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An Ethical Framework For Biological Samples Policy (Commissioned Paper)

Author(s): Buchanan, Allen

NOTE: The following paper is one of several commissioned papers in the Report on Research Involving Human Biological Materials. The full report is not yet available on the Online Ethics Center. A pdf of the report can be found on the Georgetown site: Connect to National Bioethics Advisory Commission Publications

I. Introduction
II. Interests That Weigh in Favor of Restricted Access and Substantial Control by the Source of the Sample
III. Interests That Weigh in Favor of Fewer Restrictions on Access and Less Sample Source Control
IV. The Limitations of Informed Consent
V. Policy Implications
VI. Summary of Main Conclusions
Notes

I. Introduction

The scale of the practice

Upwards of 290 million human biological samples are currently stored in the United States, chiefly in pathology archives, blood banks, researchers' collections, and state public health department newborn screening facilities.1 Some have been stored for decades, millions more will be gathered and stored in the next year, and tens of millions more in the next decade.2 Samples include blood, bloodspots on laboratory paper, saliva, and tissue from virtually every part of the human body. The individuals who are the sources of the samples are identifiable in some cases, not in others. Some samples were gathered during procedures (such as surgery) in which some form of informed consent was attained, some were not. Even where there was informed consent for the procedure that produced the sample, often there was no informed consent to the storage of the sample, nor to some or any possible future uses of it after storage. In many, perhaps most cases, individuals had no idea that their sample was being stored, nor any inkling that it might be used for a variety of research purposes, by a variety of individuals.

For example, since 1970 blood has been taken from almost all persons born in hospitals in the United States to prepare bloodspots for purposes of screening for genetic disorders. In some states, public health departments keep these bloodspots indefinitely, in others they are discarded after five years. There is no uniform policy covering all states. Most individuals do not know that these samples were taken or that they are kept after screening is done or that they could be used for an indefinite number of purposes in the future, including a complete characterization of the individual's genome.

Special concerns about genetic analysis

Not just bloodspots, but any sample containing cells from any part of the body can be subjected to genetic analysis. This is because every nucleus of every cell of the body contains the complete genetic code of the person from whom the sample was taken. It is in part because of the seemingly limitless uses of genetic analysis and the concerns that some possible uses evoke,that currently there is much interest in the ethical aspects of the practice of gathering and storing human biological samples that may be used for research.

The most obvious and tangible risk is that of insurance or employment discrimination on genetic grounds. There is also the risk of stigma or of adverse psychological reactions to information which the sample contains, given the special significance which genetic disorders has for some people. Nevertheless, as we shall see, the ethical issues raised by the practice of collecting biological samples do not depend, for the most part, on the possibility of genetic analysis, even if concern about "genetic privacy" may have fueled much of the current interest in the subject.

Framing the ethical issues

It is tempting to frame the complex set of issues involving biological samples as a simple conflict between the value of scientific research, on the one hand, and the rights to privacy and confidentiality, on the other. This way of formulating the issues is, however, quite unilluminating. The problem with this formulation is not simply that virtually all parties to the discussion acknowledge both the value of scientific research and the importance of privacy and confidentiality. More importantly, this simple formulation starts where ethical analysis should end, with the invocation of rights to privacy and confidentiality.

Formulating the issues initially in terms of rights is unfortunate in two respects. First, rights-language has a rather unyielding quality. There is a tendency to assume that if someone has a right to something, then that is the end of the matter. More specifically, there is a tendency to regard a clash between a mere value (such as scientific progress) and a right as an unequal one, whose resolution in favor of the right is clear and uncontroversial. Second, from the standpoint of ethical analysis, statements about what rights people have are better regarded as conclusions of complex strands of moral argument, rather than as starting points. It is necessary to dig beneath slogans about rights to privacy and confidentiality (or rights of individual autonomy) to unearth the morally legitimate interests that rights serve to protect.

Once a statement about what rights people have is properly supported by showing the importance of the interests the right protects, then that statement can be used to derive further moral conclusions. For example, if an individual has a right to confidentiality, then it follows that substantial protections ought to be provided to limit the access of other persons to information about that individual, and from this it follows in turn that the mere fact that allowing others access to that information would contribute to some social good does not itself establish that they should have access. Before these implications of the statement that the individual has a right to confidentiality can be drawn, however, it is necessary to establish that he has the right. In that sense, rights-statements are conclusory even though, once established, they can serve as premises from which further moral conclusions can be drawn.

Privacy and confidentiality are sometimes characterized as follows: privacy consists of appropriate limitations on access to the person as a physical being, especially to exposures of the body that are considered to be embarrassing or demeaning; confidentiality consists of appropriate limitations on access to information about a person. In order to ascertain what the appropriate limits are in both cases and hence what the contours of the rights to privacy and confidentiality are, it is necessary to articulate the various legitimate interests that are threatened by exposures of the body and by the dissemination of information about persons.

Rights as protectors of morally important interests

Even a sketch of a full-blown theory of moral rights is beyond the scope of the paper. Nevertheless, it is necessary to say something to elaborate the suggestion that we think of rights as protectors of morally legitimate interests. More specifically, rights-statements are assertions that certain interests are of such importance from a moral point of view that they deserve especially strong protections. The implication is that the interests in question are of such moral weight that they ought to be protected even if this means overriding what are otherwise typically taken to be powerful reasons for action.

Thus, even if the fact that doing something would maximize social utility is generally a very good reason for doing it, some interests are so important that they should be treated as being immune from calculations of utility. For example, when we say that there is a right to free speech, part of what we mean is that people should be allowed to express their views even if repressing them could be shown to produce more utility overall.

Notice that a rights-statement as it stands makes an assertion of what the moral priorities are but does not itself back up that assertion. Rights-statements by themselves, being conclusions of moral arguments rather than arguments, at best only indicate, in a rough way, what the interests are that deserve special protections. Thus, a statement that there is a right to free speech implies that by protecting speech certain morally important interests will be protected, but much more will need to be said both to make the import of the rights-statement clear (to show when speech should be protected and when it should not) and to give us some reason to accept the assertion it makes.

To clarify and justify a rights-statement, two things are needed: first, to identify the relevant interests, and second, to show why they are of such moral importance that they deserve the especially strong protections rights provide. In simplest terms, doing the latter means demonstrating that the interests in question play a significant role in determining whether individuals are able to flourish?o live the sort of lives that are appropriate for persons.

Once we dig beneath rights-talk to the morally important interests that rights protect, we are in a better position to appreciate that the ethical issues concerning biological samples are a matter of balancing interests. This crucial fact is obscured if we begin with talk about rights to privacy and confidentiality (or rights to freedom of scientific inquiry, for that matter), because assertions about rights presuppose that the proper balancing of interests has already been achieved.

Once it is understood that rights serve to protect interests, rights-talk becomes less mystifying. Rights no longer seem to be ghostly, abstract entities (things that go "ought" in the night). Instead, rights-talk is seen to be shorthand for assertions about what the moral priorities are, assertions grounded ultimately in the conditions of human flourishing.

This is not to say that there is no such thing as a right to privacy or to confidentiality. There are legal rights that go by these names. And we may even say that there are moral rights to privacy and confidentiality at the outset of the analysis, so long as we admit that this tells us very little, except that there is a presumption that certain interests ought to receive special protections through safeguarding privacy and confidentiality and that whatever the proper balance of conflicting interests turns out to be it must reflect this presumption. Invoking rights to privacy and confidentiality tells us nothing about the proper scope and limits of those protections, just as talk of a right to freedom of expression itself tells us nothing about the scope and limits of that right.

In order to determine the proper scope and limits of the right to freedom of expression, we must articulate and evaluate those interests that are at stake when expression is limited. These include, preeminently, the interest in being able to criticize government and thus hold it accountable, and the interest in moving closer to the truth through the free exchange of ideas. Similarly, we must determine what interests are served by the preservation of privacy and confidentiality.

For these reasons, the strategy of this paper will be to begin the analysis by cataloguing the members of two sets of interests that can come into conflict: those that weigh in favor of restricting access to biological samples (and hence to the information they contain) and in favor of giving the source of the sample more control over what is done with the sample, on the one hand, and those that weigh in favor of wider access to the sample, even though this means less control over its uses by the source. At the end of the analysis we may conclude that individuals from whom samples are taken have a moral right to privacy and confidentiality concerning those samples, but this will only be shorthand for a much more complicated ethical conclusion about how these two sets of interests ought to be balanced. If the analysis is successful, we will be in a better position, however, to engage in a reasoned debate to determine what the contours of the legal rights to confidentiality and privacy ought to be in this area.

After cataloguing the various interests on both sides of the ledger, we can then try to ascertain the adequacy of the requirement of informed consent as a means of achieving an appropriate balance of these interests. One conclusion that will emerge is that it is a profound mistake to proceed as if some version of an informed consent requirement by itself can provide protection for all the legitimate interests at stake in the practice of gathering and using biological samples. Instead, what is needed is an institutional division of labor in which informed consent plays an important but limited role. Furthermore, I will argue that attempting to safeguard against all possible harms to those who provide samples by an elaborate informed consent requirement is not only doomed to failure but would also be unconscionably costly and an excessive constraint on scientific research.

Interests, well-being, and harms

Before cataloguing the conflicting interests, we must be clear about what we mean by an interest. Put most simply, an interest is an ingredient in someone's well-being. If your interest is advanced, then, other things being equal, your are better off; if your interest suffers a setback, then, to that extent you are worse off.3 Peoples' interests vary widely, but there are some interests that are basic to us all. The doctrine of human rights can best be understood as an attempt to identify these fundamental universal interests and to proclaim that they deserve the most stringent protections.

We can also distinguish between welfare interests and ulterior interests.4 Welfare interests include access to food and shelter, as well as physical security, liberty of action, and access to information. Ulterior interests include the various ends that individuals give high priority to as they arrange their lives, choose an occupation, and plan for the future. Welfare interests are a very important ingredient in a person's flourishing, because if they are not secured she will not be able to pursue her ulterior ends. Nevertheless, once a person's welfare interests are secured, the pursuit of ulterior ends becomes not only possible, but extremely important to that person. Later we will see that the distinction between welfare interests and ulterior interests helps illuminate the full range of interests at stake in choosing a policy for regulating the gathering and uses of biological samples.

Given this understanding of what an interest is, a harm can be defined as a setback to an interest.5 Typically, when rights-statements are made, what those who make them are most keenly conscious of is the potential for harm if the right in question is not acknowledged and respected. Hence we will focus chiefly on the possible harms that persons can suffer if others gain information from their biological samples or use those samples in various ways. In doing so, we will bring to the fore the important moral concerns that lie behind the notions of privacy and confidentiality.

Biological sample information

Gathering information about an individual through the taking of a medical history or by interpreting the inscriptions on an electrocardiogram may have a different significance for the individual or others than biopsying a piece of tissue or drawing blood. But from the standpoint of many of the interests at stake in the way biological samples are used, what is most import is the information the sample can yield, not the physical embodiment of the information.

As technology advances, automated analysis of samples (for genetic and other information) may reduce significantly the need to store samples. Nevertheless, as we shall see, most of the ethical issues would remain, because they involve the uses of the information derived from the samples, not the sample itself. For this reason, I will use the term biological sample information to cover both the sample itself and the information that can be extracted from it, noting that once the sample has been taken, in most cases it is the information that matters.

II. Interests That Weigh in Favor of Restricted Access and Substantial Control by the Source of the Sample

Avoiding insurance and employment discrimination6

The potential harm of insurance and employment discrimination has already been mentioned above. It is worth noting that there is an unfortunate tendency in the media, and even sometimes in the bioethical literature, to suggest that it is only genetic information that carries the risk of discrimination. This is not the case. Persons known to have health problems are vulnerable to discrimination, regardless of whether they have genetic disorders or genetic susceptibilities to disease. Being listed in a tumor registry or replying truthfully to questions about one's family medical history may be just as risky as having a positive test for a genetic disorder in one's medical records.

The actual extent of insurance and employment discrimination on genetic grounds is a matter of speculation, because most of the evidence comes from surveys in which individuals say whether they believe they have suffered discrimination, with little or no independent check on the accuracy of their perceptions.7 Moreover, the risk exists only for insurance policies whose issuance is conditional on medical underwriting, and most Americans who have private health insurance get it through large group policies in which there is no medical underwriting. Nevertheless, it is clear that insurance and employment discrimination do occur and that when they occur the results can be devastating for the individual.

It is also important to emphasize that the risk of discrimination is not an inevitable effect of the existence of information about illness or susceptibility. It is an artifact of a particular institution, namely, a private insurance market in which most medical insurance is employment-based and in which private insurers compete in part by attempting to avoid insuring costly (and therefore sick) individuals. If this institution were abolished or modified in certain ways so as to reduce the risk of discrimination, then to that extent the weight of the interest in avoiding discrimination would diminish and with it the case for restricting access to biological sample information in order to protect the interest in avoiding discrimination. (It is also important to emphasize, however, that discrimination in life insurance and disability insurance occurs in other countries that do not rely on private insurance for health care as heavily as the United States does.)

From this it follows that the specific contours of the rights to privacy and confidentiality or of other safeguards against insurance and employment discrimination cannot be ascertained once and for all, independently of institutional context. In a society like ours, in which there is a powerful institution that poses a significant threat of discrimination, greater restrictions on access to biological sample information will be needed, other things being equal, than in a society in which different institutions for financing health care eliminate the possibility of discrimination. If federal and state laws prohibiting insurance and employment discrimination are passed and effectively implemented, the balance between interests that weigh in favor of more restricted access and greater source control and those that weigh in favor of freer access and more permissive uses of biological samples will shift accordingly.8 Whatever policy is now developed must be subject to revision in the future.

Avoiding stigmatization

Even if an individual is not denied insurance or employment, he may suffer the harm of stigmatization. Although there is an unfortunate tendency to focus only on the stigmatization that results from being identified as having a genetic disorder, other types of illness can be equally or even more stigmatizing (e.g., sexually transmitted diseases, disfiguring diseases, and cancer, at least until very recently).

Stigmatization is closely related to discrimination; indeed it can be argued that it is a species of discrimination. Like stigmatization, it is a form of exclusion by labeling. In the case of stigmatization, however, there is usually at least an intimation of unwholesomeness, blame, or taint (as in the archetypal stigmatum, the Biblical "mark of Cain"). Some, but not all, forms of discrimination include this feature.

Perhaps the most familiar type of stigmatization is that which is imposed upon an individual from without, by the judgments and perceptions of other individuals. However, we may also speak of self-stigmatization. In part because individuals are so often deeply influenced by the attitudes of their fellows, they may internalize stigmatization.

We have already seen that the weight that should be accorded to the interest in avoiding insurance or employment discrimination varies with the magnitude of the risk and hence with the institutional arrangements that either magnify or diminish that risk. Similarly, the weight that should be accorded to the interest in avoiding stigmatization varies with cultural attitudes toward disease. For instance, to the extent that the public becomes better educated about the nature (and universal prevalence) of genetic susceptibility to disease, the risk of stigmatization on genetic grounds may diminish. And as with insurance and employment discrimination, the actual risk of stigmatization associated with various types of information contained in biological samples, as opposed to the mere possibility that stigmatization, is unknown.

Avoiding ascriptive (group identity-based) harms

Closely related to discrimination and stigmatization is another potential harm that individuals may suffer because of perceived links between medical information about them contained in a biological sample and what may be called their ascriptive (or group-based) identity. A concrete example will make this concept clearer.

African Americans typically suffer certain harms because they are identified as African Americans: others often perceive African American individuals through the distorted lens of negative racial stereotypes. The harm of negative racial stereotyping is a harm to individuals, but it befalls individuals because of their ascriptive group identity. The term ascriptive here indicates that the identity in question is assigned by others, independently of the choice of the individual thus identified.

Individuals who are vulnerable to ascriptive identity harms have a special interest in avoiding situations in which information obtainable from their biological samples may contribute to the reinforcement of harmful group stereotypes, not only because they themselves may be harmed but also because they may wish to avoid harm to other members of their ascriptive group. For instance, genetic information gleaned from biological samples might be used in research on the role of genotype in criminal behavior or in intelligence. In the past, such research has sometimes both embodied and been taken to validate negative racial stereotypes.

Avoiding familial conflict

In some instances, biological sample information, like other medical information, may be a source of intrafamilial conflict. For example, genetic analysis of a blood sample may reveal that the husband is not the father of a child. Or, in some cultures, if a family finds out that the prospective spouse of one of their members has a genetic disorder, they may attempt to prevent the marriage from taking place. Regardless of whether the beliefs on which they are based are rooted in mistaken views about genetics or indefensible assumptions about responsibility for disease, the conflicts they can generate and the resulting harms are quite real.

Avoiding uses of biological samples that the source regards as impermissible per se

So far, we have concentrated on the harms that certain uses of the information that can be extracted from biological samples can produce or to which they can contribute. Individuals can also have an interest in the uses of the sample. For example, for religious or other reasons, some people may believe that DNA from samples should not be used for producing human beings by cloning because they believe that human cloning is wrong per se; or they may simply not want their DNA to be used for this purpose.

There are three factors that make it difficult to know how much weight this interest ought to be given in designing an ethically sound and feasible system for regulating practices concerning the uses of biological samples. First, at present no one knows the full range of possible uses for biological samples in the future; all we know is that molecular biology and genetic technology are evolving very rapidly and that there will be an expanding range of possibilities, including opportunities for manipulating genes. Consequently, we cannot now ascertain how likely it is that at some point in the future someone's biological sample might be used in ways that he would find inherently wrong. Moreover, our uncertainty here is not just a function of our ignorance of the technical possibilities; we also do not know how effectively or in what ways future cultural attitudes and regulations (e.g., concerning experiments on human subjects) will constrain possible uses of biological samples, independently of any control that might be exercised by the individual who is the source of the sample.

Second, in some cases, individuals' fears about how their tissue might be used in the future may be based on grossly mistaken assumptions. For example, at least part of the negative response to the possibilities of producing humans by cloning seems to be based on the fallacy of genetic reductionism (the false assumption that a genetic identity is personal identity). Of course, respect for autonomy may argue for giving some weight to an individual's preferences even when they are based on patently false beliefs, but nonetheless, the fact that a preference is based on patently false beliefs should surely reduce its moral weight, other things being equal. In other words, people can be mistaken about what is in their interest, and the strongest ground for devising constraints on the use of stored tissue is that this is needed to protect important interests, not to indulge individuals' clearly mistaken perceptions about their interests. In some cases, an individual's preference that his biological sample not be used for certain purposes may not be based on false factual assumptions and may reflect stable values and commitments. Here the individual does have an interest in avoiding such uses of his biological sample.

This brings us to the third obstacle to ascertaining the weight of the interest in avoiding certain uses of one's stored biological sample: the fact that many people are uncertain not only about what uses will become possible in the future, but also about what their own evaluations of those uses will be. These future evaluations cannot now be predicted with any reliability for two reasons. First, they will be "path-dependent" shaped by our evolving reactions to a particular series of technological innovations developing over time and we cannot predict the series of technological developments. Second, our evaluations of technological options in the future will depend in part upon the social context in which the technology would be deployed, but we cannot now know what that social context will be.

What does seem likely is that in some cases what we would now regard as wrong or at least problematic we may regard as acceptable in the future, when society has changed and we have changed with it. Thus, 20 years ago many people had negative or ambivalent attitudes toward the first "test-tube baby," but now in vitro fertilization and a number of other subsequent reproductive technologies are not regarded as ethically problematic by many people.

Concerns about profits, distributive justice, and "commercialization"

We come now to a cluster of interests, some of which weigh in favor of restricting access to or uses of biological sample information, and others which concern the distribution of the financial gains that may be produced through the uses of samples.

Some individuals and groups have sought to share in the profits that are generated by patentable biologic inventions in whose development the use of their biological samples played a role. Perhaps the most famous case is that of John Moore, who claimed ownership of a cell line that was developed from tissue from his spleen.9 The California Supreme Court rejected Moore's claim of ownership and hence any claim to a portion of the profits derived from uses of the cell line, but it did affirm that the physicians who used his spleen tissue to the develop the cell line had a duty to disclose this to him.

The two parts of the ruling mark an important distinction between two questions: The first is whether the individual is entitled to some or all of the profits gained from a product in whose development her biological sample played a role. The second is whether the individual is entitled to disclosure of the fact that her biological sample may be used to develop a profitable item and whether she is allowed to refuse to allow such uses. These questions implicate two distinct interests: the financial interest in profiting from the use of one's sample and the interest in determining whether one's tissue is used in a profit-generating endeavor. Though less tangible than the financial interest, the second interest may be extremely important for some individuals, for it may be rooted in their most fundamental values about distributive justice.

Strictly on economic grounds, there may be a case for not having a property rights system that gives individuals like Moore a legal right to a share of the profits of whatever products are developed from processes in which their samples played some role. For one thing, most of the products developed from biological samples are not uniquely dependent upon the particular sample from which they are developed. (What was needed were human spleen cells from a person with a certain type of cancer, not necessarily Moore's spleen cells.) And given the well-known relationship between supply and demand, this means that in most cases no particular individual's biological material will be valuable enough to generate a claim to a significant share of the profits and to justify the special property laws that would be needed to secure that claim.

However, there may be some cases where something profitable can be developed only through the use of a rather rare genetic mutation. (For example, it has been reported that there is a family in Northern Italy that has a mutation that protects against atherosclerosis, an "anti-cholesterol gene." Or, if it turns out that a small minority of the population has a natural immunity to HIV infection, this characteristic might be extremely valuable for the development of an HIV vaccine.) Whether or not it would be desirable to recognize a legal property right in such cases will depend upon the proper balancing of a complex array of factors and above all upon whether there is good reason to believe that individuals with extremely valuable genes will lack sufficient incentive to allow them to be used for producing significant benefits for large numbers of people without the sort of financial reward which such a property right would confer.

At this point it might be objected that it is misleading to talk only of the interest that individuals have in a share of the profits derived from uses of their biological samples and of whether this interest should be recognized by a legal property right. Individuals have not only an interest, but a property right, because their tissues, blood, and DNA are their property if anything is. And indeed, some moral philosophers have assumed or argued that a person's body is his property, in the sense of a moral property right.10

This objection is mistaken for reasons noted at the outset of this analysis: Statements about what moral rights people have, including moral property rights, must be understood as conclusory. Hence the statement that an individual has a moral property right to his biological material is to be understood as shorthand for the assertion that there are morally legitimate interests that require special protections and that these protections can best be achieved by allowing the individual control over the uses to which the sample is put. But, of course, there are many possible modes and degrees of control. Only by weighing the legitimate interests that speak in favor of various forms of sample source control against the morally legitimate interests that speak in favor of allowing others freer access and a wider range of possible uses of the item in question, can we decide which bundle of forms of control among the indefinite range of possibilities is morally preferable. At this stage of the analysis, the most that can be said is that is that a person may have a legitimate property interest in the distributive effects of the uses of her biological sample. At present, not enough is known about the probable future value of particular configurations of genes to determine what sort of legal property rights in them would make moral and economic sense.

Avoiding dignatory harms

Each person has an interest in being treated as a person?s a moral agent with her own values, preferences, commitments, and conception of the good. In Kant's terminology, each of us has an interest in not being treated as mere means, or, more positively, in being treated with the dignity and respect befitting persons. Part of the moral justification for the requirement of informed consent is to ensure that patients and research subjects are treated respectfully as agents, not as passive objects to be used for the ends of others.

First and foremost, however, the requirement of informed consent protects individuals from nonconsensual invasions of their bodies. Because the right of informed consent, which includes the right to refuse treatment, allows the individual to decide whether the risk of these harms is worth taking, it can also protect individuals from other tangible harms that may result from the bodily invasion, if the individual refuses to give consent.

It is important to notice that these harms are not restricted to the potential but usually highly unlikely harms that might occur from techniques such as venipuncture or swabbing cells from the inside of the cheek. The point, rather, is that if one allows others access to one's body for these purposes, one is thereby in a position of vulnerability to other unwanted and more dangerous intrusions. For this reason, it is somewhat misleading to say that the only physical harm from which one is protected by informed consent for a simple procedure such as venipuncture is the extremely remote possibility of harm from the needle stick (beyond the unpleasant momentary sensation of the needle itself).

Even if informed consent was originally primarily a protection against physical harm, it has come to be used as protection against a broad range of nonphysical harms lumped under the heading "psychosocial." Thus, for example, Institutional Review Boards (IRBs) strive to ensure that informed consent procedures for psychological or other social science research protect individuals from being deceived and manipulated in ways that are demeaning or threatening to a person's sense of self-worth or that in some other way treat him or her as a mere means.

A strong case can be made that current practices concerning biological samples often fail to treat persons with due respect because they systematically mislead regarding why samples are being taken and their uses. It is true that the phlebotomist who draws the blood sample may not know that the sample will be stored indefinitely and may be used in any number of ways in the future and hence may have no intention to mislead the sample source. Nevertheless, the institutionalized practice of storing biological samples for future uses is one for which those who control the practice are responsible, and this practice, as we have seen, often keeps sample sources in the dark as to what may happen to the sample. Given the various interests already listed above, a practice that is misleading in this way fails to show proper respect to sample sources.

The most obvious way to correct this defect is to modify the practice by informing individuals that their biological samples will or may be used for a wide range of purposes where this is not already done. Whether or not in addition to such disclosure, specific or blanket consent is required in order to show proper respect for sample sources is a question taken up in section IV. The main point to be appreciated here, however, is that we should not simply assume that informed consent is the only means for protecting individuals against the dignatory harm of being deceived or misled. The alternative of disclosure ought to be seriously considered.

Avoiding invasions of privacy and confidentiality per se

Persons have an interest in not being subjected to unnecessary exposure of the body to the view of others and in not having embarrassing or intimate facts about themselves disclosed, independently of whether such exposure or disclosure threatens other interests they may have or produces other harms. For example, one has an interest in others not knowing certain intimate information about one's reproductive history and in not having one's body unnecessarily exposed to view, even if these breaches of privacy and confidentiality cause no tangible harm, for example, by making one the subject of disparaging gossip.

This interest, which might be called the interest in privacy and confidentiality per se, is distinguishable from the various other interests catalogued above that serve to ground a right to privacy. It is closely related to the interest in avoiding dignatory harms, since in most if not all cultures, some modes of exposing the body, in some contexts, are thought to be undignified and demeaning, and some intimate information is thought to be embarrassing.

It is this interest in privacy and confidentiality per se that is invoked when a patient or subject complains that the setting in which she is examined or in which she answers questions about her personal medical history is "too public" or "lacks privacy." Unlike some of the interests already noted, the interest in privacy and confidentiality per se, is at stake as much in the process by which the sample is collected as in what happens to the sample after collection.

Confidentiality

For the most part, once the biological sample is removed from the body, it is the interest in confidentiality rather than the interest in privacy that is at issue. Etymologically the term confidentiality means with trust. Thus we speak of preserving the confidentiality of certain information, or of keeping confidences, of those we trust. With some risk of oversimplifying, confidentiality may be thought of as a kind of second best to privacy. In some contexts, medical and otherwise, persons must expose themselves to the gaze of others or divulge sensitive information to them in order to gain certain benefits, and the best they can hope for is that there will be no unnecessary or otherwise inappropriate viewing or disclosure to others and that those who gain this intimate knowledge will not use it detrimentally.

Sources of biological samples have an interest in confidentiality?n being able to trust that access to their samples and to the information they contain will be appropriately limited. But what counts as an appropriate limitation will depend upon a complex weighing of conflicting legitimate interests. Once again, we see that beginning with slogans about the right to confidentiality does not carry us far. To say that there is such a right is simply to assert that the interest in limiting intimate exposures is a high moral priority and as such warrants special protections; it does not tell us what the contours of the right are.

Surviving interests

Many existing biological samples were taken from individuals who are long dead, and if any sample is stored long enough it will outlast its source. It might be thought that once the source is dead, there are no interests to protect; but this is not so, for two reasons. First, the deceased source's family or other loved ones may have an interest in what is done with the sample, or members of the source's ascriptive group may have an interest in what happens to it (if, for example, research were done on the sample that contributed to racial stereotyping).

Second, persons can have interests that survive their own deaths. For example, persons ordinarily have an interest in what happens to their children and grandchildren after they themselves die and for this reason plan for the disposition of their estates. Similarly, one can have an interest in the uses to which one's biological sample are put, whether these uses occur before or after one's death. This is especially true if certain uses would be considered impermissible per se, from the perspective of one's deepest, life-long religious or ethical values. From this it follows that if a policy of unrestricted access to samples of deceased persons is to be justified, it cannot be justified on the grounds that no interests are at stake.

The "autonomy" interest in control per se

It might be argued that there is one remaining interest that weighs in favor of greater source control over access to biological samples that also matters and that is also served by informed consent requirements. This is simply the interest in being able to decide what happens to the sample, independent of any instrumental value that being able to decide might have for protecting one's privacy or dignity, preventing discrimination, enabling one to determine who profits from the sample, etc. Thus it might be said that, independently of whatever functions requiring informed consent may have, a proper consideration of the individual's autonomy weighs in favor of allowing the source maximal control over his sample and that this in turn requires specific consent for particular uses of the sample.

However, it is a mistake to assume that whenever we increase a person's range of choices we thereby enhance her autonomy. In some cases, increasing the range of choices may actually diminish a person's ability to act autonomously, especially when the information needed for a responsible choice is not available.11 Furthermore, it is also a mistake to assume that whenever we do not enable an individual to exercise choice over some matter we thereby infringe her right to autonomy or that we even slight a legitimate or important interest in autonomy. Not every possible choice counts so far as autonomy is concerned; in general, whether the ability to make a choice represents a legitimate autonomy interest (much less an interest that deserves the protection that rights accord) will depend upon how that choice is related to the individual's other interests, to her conception of herself and of what is important given her stable priorities in life. Consequently, what might be referred to guardedly as the "interest in autonomy per se" might more accurately be called the interest in choice, to signal that not all choices bear importantly on an individual's autonomy. And once it is understood that the mere ability to exercise choice over the disposition of one's biological sample is not to be confused with a legitimate interest in or a right to autonomy, it is not plausible to argue for a requirement of specific consent on the ground that it enhances individual autonomy, especially given the weight of the interests that weigh against the imposition of such an onerous and costly requirement.

III. Interests That Weigh in Favor of Fewer Restrictions on Access and Less Sample Source Control

The societal interest in the growth of scientific knowledge

Not everyone in our society values the growth of scientific knowledge, but most do, and more important, most if not all will benefit from it in some way or other. To that extent we can speak of a societal interest in the growth of scientific knowledge.

Whether or not the advance of scientific knowledge as such is valuable independent of the benefits that the application of this knowledge brings depends upon the resolution of deep and controversial issues in the theory of value that lie well beyond the scope of this paper. According to some views, the quest for knowledge is good in itself, and is an important ingredient in human good independent of its beneficial effects. According to other views, some individuals (especially scientists) may value scientific knowledge for its own sake, but there is no societal interest in scientific knowledge as such independent of the goods is application brings.

The instrumental benefits of the growth of scientific knowledge are obvious and manifold. Before proceeding to some concrete illustrations of benefits gained from the use of stored biological samples, it may prove useful to sketch a more general characterization of the value of progress in biomedicine. Scientific knowledge makes possible scientific health care, and scientific health care serves several basic human interests: the interest in avoiding pain and suffering, in restoring or preventing the loss of opportunities that depend upon normal functioning, in the avoidance of unwanted death, and in obtaining access to information about one's condition that can enable one to plan one's life more effectively or which may simply allay worries about one's condition.12

The weight that should be accorded to the societal interest in benefits of applied biomedical science will depend in part upon how widely these benefits are distributed. If there are gross inequalities in the distribution of benefits, it is misleading to speak of the common interest in medical progress. Consequently, the case for tolerating greater risks to the interests of sample sources for the sake of the societal interest in medical progress is weakened if some people, including some who provide samples, lack access to important health care benefits because they cannot afford them. Nevertheless, if the benefits of medical progress accrue to a large number of people, we may still speak of a societal interest even if not all benefit or not all benefit equally.

The range of medical benefits already obtained through the use of stored biological samples is extremely impressive. Here only a few instances will be mentioned to convey their importance and diversity.13

In the late 1960s, the study of samples of tissue from an unusual tumor of the vagina led to the discovery that a nonsteroidal estrogen hormone diethylstilbestrol (DES), then commonly given to women during pregnancy, is carcinogenic.
During the same decade a series of studies on tissue samples of precancerous lesions of the uterine cervix led to the routine use of the Pap smear, which has played an important role in the early diagnosis and more successful treatment of this type of cancer.
Analysis of tissue from autopsies of persons in certain occupations, such as chemical manufacturing and uranium mining, has established causal links between exposure to environmental substances and certain diseases, including a cancer of the liver known as hepatic angiosarcoma and cancer of the bronchial epithelium.
The analysis of autopsied lung tissue from smokers played a major role in establishing that smoking causes lung cancer, that the risk of cancer increases with the duration of exposure to the chemicals contained in cigarette smoke, and that precancerous changes in the bronchial epithelium can be reversed by cessation of smoking.
In 1953, autopsies of young American soldiers killed in the Korean conflict revealed that atherosclerosis begins at a much earlier age than was previously thought and that blockage of arteries can be far advanced in the absence of symptoms; this research contributed to findings concerning diet and exercise which have had a major public health impact in this country, evidenced by a significant reduction in coronary artery disease.

In many instances, access to stored biological samples collected over a long period has significant advantages over the exclusive use of new research protocols. Especially when the disease process under study takes place over years or even decades, studies that rely only on newly collected tissue may be very costly and produce results much less quickly than studies of stored samples.

The interest that some individuals have in contributing to scientific and medical progress

Some individuals have a preference, or in some cases a moral commitment, to helping to further scientific and medical advances. Frequently, the preference or conviction will be more specific?or example, to make some contribution toward developing a cure for a particular disease, perhaps one which has adversely affected oneself or members of one's family. Because of the important role which biological samples have played and can be expected to play in the future in scientific and medical progress, such interests generally weigh in favor of wider access to samples, other things being equal.

The interest in enhancement through biotechnology

Until recently, with a few exceptions such as cosmetic surgery, health care has been concerned primarily with preventing or ameliorating harms caused by disease and disability. In the future, however, genetic interventions as well as developments in psychopharmacology may make possible enhancements of normal human functioning. For example, it may eventually become possible to manipulate genetic material so as to raise the upper bound of some aspects of cognitive functioning, by enhancing memory or the speed with which information can be processed by the human brain; or augmentation of the normal human immune system may become possible.14 Whether or to what extent we can speak of a substantial societal interest in enhancements made possible by the growth of scientific knowledge will depend not only upon whether these enhancements are really beneficial, all things considered, but also upon whether they will be widely available or available only to the rich.

Preventing disease and disability for identifiable individuals, present and future

In addition to contributing to the prevention of harms to large numbers of people through advances in the prevention and treatment of disease and disability, freer access to biological sample information can make it possible to intervene directly to prevent harm to identifiable individuals in some instances. For example, if the source of a sample can be identified, then he she can benefit from successful treatment breakthroughs. Or, if research shows that persons with a particular genotype have a high susceptibility to some serious disease, then it may be possible to intervene earlier with better results, if those individuals can be identified from stored samples. In some cases, the individual who benefits may be the offspring of the sample source as, for example, when a genetic disorder that can be successfully treated can be predicted on the basis of information contained in the sample; in other cases it may be a sibling or other relative.

Interests in reproductive freedoms

Individuals have several important reproductive interests, including being able to have children if they wish and having control over when they have children and how many they have. They also have an interest in exercising some control over the characteristics of the child they have, for the sake of the child himself or herself, but also in part because these characteristics may affect their own well-being and that of their other children.

Few would question that prospective parents have a legitimate interest in whether the child they bring into being is spared avoidable diseases or disabilities. Whether, or to what extent they also have a legitimate interest in determining other characteristics, such as height, eye color, or cognitive abilities, is more controversial. But in general, the more their control over the characteristics of the child can be justified by appeal to the interests of the child herself, rather than simply to the interests or preferences of the parents, the stronger the case for protecting the parents' interest in exercising this control.15

In coming years, research on biological samples will most likely increase dramatically the range of reproductive alternatives available, furthering in significant ways interests in various reproductive freedoms. Not all of the interests served will be "medical" interests, in the sense of interests in the prevention or cure of diseases, but in many cases they will be important interests nonetheless. To invoke a distinction noted earlier: Research on biological samples not only serves peoples' welfare interests by preventing disease and disability, it may also serve their ulterior interests, so far as these include a conception of whether to have children, when to have them, how many to have, and even perhaps what sorts of characteristics they will have.

Interests of researchers and clinicians

For many researchers and clinicians, the ability to do their work effectively is of central importance to their well-being and their very identity. For such individuals, practicing the most scientifically informed medicine or engaging in cutting edge research is much more than a means of satisfying their welfare interests: It is an ulterior interest that plays a dominant role in how they live their lives. While these interests of researchers and clinicians in having access to biological samples may not be as morally weighty as the societal interests in medical progress, they are nonetheless significant. The pursuit of these interests is not only permissible (in the sense of not being wrong), but indeed laudable, especially when compared to some goals that our society allows individuals freely to pursue. Consequently, any policy regarding the uses of biological samples that impedes the pursuit of the interests of researchers and clinicians owes them a plausible explanation of why the restrictions it imposes are needed.

Commercial interests

It is common, and to some extent understandable, to divorce something so lofty as the interest in medical and scientific progress from economic interests, at least in political rhetoric concerning health policy. However, it is a fact, and an important fact about all societies in which biotechnology is flourishing, that economic incentives play a central role. Biotechnology not only produces great medical benefits for individuals and for society as a whole; it also creates wealth and provides productive careers for many people who are not clinicians or researchers. These include not only those involved in the manufacture and marketing of biotechnology, but also investors in biotechnology as well as all of us who benefit from the greater productivity of a healthier workforce. All of these economic interests also must be weighed in the balance, and for the most part they weigh in favor of less restrictive access to biological sample information.

The moral obligation to prevent harm

The analysis so far has focused on interests in an effort to determine which interests are relevant to the justification of moral claims concerning how practices regarding the collection, storage, and use of biological samples should be structured and regulated. The strategy has been to dig beneath familiar statements about rights and the obligations that are their correlatives to identify the important interests they serve to protect. However, it is important to note that there is not only a societal interest in preventing harm to persons, but a moral obligation to prevent harm as well?nd to determine the relevance of this moral obligation to the ethics of biological samples.

According to some ethical theories, the obligation to prevent harm is not as fundamental or as demanding as the obligation not to cause harm. Such theories maintain that one is not required to bear as high a cost to prevent a harm that one does not cause as to avoid causing a harm. (For example, one might be required to risk one's own life to rescue a stranger one has caused to be in peril, but not required to risk one's life to save a stranger whose imperilment one did not cause.) And there are a number of intuitively plausible reasons to distinguish in this way between the obligation to prevent harm and the obligation not to cause harm.16 Nevertheless, it would be extremely difficult to defend an ethical view that recognized a fundamental obligation not to cause harm, but failed to acknowledge even a limited obligation to prevent harm.

Moreover, many of the reasons for holding that the obligation to prevent harm is weaker than the obligation not to cause harm disappear or at least become less weighty when we move from the case of the individual to that of society. Clearly an individual cannot be required to prevent all harms to anyone who may be harmed, if only because she lacks the resources to do so. When it comes to the design of institutional schemes, however, it is possible not only to marshal greater resources for preventing harm, but also to target which harms are most important to prevent, to provide more effective yet still affordable harm prevention through a coordinated division of labor, and to distribute fairly the costs of preventing harm. Given that this is so, whatever structures and regulations are developed for biological sample practices should take seriously the obligation to prevent harm, understood as a societal or collective obligation.17

Two obvious ways to honor the societal obligation to prevent harm have already been discussed: As a society we can attempt to develop protections for the various legitimate individual interests catalogued above, and we can facilitate the prevention of harm through the application of scientific knowledge in health care. The difficulty, of course, is that in some cases we can reduce the risk of harm to the individual who provides the sample only through safeguards that will impede scientific progress, and to that extent interfere with the use of scientific knowledge to prevent harms, especially those that result from disease.

However, as we have also seen, there is a third way in which how we structure and regulate biological sample practices will affect the prevention of harm: Restrictions on access to stored sample information may make it impossible to prevent harm to particular identifiable individuals, including the sample source. For example, suppose that in order to protect the sample source from possible insurance or employment discrimination we render the sample nonidentifiable. (By "nonidentifiable" here I mean not simply that the source's name is not attached to the sample, but that it is also not possible for anyone to identify the source as an individual by any combination of other characterizations of the sample or the medical record that is linked to the sample.18) Later it may turn out that the individual has a particular genetic mutation which makes him highly susceptible to a potentially lethal cancer, but one which can be successfully treated if detected early. If the sample source cannot be identified, then those who have access to the sample will know that there is someone whose life might be saved if he could be identified. An opportunity to prevent a very serious harm will have been lost, and perhaps lost in order to reduce what may be an already relatively low risk of insurance or employment discrimination. Furthermore, the opportunity to contact relatives of the sample source who are at risk for the same genetically based disease will also be lost.

A common assumption among many participants in the debate about biological samples is that some version of an informed consent requirement?erhaps a very detailed and complex one?s the appropriate instrument for protecting the various interests that could be adversely affected by the practice of collecting and storing biological samples, without excessively constraining scientific research or making it too costly to pursue.19

To evaluate this assumption we must clarify the resources and limitations of the idea of informed consent for balancing the conflicting interests involved. And to do this we must expand upon our earlier discussion of what informed consent is and what the main purposes of obtaining informed consent are.

Elements of informed consent

Informed consent is now generally recognized to be both a legal and moral requirement for medical interventions generally and for all experiments on human subjects that involve more than minimal risks. We saw earlier that "risks" here are taken to include not only potential physical harms from bodily invasions, but also "psycho-social harms," especially stigmatization, dignatory harms, and other assaults on the individual's sense of self-worth.

Five elements of informed consent can be distinguished:

disclosure (of relevant risks and benefits of the procedure);
competence (on the part of the patient or subject) to make a decision whether to accept the treatment or participate in the research;
comprehension (of the relevant risks and benefits);
choice (an expressed decision to accept the treatment or participate in the experimentation); and
voluntariness (of the choice to accept treatment or to participate in research).

Clearly, informed consent will play a role in any ethically sound system for collecting and using biological samples at least to this extent: The requirement of informed consent must be met for medical treatments generally and for research (involving more than minimal risk). The question is whether an ethically sound system for collecting, storing, and using biological samples will require additional or amplified applications of the requirement of informed consent in order to reduce the risks of the various harms catalogued above in section II. To answer this question, we must first clarify the rationale for the informed consent requirement in its paradigm applications.

As already noted, the requirement of informed consent developed as a safeguard against very tangible harms the sorts of physical harms that the law generally regards as batteries.20 In other words, informed consent first and foremost protects individuals from nonconsensual invasions of their bodies. Informed consent was not originally invoked as a general protection against all the various harms that can result, whether directly or indirectly, from medical interventions or from research. Even when understood as also providing protection against "psycho-social harms," informed consent cannot reasonably be viewed as protecting the whole range of heterogeneous interests that may be affected by the uses of biological samples.

Moreover, as we also saw above, even if informed consent can serve to protect the interest in avoiding the dignatory harms of deception and manipulation, that interest might be protected instead by disclosure of the fact that the sample will be stored and later may be used for a wide range of purposes, without requiring either blanket or specific informed consent. Hence it is one thing to agree that freedom from nonconsensual bodily invasions and from "psycho-social harms" is so important that informed consent is a necessary condition for the participation of human subjects in research, quite another to say that an adequate informed consent document for biological sample practices must ensure the sample source full control over every choice that may be made in the future concerning the uses of the sample. To emphasize a point made earlier, the mere interest in having more rather than fewer choices, as distinct from the interest in significant opportunities for genuinely autonomous choice, does little to support a requirement of informed consent so far as the uses of biological samples are concerned.

Two distinct but equally important points must be emphasized at this juncture. First, as just noted, the justification for informed consent focuses primarily on some, not on all possible harms, and not on the mistaken notion that informed consent enhances autonomy simply by virtue of multiplying choices. Informed consent is primarily a protect against nonconsensual bodily invasions and against dignatory harms that can generally be ranked under the category of treating persons disrespectfully, as if they were mere means for the pursuit of others' ends. It is not a device for maximizing an individual's range of choices; one would only view it in that way if one erroneously assumed that an individual's autonomy is violated whenever he is not given the widest range of choices possible.

Second, these two types of harms against which informed consent is designed to protect are certain to occur if informed consent is not secured, because nonconsensual bodily invasions and disrespectful treatment are themselves harms, quite apart from any further harms that may occur. Yet most of the harms catalogued above in section II are not certain to occur and in many cases are in fact extremely unlikely to occur. It is one thing to argue that the prevention of the certain and uncontroversially serious harms of nonconsensual bodily invasion and disrespectful treatment justifies a serious restriction on research, quite another to argue that the mere possibility of various harms, some of which are not so serious and which are very unlikely to occur, provides an equally compelling reason to restrict research.

Furthermore, it is important to stress that the primary harm against which the requirement of informed consent is supposed to protect is a serious one for this reason: If a person is not free from unwanted invasions of his body if his body is treated as a mere object to be dealt with as others choose neither his life nor his liberty are secure. As reasons for restrictions on scientific research, the need to prevent nonconsensual bodily invasions and the treatment of persons as mere means, on the one hand, and the "need" to protect against a range of possible but in some cases highly improbable harms of varying degrees of seriousness are not on a par. This is especially true if we are talking about possible harms that might occur after the sample has already been taken and hence after no risk of unwanted bodily invasion is at issue. Once this fundamental point is appreciated, it becomes clear that there is a large gap between identifying various potential harms that might result from a system in which sample sources lose control over what is done with their samples and making a plausible case for introducing an elaborate system designed to extend their control, whether through some system of specific consent requirements or in some other way.

Even if we restrict the role of proposed safeguards in protecting against harms (as opposed to maximizing choices), the mere possibility that a harm of significant magnitude might occur is not sufficient to warrant restricting potentially beneficial research. An appropriate threshold of risk, a level of probability of harm high enough to warrant protective measures, must be identified and defended, and the question of whether we are likely to be able to determine reliably when that threshold has been met must be addressed. Yet without exception, current proposals for specific consent requirements for various uses of stored samples proceed as we know what that threshold is and that it would be exceeded without the protective measures they advocate. Or, even worse, they simply assume, quite erroneously, that the goal is to eliminate risk entirely. Such approaches simply fail to address the problem of bridging the gap between the identification of potential harms and the conclusion that special arrangements are needed to safeguard against those harms.

Reduction of risks, not elimination of risks

It is worth dwelling for a moment on why any approach to structuring and regulating biological sample practices that assumes that the various risks identified above are to be reduced to zero is radically misguided. This assumption would only make sense if risk-reduction measures were costless. But of course they are not; efforts to reduce risk are costly not only in terms of the resources needed to devise them and to apply them and monitor their application, they also are detrimental to the various interests that are furthered by freer access to samples (listed in section III above).

Blanket consent

One measure that has been proposed to protect against the various risks that can arise from the uses of stored tissue information is blanket or open-ended consent, either alone or with a requirement of specific consent for some particular uses of the sample or for those types of research that might be regarded as especially problematic. Thus, for example, it has been suggested that at the time a biological sample is to be taken the potential source must be told that at that time she may consent to or object to any future research uses that may be made of the sample, so long as the sample is rendered nonidentifiable with the source, with the additional requirement that specific permission is to be obtained from the source for any use of the sample in which the source's identity could be ascertained. The chief attraction of the blanket consent component of such an arrangement is that it requires lower administrative costs than specific consent for each future use, since one informed consent process authorizes an indefinite number of future uses.

However, the difference between blanket consent and what is ordinarily understood by informed consent is so great that it is problematic even to use the same term, "consent," to refer to both. As noted earlier, a key element of informed consent is disclosure of the relevant risks and benefits of the procedure that is to be accepted or refused. "Relevant risks" here does not mean all possible risks. In general, what counts as a relevant risk isthe risk that a reasonable person would want to be apprised of, though for some types of decisions a case can be made for a more "subjective" standard, a requirement that the individual must be informed of those risks that he would need to know to make a reasonable decision, given his particular values. But regardless of whether an "objective" or a "subjective" standard of relevance is employed, the rationale for informed consent presupposes the ability to identify a much more determinate and limited set of relevant risks than is generally available in the stored biological sample setting, if we include all of the various possible and often highly improbable risks listed in section II as reasons for restrictions on uses of stored samples.

Just as significant, the less determinate the set of potential harms and the more uncertain it is that they will occur, the less likely it is that a second essential element of informed consent will be present, namely, comprehension. Moreover, as we also saw earlier, once the sample has already been taken, the primary harm against which informed consent provides protection, namely, nonconsensual bodily invasion, is no longer at issue.

For these reasons, it must be acknowledged that blanket consent requirements are only distantly related to informed consent and do not perform the functions of informed consent. The question, then, is whether, despite this difference, blanket consent requirements serve any useful purpose effectively enough to warrant changing current practices to incorporate them.

It seems clear that blanket consent requirements will not provide protection against most of the more tangible and serious harms that might occur from the uses of stored biological samples?nless it should turn out that most potential sources refuse to give blanket consent. In that case, the blanket consent requirement would serve a protective function, but only at the cost of thwarting the various important interests that are served by scientific research which we listed in Section III.

Recall that when a person gives ordinary informed consent, she thereby avoids a definite harm?he harm of nonconsensual bodily invasion?nd in addition, because the relevant risks and benefits of treatment or participation have been disclosed for her consideration, she is in a better position to avoid a choice that is likely to produce other harms to her on balance. But when an individual gives a blanket consent to future uses of her tissue, she does not thereby avoid a harm, and her choice is not likely to reflect a reasonable estimate of what is good for her on balance, simply because the information she has about possible future risks is too indeterminate. Furthermore, as we saw in Section II, there is another source of indeterminacy that can undermine the requirement of comprehension: The individual may be uncertain about her own evaluation of the events that might occur in the future.

At this point, a proponent of blanket consent might object that protection from harms, whether physical or dignatory, is not the only point of the requirement: It also shows respect for the individual's autonomy by giving him or her control over what happens to the sample in the sense that he may refuse to allow any future uses. Now, it may be true that a system that includes a requirement of blanket consent for future uses of nonidentifiable biological samples in some sense shows more respect for individuals than one that merely requires disclosure of the fact that the sample may be used for various purposes in the future. But it would be hyperbole to say that a system that does not include the requirement of blanket consent violates anyone's "right to autonomy." For one thing, as I have already noted, not all choices warrant the stringent protections that talk about a right to autonomy implies; some choices are relatively insignificant because they are largely irrelevant to a person's well-being and values. And, as we have already seen, blanket consent may not be the only way to protect the interest in not being treated disrespectfully: Simply disclosing that the sample will be stored and may be used for an indefinite number of uses in the future would go a great distance toward protecting this interest.

Finally, given the fact that blanket consent is only a pale shadow of informed consent and given that it does not provide significant protections from the various harms it is supposed to avert, it is far from clear that the deference to individual choice it expresses is worth the costs. Among those costs is the risk that the genuine informed consent will be devalued through confusing it with blanket consent.

None of this is to say that it would be impermissible to institute a requirement of blanket consent for future uses of samples. Rather, the point is that if such a requirement is instituted we should recognize it for what it is: a largely symbolic expression of respect for individual choice and one way, though not the only way, of avoiding the disrespect that would be shown by a practice that keeps sources in the dark, not a case of genuine informed consent, not a vindication of the right to individual autonomy, and almost certainly not an effective protection against the various other possible harms that might result from uses of biological samples.

V. Policy Implications

Future samples

Most current proposals for biological sample policy draw a distinction between what should be done regarding informed consent and other protections from now on, that is, with future cases of the collection, storage, and uses of biological samples, and what should be done regarding existing stored samples. Current opinion is divided concerning safeguards and restrictions that ought to be instituted concerning biological samples gathered in the future. Our analysis has already cast some doubt on the efficacy of the proposal for blanket consent for future uses. For as we saw, blanket consent, like disclosure, may protect against the dignatory harm of being treated in a deceptive manner or otherwise treated disrespectfully, but it is not clear that it provides significant protection against many of the various other harms that might result from future uses nor that it provides a meaningful exercise of autonomy, much less that it is required if violations of autonomy are to be avoided. Moreover, blanket consent is only distantly related to genuine informed consent. Given the radical uncertainty concerning both the nature of particular future uses and our evaluative responses to them, adequate disclosure and comprehension of risks are not obtainable. The question remains, however, as to whether, instead of blanket consent, specific consent for each use or type of use of the sample should be required, at least for samples that are linkable to the individual source.

I have already argued that it is simplistic and misleading to assume that the justification for informed consent for the procedures by which samples are taken from persons' bodies applies with anything like equal force to a requirement of informed consent for the various uses to which samples can be put. The requirement of informed consent for medical treatment or research protects a person against two types of certain and significant harms, the harm of bodily invasion and the dignatory harm of being treated as a mere means. It also serves individuals' interest in autonomy to the extent that the choice whether to receive a treatment or to participate in research bears on an individual's stable values and conception of the good. The interest in autonomy, the need to avoid these harms and the certainty that they can be prevented if the informed consent requirement is met justify the quite considerable constraint on treatment and research which the informed consent requirement poses. But it does not follow that informed consent is needed for every use of a person's stored biological sample in the future. Future uses will not involve a risk of bodily harm to the individual and if some indication of the range of possible uses is disclosed in advance, dignatory harms can be avoided. In general whatever autonomy interest (if any) an individual has in whether or not his sample is used for specific purposes in the future will tend not to be as significant as his autonomy interest in being able to accept or refuse medical treatment or to participate or not participate in an experimental protocol. Consequently, an informed consent requirement for each future use of the sample is much more problematic than the requirement of informed consent for medical treatment and participation in experimentation, given the costs that implementing it would inflict on the pursuit of scientific progress and other legitimate interests.

There is a policy alternative that steers a middle course between requiring consent for each research use of stored sample indefinitely into the future, on the one hand, and a system which gives the source no control whatsoever over future uses of her sample, on the other, once she gives blanket consent. IRBs could be required by new federal regulations to develop screening criteria, based on a consideration of the taxonomy of interests developed above, to identify research protocols that bear significantly on important interests that sources may have beyond the interests in avoiding nonconsensual bodily invasions and in not being treated as a means that the informed consent requirement is primarily designed to protect. This approach would allow for selective consenting by sources, assuming that it could be combined with a secure system which allowed for authorized, confidential de-coding of encryptions designed to remove individual identity.

To use an example already alluded to above, given the history of racism in this country and the special vulnerability of African Americans as revealed by the Tuskegee Syphilis Experiment and other instances of unethical behavior by researchers and doctors toward this group, there is a special concern about group-based harms. Consequently, the selective reconsenting guidelines for IRBs might well require special arrangements for research protocols that raise questions about negative stereotyping, such as studies that test hypotheses about links between genotype and intelligence or genotype and criminal behavior. The attraction of the selective consent approach for "special scrutiny" protocols is not simply that it is less costly and cumbersome, and thereby better serves the interest in scientific progress, but also that it does so in a principled way, by rejecting the assumption that every interest that might be adversely affected by a particular use of the sample is as weighty as the interest in preventing nonconsensual bodily invasion and in not being treated as a mere means that the requirement of informed consent is primarily designed to protect.

Such a selective consent requirement might be combined with a blanket consent requirement. A person would first be offered the option of consenting to all future possible uses of the sample (compatible with human subjects regulations and other relevant law), but then the IRB would examine each future use to see whether it fell into the "special scrutiny" category. If a proposed use fell into this category, then specific consent would be required at that point.

Given the remote resemblance that blanket consent bears to informed consent and given that disclosure that the sample may be used for a variety of purposes in the future provides protection against the dignatory harms of deception and manipulation, it is not obvious that the selective consent approach would need to be supplemented with a blanket consent requirement; it appears that adding a disclosure requirement instead would suffice.

The selective consent approach for samples to be collected in the future just outlined does not envision sources as generally having the option of choosing to have their samples rendered nonidentifiable. Nor does it empower researchers to decide to render samples permanently nonidentifiable (though of course it allows the possibility of double blind experiments in which the identity of the sample source is shielded from the researcher). There are two reasons for the presumption that in general samples collected in the future should not be rendered nonidentifiable. First, doing so makes it impossible for sources to be contacted in the future if discoveries are made from which they might benefit. For example, future research may develop treatments for diseases that are now untreatable, and if samples are rendered nonidentifiable their sources will not be able to benefit from these advances. Second, if samples are not identifiable, it will not be possible to provide benefits to relatives of the sources. For example, research may yield successful treatments or preventive strategies for genetically based disorders that are currently untreatable, such as Alzheimer's dementia, or others that are not treatable with only limited success, such as breast cancer. In such cases, it will be crucial to give relatives who may be at risk for the disease the opportunity to be tested to see if they have the genotype in question and hence whether they are candidates for treatment or prevention.

At present, the ability to diagnose genetic conditions generally far exceeds the ability to treat or prevent. Thus in many cases the only way to prevent the phenotypic expression of genetic disorders is to prevent the existence of an individual who would have the genotype in question. However, in coming decades, there will almost certainly be many cases in which genetic testing will reveal potentially serious, but treatable or preventable conditions. The ability to identify stored biological samples?ll of which will include information about genotype?ay become a keystone in the application of genetic science to the improvement of human health. Consequently, an ethically sound policy for stored tissue to be collected in the future ought to operate on the presumption that in general identifiability of sources is to be the norm.

One of the most difficult ethical issues to be faced as more genetic tests become available and the gap between diagnosis and treatment or prevention narrows is whether or how public policy should encourage or require individuals who test positive for genetic conditions to inform relatives that they are at risk. The United States, like most developed countries, has public health laws that represent an attempt to balance respect for individual privacy with the need to prevent harm to individuals by the transmission of disease from one person to another. The clearest examples are laws requiring individuals with sexually transmitted diseases to cooperate with health care workers in notifying sexual partners that they are at risk. Assuming that these laws are appropriate, there is no obvious reason why it would not also be proper to use the power of the law to enforce a "duty to warn" relatives who are at genetic risk, in those cases in which

the genetic condition is a grave threat to health or life;
the condition is effectively treatable or preventable if detected early enough;
the treatment is safe and without serious side-effects;
the probability is low that relatives at risk will be diagnosed as having the condition unless they are informed that a relative has been diagnosed; and
the costs to the index case of informing relatives that they are at risk are not excessive.21 Whether or not there are now genetic conditions that meet these criteria, it is very likely that there will be in the future.

This brief discussion is not intended to advocate a legally enforceable "duty to warn relatives at genetic risk." Such a proposal would only be plausible, if at all, if the proposed legal duty were carefully limited and qualified, and this is not the proper place to explore such limits and qualifications. My point, rather, is that it would be a mistake to rule out serious efforts to encourage the prevention of genetically based harms, whether through the force of law or by relying on the individual's sense of moral responsibility, by making samples nonidentifiable.

To say that there should be a general presumption in favor of identifiability is not to say there should be an absolute requirement of identifiability in all cases. There may be some special cases in which the risk of harm from breaches of confidentiality are so great that they outweigh the interests in preventing medical harms to the source or his relatives that might be averted if the sample were identifiable. For example, in some "special scrutiny" cases where history suggests a significant possibility of special vulnerability for members of an ethnic or racial minority, it might be appropriate to offer potential sources not only the usual option of not participating at all, but also the option of participating under conditions of nonidentifiability. Whether any particular research protocol is a valid exception to the norm of identifiability should not be left to the determination of the researcher; it should be determined, within the framework of appropriate guidelines, by the IRB.

Assuming that the general norm is to be identifiability for samples collected in the future, the great challenge will be to capture the benefits of prevention and treatment that depend upon identifiability while at the same time providing adequate safeguards for confidentiality. It is beyond the scope of this discussion to pursue the technical details. However, it is worth emphasizing that once again the goal is not to provide encryption systems and other safeguards that reduce the possibility of inappropriate access to source identity to zero, but to strike a balance between maximal accessibility to identities for the sake of prevention and treatment, on the one hand, and maximal protection of confidentiality, on the other.

The use of existing, nonidentifiable samples

Some have proposed that for existing samples for which no identification of the source is possible, no special conditions or restrictions should apply beyond those already involved in requirements for review of research involving human subjects. The intuitive idea is that since it is not possible to contact the sources to ask their permission for any specific uses or to gain blanket consent, no special restrictions should apply.

Though it seems quite reasonable at first blush, this proposal is not as uncontroversial as it first appears. It will not do to say that no special restrictions are required simply because "ought" implies "can"?hat is, to cite the fact that it is impossible to contact the sources to ask permission for various uses because they cannot be identified. For there are, after all, two feasible alternatives: proceed with whatever uses of the samples are otherwise allowed under existing regulations for the protection of human subjects, or do not use these samples at all. What is needed is a reason for choosing the former alternative.

Nor is it correct to assume that because the sources cannot be identified they cannot be harmed. For as we shall see shortly, there are some interests of the sample sources that may be harmed even if the sources are not identifiable, and there may be some interests of others at risk as well.

The best case that can be made for allowing use of existing, nonidentifiable samples is that the balance of interests weighs in favor of this policy. We have already seen what these conflicting interests are, but it will be useful to emphasize those that are especially significant in this context.

Because we are assuming that the samples are not linkable by anyone to individuals, some of the most important interests that speak in favor of restricted access do not apply: If the individual cannot be identified, then there is no risk of insurance or employment discrimination, nor of stigma, nor of adverse psychological reactions or familial conflict. So to that extent, the case for not allowing use of nonidentifiable stored samples is significantly weakened.

There are at least three interests, however, that are relevant, and each adds some weight to opting for the alternative of not allowing use of nonidentifiable samples. The first is the interest that some individuals may have in avoiding uses of their tissue that they regard as impermissible per se (recall the example cited earlier: the use of cells for producing a human being through cloning). Simply not allowing any uses for existing nonidentifiable tissue would protect this interest. However, given the factors cited earlier (in Section II) that reduce the weight of this interest, and given the importance of the conflicting interest in medical progress and other legitimate interests, it is doubtful that anything so drastic as a prohibition on all uses of nonidentifiable existing samples is required. This conclusion will be strengthened in proportion to how well existing regulations for the protection of human research subjects, combined with the force of public opinion and scientific professional ethics, rule out at least some of the uses which individuals might find most objectionable per se.

Here we come to a clear illustration of a point made at the outset of this inquiry: It is a mistake to assume that protection for the sample source's interests must be achieved exclusively through protections tied specifically to the practice of collecting samples, as if there were no other factors that serve to protect these interests (such as regulations for the protection of human subjects, the force of public opinion, and the constraints of professional ethics). Approaches to policy that envision elaborate and costly consent requirements at the point of sample collection look much less plausible once this point is appreciated.

The second interest whose weight is not diminished by the fact that the samples are not identifiable is the interest in either benefiting from the profits generated from the sample or in expressing a preference about who if anyone ought to profit that was referred to above as the interest in distributive justice and in commercialization issues. There are two reasons for concluding that this interest does not weigh significantly in favor of prohibiting the use of existing nonidentifiable stored samples. First, it is far from clear how many people actually have a preference, much less a strong preference, about the distribution of profits from products involving the use of biological samples; and given that the samples are not identifiable we cannot ask the sample sources what their preferences are. But second, and more important, if all that exists in this regard is a preference and not a property right or legitimate expectation that the source will share in the profits, then the interest in determining how profits are distributed should be given very little weight.

An analogous case will make this point clearer. I may prefer that the next winner of the New York State lottery divide the money equally with me, and I may be said to have an interest in her doing so to the extent that her doing so will enhance my well-being. But unless I have a property right in a share (as I might if we had split the cost of the ticket) or have on some other grounds a legitimate expectation that she will share it (for example, if she promised to do so), my interest does not count for much in the moral scheme of things.

Similarly, it would not be plausible to maintain that individuals presently have a legal property right in their stored biological samples and to argue from this right to the conclusion that they have a right to profits generated by the use of their samples. Nor is it plausible to say that they have a moral property right that ought to be recognized by the law. It is true that individuals have a moral right to control over their bodies (whether it is misleading to call this a property right or not is a matter of dispute). However, in the present context the proper acknowledgement of that moral right was either adequately acknowledged or not, depending upon whether the ordinary requirement of informed consent was observed for whatever procedure was used to collect the tissue in the first place. Even if the requirement of informed consent was not met for some existing samples, it is not plausible to argue that sample sources have a moral property right in their stored tissue on the basis of their expectations of control over their stored samples, simply because nothing in the practices concerning sample collection and storage has encouraged such expectations. (Below I consider two quite different types of circumstances in which there was a failure of informed consent, and distinguish their moral implications.)

There is a third interest that is not rendered irrelevant by nonidentifiability and which raises a troubling question about what should be done with existing nonidentifiable samples, however. This is the interest in avoiding group-based or ascriptive identity-based harms. The problem arises because the ascriptive identity of a sample may be ascertainable even if the identify of the individual is not.

For example, biopsied tissue might be identified as having come from a member of the Ashkenazi Jewish group or from a person of African descent. Some existing members of the group may be concerned that certain uses of such tissue may contribute, if only indirectly, to the reinforcement of negative stereotypes concerning their group. (To reiterate one of the examples used earlier, some African Americans are understandably concerned about the misuses of data concerning members of their group by racist researchers or the misinterpretation of scientific studies based on such data to bolster racist views.)

Although such concerns are legitimate, it is important to remember that there are other ways of addressing them than by prohibiting the use of existing samples that can be identified according to ascriptive groups (or ascriptive groups that historically have been special targets of discrimination and negative perceptions). Informed public opinion, the professional ethics of researchers, and criteria for sound scientific research applied by IRBs, can all play a significant role in reducing the risk that uses of biological samples will contribute to racist or ethnic stereotypes. (For example, IRBs might be required to place in a "special scrutiny category" those research uses that may present a risk of racial or ethnic stereo-typing.) The stronger these other safeguards are in a particular society, the less compelling is the case for avoiding the risk of group-based harms by the drastic step of prohibiting research on existing samples that can be identified by ascriptive group.

Rendering existing identifiable samples nonidentifiable

Some participants in the debate over stored biological samples have recommended that for any existing identifiable sample, unless the sample is rendered nonidentifiable for a particular use, specific consent for that use must be obtained. The rationale for this highly restrictive proposal is that in many cases existing samples were collected without anything resembling adequate disclosure that they would be used for a range of purposes unrelated to the context in which they were collected. Given the cost of a policy of requiring specific consent for all future uses (rather than just for those falling under a "special scrutiny category"), this proposal should be examined very carefully.

There are two significant drawbacks to rendering existing samples nonidentifiable for every use that is not specifically consented to by the source. First, there is the administrative cost of rendering such samples truly nonidentifiable by anyone. Second, and more important, if a sample is not identifiable opportunities may be lost to protect the well-being of the source or her relatives (in the case of genetic conditions), when later research discovers therapeutically significant links between various diseases or between diseases and genotypes.

There is a less extreme policy that provides significant protection for sources and recognizes that their samples may have been collected without adequate disclosure, yet which does so without cutting them off?ithout their consent?rom the possibly life-saving benefits of future research. Where an existing sample is identifiable and it is reasonable to assume that there was not adequate informed consent at the time of collection (which is probably the case for most existing samples at this time), the individual can be offered the choice of either having her sample destroyed, having it rendered nonidentifiable, or giving a blanket consent to identifiable uses of the sample in the future, with a written pledge that

every reasonable effort will be made to ensure the source and her physician will be advised of research results that may affect her well-being and that
appropriate measures will be taken to ensure appropriate confidentiality regarding the sample. ("Appropriate confidentiality" here might, for example, include the provision of certificates of confidentiality that make records immune to subpoena.)

If this proposal were implemented it would be crucial to inform sources who chose the option of rendering their samples nonidentifiable that they would thereby be cutting themselves off from the possibility that future uses might reveal information from which they or their relatives might benefit.

The rationale for including the option of blanket consent in the case of existing samples rather than mere disclosure that the sample may be used for a wide range of purposes is that in most cases existing samples will have been collected without disclosure, and hence without treating the source with sufficient respect. Allowing persons whose previously collected samples are identifiable to choose either to give blanket consent to all lawful future uses or to have their samples rendered nonidentifiable for future uses can be viewed as an effort to repair this deficiency. Even if blanket consent bears only a remote resemblance to genuine informed consent, it can serve as a special expression of respect for persons in the context of proposed uses for existing samples. Simply to disclose to a person now that the sample already taken from him may be used for purposes of which he had no inkling at the time of collection may not be adequate. (As we saw earlier, in the case of samples collected in the future, disclosure, as opposed to blanket consent, may suffice.)

This more moderate policy for existing samples should be supplemented with the same "special scrutiny" selective consent approach recommended above for future samples. In other words, if the source of an identifiable existing sample chose the option of not rendering the sample nonidentifiable and giving blanket consent to future identifiable uses, he would enjoy the additional protection afforded by the requirement of specific consent for those uses of his sample that fall into the "special scrutiny" category. The same reasons that speak in favor of selective consent for "special scrutiny" uses in the case of future samples also apply to the identifiable uses of existing samples. Because it gives weight both to the source's interest in confidentiality and to her interest in being able to benefit from future research findings, this proposal better reflects a fair balancing of the relevant interests than a policy of requiring that all future uses must be specifically consented to or conducted on nonidentifiable samples.

At this point, it might be objected that in many cases it will either be prohibitively costly or impossible to re-contact all living sources of previously collected identifiable samples to give them the option of blanket consent for all identifiable uses or of having the samples rendered nonidentifiable. The objection contains more than a grain of truth: To require that every possible effort be made to re-contact every source, without regard to costs, seems unreasonable. However, this is not to say that reasonable efforts to re-contact sources should not be made and that reasonable efforts may entail significant costs. It is not a matter of either spending without limit until every source is re-contacted or making no effort to re-contact them. A third, more attractive alternative, is to require a reasonable (or "good faith") effort to re-contact sources.

Recall that the point of attempting to re-contact identifiable sources of existing samples was to respond to a dignatory harm that is likely to have occurred in many cases, namely, a failure to disclose to the source that her sample will be used for a wide range of purposes unrelated to the medical intervention or particular research project in which the sample was collected. To recognize that the original failure to disclose that the sample would be used for a wide range of purposes was an instance of not treating persons respectfully is not to say that there is no limit to the costs that ought to be borne to redress this wrong. Instead, a requirement of making "reasonable" or "good faith" efforts to re-contact sources will generally be an adequate recognition of the fact that in many cases samples were collected in a manner that failed to accord the samples due respect. What counts as reasonable efforts would have to be operationalized so that compliance with this requirement could be effectively monitored, and in such a way as to provide adequate assurance that those charged with the search actually made meaningful efforts to re-contact sources, rather than simply generating a "paper trail" to give the appearance of significant efforts without actually undertaking them. If reasonable efforts to re-contact the source fail, then in general the appropriate course of action will be to render the sample nonidentifiable in all future uses. Doing so would of course eliminate any possibility that the source might benefit from future discoveries, but this possibility will already be foreclosed, unless there is some reason to believe that at some time in the future it will become possible to re-contact the individual even though it is not possible to do so at present.

Samples tainted by violations of human rights

It was noted earlier that the chief harms that informed consent serves to prevent?nwanted bodily invasions and disrespectful treatment?ill already have either been averted or not, depending upon whether informed consent was obtained for the collection of the sample. If there is no reason to believe that the requirement of informed consent was not met for the procedure by which the existing nonidentifiable sample was collected, the best course of action on balance is to allow access to the sample. If there is reason to believe that informed consent was lacking, the matter is less clear. For in such a case one might argue that it would be wrong to use a sample that was improperly obtained. And there can be little doubt that at least some of the older stored samples in various tissue archives meet this description.

Here it is important to distinguish between two different types of cases in which the informed consent requirement was not met for the procedure that produced the sample. In the first, there was no informed consent, but there was no further wrong to the source. In the second, not only was informed consent lacking, but also the individual was seriously wronged in some other way. (To take an extreme example for purposes of clarity, suppose the source was an unwilling human subject in cruel experiments conducted by Japanese or German doctors during World War II.) The argument for not using the sample is much stronger in the latter case than in the former.

Fortunately, most of the stored samples that currently exist in this country do not fall into the second category. However, if there is reason to believe that some particular stored samples were collected as a result of serious violations of persons' basic rights beyond the possible absence of informed consent, a case might be made for not allowing access to these for any purpose. (One might argue, for example, that tissue from the victims of the Tuskegee Syphilis Experiment ought not be used, even for the most benign purposes.) Apart from such special cases, however, we may conclude that respect for the individual's right to control over his body does not require a prohibition on the use of nonidentifiable existing tissue samples, even though many of those uses could not have been anticipated at the time of collection.

In summary, a strong case can be made for the proposal that in general existing samples that are not linkable to individual sources may be used for various research purposes, subject to the usual restrictions on research with human subjects. None of the interests that might be adversely affected by such uses, either individually or cumulatively, seems to weigh heavily enough to warrant the loss of so much potentially valuable information, except, perhaps, when the circumstances in which the samples were taken involved violations of basic human rights other than the right to informed consent. There are only two exceptions to this generalization: The first is where ascriptive-group harms are a serious possibility because the source's ethnic or racial identity can be determined despite individual nonidentifiability; the second is where the process that generated the sample involved a clear violation of basic human rights. Changes in existing regulations governing IRB scrutiny of protocols to require special scrutiny for these types of cases may be called for.

Proposals for "community consent" or "community consultation."

By a community here is meant roughly a group that is more than a "mere association"?ne which figures in an individual's conception of who she is, what she values, and what is valuable about her. Thus an individual may at the same time belong to a religious community, an ethnic community, a national community, and a community based on the type of career she pursues, etc.22

Some parties to the debate over the uses of biological samples have suggested that in some cases community consent or at least community consultation, in addition to or instead of individual consent, may be appropriate for some or all research uses of biological samples. Three quite different rationales for this proposal must be distinguished.

The first and more radical of the three is that at least for certain types of communities, the assumption of individual agency upon which the doctrine of informed consent is erected is inapplicable or profoundly misleading. According to this view, in some communities (in particular some indigenous peoples) individuals are so deeply embedded in the collective that to rely exclusively on individual informed consent or perhaps to require it at all is to impose an alien value scheme that assaults the very identity of the group. In its most extreme form, this first rationale amounts to the claim that the group has a right to control what happens to the bodies of its members and that individual members are not competent to decide for themselves whether to allow the collection of biological samples from their own persons.

The second, less radical rationale is that some individuals, especially those in "traditional" societies, customarily rely upon collective decisionmaking practices or at least upon consultation with those who occupy certain important roles in the community or who are recognized representatives of the community's values. According to the second rationale, the group does not have a right to control what is done to the individual's body, but it may be important nonetheless to enable the individual to rely upon the community, or certain representatives of the community, in making his decision.23

A third rationale for community consultation is based on the interest in avoiding group-based harms. Like the second rationale, and unlike the extreme version of the first, the third rationale does not assert that the group has a right to control the individual member's body. Instead, the idea is that where there is a significant risk of group-based harms, the other members of the group have a legitimate interest in avoiding such harms since they will suffer them.

The first rationale ought to be rejected. Showing proper respect for the value that community plays in the lives of many people, indigenous and otherwise, does not require denying that individuals are moral agents or that they have the right to control what is done to their bodies. If individuals of certain groups wish to allow others to decide for them, they can do so within the framework of law and ethics that the ordinary model of informed consent provides, they can simply follow the guidance of the elders or the council, etc., or they can even in some circumstances formally delegate decision making authority to them.24

The second rationale can provide a plausible justification for facilitating the individual's consultation with the group (or certain members of it). This may require modifying the customary ways in which researchers enlist subjects and secure informed consent. However, the second rationale does not provide a justification for requiring consent by the community or its putative representatives.

Where the risk of group-based harm is substantial, the third rationale can justify community consultation and perhaps community participation in the design and implementation of a research protocol. Like the second rationale, it does not justify a community veto on individual participation.

Although the second and third rationales have their attractions, it is important to note that the concept of community consultation has several inherent drawbacks. First of all, there is the problem of determining what the relevant "community" is. In the modern world, most individuals are members of a number of different, sometimes overlapping communities. Even if consulting with all the communities which contribute to the individual's identity were feasible, it cannot be assumed that the distinctive values of the various communities to which the same individual belongs would yield the same conclusion when applied to the question of whether a sample may be taken, how it may be used, or who should decide about whether or how it is to be used. Persons' various communitarian identities are not always harmonious.

Second, there is the problem that consultation may become coercion?hat once a community (or the selfstyled leader of the community) is mobilized it may exert undue pressure on the individual to conform. Given that individuals in almost all cases belong to more than one community, there seems to be only one morally defensible way of determining which community, if any, ought to be consulted: by letting the individual herself decide. No other approach is compatible with respect for the basic rights to freedom of association and religion that are essential to a liberal democratic political order. But if this is the case, then a proper consideration for "community consultation" ought to be regarded as one possible form the process of individual informed consent may take, not as an alternative to it.

Third, it is a profound mistake to think that either a community's values or who speaks for those values can be readily and uncontroversially identified. Especially in our multicultural world where virtually no community is impervious to a multitude of influences from without, there is no such thing as unanimity of values within a community on any issue of consequence.

Furthermore, there are ongoing and sometimes quite subtle contests among members of the community to determine what the communities' "authentic" values are and who is to be regarded as voicing them. Because until recently outsiders have wrongly assumed that "primitive" or indigenous societies are not only homogeneous in values but unchanging, contests over what the group's values are have gone largely unnoticed.

Just as important, it is almost never the case that what are blithely called community decisions are in fact collective decisions of all members. Instead, they are the decisions of political elites whose interests may diverge significantly from those whom they claim to represent. To put the point most bluntly, indigenous or "non-Western" societies are frequently not only much less homogeneous but also much-less egalitarian in their decision-making than what has been called "the myth of primitive harmony" suggests.25

Once these facts are appreciated, it becomes clear that the en