The many meanings of care in clinical research

Abstract

The conduct of clinical research often involves two distinguishable sets of relationships: the researcher-subject relationship, and the clinician-patient relationship. Some scholars argue that being a patient in a clinical care setting and a subject in a research study are so different that anything that would promote in subjects the view that they are in clinician-patient relationships is exploitative and deceptive. This paper presents findings intended to initiate a more empirically-based discussion of this issue. Using data from 82 in-depth interviews with physician-investigators, nurse-study coordinators and patient-subjects in early phase clinical trials, we find that research personnel are likely to be seen, and to see themselves, as clinical caregivers. We also find evidence that while researchers and subjects often tend to view care and research as conflicting activities, both parties tend to see research as a way of caring for patients. We found no relationship, however, between subjects' perception of care-giving by researchers and the tendency to misunderstand that they are in a research study. Because research, by necessity and inclination, is unlikely ever to be 'care-free', we recommend that the ethical debate surrounding the danger of confusing research with treatment take into account the kinds of care described by respondents.