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JAMES F. CHILDRESS, PH.D.

James F. Childress, Ph.D.
Institute for Practical Ethics
with Julia Mahoney, J.D.
School of Law
University of Virginia
"Who Owns Human Tissue?"
March 28, 2001

James Childress: Now, human biological materials can be defined in various ways. And I would draw from the report of the National Bioethics Advisory Commission on research involving human biological materials, ethical issues and policy guidance. In this report, the term human biological materials is defined to encompass the full range of specimens from sub cellular structures such as DNA, to cells, tissues for example, blood, bone, muscle etc, organs, for example liver etc, gametes, embryos, fetal tissues, and waste for example hair, nail clippings and so forth. That is a wide range and the uses are many.

Storing human biological materials for medical and scientific purposes has been common for over a century. Archives range in size from a couple of hundred samples to over 90 million samples. One conservative estimate is that at least 282 million specimens from more than 176 million individual cases are stored in the United States. And the collections are growing at a rate of over 20 million cases per year.

Now, these specimens have come mainly from diagnostic and therapeutic interventions that involve the removal of disease tissue or other material to determine the nature and extent of disease and the effectiveness of treatments. They are routinely retained for future clinical purposes, sometimes for research purposes and sometimes even for legal purposes.

Now, the language concepts and moral norms that apply to the transfer and use of human biological materials are often contested. And they are contested in part because complex beliefs, symbols and ritual practices surround the human body, living and dead, and it’s various parts. Examples of problematic language include harvesting, salvaging, procurement and retrieval of tissue. Even the widely used term donor itself is often problematic. Not because it may only indicate the source of these human biological materials even though that person may never had consented to those materials being used and may have never had the capacity to consent. That is in this case, to donate.

The term ownership indicated in the title for today’s discussion may strike some as equally problematic. I mean, after all we might say, or someone might say, we don’t and can’t own our bodies and parts. And that challenge may be a way to argue against the transfer of human biological materials for money or for other goods. But, I would stress that even the donation of human tissue presupposes ownership, or if you prefer, dispositional authority. We can’t give away what we don’t own.

The language of ownership is one way to identify some modes of control, some rights over human tissue. For example, in determining access or transferring or in using, a philosopher Judith Jarvis Thompson says, "that ownership is a cluster of claims. No doubt it sounds odd," she says, "to say that people own their bodies. How could person X be thought to own something so intimate in relationship to X’s own body?" But, ownership, she says, " is really no more than a cluster of claims, privileges and powers. And if that cluster of rights that person X has in respect to his or her body or bodily parts or tissue, is sufficiently like the cluster of rights people have in respect to houses, typewriters and shoes, then there is no objection in theory…there might be one in practice…but no objection in theory to saying that X does own his or her body or parts, however odd it may sound to say so, however unaccustomed we may be to saying so."

Now there are several current modes of transfer or acquisition of human tissue. And all of these are used in our society for some access to human tissue for various purposes. We are most familiar with express consent or express donation especially in the context of transfer of organs and other tissues for transplantation. And this express donation or express consent by the individual…living individual for provision of tissue while alive or perhaps for provision after the individual’s death. Or express donation by others with authority to provide the tissue. Again, that is very common. It is taken as kind of model for the transfer of human tissue. But, it is not the only way that access is gained in our society.

We have presumed consent. Or presumed donation that operates in a variety of context where there is an absence of dissent. The tissue may have been deemed to have been effectively transferred. There are about a dozen states with presumed consent laws for the removal of corneas that fall when the body is under the auspices of the medical examiners office where an autopsy is mandated. And in those cases, there is no obligation on the part of the medical examiner removing the tissue to actually check with the family of the deceased individual. This is something like presumed consent or perhaps routine removal.

Another possibility would be expropriation. And we do have cases of access to human tissue in mandated autopsies for example or mandatory drug tests. It all involves that model of expropriation or conscription.

Abandonment is yet another possibility. There are some unclaimed body statutes for example, but in addition the claim is often been made that a person effectively transfers control over his or her biological materials by not claiming them when he or she left the hospital. The person abandoned those materials so the control falls in someone else’s hands. And that is common in the area of property discussions.

And then finally, the possibility from sales and purchases and we do have that in our society in relation to gametes, eggs, and sperm. And I will not say anymore about this one or some of the others but, Professor Mahoney and her remarks will look at the context of commerce in the US and help us think through the implications of that context for whether we should have something like sales or purchases. Or the provisional remuneration, to say it differently for those who offer tissue.

Now, we could go through these several possibilities and try to evaluate them in relation to the different human tissues that I mentioned where we are using more than one of these. We could ask which are ethically acceptable, which are ethically preferable, which are feasible, can we extend them from area to the other. But, what I emphasize is there is no single mode of transfer/acquisition of any access to human tissue in our society. And it may well be that no single mode is appropriate for all of human tissues. We may for example want to block exchanges of a certain kind.

As we try to think through, though, how we might evaluate different approaches, I would just refer for our purposes today to the Belmont Principles. The ones that appeared in the Belmont report, by the National Commission for the Protection of Human Subjects, a biomedical and behavioral research. A report that tried to sketch some principles that seem to be important throughout the range of research involving human subjects. Respect for persons including your autonomous choices. Beneficence including not harming others and no-malevolence and justice.

Now, clearly our interest in producing benefits which would fall under the heading of Beneficence, would certainly be one important reason for having considerable access to human tissue for purposes of developing biotechnologies, for purposes of developing and extending our knowledge in various areas such as research and genetics. We need considerable access to human tissue. That can be viewed as a driving force here. And yet, a principles for respect for persons including their autonomous choices and principles of justice serve to set certain constraints and limits on how we might go about obtaining the tissue and using the tissue.

Now, I would underline for purposes my presentation, that I think the beneficence point is critical. That we do need access to human tissue in order to be able to have the scientific and technological developments that we think are important for human health and the extension of human life. And yet, these other principles do set constraints. And in setting constraints, they may lead us in effect to think about the ownership that now is held by some other group…the group that has received the tissue for deposit as probably not ownership but probably something more like trusteeship or stewardship. That would be limited in part by the kinds of constraints that individual providers of the tissue may well have set on the uses of those tissue.

For example, the tissue may have been provided for a specific purpose, perhaps even for later diagnostic and therapeutic purposes. And the mere fact that an institution now possesses that tissue does not mean that institution has unfettered control over the tissue and may determine without any limits what may be done with the tissue because possession of tissue is not full ownership and control. Consent for the transfer of control, say for deposit, may not be consent for all uses.

So, a fundamental question that arises then is what kind of consent do we want from whom, for what. Now, the paradigm of voluntary and informed consent is one that we are familiar with especially in the area of research involving human subjects. But there are many other varieties of consent. It can be general or specific. It could be expressed or presumed as I already mentioned. Tacit or implicit, etc., etc.

And the consent can be given in the past or it may be given in the present, or we might anticipate future consent. And there are important variables: The degree of understanding, how informed must the consent be to be valid, and what degree of volunatriness must it have. Now, all those are important. The paradigm of consent in the context of research involving human subjects is that a voluntary, informed, express, specific consent. And one could add even further qualifiers.

But does that paradigm really operate in the area of research involving human biological materials? Should it operate in that area? Because if we are talking about tissues that have already been removed for example, for diagnostic or therapeutic purposes, then we are getting away from one part of the paradigm. Because the paradigm of voluntary, informed consent is one that focuses especially on invasive actions that are risky. So, we got rid of the invasion because the tissue is already been removed. But, risk may be associated with this even though the tissue has already been removed. There may be important psychosocial risks, for example, in the context of research on genetics. There may be a risk of breaches of privacy and confidentiality that could lead to ______ or could lead to discrimination in insurance and so forth.

So, they are important risks to consider. And the point I would want to raise then, again, is what are we going to say about the kind of consent we want for access to and use of human biological materials and research in biotechnology.

Now, I want to refer briefly to some of the recommendations of the National Bios Advisory Commission from it’s report on research involving human biological materials. And just note and we won’t be able to resolve this in the three or four minutes that remain, and then we will have professor Mahoney. But, here are some categories of human biological materials. In the repository collections, the specimens are unidentified but at the point of the provisional research samples, then you could have an unidentified sample, sometimes termed anonymous. And the terms are variable in this area so it is important to look beyond the language and to think more concretely about what is involved. Unidentified samples sometimes termed anonymous, they actually pose very few problems. Though, again, an individual may well have felt very strongly that his/her tissue not be used for example, in research in biological warfare. And that might be a reason for the person to oppose even the use of unidentified samples in that kind of research.

Unlinked samples are sometimes termed anonymized, they, like the identifiers are codes that could provide the link. The coded samples are referred to by others at times is linked to identifiable. There is a code rather than personally identifying information: a code that could potentially be broken. So there are some risks even at this point.

And then of course, identified samples are ones with much fuller personal information. Now, what we say ethically speaking about the kind of consent that should be involved will vary in part according to those different categories. But, in addition, we have to think in terms of samples and collections that already exists and those that we will collect in the future. And the policies and practices regarding these may well be different. Given the existing specimens and examples I mentioned, we may have to think through in a little different way than what we would for those we collect in the future, exactly how we will handle issues of consent. Since in the case of many of those that are stored, they are not alive, there may not be anyway to consult with them about their wishes and the like.

In addition the context in which materials are collected is obviously very, very important. And it is one thing to collect those things in the context that I have emphasized most today, and that is the clinical context where diagnostic and therapeutic procedures for that person are being undertaken. That is different from collecting material in a research context. And one of the concerns obviously is how we can move from the vast collection of materials that have been obtained for clinical purposes, through the use of those materials in research.

I am going to concentrate on what we might do for future samples. And our recommendations we argue very strongly that we should separate the consent from the research from the consent to clinical procedures. That separation, even in time, is important. Or at least in terms of different consent forms so that the patient and potential subject does not run the risk of confusing those. But then we also suggest and this is not uncontroversial even among the commissioners, that we have a kind of tiered consent in the collection, storage and use of biological materials in the future. That is looking forward. And that tiered consent will basically involved developing consent forms to provide potential subjects with a range of options. To help them understand clearly the nature of the decisions they are about to make. And we list several of those options now including: refusing the use, permitting only an unidentified or unlinked use, permitting coding or identified use for one particular study, permitting it for one particular study but with permission to re-contact for future studies, permitting them for any study relating to the original study, permitting it for any kind of future study.

There is an asterisks at the bottom and it is there because some commissioners dissented from the last couple of these feeling that you really need something closer to specific, informed consent when you are talking about this sort of research. I would just close by saying that there is a lot of debate about how we should use twin pillars of protection of research subjects in this area. The extent to which those twin pillars are important here, those pillars being institutional review board or human investigation committee examination and informed consent. And I have focused especially on the question of what kind of consent we need before we can gain access to and use these biological materials.

I will just close by quoting one of the premises in our report: "Research use of human biological materials is essential to the advancement of science and human health. Therefore, it is crucial that there be permissible and clearly defined conditions under which such materials may be used."

Thank you very much.

Julia Mahoney: Good afternoon, I am Julia Mahoney and I am associate professor of Law here at the University of Virginia. My areas of expertise are property, the legal regulation of markets in human biological materials as well as business firms, both for profit and non-profit.

I am here today to talk about the ownership of human biological materials with particular emphasis on the commercialization of such materials. Now, as you know, this is a subject that generates a huge amount of impassion debate, as you are aware in the areas of transplantable organs and blood products. There has already been a lot of talk about whether or not we should have markets allocate such issue. And the growing number of uses for human tissues ensures that these debates over commercialization are not going to end any time soon.

Now, as you know, human tissue and the products made from human tissue, or derived from human tissue is valuable. And when I say it is valuable, I mean not only in an economic sense. I am also of course referring to a non-economic sense. No one in this room, I imagine, thinks that the world value pertains only to the economic. No one, I think, believes that the economic value of a piece of human tissue even comes close to capturing all the ways in which that tissue is valuable to us.

Nevertheless, when things are valuable from an economic perspective that means that there is not enough to go around. Because, by definition, if there is an infinite supply of a resource and everyone who is interested in gaining control of or access to that resource can get as much as she wants, then there is no reason for the resource to have economic value. Economic value only comes into play when there is discussion about who is going to have rights to possess the material and to exclude the material.

So, the question rises once you have human biological materials that are scarce and valuable, how are the rights to these materials going to be allocated. Whenever any resource has economic value then individuals and institutions have incentives to attempt to gain and to retain possession of that resource and to exercise control over that resource.

Now, as professor Childress pointed out, even if there is no commercial activity the concept of ownership is very, very important because the concept of ownership refers to this cluster of rights that people might exercise over a resource. Even if you cannot sell something, you are none the less interested in possessing it and excluding others from it. So, ownership predates, and is in fact a necessary precondition of having markets.

But once we determine who has ownership of a kind of human biological material, or sometimes because ownership can be split…it is not necessarily an all or nothing proposition…we figure out which institutions or individuals have the ownership rights. We then encounter another whole set of difficult issues. And those issues relate to how the material is going to be transferred because, as you know, people like to exchange things. They like to buy things. They like to sell things. They like to give things away.

Just because someone is the owner of a resource, does not mean that that resource should remain in the possession of that owner. Often that resource will be much better off in the hands of someone else. Tissue, for example, held by patients is often better off in the hands of a qualified medical researcher who can build an immortal cell line or develop a life saving or health saving technology from it.

Now, the usual way that we go about transferring resources in our culture is of course through purchases and sales. That is not of course, I hasten to say, to imply that donation is not extremely important. I am not, repeat, not here to suggest that every transference of valuable human biological materials ought to be a purchase or a sale. That all these transfers ought to be accomplished through the market.

Nevertheless, I do want to emphasize that the usual way that we transfer resources in our society is through the market. And there are very good reasons for this. But the idea of markets in human biological materials generates horror and disgust. Surely parts of people or products made from parts of people shouldn’t be bought and sold. A lot of detractors of markets have argued. Markets in human tissue remind us of slavery. They suggest to many that the human biological materials that are the subject of the market transaction have no value other than the price they can fetch. If you can sell your kidney for $20,000.00 isn’t that the same thing as saying your kidney is only worth $20,000.00. That it has no value aside from the $20,000.00. Or so some have said.

And finally many argue that allowing markets in human tissue can reduce the amount of altruism in our society. That is if the financial compensation is available, then people will want to take the money. They won’t want to engage in donations. Which we think makes our society a better place.

This reflects of horror at the idea of markets in human tissue has spurred an enormous amount of discussion about how to keep the human body out of the market domain. For example, the final chapter of the Lori Andrews and the Dorothy Nelkin book listed in your bibliography on the handout for today is entitled, "Sequestering the body from the market" and talks about the ways in which the body can be protected from the market. You have all read numerous editorials that denounce proposals to pay the sources of transplantable organs on the grounds that such payments would bring organs into the realm of commerce. And of course, there are a growing number of web sites which question whether the United States or other governments should permit developers of products based on human genes to obtain patents with the argument being that granting such patents amounts to commercialization of the human body which is thought to be a bad thing.

The trouble with all these arguments, though, is that sequestering the body from the market is likely to have devastating effects. Because it is almost impossible to imagine transferring human biological materials without the market. Even where the market is not explicitly acknowledged, the market exists. Transplant patients pay for a package of transplant services and a transplantable organ. Sure it is often said that they pay only for the services, not for the organ. But I ask you, who is willing to pay only for services. This is, I assure you, a market. Human organs are in the market.

The same is used for tissue in biotechnology. We might think that we have protected human tissue from the market because for example biotechnology companies don’t pay for a lot of the human tissue samples that they use. But of course, biotechnology companies are by definition, in business to make money. They wish to be compensated for the products they develop using human tissue.

I would argue that there is nothing wrong with this. Where difficulties begin, I would argue is when people are confused about who is profit seeking and who is generous. When I began my research on my University of Virginia Law Review Article on markets and human tissue, I was expecting to find supporters of taking human tissue out of the market. I thought I would be writing an article about supporters of markets in human tissue and opponents of markets in human tissue. But, the more deeply I got into my research, the more clear it became to me that there is no group of supporters that advocates removing human biological materials from the market completely.

There is no group out there that wants to de-commercialize human tissue. The result of this is, at least I would say, that the debate over whether human tissue should be commercialized has pretty much ended. Human tissue is commercialized. That is not, I hasten to say, to imply that every transfer of valuable human tissue should be a market transaction. It is not to say that donation will not continue to play an important role. Or that abandonment or even perhaps expropriation won’t figure in the collections of human tissue.

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