A narrative analysis of an IRB's principles-based ethical deliberations: The construction of participant identity.

摘要

My research asserts that Institutional Review Boards cannot adequately discharge their responsibilities toward the application of respect for persons, beneficence and justice on behalf of clinical trial participants as envisioned by The Belmont Report because they lack the necessary objective distance from the science they are asked to critique. Experimental science, as evidenced by the research proposals submitted to IRBs for review and approval, defines participants by research conventions, and the biological traits and functional roles they play in it. It values them for the information their bodies hold about disease, health, the environment and genetics. My six-month's observation and narrative analysis---aspects of setting, character development, plot and point of view---of an IRB's principles-based deliberations shows the IRB agreed or acquiesced to the terms and values defined by the domain of science without balancing it by imagining and acknowledging the human traits, terms and values of the social domain of the persons to be studied. As a result, the IRB applied the ethical principles in the terms and best interests of research, but they did not apply the principles necessarily in the terms and best interests of the participants in the research, as intended by The Belmont Report. I recommend greater representation by people at the center of research studies as well as the development of reflexive deliberative techniques to address this imbalance of representation and interests.