Bioethics Luiss PPE Program Class 19 Monday April 27 2015
Topics Ethical Principles involving Humans Vulnerability and Exploitation of populations
Harming and Wronging people Why is ethics important in research? People can be harmed and people can be wronged, even if they are not harmed. Groups and populations can be exploited when they are taken advantage of by powerful agents seeking their own ends. The increase in multinational research conducted in developing countries poses some special concerns
Treatment and Experimentation Experimentation is distinguished by treatment by the extent of risk to the patients and the relative lack of any therapeutic benefit for them. It is experimentation in this latter sense that is more controversial: the kind of experimentation that offers little or no established benefit to the subject and carries with it some risk of harm.
Historical Examples The Nazi experiments Nazis forced people to drink seawater to find out how long a person could survive without fresh water. In Dachau, Russian prisoners were immersed in icy waters to see how long a pilot might live when shot down over the English Channel In another experiment, 52 prisoners were exposed to phosgene gas, a biological warfare agent, to test possible antidotes. Also in Dachau, inmates were infected with a broad range of pathogens to test homeopathic preparations. Nazi military authorities were worried about exotic diseases that German troops might contract in Africa or Eastern Europe, and physicians in the camps reasoned that the “human materials” at their disposal could be used to develop remedies. Hundreds of people died in these experiments, and many of those who survived were forced to live with painful physical or psychological scars (Annas and Grodin 1992). 1949 Nuremberg Code in the first article stated: “The voluntary consent of the human subject is absolutely essential”
T he Tuskegee syphilis study From the mid-1930s into the early 1970s, the US Public Health Service conducted observations of African American men in a rural setting who were suffering from secondary syphilis. At the time, no efficacious treatment existed. However, after 1945, penicillin became available and was routinely used successfully to treat patients with syphilis. That treatment was withheld from these men, without their knowledge or consent. The Public Health Service officials used the ethically unsound defense, claiming that now that antibiotics could successfully treat syphilis, it would impossible to study its long- term effects.
Jewish Chronic Disease Hospital In 1964, in the Jewish Chronic Disease Hospital in Brooklyn New York, 22 elderly patients were approached by a researcher who wished to study the body’ s immune mechanisms. The material actually injected into these patients was tissue consisting of live cancer cells. The subjects were told only that some tissue would be injected, that a lump would form, and would disappear in a few days. The researcher was certain that injecting cancer cells into the subjects would not cause cancer, but he wanted to determine how quickly and in what manner the patients’ immune systems would reject the cancer cells. He defended withholding the information that the tissue consisted of cancer cells, noting that the fear that the word “cancer” strikes in people is very great.
Ethical Principles in Research Involving Humans Three principles - CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002): a. respect for persons ; b. beneficence, c. justice
Respects for Persons Respect for persons: two fundamental ethical considerations: i) respect for autonomy, ii) protection of persons with impaired or diminished autonomy, which requires that those who are dependent or vulnerable be afforded security against harm or abuse.
Issues in Informed Consent The Therapeutic Misconception The widespread confusion between participating in research investigating new, unproven therapies, on the one hand, and receiving an established, effective treatment for a health-related condition, on the other. To think that that same obligation applies in the research setting is to fall prey to the confusion between the aims of research and the aim of individualized treatment of patients. The features that characterize the physician–patient relationship should not be assumed to be present in the researcher–subject relationship.
Informed consent in developing countries The quality of informed consent in clinical research in developing countries is deficient or worse than in developed countries. It is much less common for physicians to obtain consent from patients for medical treatment in those parts of the world: see the Vietnamese case
Beneficence B eneficence refers to the ethical obligation to maximize benefit and minimize harm. It requires that risks be reasonable in light of expected benefits.
Issues with Beneficence Although it is common to speak of “balancing risks and benefits,” or “assessing the risk–benefit ratio,” no objective methodology exists for doing this. The benefits may be largely unknown and difficult to anticipate, especially in an early phase of research (imponderable risks against uncertain benefits): Research that provides no direct benefits to subjects is permissible, as long as it holds the prospect of benefits to future patients or contributions to scientific knowledge. However, it is difficult to determine that the risks to subjects are reasonable in light of the anticipated benefits.
Placebo An inert substance compared with an active experimental medication in a clinical trial. The ethical problem arises when a placebo is proposed to compare with an experimental drug even if there exists a proven treatment for the condition under study. Critics argue that it is unethical to withhold proven, effective medications from trial participants. The argument is that it is unethical deliberately to make people worse off in research than they would be outside a clinical trial. Withholding from research subjects an existing treatment that they could obtain from their own physicians if they were not in the trial violates the obligation to minimize harm and maximize benefits to research subjects. See also the case of Azidothymidine (AZT) trial in Thailand
Justice The most common application to research is known as distributive justice . Distributive justice requires a fair distribution of the benefits and burdens of research: - risks of research should not be suffered by groups or populations that will not receive the benefits of the research; - those who share in the benefits of research should also share in the risks; - differences in distribution of burdens and benefits are justifiable only if they are based on morally relevant distinctions, such as vulnerability. Other forms of non distributive justice: compensatory justice , justice as reciprocity .
Issues with the Justice Principle “What, if anything, does justice require when industrialized countries sponsor or conduct research in resource-poor countries?”: a. research should be responsive to the health needs and priorities of the population where the research is conducted; b. it is unjust for research subjects to be made worse off afterwards than they were during the research – that is, by not providing them with a treatment they still need when their participation ends; c. it is ethically unacceptable for external sponsors to conduct research in developing countries and leave nothing behind when the research is over, that is, failure to provide some post-trial benefits to the community.
Exploitation of entire populations What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in research ethics? A first answer: ulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. But, what does it mean to exploit a group in medical research? Not all wrongful actions can properly be considered exploitation, and some situations may be unjust without being exploitative; some may involve harm inflicted on vulnerable people without having exploited them. A paradox Two opposing perceptions of research. One – the standard view – construes research involving human beings as a risky enterprise, one that can harm or exploit people. At the same time, research can provide direct benefits to participants, giving rise to a positive view of the research enterprise.
Protection What mechanisms exist to protect the rights and welfare of research subjects? Two main safeguards: - voluntary, informed consent of each individual research subject; - prior review of proposed research by an independent ethical review committee
Obstacles faced by Research Committee - Gap between what laws or regulations stipulate and what actually occurs in practice. - The constitution of committees, which are made up mostly of researchers and physicians who can be biased in favor of research. In Developing Countries: - in many developing countries the lack of resources undermines the efficacy of the committee; - many committees in developing countries experience serious difficulties in incorporating representatives of the community.
References Florencia Luna and Ruth Macklin, “Research Involving Human Beings”, in Kuhse and Singer, pp. 457- 468; Paul U. Macneill, “Regulating Experimentation in Research and Medical Practice”, in Kuhse and Singer, pp. 469- 486.
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