This case focuses on how to separate what is legally required of the researcher from his/her ethical responsibility as a scientist working with human subjects.
From: Graduate Research Ethics: Cases and Commentaries - Volume 3, 1999
edited by Brian Schrag
John, a licensed psychologist, is Principal Investigator for the "Assist" Project. His project is designed to identify behavioral trends among HIV+ adults in the New York City area. Participants were recruited from HIV/AIDS support groups, HIV/AIDS advocacy and service organizations, and through publicity in local bars, clinics and media outlets. John uses several measures to identify patterns among these individuals. He looks at help-seeking behaviors, physical and emotional symptoms, nutrition and diet habits, sexual behavior and knowledge of HIV/AIDS.
John uses an individual interview format as the method for the study. Each participant is asked to sign an informed consent form, which guarantees that all information revealed during the interviews will be kept confidential. The consent form describes the study and informs participants of the risks involved, which John identifies as minimal. Each participant is paid $50 for each interview. Participants in the study are also provided free psychological counseling and medical care. Participants are interviewed three times over a two-year period.
In accordance with the research protocol, John asks a participant during one of the initial interviews about her current sexual practices. The participant tells John that she is having unprotected sex with her boyfriend. She states that her boyfriend does not know about her HIV status and that she has no plans to reveal her condition. Later during the interview she mentions the name of her boyfriend. John notes the information and continues with the interview.
Upon going back to his office, John becomes anxious about what he was told by the participant. He ponders what he should do. John thinks about his moral responsibility from a relational perspective, assessing the ethical problem from the standpoint of his responsibility to preserve the scientific integrity of the project, the participants' confidentiality and the boyfriend's welfare.
John thinks about the following facts:
Posted 13 years and 1 month ago
Brian Schrag Association for Practical and Professional Ethics
In this case, the human subjects may have given informed consent to participate in the study. It is not so obvious that their consent is voluntary, however. The subjects are HIV+ adults. In exchange for participating in the program for two years, they are provided free medical care, psychological counseling and $50. Those are very powerful incentives for members of this population to participate in the study.
John must decide what to do when he learns that one of his subjects is having unprotected sex with a partner who is unaware of her HIV status and that she has no plans to inform her partner. Several alternatives are open to John: 1) He can do nothing and simply continue his research. 2) He can try very hard to convince the subject to inform her partner. 3) He can alert the subject's partner that he/she may be at risk for AIDS even if that means disclosing the subject's HIV status. 4) He may be able to alert the partner that he/she may be at risk for AIDS without disclosing the subject's HIV status (e.g., by having a third party inform the partner). Of course, there are other intermediate steps he may take that would lead to one of these outcomes.
It is worth noting that this situation could easily be anticipated before the study begins. began. There may be alternatives in the design of the study, particularly with respect to the informed consent process, which might avoid the issue in the first place. More about that later.
The stakeholders in this case include 1) the subject; 2) the subject's partner; 3) society, which may be benefited or harmed depending on whether John's action in dealing with the knowledge of this subject's behavior contributes to the spread or control of AIDS; 4) the HIV+ community and the general society, which may benefit from the results of John's study; 5) the scientific research community and the professional psychological community, whose reputation and capacity to do research may be affected by how John conducts himself.
In New York, unlike some other states, John is not required by law to warn the subject's partner. It is not clear whether he is prohibited by law from disclosing her status to the partner. The provisions of the APA Ethics Code may give conflicting directions by 1) requiring him to respect the autonomy, confidentiality and privacy of his subject, but also 2) allowing him to breach confidentiality for a valid purpose such as to protect others from harm and indeed 3) recognizing a duty to minimize foreseeable harm. One question this review of the APA code raises is whether the subject, in the process of giving her informed consent, has been made aware that John is subject to points 2) and 3) of the professional code. Since the code may provide for breaching her confidence, she may not be fully informed unless she is made aware of that fact.
There is a general point to be made with respect to the relative weight of an individual's moral obligations, professional moral obligations and the law. What happens when they conflict? In that event, which considerations override? In general, we recognize that legal obligations are not always trump. Indeed, moral considerations can be used to critique the law. A law may be immoral, and one might sometimes be morally justified in violating an immoral law on the basis of moral considerations. That is the standard justification for civil disobedience. Thus, state or federal statutes that prohibit John's disclosure of the HIV status of his subject might conflict with general moral obligation or specific professional obligations. In the case as stated, there do not appear to be any legal constraints on John's actions.
Some moral obligations are incurred in virtue of one's professional status. However, as a professional, one is subject not only to professional obligations but also to the constraints of ordinary morality. It does not follow that professional obligations automatically trump the moral obligations that one has as a human being. The special status of the professions is justified by appeal to general moral considerations such as the welfare of society. Hence one cannot simply invoke the status of the profession to justify overriding such general moral considerations. So, for example, merely because one is a researcher, one is not justified in violating society's general strictures against lying in order to carry out research that involves lying to subjects. In the event of a conflict between general and professional moral obligations, it does not necessarily follow that one's status as a professional excuses one from one's general moral obligations as a human being, or that professional obligations override. The burden of proof is on those who would argue that a particular professional obligation overrides general moral obligations.1 Consider John's situation. He is now in possession of information that a particular, identified person whom he has the capacity to contact is at risk for contracting a fatal disease. Should he simply do nothing and continue his research?
What would we say of an ordinary person not in a professional relation, who is in possession of such information? Conventional morality would argue that persons who are aware of a life-threatening danger to others and who can warn the others without serious harm to themselves, ought to do so. That is so even when there are special relations to the person who presents the threat. Imagine a parent who has been told in confidence by his daughter that she is HIV+, that her husband does not know and that she will not tell him. If it is clear that she refuses to tell him, would we not say that the parent would be morally culpable if he failed to warn the husband that he was at risk? What if the father had promised the daughter never to reveal anything she told him in confidence? Would that fact alter our assessment? Why should the autonomy and confidentiality of the daughter or the value of his promise be viewed as outweighing the life of the husband? Would we really say that the possibility of damaged trust between father and daughter justifies allowing the harm to the husband?
What changes in the moral landscape if we consider John's situation instead of the father's? One might argue that as a professional and a researcher, John has promised to maintain the confidentiality of his sources. Why should his promise of confidentiality trump the welfare of the partner? It is true that if he violates his subject's confidence in this instance he has done her harm. Is that harm greater than the harm to her partner when John knows the partner is at risk and may be the only one able to do something about it? Why should his promise of confidentiality trump concern for the welfare of a partner who may contract (or perhaps already has contracted) a fatal disease? It is not likely that the knowledge John gains by having this subject in the study will outweigh the harm done to the subject's partner if John does not advise him or her of the situation. Since this situation is easily anticipated in doing this study, one might ask whether John was morally justified in offering such a promise in the first place. If not, does that lessen his obligation to keep this promise?
One might argue that unless he honors his confidentiality agreement with this subject, John may not be able to continue the study. That is not likely. There are plenty of others in the study who apparently do not fall into the same situation as this subject. It is unlikely that breaching her confidence will cause the others to bolt unless they are all in her circumstances. John may be required to contact all the others in the study and explain what has happened. Perhaps he should indicate to the other subjects that he is morally obliged to report all similar cases, reassure them that confidentiality will be maintained otherwise and give them a second opportunity to affirm their consent.
One might argue that unless John promises all the participants absolute confidentiality (not qualified confidentiality), at the beginning of the study, he will not be able to gain their consent and hence will not be able to carry out the study. Is that really so? Suppose that he indicates that if he learns they are having unprotected sex with identifiable partners, he will be obliged to alert the partners, if they themselves do not. He pledges to do that in a manner that protects their identity, if possible. Who would consent to be in his study? Those who would still consent may well include: 1) those who are not currently in a relationship; 2) those who have told their partners; 3) those who have not told their partners but would be glad if someone else did. Presumably, some subjects such as the one in this case would not join. But would that really impair the quality of the study? If potential participants were informed of this condition up front, some might bring themselves to inform their partners just so they could participate in the study and get the benefits. It is not obvious that constraining the population in this way would seriously impair his study.
If the restriction on unlimited confidentiality does reduce the amount of knowledge one could glean from a study, does that automatically mean we should consider the loss of knowledge trump and opt for the study with promise of unqualified confidentiality? Not necessarily.
Consider the long-term cost to research if it becomes known that a researcher sat on this information and the partner - and perhaps other partners in similar situations - contracted AIDS and died. In that case, one has the irony of a person doing research to prevent illness and death from AIDS but failing to act on information that would prevent actual persons, who do not know they are at risk, from contracting the disease. If that were to become known, would society's trust of researchers increase or decrease? Would potential subjects be more or less likely to participate in research?
This case has parallels, although not exact ones, to the Tuskegee syphilis study. It is true that in that case both subjects and their partners were kept in the dark regarding their condition and prevented from seeking known effective treatment (as well as preventive measures, in the case of sexual partners). What may be relevant to this case is that the loss of credibility of researchers as a result of the Tuskegee case has turned out to be far greater and have far longer lasting effects than any of the researchers imagined at the time.2
One might argue that a research practice of not promising unqualified confidentiality would render a great deal of psychological research impossible to carry out. It seems to me that is claim must be evaluated on a case-by-case basis.
What, then, should John do? All things considered, it seems reasonable to expect that once John becomes aware of the situation, he cannot ignore it. It would be reasonable first to vigorously counsel with the subject and try to persuade her to inform her partner. If it is clear that she will not do so, then John should inform the partner and, as indicated, inform the rest of the subjects in his study of his modified practice of limited confidentiality. In future studies, John and others should build these considerations into the informed consent process used when subjects are enrolled in the study.
From: Graduate Research Ethics: Cases and Commentaries - Volume 3, 1999 edited by Brian Schrag
Posted 13 years and 4 months ago
One of the major issues in this case is separating what is legally required of the researcher from his/her ethical responsibility as a scientist working with human subjects. Sometimes the law offers incomplete answers to ethical questions that may arise in research involving vulnerable populations. (Fisher, 1997) The goal of science is to discover truth through controlled experiments, but the researcher also has an ethical duty to protect participants' welfare, In some instances these goals appear to conflict. (Fisher, 1993)
In HIV/AIDS research, many laws have been enacted as a response to litigation. Science and research, in trying to keep up with the rapid increase of this relatively new epidemic, have leapt ahead of the legal guidelines. Current federal regulations and professional ethics codes should be revised to accommodate new concerns in this field. In the meantime, scientists should take great care to implement and design ethical procedures that take a proactive stance regarding the impact of the research on individuals. They should adopt a relational ethical perspective, which involves dialogue between participants and researchers. This approach allows the investigator to reflect on participants' needs and concerns in the research context and serves as a guide to researchers in understanding their own boundaries, competencies and obligations. (Fisher, 1997)
It is important for research scientists to identify and evaluate the risks and benefits of research before they begin a study. An important factor in determining the benefit of research is whether the study has scientific merit. In order for research to be scientifically valid, it must produce reliable information. (Fisher, 1996) Many researchers promise confidentiality to ensure that participants feel comfortable enough to give accurate information. In many instances, confidentiality is integral to ensuring participant cooperation.
John made several mistakes in the design of his research. As a psychologist, he is required to be knowledgeable about the population with whom he is working. He should have consulted with others who have conducted similar research and with HIV+ patients themselves. If he had used the experience of the investigators and the perspectives of prospective participants as a resource, John would have realized that it was highly likely that a participant would report having unprotected sex. John should have developed a protocol that would deal with all of the possible consequences of data revealed by the research.
Informed consent procedures are designed to protect participants by ensuring that their decision to participate is informed and voluntary. According to Federal Policy 46.116, informed consent forms must include:
John's protocol complies with most of the informed consent requirements, but he fails to detail the extent and limits of confidentiality. His informed consent form should have stated that information indicating that a participant is having unprotected sex with a partner who is unaware of the participant's HIV status would lead to disclosure. This clause would have given participants the information needed to make an informed decision about participating in the study. John also could have added the option of helping participants disclose their HIV status to their partners.
In general, the scientific community needs to be more sensitive to misleading or inadequate informed consent protocols, especially when working with vulnerable populations. Individuals in need of services or monetary compensation are at greater risk of coercion to participate in research. Participants must be given all the facts regarding a study in order to make an informed decision regarding participation.
Researchers are aware that if individuals are told that their actions will be disclosed if they report harming another person, some may either refuse to participate or withhold that information. The possibility of disclosure is likely to bias the sample and does not allow the researcher to gain an accurate understanding of the behavior in question.
Does the "good" accomplished by warning a third party about potential HIV risk outweigh the "good" that can be gained from a large subject pool whose members provide honest answers? Does the benefit of gaining a better understanding of a phenomenon outweigh the cost of potentially violating a participant's right to privacy in order to protect an individual outside the scope of the research?
Who is John responsible to - himself, the participant, the participant's boyfriend, the HIV community, society at large, or the obligation to increase the body of scientific knowledge? Are these categories mutually exclusive? The answers depend on the scientific community's concerted efforts to address these ethical concerns. A balance between a consideration for the welfare of others and a scientist's obligation to ensure the validity of research findings is an important goal for investigators as we head into the twenty-first century.