Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants.
OBJECTIVE
To document the current state of institutional review board (IRB) and conflict of interest committee policies regarding disclosures of financial conflicts of interest to potential research participants, and to use this information to identify and share models for effectively achieving disclosure.


METHODS
The authors identified the 123 U.S. academic medical centers that have IRBs and sought their IRB and institutional policies regarding financial conflicts of interest. In February and March 2004, using manual and key word searches, each institution's Web site was searched to identify documents containing information regarding the disclosure of financial conflicts of interest. Letters were sent to 24 institutions that had either no information or incomplete information posted on their Web sites. To assess institutions' guidelines for disclosure, the authors extracted and content coded each institution's information on disclosure.


RESULTS
Relevant information was obtained from 120 (98%) academic medical centers (AMCs), of which 57 (48%) mentioned disclosing financial conflicts to potential research participants. Of these 57, 33 (58%) included verbatim language that could be used in informed consent documents. AMCs' recommendations and requirements for disclosure included details of the financial arrangement, administrative management of conflicts of interest, and encouragement of dialogue between the investigator and the potential research participant.


CONCLUSIONS
Considerable variability exists concerning the specific information that should be disclosed. Most of the AMCs' policies were consistent with the goal of protection from legal liability. Significant questions remain, however, concerning the goals of disclosure and the most effective methods for achieving those goals.
Weinfurt
Kevin P
KP
Center for Clinical and Genetic Economics, Duke Clinical Research Institute, P.O. Box 17969, Durham, NC 27715, USA. kevin.weinfurt@duke.edu
Dinan
Michaela A
MA
Allsbrook
Jennifer S
JS
Friedman
Joëlle Y
JY
Hall
Mark A
MA
Schulman
Kevin A
KA
Sugarman
Jeremy
J
D000046:Academic Medical Centers / Q000191:economics / Q000941:ethics / Q000458:organization & administration*; D035843:Biomedical Research / Q000191:economics* / Q000941:ethics; D016265:Conflict of Interest / Q000191:economics*; D003625:Data Collection; D030881:Disclosure / Q000941:ethics*; D028744:Ethics Committees, Research; D006801:Humans; D016134:Organizational Policy; D012108:Research Personnel / Q000941:ethics; D012109:Research Support as Topic / Q000191:economics* / Q000941:ethics; D014481:United States