Chapter 16: IntroductionIn reporting to the American people what we have learned about the current status of human subjects research, the Committee wanted to incorporate the voices and experiences of subjects themselves. What is it like to be a subject in biomedical research today? Why do people become research subjects, and what does participating in research mean to them?
To provide answers to these questions, the Advisory Committee conducted the Subject Interview Study (SIS), a descriptive study in which both patients who were research subjects and patients who were not research subjects were interviewed to determine whether they believed that they were participants in medical research, their general attitudes and beliefs about medical research, and if applicable, why they did or did not decide to participate in research. The Committee would have liked to have heard not only from patient-subjects but also from the many "healthy volunteers" who are critical to the success of much biomedical research. Unfortunately, time constraints made this impossible. Clinical research--research involving patients--does account for a large proportion of contemporary medical research involving human subjects, however, and it was toward this enterprise that the SIS was directed.
In this chapter, we report what patients and patient-subjects told us about research and what we learned about their experiences. We begin by describing the methodology of the SIS: how the patients were selected and how they were interviewed. Next, we report the results of these interviews, as well as the results of our review of the records of the patients to whom we talked. We close with a discussion of the limitations and implications of the SIS.