More often than not, when a person decides to donate something of hers, there are no strings attached. The recipient of the gift is able to use it for whatever purpose or goal he desires. The concept of donation becomes more problematic when we begin to add in details such as intent, both of the donor and of the recipient. Has he promised or implied that the gift would be used for a specific purpose? Did she give the gift with limitations on how the gift was to be used?
While such a scenario may trigger certain implications in terms of common law property or contract cases (does anyone want to remember fee simple defeasible estates?), when we take familiar concepts and apply them to the developing landscape of biotechnology, the case law manages to say plenty while leaving much unanswered. Few cases have managed to make their way into print regarding what rights a donor has in what happens to his genetic or biological material once it leaves his body. Those few cases paint a fairly bleak picture for those donors that may feel strongly about what happens to their gifts should they have a specific outcome planned. Just like Aunt Meryl who may want to leave a diamond ring to her niece, so long as little Suzy doesn't sell or give it away, shouldn't the donors of biological material be given more flexibility in what they decide to do with their gifts?
In the movie X-Men: The Last Stand, the viewers are introduced to the character of Jimmy, a mutant who has the power to negate the abilities of other mutants[1]. It is his DNA that forms the basis of both a therapeutic treatment to cancel out the manifestation of the X-gene in other humans as well as an anti-mutant weapon. While most of us who watched the movie undoubtedly were not doing so for the legal viewpoint, the character of Jimmy and his situation brings us right back to principle question that this paper will seek to address. What are his rights as a donor, and what can and could be done to enhance those rights? Was he paid for his time and effort or does he even have a clue why he is really being kept secluded from the rest of society[2]? How much was he told beforehand, and if he now objects to the way his DNA is being used, can he do anything about it? Although these questions are never raised, let alone dealt with in the context of the movie, they are more than mere science-fiction potential problems. These concerns have been pressing for at least the past decade, if not longer, with no clear conclusion in sight.
This paper will look into the current landscape of donor rights regarding their genetic material, using the Moore and Greenberg cases as the key decisions in the legal field in this area. These cases lay out both holdings and dicta that have much to say regarding the status quo of donor rights. I will then move on to current state and federal law and regulation regarding informed consent, property rights and what these laws currently mean for donors. In the next section, there will be an examination of the interests of both the donors and the researchers that are at stake in these matters. Finally, a look into possible solutions, including maintaining the status quo, creating a new property interest in one's biological material and enhanced informed consent laws.
Legal Framework: Moore, its legacy and current laws
One can only assume what John Moore was thinking when he was diagnosed with hairy-cell leukemia. Obviously, treatment must have been one of the top things on his to-do list, and he ended up seeking treatment for his condition at the Medical Center of the University of California at Los Angeles (UCLA)[3]. They drew blood samples, marrow samples, other samples in order to confirm and work with Moore's condition[4]. Golde, one of his attending physicians and several others at the University “were aware that 'certain blood products and blood components were of great value in a number of commercial and scientific efforts',” but never brought up this observation with Moore during his time at the facility[5].
During his treatment at UCLA, Golde recommended that Moore have his spleen removed in order to slow down the progression of the disease[6]. Before performing the procedure, Golde and another physician, Quan, decided to keep portions of the spleen after it was removed from Moore and made preparations to do so[7]. After the surgery, Moore returned several times to UCLA at Golde's request, believing that these visits were to ensure that his health and well-being continued to improve[8]. These visits, from which Moore traveled from his home in Seattle, resulted in the production of additional samples of blood, bone marrow aspirate and other fluids[9]. During this period, Golde and others took efforts to make sure that their efforts were hidden from Moore, using the newly gathered materials for research that was unrelated to his condition[10]. Three years after he'd originally gone to UCLA for treatment, Golde established a cell line from Moore's T-lymphocytes, and in 1984, a patent was granted with Golde and Quan listed as the inventors of the cell line[11]. Based on these facts, Moore filed suit.
Although Moore filed thirteen causes of action against Golde, Quan, and the regents of the University of California, only two causes made their way to the California Supreme Court: conversion and breach of fiduciary duty/ lack of informed consent[12]. Of those two causes of action, only one was decided in Moore's favor, and that decision was regarding the breach of fiduciary duty[13]. The majority opinion said that due to the right of a person to decide whether or not to submit to medical treatment led to the following conclusions: “(1) a physician must disclose personal interests unrelated to the patient's health, whether research or economic, that may affect the physician's professional judgment; and (2) a physician's failure to disclose such interests may give rise to a cause of action for performing medical procedures without informed consent or breach of fiduciary duty.[14]” The court was concerned about the conflicting loyalties that a physician may have when placed in a position such as Golde's in seeking the patient's best interest or his own in such matters, and
[t]he possibility that an interest extraneous to the patient's health has affected the physician's judgment is something that a reasonable patient would want to know in deciding whether to consent to a proposed course of treatment. It is material to the patient's decisions and thus, a prerequisite to informed consent[15].
While in favor of Moore's first claim, the majority refused to recognize a property interest in the tissue taken from him for various reasons. The court started their examination of this claim with a quote from another case, saying that to “establish a conversion, plaintiff must establish an actual interference with his ownership or right of possession,” and when “plaintiff neither has title to the property alleged to have been converted, nor possession thereof, he cannot maintain an action for conversion.[16]” Reasoning that Moore did not intend to keep any of the cells used for research after they left his body, the only way he could maintain a claim for conversion would be if he retained any sort of property interest in the biological material. The court gave three reasons they did not believe he did: (1) no judicial decision supported such a claim, (2) California statutes limited any interest he may have and (3) that “the subject matters of the Regent's patent – the patented cell line and the products derived from it – cannot be Moore's property.[17]” Furthermore, the court went on to say that even if a Moore had a property interest in his biological material after it left his body, it would decline to extend liability in a situation such as this[18]. Again, three reasons were given for why they ruled in this manner, those reasons being that a balancing of policy considerations counseled against, such matters should be resolved through legislation and that conversion was not necessary to protect patients' rights[19]. With these holdings, the court sent Moore home to claim what injury he could that resulted from the lack of informed consent regarding his splenectomy.
While Moore was only a state case, it was a decision by the supreme court of that case, and in a state as prominent as California in an area of law so unfamiliar, it would make sense that other cases would follow and look to Moore for guidance in how to deal with legal matters regarding the ownership or lack thereof of tissue and other biological materials that ultimately ended up in the hands of researchers.
In the case of Greenberg v. Miami Children's Hospital, the facts were a little different, but some similar claims popped up. The case revolved around research into the genes responsible for Canavan disease. Greenberg, other individuals and organizations were working with Dr. Matalon to identify the genes that were responsible for this disease[20]. Tissue, blood samples, urine and financial support was given by the parties in order to work towards solving this medical mystery[21].
The research started in the late 1980s until a breakthrough in 1993 when Matalon and his research team finally discovered and isolated the gene responsible for Canavan disease[22]. In 1994, without informing the other parties involved, Matalon submitted a patent for the genetic sequence the team identified, which was issued in 1997[23]. Greenberg and the others did not discover the patent until 1998 when Miami Children's hospital let it be known that it intended to limit testing for Canavan disease through a restrictive licensing campaign[24]. Greenberg and the other plaintiffs alleged that at no time were they ever informed of the defendants intent to either patent or commercialize the results of the research[25].
Five claims were filed in federal district court against Matalon and Miami Children's Hospital, all to which they demurred[26]. The first claim the court dealt with was the claim for lack of informed consent. Trying to use the same argument that prevailed in Moore, Greenberg attempted to claim that since the commercial interests were not disclosed, there had not been informed consent[27]. The court first looked at the claim in general, saying that the state law was unclear regarding any duty of informed consent in this specific case[28]. The state law dealt with physicians treating patients and human subjects of experimentation, but did not cover a situation quite like the one the Greenbergs had found themselves in. Defendants conceded the point, saying that even if there was a duty to inform in this situation, it should not extent to require the revealing of economic interests[29]. The court agreed, saying that “a possible informed consent duty to disclosing economic interests has no support in established law, and more ominously, this requirement 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.[30]”
The next claim was for breach of fiduciary duty, which the court dealt with almost as quickly as they did the last. They found no such duty had been formed in the relationship between the plaintiffs and the defendants based on the exchanging of materials, stating that there was no acceptance of trust in order to satisfy the claim[31]. The other big claim that was made, and the only one that survived demurrer was the claim of unjust enrichment[32]. The one defense that the defendants put up was the fact that they held a patent over the material now, but the court held that such a defense “does not preclude the Defendants from being unjustly enriched.[33]” The fact that the plaintiffs had invested so much time and effort into what had begun as collaborative research and the additional fact that the defendants now benefited exclusively from that research was enough for the courts to deny the demurer.
The court kicked the complaint claiming unjust enrichment back to the defendants, instructing them to answer, but they never did. Miami Children's Hospital settled out of court with the plaintiffs and the case never went to trial. However, with the facts alleged and the Florida law regarding unjust enrichment, it is very probable that the court would ultimately have ruled in favor of the plaintiffs. With the rulings of cases based on the specific facts alleged, one can only imagine how many other situations might exist where an unjust enrichment claim would hold muster in court. It would undoubtedly have to be in another collaborative scenario where the plaintiff knew that s/he was conveying a benefit of some sort to the defendant. If this is true, a patient could never claim unjust enrichment against his/her physician in a situation like Moore's. While Moore has his own defense in the form of an additional informed consent requirement, we must remember that his case was decided in a state supreme court, so it is only binding in California. A federal case such as Greenberg's holds a little more weight, but only within the district or state which the law emerged from.
The other two cases that may have something to contribute to this conversation are the 2005 Tilousi v. Arizona State University case and the 2006 Washington University v. Catalona case. In Tilousi, members of the Havasupai Native Americans donated blood samples and hand prints for what they believed would be a study of diabetes within the tribe[34]. The allegation is that the samples given by the tribe to Arizona State for research were being used for other research, including schizophrenia and ancient human population migrations[35]. Tilousi and the other plaintiffs tried to allege breach of fiduciary duty and lack of informed consent; fraud and misrepresentation; negligent infliction of emotional distress against all the defendants; and intentional infliction of emotional distress against the specific researches with which the plaintiffs worked[36]. With the lack of informed consent count, Tilousi tried to claim the defendants falsely represented they would only research diabetes within the tribe with the samples given. The federal district court in this case attacked the core of Tilousi's argument, saying the “consent is not made ineffective even if defendants did make fraudulent representations to induce that consent.” The court drew this conclusion from a comment to the Restatement (Second) of Torts, § 18 cmt f[37]. To completely dismiss the breach of fiduciary duty count, the court went on to say there were no facts alleged to establish such a relationship between the plaintiffs and the defendants, citing Greenberg in its opinion[38]. The fraud count was dismissed as no statements were alleged which would establish a foundation for such a count, and the court quickly moved on to the IIED and NIED counts[39]. Interestingly enough, these two counts were the ones to survive the defendants' motion to dismiss. The court stated that the plaintiffs' complain may have alleged facts sufficient enough to constitute a claim for NIED “if plaintiffs can present evidence to establish long continued mental disturbance of the sort contemplated by the Restatement.[40]” Regarding the IIED claim, the court held that sufficient facts had been alleged, considering that the plaintiffs alleged to suffer “severe mental and emotional harm, suffering, fright, anguish, rage, shock, nervousness, anxiety, sleeplessness, unrest, depression, humiliation, loss of self esteem, and loss of dignity.[41]” The court denied the motion to dismiss only for these two counts[42].
Washington University v. Catalona is another federal district court case regarding the use of tissue and other biological research materials once they have left the body of the donor, but with a slightly different set of facts. Catalona was a urologist and researcher who was employed by Washington University when undertook the prostate cancer studies that are the subject of this dispute[43]. The other defendants of the case still were or had been patients of Catalona and had volunteered in one of these studies, signing informed consent documents and donating materials for the research[44]. In 2003, Catalona left Washington University and had intended to continue his research at his new university. However, Washington University ended up filing this declaratory judgment action before to court to determine that the biological materials were not property of the university, presumably in order to prevent Catalona from continuing his research elsewhere and retaining the benefit of his labor while he was still an employee.
In a rather lengthy opinion, the court ultimately decided that the biological materials donated by the other defendants were the property of Washington University, primarily on the basis of the informed consent documents that were signed prior to the beginning of research. Truthfully speaking, looking at the details of the case, it can all be resolved with the various contracts that were signed by either the participants in the studies or Catalona himself. The court pointed out that
[I]n all MTAs (Material Transfer Agreements) concerning these materials, including those wherein Dr. Caralona was the 'Provider's Scientist', WU (Washington University) clearly exerted its ownership interest without objection by Dr. Catalona. Even in the instance wherein Dr. Catalona attempted to change the language of a MTA to reflect 'co-ownership with WU, and WU refused to modify the language in the MTA, Dr. Catalona still signed.[45]
Citing Greenberg and Moore, the court affirmed that “research participants retain no ownership of biological materials they contribute for medical research” in order to put the final legal nail in the coffin regarding the defendants' claims for ownership regarding the biological materials.
So where do these four cases leave the landscape regarding the rights that a donor has after giving material, knowingly or otherwise? There are a few legal conclusions we can come to definitively, and I will try to sum them up succinctly. A physician must disclose his economic or research-based interests to his patient. A donor has no property interest in his biological material once it has left his body since he does not intend to retain ownership. A conversion action will fail due to inability to prove ownership on part of the plaintiff(s)[46]. An unjust enrichment action may be sustainable when dealing with a person patenting or otherwise benefiting from the research materials provided by another. A claim for infliction of emotional distress, negligent or intentional, may be sustainable provided that the proper facts are alleged. Last, but by no means list, contracts law plays a large portion in deciding who has ownership or who retains what rights, if any.
Stepping away from the case law that has been established in this underdeveloped area, laws and regulations do not contribute much more to the discussion. Starting at the top, there is 42 USC § 289 discusses the creation of Institutional Review Boards and how to manage ethics within “each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research involving human subjects.[47]” These Institutional Review Boards (IRBs) are to be established within the entities to review research and ensure that subject rights aren't being violated[48]. Of course, in typical manner of regulatory statutes and laws, there is no real explanation of how the IRBs are supposed to go about that process. The one tidbit of help that is given is within (b)(1), and that states that “The Secretary shall establish a program within the Department of Health and Human Services under which requests for clarification and guidance with respect to ethical issues raised in connection with biomedical or behavioral research involving human subjects are responded to promptly and appropriately.”
Thankfully, the Code of Federal Regulations does give a bit of an idea of what these IRBs are supposed to do, but the critical flaw in the CFRs is that they are not technically binding as law. However, Courts tend to consider them with as much weight since they are the clarifications of various areas of the law by the lawmakers themselves. CFR §46.116 covers the general requirements for informed consent, which most of the cases examined above seem to revolved around. This code lays out what the basic elements of informed consent are supposed to include. This list includes any reasonably foreseeable risk or discomfort; a statement of the purpose of the research; a statement that participation is voluntary and other details[49]. What is not included within this list is the requirement to notify the participant that there may be commercial interests at stake, nor that the biological material donated may be used for research purposes other than those stated within the informed consent form.
Furthermore, there are express conditions under which the aforementioned requirements can be waived, given that the IRB finds and documents certain things. One of the options is designed to cover research designed to examine public benefit of service programs and possible changes to those programs[50]. The other option allows for a consent procedure that can leave out or alter all of the requirements provided that the IRB determines that “(1) The research involves no more than minimal risk to the subjects; (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects; (3) The research could not practically be carried out without the waiver or alteration; and (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.[51]” Considering the fact that those who donate biological material are almost never at any risk themselves, the only substantial hurdle an entity would have to overcome for to meet this standard is to establish that the research could not be “practicably carried out” if the patients knew what it was for. Immediately, the Tilousi case comes to mind, considering the claims that the Native Americans made in reaction to the use of their samples for other research studies. With the holding in that case establishing that misrepresentation was not enough to destroy informed consent, one must wonder what kind of things can be slipped under the rug at the expense of the research participant because of this generous exception established by the CFR.
Now, on a state level, the informed consent requirements can vary and either be more generous or more apathetic towards the rights of the subjects (or patients or participants as the law dictates). I will take an example from New York, which I will return to later on in the paper for discussion regarding possible resolutions to this legal situation. The New York Civil Rights Law §79-1 governs the requirements for informed consent regarding genetic testing. There is an initial set of informed consent requirements for the testing, and then a second set of requirements should the researcher which to conduct tests outside the original scope. The first set notably includes those whom the results of the genetic testing may be disclosed and a statement that “no other tests shall be conducted, and sample will be destroyed after testing is complete, or at the end of 60 days unless longer has been expressly authorized.[52]” As pro-donor as that first informed consent statement is, the second is much more in favor of the researcher. That statement need only say that the sample is being kept for future genetic tests, and will be held for “as long as deemed useful for research purposes.” The participant is given the right to withdraw, as well as the option to be contacted in the future regarding the research, findings and other matters[53].
Looking at New York's attempt to deal with how to balance the interest of the donor with the interests of the researcher, we see that it is possible to create an informed consent requirement that more narrowly tailors the interest of the donor. However, we also see from both New York and federal regulation that informed consent can be so broad that it need not say much at all, or can even be misleading. So, returning to the original framework of the paper, how are we to balance the interests of these parties which seem to be at such odds with each other?
Juggling the Interests: Identifying and discussing the interests of researchers and donors
While this paper has mostly taken an antagonistic approach towards the interests of the researches and the donors, that by no means is always the case. Using the cases discussed, we'll look at the interests brought up within them so we are working from a real context. In Moore, the donor interest was a little hard to identify other than a general concept of control, which could be said to be the key issue that any donor is concerned with: control of the destination of his/her biological materials. There is no real telling what Moore wanted done with his various samples, but even the option of sheer destruction is still an option and falls under the idea of control. The University of California obviously had a commercial interest in the research, which was demonstrated by the quick patenting of the cell line which came from Moore's biological material.
The truth of the matter is that it is only natural for researchers to be interested in the commercial aspects of any invention or discovery because research must be funded. While there are donations, grants and private investments, there are also those that want to know just one thing: “what is in it for me?” For better or worse, money does push the world quite a bit in this area, and while some researchers are undoubtedly doing what they do out of the goodness of their hearts, not everyone has that luxury.
The issue of control is probably more clearly defined by the two other cases examined, starting with the Havasupai tribe. There were specific purposes towards which they were willing to give biological materials towards (i.e., the research of diabetes within the tribe). Control in this case would include the decision for what purpose one is donating biological material. Similarly, they were unwilling to give such materials for any purpose which the tribe considered to be harmful towards the tribe's dignity. A slightly lesser question of control could be to whom a donor is giving one's biological material, as was part of the issue within the Washington University case. The patients of Catalona wanted the material they had donated to remain with him, which is understandable since he was the physician and researcher with whom they were acquainted with. On a one level, it makes sense, since most people would feel more comfortable with a physician or a specialist with whom they had been working with for some time.
Within the same cases, we can see the researchers' interests at work. Arizona State University undoubtedly had a broad range of studies and research it was conducting, and the more samples that one can get one's hands on, the better. If there were enough samples for the university to conduct both studies of the Havasupai tribe and other matters, then why not make the best of the left over materials? And looking at the situation at Washington University, it would make sense for a university to protect what it undoubtedly considered an investment. Most universities receive donations and additional funding dependent upon previously successful and noteworthy research, so to ensure ownership of the material that made up that research would only be natural so that it would continue to perform work which may be unfinished, need improving or be lacking.
One common interest, which can be found in all of these cases, is the desire to reveal more about various diseases, whether it be the gene responsible for it or the treatment of it. The original collaboration within Greenberg is a perfect example of the shared goal between both donors and researchers. All parties involved were working towards identifying the gene which was the cause for Canavan disease. The fact that one party sought to patent it does not take away from the original shared intent and collaborative effort. It is this shared goal that seems to be the foundation for research in this area, be it genetic diseases, cancer or simply discovering how the human body and mind work.
Natalie Ram explores this issue in her paper Assigning Rights and Protecting Interests: Constructing Ethical and Efficient Legal Rights in Human Tissue Research, and outlines some additional interests at play in this dynamic, where she points out confidentiality concerns as an issue that tissue providers may have[54]. She points out some concerns we discussed in class, such as genetic information getting into the hands of insurance companies or employers, which could have dire consequences for the person with the wrong condition[55]. While she acknowledges that the Genetic Information Nondiscrimination Act is supposed to protect against these fears, Ram also points out that it is unclear exactly how this Act is supposed to function in a legal context[56]. Another concern she demonstrates is the fact that the genetic material not only identifies the individual donor, but to a certain extent it identifies close family members as well since immediately family shares a large portion of the same genetic information[57].
One interest of researchers and society which she points out that caught me off guard that I felt was certainly worth mentioning was that of cost of research as a whole[58]. If researchers had to pay for all the materials, or even a large portion of the materials that were necessary to do the research into various diseases and conditions, then society as a whole would ultimate pay the price for the increased cost for the consumers of whatever product resulted. Furthemore, Ram points out that when there are “fewer permissions to obtain, research can proceed more quickly and with less cost,” which would result in genes being identified sooner rather than later[59]. The sooner research can start, the sooner the researchers are on their way to reaching the goal they have established, which generally benefits society and humanity as a whole.
With so many interests at stake, and it impossible to say that any one outweighs that of another, is it possible to find a solution that will take all of these interests into consideration? Considering that there is no perfect law because there is no perfect lawmaker, the answer is obviously no, but such an observation should not stop us from seeking a more just and well-rounded approach that balances the interests of donors and researchers.
Balancing Act: Possible Solutions to Reconciling Donor and Researcher Interests
The first solution may be said to not be one at all, but that is to leave the legal field as it is and let things develop naturally, if they develop at all. In the Moore decision, the opinion stated that this issue was one yet unreviewed by the courts and that, “Moore's novel claim to own the biological materials at issue in this case is problematic, at best.[60]” While it was easy to deal with the rather well-established concepts of fiduciary duty and informed consent, the concept of owning one's biological material AFTER it was no longer attached was another matter. Arabian, in his concurrence, pointed out that there were “conflicting moral, philosophical and even religious values at stake.[61]” He preferred to leave such a decision to the Legislature to determine the questions of whether a man owned his genetic material after it left his body.
This decision had two dissents, both of which would have recognized a conversion claim in favor of Moore. The first, by Broussard, stated that if the allegations were true, “plaintiff's doctor improperly interfered with plaintiff's right to control the use of a body party by wrongfully withholding material information from him before its removal,” which under common law may have established a conversion action for Moore[62]. Rephrasing the inquiry, Broussand shaped the question as to “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.[63]” The other dissenting opinion was by Mosk, who spoke eloquently of the court's role in shaping law.
My point is that if the cause of action for conversion is otherwise an appropriate remedy on these facts, we should not refrain from fashioning it simply because another court has not yet so held or because the Legislature has not yet addressed the question. We need not wait on either even, because neither is a precondition to an exercise of our long-standing “power to insure the just and rational development of the common law in our state.[64]”
It is quite probably that some state court at some point may take it upon itself to start shaping state law into a position to favor a property interest in one's tissue or other body parts, much along the lines of which Broussand spoke. The only thing keeping a court from doing so is a desire to stay out of the law-making arena as a whole. However, it would have to be state law where such laws were shaped as federal laws can only reflect what state law already establishes. As property interest is a state law issue, federal laws will likely never decide on the issue unless it is being particularly activist.
One problem with waiting to see whether a common law property interest will form through court cases is obviously the lack of court cases. Whether due to sheer ignorance of what became of one's biological material or to the fact that the case was settle out of court, many questions in this area are still unanswered, such as those covering unjust enrichment and infliction of emotional distress which were brought up above.
Another problem with leaving things at the status quo is that the clearest way to negotiate around such interests seems to be contract law, and the bargaining power very much rests in the hands of the researchers and entities which create the informed consent documents. In his note, Kevin Overdorfer supported this observation and that “[b]ecause research institutions have greater bargaining power than individual tissue sources, an individual tissue source has limited ability to control the terms under which biomedical research is conducted.[65]” His suggestion is that individuals work through organizations in order to amass bargaining power and be able to play on the same proverbial field as the researchers. While he cites Greenberg as an example of a successful collaborative effort, there are still some concerns with this suggestion, as practical as it may seem.
Let's take Jane Doe. She discovers she has a condition that may be related to her genes. In the process of being treated, she is given the typical slew of paperwork to fill out, and the physician or nurse kindly highlighted the areas she needed to sign or initial before they could draw the first blood samples and proceed with discovering the source of this pesky problem. As a one-time average Joe, I can say that I rarely read most documents handed to me anywhere near as thoroughly as I do now that I am in law school. How likely is it that the average Doe bothers reading the fine print, let alone understands the true legal implications of any of the legal jargon. Worst of all, the informed consent form may be innocently attached to a waiver of property interest in any samples that may be taken for research purposes. If you can recall the wording used to describe a document you needed to sign before you knew any better, it usually put the legal text into the most general and benign statement possible. “Oh, this just says that it is ok if we use your samples/blood/etc. for research.” Most of the time, the thought that goes through the head of a person is “Why not?” or “Whatever, just let me get through the paperwork.”
Now, considering the fact that the sophistication of people in the area of technology and legal rights has undoubtedly grown over the years, perhaps there is a person who knows exactly what they want to do with that paperwork when presented with it. However, neither physician nor nurse will give our dear Jane an option. It's either sign the paper and let them do whatever research they desire and whatever they desire with the results or decline and begin treatment. When confronted with that moment in time, few are in the position to leave, go do research into finding an organization or even similarly situated individuals that may be willing to form together for the sake of bargaining, and then return to discuss this matter with the would-be researcher. As I stated, seems to be good in practice, or if there is already an organization in existence for your particular condition, but otherwise, you may well be on your own, with no bargaining power to speak of.
Considering the status quo leaves you with questionable results at best, the situation may warrant looking into changing the landscape in order to balance the interest a little more in favor of the donors. The two options I will discuss here are recognizing a property interest in favor of the donors and enhancing current informed consent requirements.
Creating a Property Interest
While a perfectly feasible idea, there would be some critical questions that one would have to ask in order to make sure that such an interest did not end up starting a slippery slope that ends up too much in favor of donors. As stated above, no interest is more important than the others, and the idea is to balance, not overthrow, the current state of affairs in this area. The most simplistic of such solutions would be to create federal law that would recognize such an interest. The first problem with doing so would be that the area of property rights has historically rested with the states, so those of a federalist mindset may rebel against such a notion. Furthermore, how the law was worded could be a cause for contention as well. It would not be the first time federal law had been too narrow or too broad or too vague for the taste of those who had to implement it. Such a solution could create as many problems as it solved.
The one suggested by Ram is worth discussing at some length, and that solution is the recognition of an informational property interest. She explains the concept of informational property as a recognition of “a limited right to control how the information contained within one's cells is used. […] Personal genetic information protected by a copyright-like informational property right would thus be unavailable for unauthorized use no matter how or from where it was obtained.[66]” With this property right, researchers would have to go through the source of the material that they wished to use. She suggests using a sort of licensing system in order to facilitate the negotiations between the researcher and the would-be donor and the theoretical availability of a fair use standard as well in terms of those areas of DNA that were common to all people[67]. Some of the obvious problems, even without going into further detail, are the fact that it would require more work, time and perhaps money on the part of the researchers. Another concern brought up by Ram herself would be the application of the fair use standard. Exactly how would one determine what sections of DNA were applicable, or would such a standard automatically make most tissue samples fair use[68]?
An ideal solution would not be followed by a slew of litigation attempting to make heads or tails of the various definitions within whatever right was newly vested. Aaron Carbone suggested another solution within the context of the unique informed consent law of New York. He examined the various issues and the legacy left by Moore and recommended amending the informed consent law to recognize “a property interest in his or her tissues and genetic information.[69]” Looking at past cases within New York legal history, he reasoned that “tissue fulfills the prima facie elements of property under New York common law, and New York courts have favorably supported providing such a property interest in other contexts.[70]” Although he only looks at this issue within the context of state law, would one have to stretch that far to get something similar within the Code of Federal Regulations? The critical factor is what could and what would the lawmakers consider in amending the CFR regarding informed consent to recognize such an interest.
The option I believe to be the least problematic overall would be establishing an enhanced form of informed consent, perhaps similar to what New York has created, but extending the coverage to research in general, rather than limiting it to just genetic testing. Oberdorfer mentioned a form of enhanced consent that would require greater levels of disclosure, which would take relatively little work on part of the legislatures, federal and state. Using the New York law as a model, instructing the potential donor about the potential uses of the material and a blanket notice of the possibility of commercial usage would allow a person to make a better formed decision regarding what decision to make regarding the future of his donation. Also, similarly to the New York law, should a research want to conduct further tests on the material in question, a second informed consent notice should be issued with similar standards. With the understanding that the interests must be balanced with the second notice, a time frame should be established in which the donor has to respond to the second informed consent. Giving the researcher the benefit of the doubt, silence would be presumed to be consent with the option to withdraw consent at any time. Such a shaping of informed consent law would better protect donors by providing them with a greater degree of information than previously established, but still allow researchers some leeway in pursuing additional research as well as their commercial interests.
While Greenberg expressed a concern about allowing the donors to dictate the direction of research, I do not honestly believe that it would amount to such a large concern as that. If people were given a property interest, then perhaps people would be more concerned with how much money they could make from their biological material. Simply enhancing informed consent would not give donors quite so large a leash on the researchers. If she disagrees with the potential commercialization of her biological material in some shape, then she need not consent to the research at all. To presume that everyone would be so concerned is to put everyone into the shoes of Moore, which is a large jump to make from a handful of cases. I believe that many people simply want to know in good faith what is happening with their donations more than want to cash in on whatever profit may be available. An enhanced form of informed consent could also be tailored to curb any latent interests, stating that a minimal compensation (if any at all) may be available at some point. In my opinion, the informed consent framework is more flexible and can more easily be tailored to meet the needs of the nation as a whole as it approaches a society that grows increasingly more legally complex in the areas of biotechnology.
Conclusion
As science expands to encompass more and more aspects of our lives, it will inherently intertwine with the law now and again, and the courts will have to decide what to do with each unique case as such come before its court. However, when the courts leave unsatisfactory or unbalanced answers, there may still be a sense of injustice with the way the legal field is shaping in that area. While not every injustice can be readily dealt with, I believe that when it is a simple matter of balancing interests, a greater sense of fairness can be established.
Researchers and society have a very valid interest in pursuing effective, low-cost research in order to deal with any myriad of issues that the human race has developed. The average donor does not necessarily want to impede in that research, but only wants to be able to have the chance to play the role that he elects for himself and not one that is forced upon him without his knowledge. To provide a more balanced method of informing donors of their rights and the final destination of their biological material may only matter to a few at the end of the day, but if such a change can make a greater sense of justice, then perhaps it is worth pursuing.
As examined above, the cases acknowledge stepping on new ground here, so there is a chance that there may be shifts as the courts wrestle with the various issues again and again. At the moment, there is little or no recourse for the person who gave for one purpose and discovered the gift was being used for another, or that a gift was being made at all. Courts have claimed to rule in favor of research and society, but there must be a way to better balance the rights of the donor, knowing or otherwise. This paper has merely given a brief look at the issue and made some humble suggestions for what is undoubtedly a legal landscape awaiting some form of change.
[2] Of course, his parents would be the people making the legal decisions in this matter, but for the sake of brevity and at the risk of getting too caught up with legalism this early on in the page, I acknowledge the discrepancy and move on.
[3] Moore v. Regents, 51 Cal. 3D 120, 125.
[4] Id.
[5] Id. at 126.
[6] Id.
[7] Id.
[8] Id.
[9] Id.
[10] Id.
[11] Id. at 127.
[12] Id. at 128.
[13] Id. at 129.
[14] Id.
[15] Id. at 130.
[16] Id. at 136,
[17] Id. at 137.
[18] Id. at 142.
[19] Id.
[20] Greenberg v. Miami Children's Hospital, 264 F. Supp 2d 1064, 1066.
[21] Id. at 1067.
[22] Id.
[23] Id.
[24] Id.
[25] Id.
[26] Id. at 1066.
[27] Id. at 1068.
[28] Id. at 1069
[29] Id. at 1070.
[30] Id.
[31] Id. at 1072.
[32] The other two claims were for fraudulent concealment and conversion. The former claim has little to do with the context of the paper, and so I will skip discussing it within the text of the paper. The conversion claim went much as the one in Moore, so I will also skip that for the sake of conserving text and needlessly summarizing matters that are irrelevant to the substance of the paper.
[33] Id.
[34] Tilousi v. Arizona State University, 2005 WL 6199562 (D.Ariz), 1.
[35] Id.
[36] Id. at 2-3.
[37] Id. at 2.
[38] Id.
[39] Id. at 3. Additional counts included conversion (4), civil rights violations (5), unreasonable disclosure of private facts and intrusion on seclusion (6). None of these claims survived, and the only one worth discussion in terms of this paper (conversion) adds nothing new to the conversation, and thus will be skipped over for the purposes of this paper.
[40] Id. at 4.
[41] Id.
[42] Considering the fact that this case was unpublished, I did some additional research on the internet to try to discover what had become of this case and whether the tribe won their claim against the university. What I was able to find through an online blog was that the case settled out of court April 2010, and Arizona State University agreed to pay the tribe $700,000 for their pain and suffering.
[43] Washington University v. Catlona, 437 F.Supp.2d 985, 989.
[44] Id.
[45] Id. at 995.
[46] At least in terms of dealing with the donor as the plaintiffs. If we were to take the facts of Washington v. Catalona, and Catalona decided to take the biological materials from WU anyway, then WU would have a conversion action against Catalona since WU can claim a property interest in those biological materials.
[47] 42 USC § 289(a). http://vlex.com/vid/institutional-boards-ethics-guidance-19246426
[48] Id.
[49] CFR § 46.116(a)(1)-(8). One thing worth mentioning is that the introductory text to the section specifically only discusses human subjects of research. For the sake of argument, we can include donor of biological materials to those due informed consent since it seems that the court do already. See Washington, 437 F.Supp.2d at 998.
[50] CFR §46.116(c)(1)
[51] CFR §46.116(d)(1)-(4)
[52] N.Y. Civ. Rights §79-1(2)(6), (8).
[53] N.Y. Civ. Rights §79-1(7)(1)-(5)(ii).
[54] Natalie Ram. Assigning Rights and Protecting Interests: Constructing Ethical and Efficient Legal Rights in Human Tissue Research. 23 Harv. J.L. & Tech. 119, 129-30.
[55] Id. at 130.
[56] Id.
[57] Id. at 132.
[58] Id. at 137.
[59] Id. at 138.
[60] Moore, 51 Cal.3d at 142.
[61] Id at 149.
[62] Id. at 151.
[63] Id. at 154.
[64] Id. at 163, quoting Rodriguez v. Bethlehem Steel Corp, 12 Cal.3d 382, 394.
[65] Kevin L.J. Oberdorfer. The Lessons of Greenberg: Informed Consent and the Protection of Tissue Sources' Research Interests. Note. 93 Geo. L.J. 365, 389.
[66] Assigning Rights, 23 Harv. J.L. & Tech. at 141-42.
[67] Id. at 146-54.
[68] Id. at 153-54.
[69] Aaron F. Carbone. What Do I Own, If Not Myself. Comments. 18 Alb. L.J. Sci. & Tech. 569, 581.
[70] Id at 591.
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