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Opinion 2.071 - Subject Selection for Clinical Trials

Ethical considerations in clinical research have traditionally focused on protecting research subjects. These protections may be especially important for those from socioeconomically disadvantaged populations who may be more vulnerable to coercive pressures. The benefits from altruism that result from participation in research, particularly for severely chronically ill persons, may justify equitable consideration of historically disadvantaged populations such as the poor. With these considerations in mind, the following guidelines are offered:

(1) Although the burdens of research should not fall disproportionately on socioeconomically disadvantaged populations, neither should such populations be categorically excluded, or discouraged, from research protocols.

(2) Inclusion and exclusion criteria for a clinical study should be based on sound scientific principles. Conversely, participants in a clinical trial should be drawn from the qualifying population in the general geographic area of the trial without regard to race, ethnicity, economic status, or gender.

If a subject’s primary care physician determines that the subject received a clear medical benefit from the experimental intervention which is now moving towards marketing approval and chooses to seek authorization from the Food and Drug Administration (FDA) for continued use of the investigational therapy during the time period between the end of the protocol and the availability of the drug on the market, the investigator should work with the primary care physician, the product sponsor, and the FDA to allow continued availability of the product. (I, V, VII)

Issued June 1998 based on the report "Subject Selection for Clinical Trials," adopted December 1997 (IRB. 1998; 20(2-3): 12-15).