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Perspectives of clinical research coordinators on disclosing financial conflicts of interest to potential research participants

Center for Clinical and Genetic Economics, Duke Clinical Research Institute

Jeremy Sugarman

Berman Institute of Bioethics, The Johns Hopkins University, Baltimore, MD, USA

Jatinder K Dhillon

Center for Clinical and Genetic Economics, Duke Clinical Research Institute

Venita DePuy

Center for Clinical and Genetic Economics, Duke Clinical Research Institute

Christine K Pierre

RxTrials, Inc, Ellicott City, MD, USA

Michaela A Dinan

Center for Clinical and Genetic Economics, Duke Clinical Research Institute

Jennifer S Allsbrook

Center for Clinical and Genetic Economics, Duke Clinical Research Institute

Kevin A Schulman

Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Department of Medicine, Duke University School of Medicine, Durham, NC, USA

Kevin P Weinfurt

Center for Clinical and Genetic Economics, Duke Clinical Research Institute, kevin.weinfurt{at}duke.edu, Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA

Background Disclosing financial interests to potential research participants during the informed consent process is one strategy for managing conflicts of interest. Given that clinical research coordinators are typically charged with administering the informed consent process, it is critical to understand their experiences, attitudes and beliefs regarding the disclosure of financial interests in research.

Purpose To understand the role of clinical research coordinators in disclosing financial interests in research, and potential barriers to such disclosures.

Methods We developed a survey designed to measure clinical research coordinators' awareness of financial interests in clinical research, previous experience with disclosing financial interests, comfort with answering questions about financial interests and barriers to disclosing financial interests to potential research participants. Next we conducted cognitive interviews with 10 clinical research coordinators to assess understandability and content validity and to further refine the survey. We then administered the survey to clinical research coordinators attending the 2006 Global Conference of the Association of Clinical Research Professionals.

Results Among 300 clinical research coordinators who completed the survey, there was a general awareness of financial interests in research. Forty-one percent reported disclosing such financial interests to potential research participants, and 28% reported being asked about them. Greater comfort in responding to questions about financial interests was associated with previous experience with disclosure, previous experience answering questions about financial interests, and greater length of time obtaining informed consent. Respondents indicated that there were barriers to disclosure, including lack of information (76%) and that participants would not understand disclosures (26%).

Limitations Possible sample bias due to using a convenience sample.

Conclusions Making information about financial interests in research readily available to clinical research coordinators, as well as providing education and training, should facilitate the disclosure of financial interests in research to potential research participants during the informed consent process. Clinical Trials 2007; 4: 272—278. http://ctj.sagepub.com

Clinical Trials, Vol. 4, No. 3, 272-278 (2007)
DOI: 10.1177/1740774507079239


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