action, breach of fiduciary duty, on two grounds. First, just as the court had declined to find a duty of informed consent between the researcher and the research participant with respect to disclosure of the researcher's economic interests,347 the court held that "[t]here is no automatic fiduciary relationship that attaches when a researcher accepts medical donations."348 Second, the court held that the plaintiffs must allege not only that they placed trust in the defendants, but also that the defendants accepted that trust, and that the Greenberg plaintiffs had failed to plead this second element.349 According to the court, "the acceptance of trust . . . cannot be assumed once a donation is given."350

The problem with the court's approach, however, is that it departs from the accepted notion that physicians owe their patients a fiduciary duty.351 As a practical matter, research participants perceive their researchers as fiduciaries, even in the absence of a therapeutic relationship, and will tend to repose trust in them. Indeed, without such a relationship of trust and confidence, the scientific collaboration could not proceed. If researchers are not required to honor this trust, the situation is ripe for exploitation of the research participants.

3. Fraudulent Concealment

In light of its holding that the defendants owed no fiduciary duty to the plaintiffs, the Greenberg court also rejected the plaintiffs' claim for fraudulent concealment, stating that there existed "no special relationship that gives rise to a duty to speak."352 Indeed, the court placed the onus on the plaintiffs to uncover facts about the issuance of the patent, stating that "if they were so concerned about a possible intent to patent then a simple phone inquiry to the Defendants would have uncovered the fact."353 This holding clearly decreases protection for the research participant, requiring him to inquire about the possibility of a patent, despite the fact that it is the researcher, not the tissue contributor, who is most knowledgeable about potential plans to commercialize the scientific findings resulting from the research.

4. Conversion and Misappropriation of Trade Secrets

Although the Greenberg court noted, in its analysis of the plaintiffs' claim of lack of informed consent, that Moore did not represent controlling authority in Florida,354 the court nonetheless invoked Moore in deciding the conversion claim. The court cited Moore for the proposition that the "[p]laintiffs have no cognizable property interest in body tissue and genetic matter donated for research under a theory of conversion."355 The court also emphasized that, under Florida law, a research participant cedes property rights in blood and tissue samples once the sample is voluntarily given to a third party.356 Furthermore, the court held that a property right inheres in the information contained in the plaintiffs' tissue, not the tissue itself, and that this information was developed through the efforts of the defendants, not the plaintiffs.357 According to the court, "[i]f adopted, the expansive theory championed by Plaintiffs would cripple medical research as it would bestow a continuing right for donors to possess the results of any research conducted by the hospital."

The court's ruling on the conversion cause of action invites several challenges. First, although the court relied upon the notion of voluntary donation by the plaintiffs, this justification proves to be entirely fictional when one considers that the plaintiffs were unaware of the true use of their tissue, largely because they did not have the benefit of informed consent. Second, the court conflated the notion of property rights in human tissue and ownership of the patented invention developed from it.359 The law must distinguish between the two, recognizing a research participant's property rights in the tissue itself, even if patented invention ultimately belongs to another. The commercial profits from the invention, along with the characteristics of the tissue and the behavior of the researchers, should be considered in calculating the damages due to the research participants.360

The court also rejected the plaintiffs' claim of misappropriation of trade secrets in connection with the Canavan Registry, holding that the complaint proved inadequate in two respects. First, the plaintiffs failed to allege that the economic value of the registry derived from its confidentiality.361 Second, the plaintiffs failed to demonstrate reasonable efforts on their part to maintain the secrecy of the registry.362

5. Unjust Enrichment

Only the plaintiffs' unjust enrichment cause of action survived the defendants' motion to dismiss. The court recognized "a continuing research collaboration that involved Plaintiffs also investing time and significant resources in the race to isolate the Canavan gene."363 For the purposes of this claim, the court recognized that the defendants' patent did not relieve them of responsibility to compensate the plaintiffs for the valuable tissue they furnished to researchers.364 This approach is too ad hoc, however, to be relied upon for future research participants.

Had the Greenberg plaintiffs negotiated expressly with their researchers, as PXE International has done, it is likely that they would have been able to enforce their contractual rights. Reliance upon a property rights model alone, however, fails to protect those research participants who remain unaware of their researchers' commercial agenda. This situation arises often, as demonstrated by the Moore and Greenberg actions. Indeed, the decisions in these cases increase the likelihood that scientists will not divulge their economic interests to research participants, in light of the Moore court's holding that a physician-researcher is not a patient's financial advisor365 and the Greenberg court's decision exempting researchers who lack a therapeutic relationship with their research participants from the law of informed consent and fiduciary duty.366 Thus, Congress should recognize explicitly research participants' property rights in their tissue through a hybrid property rights/liability model. This approach would safeguard the rights of entities such as PXE International that choose to negotiate with researchers, and also ensure that individuals facing the same situation as the Greenberg plaintiffs in the future will recover damages when researchers deprive them of information that would allow them to bargain effectively for rights in their tissue.

V. Proposal for Congressional Enactment of a Hybrid Property Rights/Liability Model Recognizing the Property Interest of Research Participants in Their Body Tissue

Current United States policy regarding research participants' rights in their tissue lacks transparency, consistency, and equity. As one commentator stated:

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.

As discussed above, this leads to an anomalous situation in which research participants such as the members of PXE International enjoy property rights in their tissue, on the one hand, whereas the Moore and Greenberg plaintiffs do not, even though the only significant difference between their research participation is that the members of PXE International were aware that they were participating in commercially motivated research, while the others were not.368

Commentators suggest that "legislatures may be in the best position to design and institute appropriate remedies" for this problem,369 a view shared by the Moore majority, which emphasized that "[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."370 This Article proposes that Congress implement a hybrid property rights/liability model that: (1) recognizes that individuals possess property rights in their tissue and therefore have the right to exchange it for valuable consideration, or to waive such rights if they prefer to make a gratuitous donation;371 and (2) permits individual research participants to maintain an action for conversion of their tissue in the event that: (a) they were not informed that researchers were using their tissue for commercial purposes; or (b) they did enter into an agreement regarding the use of the tissue that is voidable under the doctrines of fraud, duress, undue influence, or mutual mistake.

There is ample precedent for federal regulation of property rights in human tissue. First, federal law already prescribes certain rules concerning the treatment of human research participants involved in federallysponsored research,372 and FDA regulations apply to research involving experimental drugs, biological products, and medical devices that are subject to FDA approval.373 In addition, Congress recognizes property rights in intangible intellectual property created by human ingenuity, in part to stimulate such innovation,374 and can similarly create an incentive to supply tissue by affording research participants a property interest therein.375

A. Parameters of the Property Rights/Liability Model

In order for the property rights/liability model to operate, research participants ought to be able negotiate mutually satisfactory agreements with their researchers, fully informed as to all the risks associated with the research and the scientists' economic interests.376 In addition, research participants should possess the right to initiate an action for conversion, a strict liability tort, against any researcher who uses their tissue without informed consent. In conversion cases, researchers' participants would be entitled to compensation only if the researchers earned a profit from commercializing their tissue, as the research participants essentially would be functioning as investors who donate capital and stand to lose the value of their investment. Despite fears about a proliferation of conversion actions, research participants likely would file lawsuits only if they were sufficiently aggrieved, and could expect a rather small damage awards if their tissue were not unique.

B. Advantages of a Property Rights/Liability Model

A property rights/liability model promises to stimulate biomedical research in many ways. First, the promise of compensation encourages research participation by individuals who might otherwise decline to behave altruistically while others profit, and, what is more, who face the inconvenience, medical risks, loss of privacy, and possibility of genetic discrimination inherent in such participation.377 Second, the promise of profits also fosters self-checking by individuals who will initiate significant research by informing biomedical researchers of the value and uniqueness of their tissue.378 Third, the possibility of a liability action creates even greater incentive for researchers to provide informed consent,379 especially because the monetary damages will prove great enough to serve a deterrent effect.380 Fourth, this model's recognition of research participants' right to bargain with researchers will help to ensure that the tissue ends up in the hands of the highest bidder, who, it is hoped, will put the tissue to its most valuable use.381 Fifth, and just as important, notions of equity militate that research participants, who supply useful scientific raw materials,382 and encounter risks through their participation,383 are entitled to compensation, in light of researchers' own pecuniary gain. Any other approach threatens to lead to a decrease in public support of such research,384 lest the public perceive that researchers obtain scientific inputs from them for free and then charge them for the commercial outputs.

C. An Examination of Alternative Models

1. The Harrison Hybrid Donative/Liability Model

In an extremely thoughtful article considering the issue of compensation for human research participants, one commentator, Ms. Charlotte Harrison, a former Fellow in Medical Ethics at Harvard Medical School during the 2000-2001 academic year, proposed retention of the general rule of tissue donation (premised, of course, upon the research participant's consent), along with implementation of an objective, nonmarket mechanism for compensating research participants after scientists have commercialized their research results. She advocates remuneration of the research participants only in those rare cases where the tissue proves of significant commercial value, and considers various objective third parties that could reach this determination, including an administrative agency, an arbitration panel, or a tribunal. In cases where tissue donors cannot be tracked, or do not wish to receive compensation, the companies would be required to dedicate the adjudicated sum to a charitable purpose, thereby discouraging biotech firms from intentionally losing linking information or from dissuading research participants from claiming their share of the proceeds.385 Ms. Harrison highlights the significant advantages of the proposed system, including that it would "enable the acquisition and study of tissue to go forward without the delays, commodifying tendencies and other disadvantages of up-front negotiations;" "would operate evenhandedly after the fact of use;"386 and "could be applied uniformly . . . to the full range of tissues collected in hospitals anywhere in the world."387

While the Harrison donative/liability model does address many of the deficiencies of our current system, it is marked by two significant flaws. First, this model does not take into account that relationships between scientists and research participants are increasingly governed by private arrangements negotiated by the parties, as in the case of PXE International. As a related matter, Ms. Harrison's model does not address research participants' noneconomic interests, in particular the right to participate in licensing decisions,388 an issue of fundamental importance to those afflicted by disease, as demonstrated by the degree to which the members of PXE International and the Greenberg plaintiffs devoted their efforts toward ensuring availability of the commercial products developed from their tissue. The model proposed in this Article offers scientists and research participants the opportunity to negotiate agreements regarding the licensing of intellectual property developed from human tissue. As noted above, in those instances where researchers did not act in good faith, courts could consider, as an equitable remedy, permitting tissue contributors to participate in the decision-making with respect to the licensing of the intellectual property developed from their tissue.389

2. A Gene Trust

Some commentators also have proposed the establishment of a human genome trust, to prevent ownership by private entities.390 According to this view, "[t]o ensure proper dissemination of genetic information, protection of intellectual property rights, and regulatory guidance for genetic research, an international body should be established to hold in trust the Human Genome as it is discovered, granting rights for continuing research that may culminate in" patentable inventions.391 In addition, such a system acknowledges the growing globalization of science,392 as it renders United States law compatible with widespread European opposition to commercialization of the human genome.393 Creation of such an institution would be difficult to achieve, however, in light of the need for widespread international cooperation and financial support.394 Most importantly, as noted previously, the creation of a nonprofit, nongovernmental organization to control valuable tissue is unlikely,395 as private ownership of human DNA sequences is already firmly entrenched in both the United States and throughout Western Europe.396 For this reason, a hybrid property rights/liability model proves a superior solution.

VI. Conclusion

The Greenberg litigation illustrates the inadequacies of our current system of apportioning property rights among the participants in biomedical research on human tissue. Although the Greenberg plaintiffs remained unaware during their participation in research on Canavan disease that researchers aimed to commercialize the results of these experiments, the Moore holding serves to deny the plaintiffs relief under the theories of lack of informed consent and breach of fiduciary duty. The Greenberg court interpreted Moore to oblige only physicians who have a therapeutic relationship with the research participant, not pure researchers, to honor these duties. What is more, the Moore court declined to extend the strict liability tort of conversion to apply to human tissue, out of concern that every tissue sample would become the subject matter of a lawsuit.

Had the Greenberg plaintiffs negotiated in advance with their researchers, as the patient advocacy group PXE International has done, it is possible, though hardly assured, that they would have enjoyed the right to control the use of their tissue. No court has yet ruled on the legitimacy of such agreements, which seem to conflict with legal precedent and some scholarly opinion that suggest that it is inappropriate to recognize a market in human tissue. Nevertheless, it is clear that researchers, tissue banks, and tissue brokers, as well as patients themselves, already buy and sell human biological material, including blood and gametes.

In light of the fact that a market in human tissue already exists, this Article advocates for congressional enactment of a hybrid approach to property rights in human tissue. The law should entitle plaintiffs to invoke a property rule where they negotiated in advance for rights in their tissue, and, when necessary, to invoke a liability rule in the form of an action for conversion when researchers withheld from them vital information that would have facilitated their ability to bargain for such rights. As noted above, it is inequitable to deny relief to the Greenberg plaintiffs, who contributed valuable tissue to research just like the members of PXE International, yet were not informed of their researchers' goal of commercialization. While the Greenberg court's apparent acceptance of the plaintiffs' unjust enrichment argument is promising, such an approach is too ad hoc to lend certainty to this pressing issue.

The hybrid property rights/liablity approach proposed in this Article will create an incentive for individuals to participate in research, compensate them equitably for their contribution, and also enable them to make decisions that will foster the availability and affordability of diagnostic and therapeutic biomedical products to other consumers. What is more, under this system, it is more likely that tissue will end up in the hands of researchers who will use it most productively, as evidenced by their willingness to pay valuable consideration for it. Congressional enactment of legislation implementing this model offers the opportunity to advance biotechnological innovation, enhance the public accountability of researchers, and foster citizen involvement in pressing public health decisions, all while ensuring honorable and equitable treatment of research participants.

Donna M. Gitter*

* Assistant Professor of Legal and Ethical Studies, Fordham University Schools of Business; J.D., University of Pennsylvania Law School; B. A., Cornell University.

I am indebted to two individuals who so graciously shared with me their invaluable work authored in the course of their personal involvement in the case of Greenberg v. Miami Children's Hospital Research Institute, Inc. discussed herein: Professor Jon Merz of the Center for Bioethics, University of Pennsylvania School of Medicine, and Laurie A. Rosenow, Esq., Fellow at the Chicago-Kent College of Law Institute of Science, Law and Technology. I am also grateful for the able research assistance of Lisa Brubaker, Dorota Czlapinska, Ulrike Tinnefeid, and Roland Wig, as well as the generous support provided by the Fordham University Schools of Business.

Copyright Washington & Lee University, School of Law Winter 2004
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