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
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.
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.
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.
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 its
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.
term ownership indicated in the title for todays discussion
may strike some as equally problematic. I mean, after all we might
say, or someone might say, we dont and cant 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 cant give away what we dont own.
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 Xs 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
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."
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
individual for provision of tissue while alive or perhaps for provision
after the individuals 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.
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
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.
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
elses hands. And that is common in the area of property discussions.
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.
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.
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
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
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
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.
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.
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,
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.
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.
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.
I want to refer briefly to some of the recommendations of the National
Bios Advisory Commission from its report on research involving
human biological materials. And just note and we wont 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.
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.
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.
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
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.
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
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."
you very much.
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.
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.
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
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.
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.
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.
once we determine who has ownership of a kind of human biological
material, or sometimes because ownership can be split
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.
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.
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
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 shouldnt 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
isnt 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.
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 wont want to engage in donations. Which we think makes
our society a better place.
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.
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.
same is used for tissue in biotechnology. We might think that we
have protected human tissue from the market because for example
biotechnology companies dont 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.
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.
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
wont figure in the collections of human tissue.
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