Perspectives of clinical ÌÇÐÄ´«Ã½ coordinators on disclosing financial conflicts of interest to potential ÌÇÐÄ´«Ã½ participants
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Perspectives of clinical ÌÇÐÄ´«Ã½ coordinators on disclosing financial conflicts of interest to potential ÌÇÐÄ´«Ã½ participants CLINICAL TRIALS 2007; 4 (3): 272–78Abstract
Disclosing financial interests to potential ÌÇÐÄ´«Ã½ participants during the informed consent process is one strategy for managing conflicts of interest. Given that clinical ÌÇÐÄ´«Ã½ 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 ÌÇÐÄ´«Ã½.To understand the role of clinical ÌÇÐÄ´«Ã½ coordinators in disclosing financial interests in ÌÇÐÄ´«Ã½, and potential barriers to such disclosures.We developed a survey designed to measure clinical ÌÇÐÄ´«Ã½ coordinators' awareness of financial interests in clinical ÌÇÐÄ´«Ã½, previous experience with disclosing financial interests, comfort with answering questions about financial interests and barriers to disclosing financial interests to potential ÌÇÐÄ´«Ã½ participants. Next we conducted cognitive interviews with 10 clinical ÌÇÐÄ´«Ã½ coordinators to assess understandability and content validity and to further refine the survey. We then administered the survey to clinical ÌÇÐÄ´«Ã½ coordinators attending the 2006 Global Conference of the Association of Clinical Research Professionals.Among 300 clinical ÌÇÐÄ´«Ã½ coordinators who completed the survey, there was a general awareness of financial interests in ÌÇÐÄ´«Ã½. Forty-one percent reported disclosing such financial interests to potential ÌÇÐÄ´«Ã½ 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%).Possible sample bias due to using a convenience sample.Making information about financial interests in ÌÇÐÄ´«Ã½ readily available to clinical ÌÇÐÄ´«Ã½ coordinators, as well as providing education and training, should facilitate the disclosure of financial interests in ÌÇÐÄ´«Ã½ to potential ÌÇÐÄ´«Ã½ participants during the informed consent process.
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