Human Genetic

Protecting Human Research Subjects
National Institutes of Health
Office for Protection from Research Risks (OPRR)
1993 Institutional Review Board Guidebook

“Efforts to isolate DNA mutations involved in disease in order to understand the origins of the pathophysiological process are becoming increasingly common across the broad sweep of biomedical research, from cardiology to oncology to psychiatry. Institutional review boards (IRB) should expect to see more of these kinds of studies in the future. The U.S. Human Genome Project (HGP) (part of the worldwide research effort known as the Human Genome Initiative) is one of the genetic toolmaking efforts that is facilitating this growth, through the production of better genetic maps and sequencing technology.”

“The ethical issues raised by this scientific trend primarily concern the management of psychosocially potent personal genetic information. For researchers and IRBs, the major challenge in addressing these issues is the fact that genetic studies typically involve families; the research subjects involved in genetic studies are usually related to each other. As a result, research findings about individual subjects can have direct implications for other subjects, information flow between subjects is increased, and participation decisions are not made entirely independently. A second set of ethical issues emerge in cases in which the results of these studies are used to develop therapeutic interventions at the genetic level. Such concerns involve the special safety precautions and subject selection considerations required for gene therapy research.”

Subject Recruitment and Retention

“The familial nature of the research cohorts involved in pedigree studies can pose challenges for ensuring that recruitment procedures are free of elements that unduly influence decisions to participate. The very nature of the research exerts pressure on family members to take part, because the more complete the pedigree, the more reliable the resulting information will be. For example, revealing who else in the family has agreed to participate may act as an undue influence on an individual’s decision, as may recruiting individuals in the presence of other family members. (Both would also constitute a breach of confidentiality. The problem of confidentiality will be dealt with later in this section.)”

“Recruitment plans, some of which are described here, can attempt to address these problems; each approach has its own strengths and weaknesses. One strategy is to use the proband as the point of contact for recruiting. This approach insulates families from pressure by the investigator, but presents the risk that the proband may be personally interested in the research findings and exert undue pressure on relatives to enroll in the study. Furthermore, the proband may not want to act as a recruiter for fear that other family members will then know that he or she is affected by the disease. Another approach is direct recruitment by the investigator through letters or telephone calls to individuals whose identity is supplied by the proband. Direct recruitment by the investigator may, however, be seen as an invasion of privacy by family members. (Similar issues arise in epidemiologic research. See guidebook,Chapter 4, Section E.) A third approach is to recruit participants through support groups or lay organizations. Adopting this strategy requires investigator and IRB confidence that these organizations will be as scrupulous in their own efforts to protect subjects as the investigator would be. A fourth possibility is to contact individuals through their personal physicians. Prospective subjects contacted by their physician may, however, feel that their health care will be compromised if they do not agree to participate. In the end, the IRB must ensure that the recruitment plan minimizes the possibility of coercion or undue influence [Federal Policy §116].

In contrast to inappropriate pressure placed on prospective participants to join the study is the possibility that a subject may agree to participate out of a misguided effort to obtain therapy. The purposes of the research and how subjects will or will not benefit by participation must be clearly explained. (See discussion below on informed consent.)”

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