The right to participate in research studies

Abstract

Institutional review boards for the use of human subjects in scientific studies were initially established to focus on protection of human subjects from the risks of research. It has become evident in recent years, however, that it is also important to protect the rights of individuals to have access to the benefits of research participation. These include, but are not limited to, certain experimental drugs or treatments, closer monitoring, free care or direct remuneration, and societal benefits of results of studies on specific populations. Researchers, so long sensitized by their respective institutional review boards to the need for protection of the subjects, now must also focus on the added burden of efforts to include individuals and the increased efforts it may take to protect the safety and rights of certain populations, including patients with AIDS, women, minorities, children, and the elderly. Additional care must be taken to design appropriate studies, recruit an appropriate spectrum of the population, craft a complete yet understandable and nondeterent informed consent form, and make efforts to assure that participants are informed.