DAVID B. RESNIK
EXPLOITATION IN BIOMEDICAL RESEARCH
ABSTRACT. This essay analyzes exploitation in biomedical research in terms of three basic elements: harm, disrespect, or injustice. There are also degrees of exploitation, ranging from highly exploitative to minimally exploitative. Although exploitation is prima facie wrongful, some exploitative research studies are morally justified, all things considered. The reason an exploitative study can still be ethical is that other moral considerations, such as the autonomy of the research subject or the social benefits of research, may sometimes justify studies that are minimally exploitative. Calling a research project exploitative does not end the debate about the merits of the study but invites one to ask additional questions about how the study is exploitative, and whether the study is justifiable nevertheless. KEY WORDS: benefits vs. harms, biomedical research, exploitation, HIV research, justice, respect for persons, vulnerable subjects
INTRODUCTION Exploitation has cast a long shadow over the history of biomedical research. The darkest episodes, such as the Nazi Experiments, the Tuskegee Syphilis Study, the Willowbrook Hepatitis Experiments, and the Jewish Chronic Disease Hospital Study, demonstrate how unspeakable offenses and arrogant misdeeds may occur when researchers take advantage of vulnerable populations.1 In The Belmont Report, The National Commission drew special attention to ethical questions concerning the selection of research subjects and potential problems relating to exploitation. It stated that vulnerable subjects, “should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition.”2 In its Final Report on the Human Radiation Experiments, the President’s Advisory Committee found that “the Committee was troubled by the selection of subjects in many of the experiments we reviewed. These subjects were often drawn from relatively powerless, easily exploited groups, and many of them were hospitalized patients.”3 Exploitation has also shaded the recent ethical controversies in international research. In a symposium on randomized, placebo-control clinTheoretical Medicine 24: 233–259, 2003. © 2003 Kluwer Academic Publishers. Printed in the Netherlands.
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ical trials on the perinatal transmission of the human immunodeficiency virus (HIV) in developing nations, Glantz, Annas, Grodin, and Mariner warned that research subjects in underdeveloped countries face the threat of “inadvertent or deliberate exploitation by researchers from developed countries.”4 In that same symposium, Crouch and Arras opined that “if the results of a clinical trial are not made reasonably available in a timely manner to study participants and other inhabitants of the host country, the researchers might be justly accused of exploiting poor, undereducated subjects.”5 Many other articles have also addressed the topic of exploitation in international research and exploitation in clinical trials.6 Although exploitation has become a hot topic in research ethics, no one, to my knowledge, has articulated a clear definition of ‘exploitation’ in research or analyzed this concept in any depth. Ruth Macklin rebukes several authors for raising or addressing the issue of exploitation without providing a clear definition of the term. According to Macklin, The third point of clear agreement is on the proposition that it is unethical to exploit vulnerable populations or individual participants in the conduct of research. No one is in favor of exploitation, so it is easy to come to apparent agreement on this point. Yet, here again, agreement evaporates once we examine various allegations in specific cases . . . In the absence of a fuller account on which opponents in these different controversies can agree, an appeal to exploitation will accomplish no more than to identify the chief grounds for criticizing a study.7
The aim of this essay is to respond to Macklin’s challenge to provide a fuller account of exploitation in research. I will accomplish this goal by providing an analysis of exploitation (in general) and applying this analysis to the biomedical research context. I will argue that not all exploitative research studies are unethical. The reason an exploitative study can be ethical is that in making any ethical decision we must weigh and consider the various values and principles that may have some bearing on different courses of action. An act may be prima facie wrongful yet still morally justified in some circumstances. Likewise, an act may be exploitative yet still morally justified in some situations. Describing a study as exploitative, does not definitively settle questions about the morality of the study. Even if we all agree that a study is exploitative, we must still ask whether the study is morally justified, and, if not, how we should respond to it.
WHAT IS EXPLOITATION? Many different scholars have written about exploitation. There are Marxist accounts of exploitation, libertarian, and Kantian accounts, to name but a few.8 Instead of attempting develop my own theory of exploitation, I will
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present an account of exploitation based on Alan Wertheimer’s highlypraised analysis of exploitation. Wertheimer’s account has several virtues. First, he synthesizes and analyzes insights about exploitation from diverse authors. Second, he addresses all of the major issues that arise in thinking about exploitation. Third, his account is clear and succinct. And fourth, Wertheimer illustrates how his account applies to practical problems, such as surrogate pregnancy, athletic scholarships, and psychotherapy. Wertheimer distinguishes between two senses of the word ‘exploit’, a morally-neutral sense and a non-neutral sense.9 To exploit a thing, in the neutral sense of ‘exploit’, is to benefit from using a thing for some purpose. The sentence “Joan exploited her rich vocabulary in the debate” does not connote any moral judgments about Joan’s actions. This is not the sense of the word that most people use when criticizing biomedical research. Henceforth, this paper will focus on non-neutral sense of the word, i.e., to exploit something is to use it wrongfully. What is wrongful about exploitation? According to Wertheimer, exploiting someone wrongfully always involves taking unfair advantage of someone for one’s own benefit.10 If we view exploitation as a relationship or transaction between A and B, then A, the exploiter, benefits from taking advantage of B, the exploitee, unfairly. The operative word here is ‘unfairly’, since presumably there is nothing wrong with taking fair advantage of a person. For example, children selling lemonade on a hot summer day take advantage of their customers, but we would not regard this activity as unfair or exploitative. But suppose a man is selling water at the edge of the dessert at exorbitant prices. Or suppose that he is selling what he insists is rare French wine, when it is really cheap American wine in a French bottle. Or suppose that he is selling a product to his customers that produces fantastic pleasures but is very dangerous. We would probably regard each of these situations as exploitative. These three situations illustrate three basic elements of taking unfair advantage of someone: harm, disrespect, or injustice. If you take advantage of a person and harm that person, show lack of respect for that person, or treat that person unjustly, then you have exploited that person. We can define exploitation as follows: A exploits B in a transaction or relationship if and only if: (1) A takes advantage of B and (2) A harms B, A disrespects B, or A acts unjustly toward B.
Although this definition treats exploitation as relationship or transaction between two people, it may involve many people. Thus, there are situations where a group exploits an individual; situations where an individual exploits a group; and situations where one group exploits another group. For example, the institution of slavery may involve exploitation between a
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single slave-owner and a single slave; exploitation between a single slaveowner and a group of slaves; exploitation between a group of slave-owners and a single slave, and exploitation between a group of slave-owners and a group of slaves. We can now discuss each of the different elements of exploitation. Exploitation and Harm Sometimes we view relationships or transactions as unfair because the exploiter harms the exploitee.11 For example, consider the psychotherapist who has had several sexual relationships with his patients. Some of them have sued him for negligence and intentional infliction of emotional distress. One reason why we would regard the psychotherapist’s conduct as exploitative is that he has harmed his patients to satisfy his own desires or wants. Since most people will agree that it is wrong to harm someone, controversies relating to harm usually center on the definition of ‘harm’. Since most human relationships and transactions involve a variety of benefits and harms, the best way to understand ‘harm’ is to construe it as an unfavorable harm/benefit ratio. Thus, a dentist does not harm his patient when he puts in a filling because the long-term benefits of the filling outweigh the short-term harms (i.e., pain and inconvenience). Someone who harms someone else makes that person worse-off in the long run. We usually do not refer to egregious cases of taking advantage of someone, such as murder, as exploitation. If one person shoots another in a carjacking, we usually call this murder instead of exploitation. According to Wertheimer, this is still a type of exploitation, albeit an extreme form of exploitation. It would not be inaccurate to say that a murderer exploits his victim, but the stronger moral description, “murder,” overshadows the weaken description, “exploitation.”12 Perhaps the best way to describe such cases is to say that they involve murder and exploitation. Exploitation and Disrespect Although many cases of exploitation involve harm, harm is not a necessary condition for exploitation because exploitation may occur without any harm to the exploitee. Exploitation can occur when the exploiter fails to show adequate respect for the dignity or autonomy of the exploitee.13 Paternalistic actions involve exploitation even when they benefit the exploitee. Suppose that A and B are both morally autonomous: they are both rational individuals who are capable of making intelligent choices. A deceives B in order to induce B to make a particular decision, such as participating in a medical experiment. Even if B benefits from participation, we would still say that A has exploited B because A has violated B’s
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autonomy. Suppose that B is not autonomous and that he has a surrogate decision-maker, C, who is authorized to make decisions on his behalf. If A deceives C in order to induce C to allow B to participate in an experiment, and B benefits from the experiments, we would say that A has exploited C and B. Even though B is not autonomous, A has failed to show proper respect for B’s dignity. Many types of exploitation involve problems with consent, including coercion, manipulation, undue influence, deception, duress, fraud, lack of adequate information or understanding, and consent without a proper surrogate decision-maker (if the exploitee is not autonomous).14 The psychotherapist example, mentioned earlier, involves several potential problems with consent, including manipulation, coercion, or undue influence. For another example, consider a contract with fine print. A landlord has a tenant sign a one-year lease on a house. In the fine print on the third page of the contract, there is a provision that says “the $1000 deposit is not refundable if the tenant is even one day late in paying his rent”. If the landlord does not tell the tenant about the provision, then we would view this as exploitation, because the tenant does not understand the terms of the lease, or he lacks sufficient information about the lease. If, on the other hand, the landlord attempts to hide the fine print and encourages the tenant not to read it, we would also view this as exploitation, because the landlord has deceived the tenant about the terms of the lease. If the landlord makes a false claim in the lease that induces the tenant to sign the lease, e.g., he tells the tenant that the house has central air conditioning, when it does not, then we would view this as exploitation, because the landlord has committed fraud. In egregious violations of consent, we do not usually say that one person has exploited another, since we use other words to describe the wrongfulness of the situation, such as slavery or oppression. However, the fact that we also use these other words in egregious cases need not imply that the label ‘exploitation’ is inaccurate. Although slavery is a form of exploitation, the wrongfulness of slavery far exceeds the wrongfulness connoted by the word ‘exploitation’. Perhaps the best way to characterize slavery is that it is inhumane and exploitative. Exploitation and Injustice Many cases of exploitation involve injustice. For example, suppose that the tenant (in the example above) does not read the small print in the contract and pays his rent one day late. The landlord then claims the $1000 deposit. Suppose this lease does not violate the tenants dignity or
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autonomy, and that he freely signs it. Would we still view the lease as exploitative? According to Wertheimer, we could regard this transaction as exploitative because it would be unjust. This would be an example of what Wertheimer calls “mutually advantageous exploitation.”15 In such cases, the exploiter and exploitee both benefit from the transaction and freely agree to it, yet we might still regard the transaction as exploitative. For another example of mutually advantageous exploitation, consider the price gouger, a private contractor who specializes in tree removal. During the hurricane season, he travels to areas that have been devastated by hurricanes and charges exorbitant prices for tree removal. Most people would regard this behavior as exploitative, but why? There is not a problem with harm here, because the exploitees benefit from having their trees removed. Let’s suppose that the contractor is not engaging in manipulation or deception and is not wielding undue influence. So there is no problem with disrespect. Even so, we could still say the transaction is exploitative because it is unjust. The contractor is taking unfair advantage of his victim’s unfortunate circumstances (or vulnerabilities) in order to charge them a price that far exceeds the market value of his services. Some people might regard cases of mutually advantageous exploitation as perfectly acceptable. According to the libertarian approach to justice, transactions or relationships are just if they do not violate basic rights to life, liberty, and property. If two parties both freely consent to a transaction or relationship that benefits each party, then there is nothing morally problematic about the transaction or relationship. Other approaches to justice, such as egalitarianism or utilitarianism, would hold that mutually advantageous situations could be unjust (and exploitative) under some circumstances. For example, a utilitarian could hold that a mutually advantageous transaction or relationship would be unjust when it has a negative impact on social utility. An egalitarian could regard such situations as unjust when they undermine equality of opportunity or do not benefit the least advantaged members of society.16 In order to make sense of the idea of mutually advantageous exploitation, it would be useful to say a bit more about concepts and principles of justice. Unfortunately, there is not sufficient space in this essay to explore and critique even the three approaches to justice mentioned in the previous paragraph. Instead, I would like to focus on two problems that can render relationships or transactions unjust. As we shall see later on, these problems can also occur in biomedical research. The first problem concerns inequitable (or imbalanced) transactions or relationships. Many different theorists, with the possible exception of libertarians, would view inequitable transactions or relationships as unjust.
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A transaction or relationship is inequitable if one party benefits far more than the other party, even though both parties benefit.18 Consider a textile company that moves its operations from the U.S. to Mexico so that it can take advantage of cheap labor. Although the company and the laborers both benefit from this relationship, one might argue that it is very imbalanced because the company benefits far more than the laborers. The company does not share its benefits fairly with the laborers. For another case, consider a star men’s basketball player on scholarship at a major university. Although the player benefits from his enrollment in the university and the opportunity to obtain a college education, the university obtains millions of dollars in ticket sales, merchandizing, television and radio licensing fees, and alumni donations from his participation in athletics. His scholarship costs $20,000 but he is worth $1,000,000 to the university. Even though both sides benefit, the benefits are uneven. As we shall see later, benefit sharing is also an important issue in biomedical research. The second problem concerns relationships or transactions that take advantage of someone’s vulnerabilities. For example, the price gouger is able to charge a high price because his customers are so desperate for help that they are willing to pay him a price well beyond the market value of his services. This transaction is unjust because the price gouger takes advantage of these circumstances. There are many different ways that people may be considered vulnerable: a person may be vulnerable due to his or her psychological, medical, economic, cultural or social characteristics or circumstances.19 From an economic and legal point of view, one might say that vulnerable individuals lack bargaining power.20 One might argue that someone who is vulnerable cannot give free and informed consent. Thus, taking advantage of a vulnerable person is similar to other problems related to the consent process, such as coercion, duress, or undue influence. Taking advantage of vulnerable people is more like violating autonomy or dignity than acting unjustly. Although a person’s vulnerabilities may be so severe that they prevent him or her from giving valid consent, we should allow some conceptual space for saying that consent may be compromised but still valid.21 Even though a person may be more willing to accept an imbalanced offer, due to his or her vulnerabilities, this fact does not imply that he or she is not free to accept or reject the offer. Someone who needs money desperately may be more willing to accept an inequitable loan, but we would not say that his or her acceptance of the offer is invalid, unless we have some evidence of fraud, misrepresentation, duress, coercion, or some other problem with consent. Likewise, a person who is desperately ill may be more likely to agree to participate in a medical experiment, but we would not say that his or her consent is
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invalid, unless we believe there are other conditions, besides his or her illness, that undermine his consent. Vulnerable people can still make valid agreements, and we should still recognize their ability to make free and informed choices. DEGREES OF EXPLOITATION Thus far, I have argued that there are three basic elements of exploitation, harm, disrespect, and injustice, and that all cases of exploitation manifest at least one of those three elements. While it is possible to distinguish between three distinct elements of exploitation for the purpose of developing moral theories and concepts, in the real world these different elements often overlap and interact. For example, the unethical psychotherapist might exploit his victims by harming them and by violating their consent. Some cases of exploitation, such as rape or slavery, may satisfy all three of these basic elements. For example, the slave owner may harm the slave, violate the slave’s dignity or autonomy, and treat the slave unjustly. On the other hand, some cases, such as mutually advantageous exploitation, may satisfy only one element. I think it also makes sense to say that there are degrees of exploitation, ranging from highly exploitative situations, such as slavery, to minimally exploitative situations, such as rent-to-own deals. There are two reasons for thinking that there are degrees of exploitation. First, each of the elements that comprise the concept of exploitation have gradations. For example, murder is more harmful to a person than theft, rape is a greater violation of human dignity than slander, and sending an innocent person to jail for ten years is more unjust than sending an innocent person to jail for one day. If each element of the concept has gradations, then the concept, as a whole, has gradations. Second, other moral concepts, such benefit and deception, have gradations. Giving a starving child a week’s worth of meals is more beneficial to the child than giving the child a day’s worth of meals. Telling a whole series of lies is more deceptive than one lie. If exploitation is like these other moral concepts, then it should have gradations. Thus, I think it makes sense to distinguish between degrees of exploitation ranging from minimally wrongful exploitation, to moderately wrongful exploitation, to highly wrongful exploitation. If there are degrees of exploitation ranging from minimally wrongful to highly wrongful, could there be some cases of wrongful exploitation that are not, all things considered, wrong? Surprisingly, the answer should be “yes” to this question.22 Exploitation (in the non-neutral sense of the word) is prima facie wrongful. That is, other things being equal, one has
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a moral duty to avoid exploitative transactions or relationships. However, this duty is only a prima facie obligation, which can be overridden by other obligations. In any particular case, other moral considerations may justify exploitative conduct, when we are faced with a choice between avoiding exploitation and not avoiding exploitation. While this result may seem counter-intuitive to some, it should not be all that surprising, if we compare exploitation to other moral concepts, such as promising. Although promise breaking is prima facie wrong, one may be justified in breaking a promise in a particular situation. Suppose that I must decide whether to break a promise to a friend to meet him at 12-noon for lunch, or to help my neighbor put out a fire in his backyard. Although breaking a promise is prima facie wrong, in this case breaking a promise is the best thing to do because my other moral obligations outweigh the obligation to not break my promises.23 What moral values or duties might justify exploitation? We might decide to accept an exploitative practice in order to promote social utility. Consider the textile company once again. One might admit that the company is exploitative yet also claim that it should be allowed on the grounds that it benefits many people in a society, provides jobs, economic development, and so on. The social benefits that the company provides justify its exploitation of its workers. One might also argue that exploitative practices can be justified on the grounds that they respect individual rights to liberty, property, or contract. For example, consider a recording company that signs a rock-and-roll band to a contract. Under the terms of the contract, the company will give the band $10,000 in return for 100% of the profits from marketing its first compact disc (CD). The band will receive no royalties from these sales. As it turns out, the company makes $1 million from marketing the CD. One might argue that this contract is exploitative because it takes advantage of the band’s economic vulnerabilities and results in an imbalanced deal. The contract is wrongful. Nevertheless, one might argue that the contract is morally acceptable as long as the musicians give their free and informed consent to it. They have a right to enter into contracts, even exploitative ones, in order to promote their careers. The recording company also has a right to make contracts with musicians, even exploitative contracts. The point of these examples is not to debate the morality of textile factories in the developing world or recording contracts, but to show that calling a human activity exploitative does not prove that the activity is wrong. We need to understand the nature of the exploitation as well as the different moral considerations at stake, before we can determine the activity’s moral status. We may then make a moral judgment as to whether
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the exploitative practice is morally justifiable and whether it should be changed, regulated or eliminated. This type of inquiry has been missing in recent debates about the ethics of human research, since many different authors have made the charge of exploitation without explaining what they mean by this word or how we should respond to this accusation.
EXPLOITATION IN BIOMEDICAL RESEARCH I will now apply the analysis developed in the preceding sections to biomedical research. In biomedical research, potential exploiters are the people who conduct research, the institutions that support research, and the sponsors that fund research. Potential exploitees are the subjects/patients who participate in research. In most of the egregious cases of exploitation in biomedical research, such as the Nazi Experiments, the Tuskegee Syphilis Study or the Willowbrook Hepatitis Experiments, researchers have exploited large groups of subjects. In the disputed HIV research, some commentators have claimed that researchers have deliberately or inadvertently exploited populations in developing nations.24 In some wellknown cases, researchers have exploited individuals. For example, John Moore sued his doctors because they used tissue from a tumor that they removed from his spleen to develop and patent a cell-line without his permission.25 Some other well-known cases of alleged exploitation of individuals include James Phipps, an eight-year-old healthy boy who was the subject of Edward Jenner’s test of a smallpox vaccination,26 and Baby Fae, the infant who received an experimental baboon heart transplant in an attempt to keep her alive long enough to receive a human heart.27 Exploitation and Harmful Research Since medical research often results in a variety of benefits and harms to research subjects, completely harmless research is rare. Even studies classified as “no more than minimal” risk are not harmless, since minimal risk is defined by U.S. Federal Regulations as the level of risk encountered in routine medical tests or examinations or in ordinary life.28 Potential harms to subjects include physical, psychosocial, economic, social, and legal harms. The risk associated with new chemotherapy treatments range from nausea, dizziness, and headaches to kidney failure, liver failure, and death. Even surveys of attitudes and beliefs can cause subjects to relive painful and traumatic experiences. Placebo-controlled studies often have benefit/harm ratios that are unfavorable to the individual subjects that receive placebos, since these individuals do not receive a medically proven
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effective therapy but may still face the risks of non-treatment as well as the risks associated with tests and procedures used in the study. If the benefits outweigh the harms for the individual subject, then a research study is not harmful to the subject because the subject stands to gain from participating in research and is not made worse-off by the research. But suppose that the benefit/harm ratio is not favorable to the subject but favorable to other patients or biomedical science. Should this research be regarded as exploitative? According to the analysis defended here, such research may be exploitative because benefits accrue to people other than the research subject. Although it might seem to many readers that this research is not exploitative, suppose that a study has no potential benefits to other patients or medical science. Suppose a researcher is testing a new drug on a single patient but that his experiments will not obtain useful results, due to the difficulties in generalizing from this single case to other patients. We would all agree that this experiment would be exploitative. What makes an experiment that harms a human subject morally acceptable to us is that the subject (or his surrogate decisionmaker) has consented to the research and the research is expected to benefit other patients or medical science. Although these moral considerations justify the experiment, the experiment is still exploitative. All of the influential human research policies and codes hold that research can be justified because it may benefit other patients, science or society, even though the benefit/harm ratio does not favor individual subjects.29 The U.S. Federal Regulations make this point explicit by stating that risks to subjects should be minimized and that risks to subjects should be reasonable “in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be reasonably expected to result”.30 The Federal Regulations have several different risk categories for minors in research, but they still allow research to be conducted when the benefit/harm ratio favors other patients or medical science instead of the patient.31 The Declaration of Helsinki of the World Medical Association also affirms the notion that the benefit/harm ratio need not favor the individual subject but should favor the population: “Medical Research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research”.32 Many of the controversial studies in human subjects research have involved disputes about justifying the exploitation of individuals in order to benefit other people or medical science. For example, the researchers who conducted the Willowbrook Hepatitis Experiments believed that deliberately infecting mentally disabled children could be justified on the basis of benefits to subjects, other patients, or to medical science, but many
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commentators disagreed with their assessment of their own experiments.33 Stanley Milgram argued that his obedience to authority experiments, which involved deception of subjects and some psychological harm, could be justified based on the knowledge to be gained about human psychology, but many commentators have disputed the assertion.34 Some of the researchers who conducted the U.S. government’s secret radiation experiments on human beings believed that these experiments were justified as a means of obtaining important information to be used in the Cold War.35 In studies where individual patients are not expected to benefit, the key issue is whether the harms to the individual patient/subjects can be justified in relation to the benefits to other people. If a study has little or no chance of benefiting other people but will harm the subjects, then most people would agree that it is not justified. If a study will cause only minimal harms to subjects but will offer many potential benefits to other people, then most people would agree that the study is justified. The hard cases lie somewhere in between these two extremes. Exploitation and Disrespectful Research Many of the most disturbing historical cases of exploitation in human subjects research involve problems with lack of respect for human dignity or autonomy. The Nazi researchers simply conscripted their subjects with no pretense of consent.36 In the Tuskegee Syphilis study, the researchers violated their patient’s informed consent by not telling them that they were participating in experiments and by withholding important information from them, such as the availability of antibiotics to treat syphilis.37 Inadequate consent was also a problem with The Human Radiation Experiments.38 While most researchers today obtain the proper documentation for informed consent, many different commentators have questioned the quality and meaningfulness of the consent process. Informed consent should be much more than signing a piece of paper: it should be an ongoing dialogue between the researcher and the subject. A researcher may uphold the letter of the law of informed consent while violating the spirit of the law by failing to communicate honestly and openly.39 A growing body of empirical research has documented a number of different problems that can arise in the consent process, including the therapeutic misconception, conflicts of interest, and difficulties in communication.40 Every major research ethics code or regulation addresses informed consent duties and requirements. The most difficult question relating to consent to determine whether it might be ethical, in some circumstances, to conduct research that violates or does not completely satisfy consent requirements. One important exception to the informed consent require-
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ment is emergency research: if the patient is incapable and making a decision and his or her surrogate decision-maker cannot be contacted, then it may be acceptable to perform procedures needed to save his or her life or prevent a serious worsening of his or her medical condition, in an emergency situation. Although this research violates informed consent, one might still argue that it is morally justified because it is likely to benefit the patient, and presumably the subject or his or her surrogate would agree to participating in the experiment.41 There are many research studies that cannot be conducted effectively if the subjects or their surrogate are fully informed. One might argue that one does not need to meet the full requirements of informed consent in these studies. For example, in Milgram’s experiments on obedience to authority, the subjects would have behaved much differently if they knew that they were not really following orders to give someone an electric shock.42 One could argue that Milgram’s research was exploitative because he deceived his subjects about the nature of the research and some of his subjects suffered psychological harm as a result of their participation. But calling deceptive research ‘exploitative’ still does not settle the question of whether such research is immoral, since one might argue that some non-consensual research can be justified if the research may answer important scientific questions, it does not involve significant harm to subjects and there are procedures to debrief subjects after the experiments are concluded.43 Issues relating to consent may also arise when the subjects have a diminished capacity for decision-making that could undermine their ability to give consent. Children, prisoners, the mentally disabled, and the gravely ill may have diminished decision-making capacity. Although most people accept the idea that a surrogate may make a decision for a subject/patient who lacks decisional capacity, there is less agreement about how to address the situation in which the subject with diminished capacity makes a decision. For example, a patient who has a mental illness, such as depression or schizophrenia, may lack the ability to understand or appreciate information and may have difficulties with reasoning and communication. He or she may also become disoriented with respect to time, place, or person and have delusional beliefs. If a patient with diminished capacity consents to participate in an experiment, then we might regard this research as exploitative because it takes advantage of the patient’s diminished capacity. But once again, calling this research ‘exploitative’ would not settle the question of whether it is wrongful, since one might argue that some studies offer important benefits to patients with diminished capacity, to other patients, and to medical science. One might argue that non-
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consensual research on patients with mental illnesses can be justified if adequate provisions are made to protect these patients from harm.44 Exploitation and Unjust Research Most of the infamous studies mentioned previously in this essay were harmful, disrespectful, and unjust. These studies either took advantage of vulnerable populations or resulted in inequitable transactions or relationships (or both). Almost everyone would agree that a research study that harms vulnerable patients and violates their consent is exploitative and unjustified. But how should we regard research that is mutually advantageous? Would such research be exploitative? If it is exploitative, could it still be justified? One might regard some mutually advantageous research as exploitative because it results in an inequitable distribution of benefits or it takes advantage of vulnerable subjects. For example, consider the development of a genetic database compiled from several sources, including blood samples, skin scrapings, and tissue collected as part of routine surgical interventions associated with medical diagnosis or treatment. The patients will not be compensated for their tissue. The tissue samples will be studied to determine their genetic, biochemical, and morphological characteristics. The researchers may or may not be able to develop patentable products from the research. If they do, the subjects will not be compensated. The researchers may be able to sell access to a tissue database, but patients will not share in the profits from licensing fees. Let us suppose that the patients obtain some nominal benefit from this study in that they gain the satisfaction of knowing that they have helped the cause of medical research. But it is likely that the researchers, the research institutions, the research sponsors, and other patients will gain far more from this study than the patients will gain. Since this research does not share benefits evenly, one might argue that this study is exploitative, even though both sides benefit. But would it be immoral? One might argue that this type of study would not be immoral because it offers considerable benefits to society and to medical research. As long as the study minimizes risks to patients, protects privacy and confidentiality, allows patients to withdraw from the study, and has adequate procedures from obtaining informed consent, then the study is ethical, even though the distribution of its benefits is inequitable.45 On the other hand, one might say that the study is immoral because it allows researchers to profit from patients and it has no procedures for sharing benefits.46 If the researchers discover and patent some valuable genes, then the patients will not benefit.
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Let’s consider another example. Many healthy people make a living as research subjects in medical research. The average wage for research participation has been estimated at about $10 per hour, which is roughly equivalent to the average wage of a non-farm production worker.47 Although these subjects benefit from research participation, one might argue that they are being grossly underpaid, given the risks, discomforts, and other burdens they must bear. One might also argue that subjects who attempt to earn a living as research participants are usually economically disadvantaged and are therefore willing to accept this unfair wage in order to make money. Underpayment of research subjects is therefore a classic case of exploitation in research.48 One might argue that the current payment system is unjust and ought to be revised to allow research subjects to receive a fair wage for their labor.49 On the other hand, one might claim that paying subjects more money for participation could undermine consent through undue influence or could transform research into a business and negate altruistic motives for participation.50 The point of these examples is not to settle questions about compensating research subjects for their participation in research but to demonstrate that there are cases of mutually advantageous exploitation in research, and that we may disagree about whether these cases are morally justifiable. It would therefore be simplistic and misleading to describe these cases as exploitative/immoral. Describing such cases as exploitative is a way of calling our attention to some of their wrongful features, but it does not end our moral discussion. Even if we decide that these cases are exploitative, we must also decide whether they are ethical, unethical, or ethical only if conducted under specific conditions. Exploitation in HIV Research Before concluding this essay, I would like to apply this analysis to a case that has received considerable attention and which I have already mentioned in this essay. As noted earlier, one of the charges made in the controversial HIV research was the allegation of exploitation. For readers unfamiliar with this example, the study enrolled approximately 12,000 HIV-infected women from nine countries in the developing world. Officials from the National Institutes of Health, the World Health Organization, and UNAIDS convened in 1994 to design these studies after the AIDS Clinical Trial Group had demonstrated the effectiveness of the 076 protocol in reducing the transmission of HIV from mother to infant. The 076 protocol requires women to take approximately $800 worth of zidovudine (or AZT), which is a cost far above the per capita health care allocation in these nations. The 076 protocol also requires a significant
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health care infrastructure to support patients who are receiving care. In order to find a cheaper and easier way of preventing the mother-infant transmission of HIV, researchers decided to determine whether it would be possible to achieve success using ten times less AZT. The rationale for testing this hypothesis is that it would help people in developing nations obtain access to an affordable and realistic way of preventing the perinatal transmission of AZT. In order to test this hypothesis, researchers administered placebos to subjects in several of these studies. They argued that a placebo-control group was necessary in order to prove that a lower dose of AZT is effective in developing world populations. The use of placebos was suspended after the studies proved that $80 worth of AZT can reduce the transmission rate by 50%. Critics of these studies argued that they violated international research ethics principles because they denied an effective therapy to patients. Critics also said that the studies constituted a doublestandard because the same studies would be viewed as unethical in the U.S. or in any other developed nation.51 With the analysis of exploitation developed in this paper, we now have some additional insight into how these studies may have been exploitative. Our first inquiry should be: were the studies harmful to the subjects? The studies offered some benefits to patients who took AZT but denied these benefits to patients taking placebos. All patients received some routine medical care in addition to experimental drugs or placebos. The patients who took placebos were conceivably harmed by this study, because they were denied therapy. But does denial of therapy always constitute a type of harm? When we think of harm in an ordinary context, we associate harm with acts of commission, such as punching someone, giving someone a dangerous drug, etc. However, in a medical context, acts of omission can be considered harmful, since health care professionals have positive duties to benefit patients, which are set by the standard of care.52 A doctor can harm his patient by failing to recommend a medical test, by failing to prescribe a drug, by failing to inform the patient about risks, etc. Thus, one might argue that the patients taking the placebos were harmed because they were denied therapy. If they were harmed, and if they did not receive any significant benefits that outweigh those harms, then these subjects were exploited. On the other hand, one might also argue that the positive duty to benefit patients is a duty to provide the standard of care within the limitations of one’s reasonably available medical resources. One is not morally (or legally) required to do something that is practically impossible to do. For example, a physician has no moral or legal duty to obtain a Magnetic Resonance Imaging (MRI) test for a patient with abdominal pain if she
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is practicing in an undeveloped country and there are no MRI machines within 1,000 miles of her clinic. On the other hand, she may have a duty to procure an MRI if there is an MRI machine in a hospital that is only 20 miles away. Although there is a single standard of care, we may allow physicians to deviate from that standard due to their difficulties in acquiring access to local resources. In the HIV case, very few patients had access to HIV medications prior to the experimental trial. A doctor treating a patient with HIV in such a setting would not be expected to provide his or her patient with AZT, due to the fact that it was not reasonably available. This practical limitation does not change when the patient becomes a research subject. Whether the patient receives AZT or a placebo, the duty is to provide the standard of care within the limitations of one’s reasonably available resources. The physician does not violate this duty when the treatment is not reasonably accessible. Thus, the researchers who gave patients placebos did not harm those patients because they had no positive duty to provide them with AZT.53 Our next inquiry should be: did the researchers respect the dignity and autonomy of their patients/subjects? If the patients did not consent to these studies, then we could regard these studies as disrespectful. Although the studies included informed consent as part of the research design, and the researchers made sincere efforts to obtain consent, some reports have indicated that the consent process was far from ideal. Many of the subjects thought they would be getting treatment even if they received a placebo; they succumbed to the therapeutic misconception that affects so much clinical research.54 The subjects’ decision-making capacity was also probably compromised due to poverty, lack of education, and cultural and linguistic differences. Given these circumstances, one could argue that many of the subjects in these studies were exploited. Even though the study design included provisions for informed consent, the researchers did not implement the design effectively. Our final inquiry should be to address questions relating to justice. One might argue that these studies were unjust because they were highly inequitable or took advantage of vulnerable populations. One might argue that research was inequitable because the researchers, research institutions, and sponsoring organizations benefited more from the studies than the subjects. Although the babies born without HIV clearly benefited from the study, most of the female participants did not have access to AZT medication at the conclusion of the study, due to the prohibitive cost of even $80 worth of the medication and insufficient local public health resources.55 One might also argue that research was unjust because it took advantage of subjects who were vulnerable as a result of their economic, social, cultural,
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and medical conditions. On the other hand, one might argue that the studies were equitable because they offered benefits to individual subjects as well as to the patient population, since future patients will benefit from having access to affordable medications to prevent perinatal HIV transmission. Pharmaceutical companies have also helped out with problems related to access to medications by cutting the drug prices and offering free medications. In order to settle questions about injustice in this case, we need a more complete analysis of justice in research as well as more specific facts pertaining the distribution of benefits and burdens in these studies. As one can see from my discussion of this case, one could argue that the disputed research was harmful, disrespectful, or unjust. Indeed, those who have described the research as exploitative have focused on one or more of these three concerns. On the other hand, proponents of the research have sought to counter the charge of exploitation by arguing that the studies were not exploitative. Suppose that one concludes that these studies exploited those individuals that received placebos and possibly some other subjects. Does it automatically follow that they were unethical? According to the analysis I am proposing here, the inference from “X is exploitative” to “X is morally wrong” does not follow with logical necessity, since the moral reasons in favor of X may outweigh the wrongfulness of its exploitative features. Even if we suppose that the HIV studies exploited individuals or groups, the studies still could be justified on the grounds that they benefited patients, society, or medical science generally. Proponents of the study argued that the study could be justified on scientific and utilitarian grounds: the experimental design was a necessary means to developing inexpensive and effective methods for preventing the perinatal transmission of HIV.56 These studies were not very different from other studies that use placebocontrols. Although individual subjects who receive placebos may have an unfavorable risk-benefit ratio, the research can be justified when it is expected to benefit other patients or medical science.57 On the other hand, opponents of the research argued that these experiments were exploitative and immoral because they used placebo control groups in developing nations, even though an effective therapy was available in developed nations.58 According to the Declaration of Helsinki, “The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.”59 The Declaration is saying, in effect, that it is ethical to give a placebo in research, unless there is a proven, effective therapy. Since the
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076 protocol was a proven, effective therapy when these HIV studies were conducted, then these studies were unethical, according to the Declaration. Opponents also challenged the claim that these experiments benefited (or were likely to benefit) other patients or society on the grounds that the treatment that was tested would still not be available to patients in developing countries due to its high cost. Although a reduction in cost from $800 to $80 is significant, most of the people in the countries that participated in this research cannot afford even the $80 per patient cost of AZT. The results of the research must be “reasonably available” to the patient population in order to justify the research, according to these critics.60 According to Guidelines issued by the Council for the International Organization of Medical Sciences (CIOMS), Before undertaking research in a population or community with limited resources, the sponsor and the researcher must make every effort to ensure that: the research is responsive to the health needs and the priorities of the population or community in which it is to be carried out; and any intervention or product developed, or knowledge generated, will be made reasonably available for the benefit of that population or community.61
On the other hand, one might argue that there is still a great deal of ambiguity in the phrase “reasonably available.”62 Should the medication be available for free? For $80? For $20? Unless all governments decide to subsidize international research on infectious diseases, pharmaceutical companies will have to cover the cost of a great deal of this research. If they are to obtain a reasonable return on their research and development costs, then they must balance their need to make a profit against their social responsibilities to developing nations.63
CONCLUSION In this essay I have developed an analytical framework for thinking about exploitation in biomedical research. I have argued that exploitation in research occurs when one takes advantage of a research subject unfairly. There are three basic elements of exploitation, harm, disrespect, and injustice. An exploitative study may satisfy one or more of these elements. There also can be degrees of exploitation, ranging from highly exploitative studies to minimally exploitative ones. Although highly exploitative research is immoral, minimally exploitative research may be morally justified because other moral considerations may outweigh the wrongfulness of exploitation. The exploitation of individuals in biomedical research can sometimes be justified on the grounds that it respects autonomy or benefits other patients, society, or medical science. Describing research as exploit-
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ative focuses our attention on some of its wrongful features, but it does not settle the question of whether the research is morally justified.64 The take home message of my essay is that exploitative research may be still ethical under some circumstances. Indeed, it is likely that a great deal of biomedical research is minimally exploitative yet still morally justified.65 This may sound counter-intuitive and even scandalous to those readers who use the word ‘exploitation’ in a casual and freewheeling way, i.e., as a substitute for ‘immoral’, ‘unethical’, ‘unjust’, or any other term that connotes disapproval. But I am perfectly willing to annoy some readers in order to promote more careful attention to our use of language in debates about bioethical issues. Instead of impulsively labeling a study as exploitative, we should ask the hard questions, i.e., in what way is it exploitative? Is it wrong? And what should we do about it?
ACKNOWLEDGMENTS I would like to thank John Davis, Loretta Kopelman, and two anonymous reviewers for useful comments. I have presented a version of this paper to the Department of Medical Humanities and the Department of Biology at East Carolina University during October 2002. I have benefited from helpful questions and comments from these audiences. I would also like to thank Georganne Perry for assistance in preparing the manuscript.
NOTES 1 See J. Katz, Experimentation with Human Beings (New York: Russell Sage Foundation,
1972); R. Veatch, The Patient as Partner: A Theory of Human Experimentation Ethics (Indianapolis: Indiana University Press, 1987). 2 National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. The Belmont Report. Reprinted in Ethics of Research with Human Subjects: Selected Policies and Resources, eds. J. Sugarman, A. Mastroianni and J. Kahn (Frederick, MD: University Publishing Group, 1998), p. 30. 3 Advisory Committee on Human Radiation Experiments, Final Report of the President’s Advisory Committee (New York: Oxford University Press, 1996), p. 502. 4 L. Glantz, G. Annas, M. Grodin and W. Mariner, “Research in Developing Countries: Taking Benefit Seriously,” Hastings Center Report 28(6) (1998): 39. 5 R. Crouch and J. Arras, “AZT Trials and Tribulations,” Hastings Center Report 28(6) (1998): 29. 6 See, for example, M. Angell, “The Ethics of Clinical Research in the Third World,” The New England Journal of Medicine 337 (1997): 847–849; P. Lurie and S. Wolf, “Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries,” The New England Journal of Medicine 337 (1997):
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853–856; H. Varmus and D. Satcher, “Ethical Complexities of Conducting Research in Developing Countries,” The New England Journal of Medicine 337 (1997): 1000–1005; D. Resnik, “The Ethics of HIV Research in Developing Nations,” Bioethics 12 (1998): 286–306, and “The Human Genome Diversity Project: Ethical Problems and Solutions,” Politics and the Life Sciences 18(1) (1999): 15–24; E. Mbidde, “Bioethics and Local Circumstances,” Science 279 (1998): 155; R. Bayer, “The Debate over Maternal-Fetal HIV Transmission Prevention Trials in Africa, Asia, and the Caribbean: Racist Exploitation or Exploitation of Racism?,” American Journal of Public Health 88 (1998): 567–570; S. Benatar, “Avoiding Exploitation in Clinical Research,” Cambridge Quarterly of Healthcare Ethics 9 (2000): 562–565; K. Bhagat and N. Nyazema, “Ethics and HIV Research in Zimbabwe,” Central African Journal of Medicine 46 (2000): 105–107; F. Miller and H. Brody, “What Makes Clinical Trials Unethical?,” American Journal of Bioethics 2(2) (2002): 2–10. 7 R. Macklin, “After Helsinki: Unresolved Issues in International Research,” Kennedy Institute of Ethics Journal 11 (2001): 23, 25. 8 See, for example, the collection of essays in Modern Theories of Exploitation, edited A. Reeve (Beverely Hills, CA: Sage Publications, 1987); J. Feinberg, Harmless Wrongdoing (New York: Oxford University Press, 1988); A. Wood, “Exploitation,” Social Philosophy and Policy 12 (1995): 136–150; N. Holmstrom, “Exploitation,” Canadian Journal of Philosophy 7 (1997): 353–370; A. Carling, “Exploitation,” in Encyclopedia of Applied Ethics, Vol. 2, edited by R. Chadwick (San Diego: Academic Press, 1998), pp. 219–232; R. Arneson, “Exploitation,” in Encyclopedia of Ethics, Vol. 1, edited by L. Becker and C. Becker (New York: Routledge, 2001), pp. 515–517. Karl Marx developed a specific notion of exploitation that I will not explore here. See J. Elster, Making Sense of Marx (Cambridge, Cambridge University Press, 1985). Although Immanel Kant does not use the word “exploitation” in his work, many scholars view his humanity-as-an-end formulation of the categorical imperative as prohibiting exploitation. See I. Kant, Grounding for the Metaphysics of Morals, translated by J. Ellington (Indianapolis: Hackett, 1981 [1785]). 9 A. Wertheimer, Exploitation (Princeton: Princeton University Press, 1996), p. 5. 10 Wertheimer, cited in note 9, p. 10. 11 Wertheimer, cited in note 9, pp. 13–14. 12 Wertheimer, cited in note, p. 15. 13 Wertheimer, cited in note 9, pp. 13–14. I part company with Wertheimer’s analysis on this element of exploitation. Wertheimer uses inadequate consent as one of the elements of exploitation. Although inadequate consent is problematic, I view lack of respect for persons as the deeper problem with lack of consent. 14 Controversies relating to the adequacy of consent usually focus on the degree of voluntariness, information, or decision-making capacity that are required for adequate informed consent, whether a particular decision can be made by an authorized representative proxy, or whether a particular person qualifies as an authorized representative. See J. Berg, P. Appelbaum, C. Lidz, and L. Parker, Informed Consent: Legal Theory and Clinical Practice (New York: Oxford University Press, 2001); A. Buchanan and D. Brock, Deciding for Others (Cambridge: Cambridge University Press, 1989); S. Wear, Informed Consent: Patient Autonomy and Physician Beneficence within Health Care, 2nd ed. (Washington: Georgetown University Press, 1998). 15 Wertheimer, cited in note 9, pp. 14–15. 16 Wertheimer, cited in note 9, p. 25. For further discussion of libertarianism see R. Nozick, Anarchy, State, and Utopia (New York: Basic Books, 1975). For further discussion
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of utilitarianism and egalitarianism, see J. Rawls, A Theory of Justice (Cambridge, MA: Harvard University Press, 1971). 17 Rawls, cited in 16, p. 85. 18 In contract law, the courts have developed a common law doctrine of unconscionability, which applies to cases that involve inequitable contracts. A court may rule that a contract in unenforceable due to gross inequities. See J. Calamari and J. Perillo, The Law of Contracts, 4th ed. (St. Paul, MN: West Group), pp. 365–376. 19 R. Levine, Ethics and the Regulation of Clinical Research (New Haven, CT: Yale University Press, 1986), pp. 67–93. 20 Wertheimer, cited in note 9, pp. 25–28. 21 Berg, Appelbaum, Lidz and Parker, cited in note 14. 22 Wertheimer, cited in note 9, pp. 28–32. 23 A fuller discussion of moral reasoning is beyond the scope of this essay. The view I employ in this essay could be described as a principal-based approach, since I am claiming that we should weigh and consider moral principles in moral judgment and decisionmaking. For further discussion, see R. Fox and J. DeMarco, Moral Reasoning (Fort Worth, TX: Holt, Rinehart, and Winston, 1990); O. O’Neill, “Practical Principles and Practical Judgment,” Hastings Center Report 31(4) (2001): 15–23; T. Beauchamp and J. Childress, Principles of Biomedical Ethics, 5th ed. (New York: Oxford University Press, 2001); W. Ross, The Right and the Good (Oxford: Oxford University Press, 1930); B. Hooker and M. Little eds., Moral Particularism (New York: Oxford University Press, 2000). 24 Glantz, Annas, Grodin and Mariner, cited in note 4. 25 Moore v. Regents of the University of California, 51 Cal. 3d 120 (1990). In a concurring and dissenting opinion in this case, Justice Broussard objected to the majority’s holding that Moore could not sue for conversion because he did not have a property interest in his own cells. According to Broussard, “Far from elevating these biological materials above the marketplace, the majority’s holding simply bars the plaintiff, the source of cells, from obtaining the benefit of the cells’ value, but permits defendants, who allegedly obtained the cells from plaintiff by improper means, to retain and exploit the full economic value of their ill-gotten gains . . .” Moore, 51 Cal 3d at 161. For further discussion of exploitation in the Moore case, see L. Andrews and D. Nelkin, Body Bazaar (New York: Crown Publishers, 2000), pp. 24–41. 26 R. Porter, The Greatest Benefit to Mankind (New York: WW Norton, 1997), pp. 276– 277. 27 G. Pence, Classic Cases in Medical Ethics, 2nd ed. (New York: McGraw-Hill, 1995), pp. 314–327. 28 45 C.F.R. 46, subpart A § 46.102(i). 29 Levine, cited in note 19. I use the phrase “benefit/harm ratio” because I think the commonly used phrase “risk/benefit ratio” is epistemologically and morally misleading. It is epistemologically misleading because “risk” is a statistical concept defined in terms of the product of the probability and magnitude of harm, while “benefit” is not a probabilistic concept. A “probable benefit,” “expected benefit,” or “opportunity” would be a better complement for “risk.” Benefit/harm is morally misleading because one would hope that expected benefits outweigh risks. Thus a favorable ratio would be where expected benefits/risks > 1.0, not a ratio where risks/expected benefits > 1.0. 30 45 C.F.R. 46, subpart A § 46.111(a2). 31 45 C.F.R. 46, subpart D § 46.405–46.407.
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32 World Medical Association, Declaration of Helsinki (Helsinki, Finland: World Medical Association, 2000), section B, paragraph 19. 33 D. Rothman, “Were Tuskegee & Willowbrook ‘Studies in Nature’?,” Hastings Center Report 12(2) (1982): 5–7. 34 S. Milgram, “Subject Reaction: The Neglected Factor in The Ethics of Experimentation,” Hastings Center Report 7(4) (1977): 19–23. 35 Advisory Committee on Human Radiation Experiments, note 3. 36 Katz, cited in note 1. 37 J. Jones, Bad Blood (New York: Free Press, 1980). 38 Advisory Committee on Human Radiation Experiments, note 3. 39 Veatch, cited in note 1. 40 J. Sugarman et al., “Empirical Research on Informed Consent: An Annotated Bibliography,” Hastings Center Report 29(1) (Supplement) (1999): S1–S42. 41 M. Biros et al., “Informed Consent in Emergency Research: Consensus Statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers,” Journal of the American Medical Association 273 (1995): 1283–1287. 42 S. Milgram, Obedience to Authority (New York: Harper and Rowe, 1974). 43 R. Levine, cited in note 19, pp. 221–228. Federal Regulations allow Institutional Review Boards to approve proposals that deviate from the informed consent requirements if the research cannot be practically conducted with an alteration or waiver of consent. 45 C.F.R. 46, subpart A § 46.116(d). 44 National Bioethics Advisory Commission (NBAC), Research Involving Persons with Mental Disorders that May Affect Decision-Making Capacity (Washington: NBAC, 1998). 45 L. Beskow et al., “Informed Consent for Population-Based Research Involving Genetics,” Journal of the American Medical Association 286 (2001): 2315–2321; E. Clayton et al., “Informed Consent for Genetic Research on Stored Tissue Samples,” Journal of the American Medical Association (1995) 274: 1786–1792. 46 Andrews and Nelkin, cited in note 25, pp. 24–41. 47 N. Dickert and C. Grady, “What’s the Price of a Research Subject? Approaches to Payment for Research Participation,” New England Journal of Medicine 341 (1999): 198– 203. 48 R. Ashcroft, “Money, Consent, and Exploitation in Research,” American Journal of Bioethics 1(1) (2001): 62–63. 49 T. Lemmens and C. Elliott, “Guinea Pigs on the Payroll: The Ethics of Paying Research Subjects,” Accountability in Research 7 (1999): 3–20. 50 R. Macklin, “Due and Undue Inducements: On Paying Money to Research Subjects,” IRB: A Review of Human Subjects Research 3(5) (1981): 1–6; T. Chambers, “Participation as Commodity, Participation as Gift,” American Journal of Bioethics 1(1) (2001): 48. 51 For further discussion, see Angell, cited in note 6. 52 Beauchamp and Childress, cited in note 23. 53 For more on the standard of care in international research see A. London, “The Ambiguity and the Exigency: Clarifying ‘Standard of Care’ Argument in International Research,” Journal of Medicine and Philosophy 25 (2000): 379–398 and R. Levine, “The Need to Revise the Declaration of Helsinki,” The New England Journal of Medicine 341 (1999): 531–534. For a case discussing the legal standard of care, the locality rule, and practical limitations, see Hall v. Hilbun, 466 So.2d 856 (Miss. 1985). The court held that the skills, knowledge, and competence that define the standard of care should be the same
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everywhere but that the physician is not at fault for failing to provide access to resources that are not reasonably available. 54 H. French, “AIDS Research in Africa: Juggling Risks, Hopes,” The New York Times (October 19, 1997): A1, A14. 55 U. Schüklenk, “Unethical Perinatal HIV Transmission Trials Set a Bad Precedent,” Bioethics 12 (1998): 312–319. 56 Varmus and Satcher, cited in note 6. 57 Levine, cited in note 53. 58 Lurie and Wolf, cited in note 6. 59 Declaration of Helsinki, note 32, section C, paragraph 29. 60 Schuklenk, cited in note 55. 61 Council for International Organization of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects, Revised draft (Geneva: CIOMS, 2002), guideline 10. 62 D. Cooley, “Distributive Justice and Clinical Trials in the Third World,” Theoretical Medicine 22 (2001): 151–167. 63 D. Resnik, “Developing Drugs for the Developing World: An Economic, Legal, Moral, and Political Dilemma,” Developing World Bioethics 1 (2001): 11–32. 64 I. Hacking suggests that the primary function of concept of exploitation is to raise consciousness. See his book The Social Construction of What? (Cambridge, MA: Harvard University Press, 1999), pp. 5–6. 65 The concept of “minimal exploitation” may set of a few alarms for people who find the concept of “minimal harm” to be vague and confusing. I don’t need to define “minimal exploitation” in order to make my main point that exploitative research can sometimes be justified.
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Biros, M. et al. “Informed Consent in Emergency Research: Consensus Statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers.” Journal of the American Medical Association 273 (1995): 283–1287. Buchanan, A., Brock, D. Deciding for Others. Cambridge: Cambridge University Press, 1989. Calamari, J., Perillo, J. The Law of Contracts, 4th ed. St. Paul, MN: West Group, 1999. Carling, A. “Exploitation,” in Encyclopedia of Applied Ethics, Vol. 2, edited by R. Chadwick. 219–232. San Diego: Academic Press, 1998. Chambers, T. “Participation as Commodity, Participation as Gift.” American Journal of Bioethics 1(1) (2001): 48. Clayton, E. et al. “Informed Consent for Genetic Research on Stored Tissue Samples.” Journal of the American Medical Association 274 (1995): 1786–1792. Cooley, D. “Distributive Justice and Clinical Trials in the Third World.” Theoretical Medicine and Bioethics 22 (2001): 151–167. Crouch, R., Arras, J. “AZT Trials and Tribulations.” Hastings Center Report 28(6) (1998): 29. Council for International Organization of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects, Revised draft. Geneva: CIOMS, 2002. Dickert, N., Grady, C. “What’s the Price of a Research Subject? Approaches to Payment for Research Participation.” New England Journal of Medicine 341 (1999): 198–203. Elster, J. Making Sense of Marx. Cambridge, Cambridge University Press, 1985. Fox, R., DeMarco, J. Moral Reasoning. Fort Worth, TX: Holt, Rinehart, and Winston, 1990. Glantz, L., Annas, G., Grodin, M., Mariner, W. “Research in Developing Countries: Taking Benefit Seriously.” Hastings Center Report 28(6) (1998): 39. Hacking, I. The Social Construction of What?. Cambridge, MA: Harvard University Press, 1999. Hall v. Hilbun, 466 So.2d 856 (Miss. 1985). Holmstrom, N. “Exploitation.” Canadian Journal of Philosophy 7 (1997): 353–370. Hooker, B., Little, M., eds. Moral Particularism. New York: Oxford University Press, 2000. Feinberg, J. Harmless Wrongdoing. New York: Oxford University Press, 1988. French, H. “AIDS Research in Africa: Juggling Risks, Hopes.” The New York Times (October 19, 1997): A1, A14. Jones, J. Bad Blood. New York: Free Press, 1980. Kant, I. Grounding for the Metaphysics of Morals, translated by J. Ellington. Indianapolis: Hackett, 1981 [1785]. Katz, J. Experimentation with Human Beings. New York: Russell Sage Foundation, 1972. Lemmens, T., Elliott, C. “Guinea Pigs on the Payroll: The Ethics of Paying Research Subjects.” Accountability in Research 7 (1999): 3–20. Levine, R. Ethics and the Regulation of Clinical Research. New Haven, CT: Yale University Press, 1986. Levine, R. “The Need to Revise the Declaration of Helsinki.” The New England Journal of Medicine 341 (1999): 531–534. London, A. “The Ambiguity and the Exigency: Clarifying ‘Standard of Care’ Argument in International Research.” Journal of Medicine and Philosophy 25 (2000): 379–398.
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