: This application requests funding to administer two surveys on ethical norms, policies, and practices concerning the allocation of control over various aspects of industry-funded clinical trials between academic investigators and sponsors. The development of the survey instruments was funded under the 2001 RFA on """"""""Research on Research Integrity."""""""" Industry funding has become an indispensable part of biomedical research, accounting for 70% of the funding for clinical drug trials in the U.S. While academic-industry research partnerships carry great benefits, the terms of the contracts between academic institutions and sponsors pose a possible threat to research integrity if they restrict investigators' academic freedom. There exists little empirical data on the nature and consequences of these legal relationships. This study explores five research questions: (1) To what extent do faculty investigators and institutional research administrators view it as acceptable or unacceptable to cede control over various aspects of clinical trials to industry sponsors? (2) Do norms regarding acceptable sponsor controls vary among faculty investigators (by academic rank, percentage of research funding received from industry, and institutional size), or among research administrators (by institutional size and percentage of institutional research funding received from the industry)? (3) Do norms regarding acceptable sponsor controls differ between faculty investigators and research administrators? (4) What is the nature of tensions and conflicts arising from industry-sponsored clinical trials? (5) What institutional structures (such as formal policies and the use of legal counsel) are in place in academic medical centers to ensure the integrity of industry-sponsored clinical trials and prevent related conflicts? We hypothesize that the allocation of control over many aspects of clinical trials to industry sponsors will be seen as acceptable, but that large institutions, institutions with formal policies on industry-sponsored research, junior faculty, and faculty and institutions with little industry funding will be less likely than other faculty and institutions to view sponsor controls as acceptable. We further hypothesize that the ethical norms of some investigators will diverge from those of research administrators. These hypotheses will be tested through self-administered surveys of clinical faculty and research administrators at academic medical centers. Survey topics include institutional policies and procedures, the acceptability of specific types of sponsor controls, sources of tensions and conflicts between sponsors, investigators, and administrators, and perceived pressures in the research environment.
| Mello, Michelle M; Clarridge, Brian R; Studdert, David M (2005) Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors. Account Res 12:163-91 |
| Mello, Michelle M; Clarridge, Brian R; Studdert, David M (2005) Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 352:2202-10 |
