In implementing clinical trials (CTs), clinician researchers face two competing sets of expectations: that they will faithfully implement the research protocol, on which the validity of the research depends, and provide the clinical care that """"""""patients"""""""" deserve. Much has been written about the ethics of designing clinical trials so as to serve both goals. However little attention has been paid to how research clinicians manage these competing commitments on a day-to-day basis. This proposal suggests that there may be circumstances in which the competition between these commitments may seriously undermine the validity of the CT. The proposed study will do extensive interviews with staff and physicians who implement CTs and follow this with a national survey of such individuals. The goals of the study are to: 1. Describe how clinical researchers conceptualize their commitments to the clinical care of their patients and their commitments to implementing good research in CTs and whether they perceive competition between the two commitments. 2. Describe how this competition presents itself in different methodological domains (e.g., recruitment, randomization), study designs and medical situations and the circumstances in which clinical investigators feel it appropriate to violate the rules of the specific CT. 3. Ascertain the frequency of perceived conflicts between clinical care and quality research and of violations of rules of the CT. 4. Determine the correlates of violations of the rules of the CT including variables that describe: the clinicians, the design of the trial and the nature of the experimental intervention and the disorder under study.
| Lidz, Charles W; Appelbaum, Paul S; Joffe, Steven et al. (2009) Competing commitments in clinical trials. IRB 31:1-6 |
