Principles Of Research Ethics

This chapter examines ethical issues associated with geriatric research. The research discussed in this chapter generally falls under the umbrella of clinical research. This includes research about medical care, as well as psychiatric and psychosocial aspects of health and health care. Few of the issues described are unique to geriatrics. Rather, most topics discussed are common to clinical research in general. The chapter briefly reviews some of the historical development of contemporary research ethics and touches on current controversies and themes that are common in research ethics today.

Commonly cited principles of contemporary U.S. research ethics are voluntarism, nonmaleficence, beneficence, utility, and justice. These principles are remarkably similar to the ethical principles of health care, reflecting the close ties between health care ethics and research ethics.

The first principle, voluntarism, is a modification of the autonomy principle. All research subjects must voluntarily consent to participation in research. Lack of voluntary consent can occur in a variety of ways. The most extreme is explicitly forcing subjects to participate completely against their will. The most notable example of forcing subjects to participate totally against their will is Nazi research conducted during World War II. Most other violations of the principle involve not informing subjects that they are research subjects, not informing them that they can refuse to participate, or not providing sufficient information so that they can make an informed decision whether to participate or not. An example of a study that did not inform subjects that they were participating in research is the Jewish Chronic-Disease Hospital Study of elderly patients, including some who were demented, who were injected with cancer cells to examine whether cancer was contagious. Subjects were not informed that they were participating in a research study (Faden & Beauchamp, 1986, pp. 161-162). Other examples are the radiation experiments conducted in the 1950s and 1960s that were recently reviewed by the President's Advisory Committee on Human Radiation Experiments (U.S. Advisory Committee on Human Radiation Experiments, 1996).

While egregious violations of the principle of voluntarism are relatively rare under current regulation and oversight, the principle of voluntarism still faces occasional obstacles. The most common examples are associated with not providing subjects full information to understand risks and benefits of participation. Without proper understanding of the study, people may consent to a study they would refuse to participate in under circumstances of more information. Other violations of voluntarism include providing payments or other incentives to subjects that are large enough to be coercive, and linking participation in research to other services such as routine clinical care. A classic example of providing incentives to encourage participation is the Willowbrook Hepatitis Study. That study was designed to test the efficacy of a new hepatitis vaccine. The study was conducted on retarded children living in a state-run home. The protocol included deliberately infecting children and adults with the virus, and participation in the research was made a requirement for admission to the home (Faden & Beauchamp, 1986, pp. 163-164).

The second principle, nonmaleficence, holds that subjects should not be harmed or knowingly subjected to harm through participation in research. This principle does not deny that most clinical research involving drugs or procedures has some level of risk involved. The principle does hold that the risk involved should not be significantly greater than what the subject would face during the normal course of clinical care unless the subject understands these different risks and knowingly consents to face them. The standard allows for different risks as long as the risks of the new drug are not significantly worse than those of the old drug without any difference in potential benefit. For example, most cancer chemotherapies involve some side effects. The standard for a new chemotherapy would be that there is no reason to believe that subjects face greater risks than they would if they received ''standard therapy'' or that, despite greater risks, there are greater probabilities that the new therapy will be effective.

Third is beneficence. Whenever possible, people should be better off having participated in research than if they had not. Later, in discussions of randomization, this issue will be discussed in more detail with regard to the issue of conditions under which subjects can legitimately be assigned to different treatments in a research study.

Fourth is utility. This principle holds that conducting the research should result in some broad societal benefit. If the research does not have any promise of helping people through the development of new treatments or adding to the scientific knowledge base, then any risks, however minor (including something as benign as inconvenience), cannot be justified. While utility is a central com ponent of research ethics, it comes into play after the first three principles are satisfied. That is, research cannot be justified on the grounds of utility alone if it allows subjects to be harmed or does not involve voluntary consent. In the past, much harm to research subjects has been justified by utility alone (e.g., it was used by Nazi researchers as a defense during their war-crimes trials). The current ordering of ethical principles recognizes the importance and also the limitations of utility.

Finally, there is justice. Discussions of this principle have shifted slightly since the first codes of research ethics were developed. Originally, the purpose was to guarantee that the risks of research be evenly distributed across population groups. This principle was in response to a history of conducting potentially harmful research on marginalized groups such as the elderly, the handicapped, the poor, minorities, and prisoners for the benefit of others (Bee-cher, 1966). Recently, however, the emphasis on justice has shifted to guaranteeing that the benefits of research are evenly distributed across population groups (Rothenberg, 1996). This shift reflects recent changes in public perception of participation in research from being inherently risky to being more beneficial than harmful.

The first modern code of research ethics is the Nuremberg code. It was included in the judgment in United States v. Karl Brandt at the Nuremberg trial of the horrifying conduct of Nazi researchers (United States vs. Karl Brandt, 1948) and represents the values violated by Nazi researchers during World War II. Similarly, the Helsinki Code (18th World Medical Assembly, 1964) and the Belmont Report of 1978 (U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978) represent translations of research abuses into specific values and explicit rules (Jonsen & Toulmin, 1988). All three reports emphasize the same underlying values of autonomy, nonmaleficience, benificence, utilitarianism, and justice.

While the research codes serve many purposes, one obvious purpose was to establish explicit criteria to determine what is ethical conduct and thereby guarantee that future subjects would not be subjected to abuse in the name of science. In addition to clarifying codes, institutional review boards (IRBs) were developed as human-subjects-research ethics committees and are regulated by the Office for Protection from Research Risks (OPRR) of the National Institutes of Health and the Food and Drug Administration (FDA). Institutions and organizations (including universities, hospitals, and drug manufacturers) voluntarily complying or obligated to comply with federal guidelines must establish an IRB that follows the rules outlined in the Belmont Report. In brief, before any research using human subjects in any form (including examination of cells, review of medical records, and direct patient contact) can begin, the IRB must approve the study and its detailed protocol. From this, the IRB will determine whether the subjects need to sign a consent form, and, if necessary, approve the content of the written consent form. The IRB is charged with examining the research to ensure that subjects are fully informed of its risks and benefits so they can make their own (autonomous) voluntary decisions about participation. The purpose of developing these codes and instituting IRBs was to create clear rules that could be applied to a wide range of human-subjects research. This combination ensures that researchers will be actively monitored and, if necessary, forced to comply with the rules. Without such oversight, it was feared that outrageous abuses of human subjects would continue.

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