Nursing and Ethics - Biomedical Research

Alabama Nurse,  Mar-May 2004  by Bross, William

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In the last issue, and the first in this series, we discussed what ethics was and the role of the nurse and our ethical responsibilities. I received several requests to explore research and the role of healthcare professionals. I would like to briefly discuss biomedical research and the role of the nurse in this rapidly evolving area. While biomedical research involves both human and animal subjects, we will focus on human subjects. As we review this area, I want you all to send me your thoughts or questions on this subject.

The ethical problems related to research using human subjects involves not only the research itself, but the use made of this research, and the role of the researcher. One does not have to go far to see the outcomes of unethical research, much of which was in control of the researchers involved. Here in Alabama, the Tuskegee Syphilis Study (conducted by the U.S. Public Health Service which became the subject of Congressional Hearings in 1973) represented some of the most unethical research ever conducted. If you have never reviewed this project, I suggest you do so. There are numerous links to this study on the Internet. This study and the studies done with Nazi war criminals, led to the development of standards, including the Declaration of the World Medical Association of Helsinki (1964 and revised in 1975), and a further revision set out by the Department of Health, Education and Welfare in the Belmont Report (1978). Further, professional associations such as the American Psychological Association (1982) and the American Medical Association (1996) spell out the obligations of members in conducting research. I bring these up, because many of you are involved directly or indirectly with medical research either in hospitals, physician offices, research centers, or other areas.

Research is never justified unless the benefits to be derived outweigh the risks taken. A mere increase in knowledge is not sufficient to justify the risks taken. The benefits must be balanced against human and economic costs. This shows you, again, that ethics is not clear. One can readily see the difficulty in deciding how to balance the need for knowledge and the respect for human welfare. In the United States, institutions involved in clinical research have Institutional Review Boards (IRBs) to oversee clinical research. IRBs are composed of a cross-section of society including medical, religious, and lay members to ensure that all areas of society and persons are taken into account. If you are in a health care facility and/or involved in clinical research, be sure that you know how to access your local or internal IRB.

As nurses, there are several things you need to be aware of when dealing with research and research subjects. As I mentioned, many of you might be involved indirectly with research. You may be caring for patients that are a part of a clinical trial. Often, we see pharmaceutical or medical device research being conducted in our facilities or Physician offices. For those of you that work in the role of a research assistant or investigator, you are more aware of the important role you play.

First, let us consider informed consent in the research context. I know you are all aware of the importance of obtaining informed consent in whatever test or procedure your patients are undergoing. However, this is even more critical in the area of research. Indeed, the informed consent documents prepared for research are often developed by the Company conducting the research and must be approved by many levels and IRBs before being used in the actual research. It is not uncommon for a consent document of this type to be ten to twenty pages in length. The subject must always be told the purpose of the research, and whether random assignment will be used. That is, the subject must be informed that he or she may end up in a control group with no treatment, with a placebo, or with an alternative treatment. The subjects must also be informed of prior animal research and the results, with warnings about what might occur in the human population. Subjects must be told of possible therapeutic benefits to themselves or others, but should not be given too much hope to influence a decision to participate or not. Likewise, the subject must be aware that he/she can withdraw at any time from the study.

A Principal Investigator, usually, but not always, a Physician, is responsible for ensuring that informed consent is obtained. As nurses, we must follow-up and ensure that adequate information has been provided. If we perceive that the subject is not informed, it is our responsibility to notify the Principal Investigator. If we perceive that the Physician is not following the guidelines or that he/she is behaving in an unethical manner, we need to notify the IRB. There are numerous examples of Physicians losing their licenses related to problems with informed consent.

As healthcare providers, we must be mindful of the consent given on behalf of minors, persons not competent, and other special classes of subjects including institutionalized persons and prisoners. Surrogates that are giving consent on behalf of these persons are charged with great responsibility in ensuring that the subject consents to research that is of potential benefit to him/her. We must pay attention to these situations as well and look out for the interests of these classes of individuals. Many times, the interest of the surrogates might not be what is best for the subjects themselves.