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

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.

Duke Scholars

Author Michaela Ann Dinan Population Health Sciences

Author Kevin Phillip Weinfurt Population Health Sciences