Chapter 1 - Introduction

Currently, researchers from all disciplines strive to protect research participants from harm or discomfort. This is due in part to moral obligation and in part to institutional and federal regulation. The last fifty years have seen the formulation of inter-institutional and multi-national guidelines for the protection of human subjects. Prior to the 1940's researchers were solely responsible for the protection of participants. Unfortunately, history holds many accounts of unethical treatment of human subjects. Research that placed participants at undue risk resulted in a range of harm to the participants from questionable psychological distress (Milgram obedience studies) to chronic illness and death (Tuskegee syphilis studies, radiation experiments; for example, see Maloney, 1984, or Rothman, 1991). Despite many clear violations it took the atrocities of war to bring attention to this area of human rights.

An initial step in the evolution of formal ethical regulation was the creation of the Nuremberg Code (Appendix 6.2a). This doctrine was established by the prosecution at the Nuremberg trials to serve as basic ethical principles universally applicable to human research. The ten principles found in the Nuremberg Code were used in the war crimes trials of 23 Nazi physicians. The establishment of the Nuremberg Code marked the beginning of a series of concerns regarding research involving human participants.

The next major step in the evolution of ethical guidelines was the Declaration of Helsinki (1974), (Appendix 6.2b). The Declaration extended the Nuremberg Code by allowing surrogate consent when the actual participant was unable to give consent. In addition, it included a distinction between therapeutic clinical research and non-therapeutic clinical research. Subsequent revisions of the Helsinki Declaration (1975, 1983, 1989) continued to emphasize the need for informed voluntary consent in human research (World Medical Association, 1991; Perly et al., 1992).

Other documents continue to foster ethical responsibility in research. These include the Federal regulations regarding Institutional Review Boards and the American Psychological Association Code for Social and Behavioral Research. Based on these documents, the “Belmont Report” (1978) (Appendix 6.2c) was published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report sets forth basic ethical principles for researchers to follow in designing responsible research. These principles include respect for persons, beneficence, and justice. These principles can be realized by designing research that respects the individual's right to self determination through voluntary participation. Researchers also have the responsibility to maximize benefits to individual participants or to society while making concerted efforts to minimize possible risks from participation. Moreover, researchers carry the burden of making equitable participant selection in order to represent the population adequately, while not manipulating compromised classes of subjects into consent. It is the responsibility of all researchers to observe and maintain these ethical principles in all of their work.

These documents were developed to aid investigators in designing research that would assure that human subjects were treated in an ethical manner. Despite the considerable effort placed in the creation of these documents, no formal monitoring mechanism was established. Again, the responsibility of assuring ethical treatment of participants fell on the researcher. However, the guidelines alone did not prevent unethical treatment of human subjects. The Tuskegee study continued unabated throughout the evolution of these various guidelines for over 40 years. While many informal research evaluation committees were formed across the country, there was a growing need for a formal review process. In 1974 the federal government mandated the establishment of IRBs at all institutions that receive funding from the Department of Health and Human Services (DHHS).

IRB administration is overseen by the Office for Human Research Protections (HRP), a division of the National Institutes of Health (NIH). The IRB was designed to be a local review committee representing the needs of the local community. It is believed that this local review can far better protect human subjects than a national review process. An IRB is made up of various people in the community representing a number of areas of expertise. An IRB is guided by CFR 45 part 46 and CFR 21 parts 50 and 56, which mandate the minimum requirements for the protection of human subjects and allow considerable latitude on the local level for decisions regarding research.