Perspectives of clinical research coordinators on disclosing financial conflicts of interest to potential research participants.
ABSTRACT 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.
To understand the role of clinical research coordinators in disclosing financial interests in research, and potential barriers to such disclosures.
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.
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%).
Possible sample bias due to using a convenience sample.
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.
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ABSTRACT: While allowing that transparency should be one of the tools employed to manage clinical researchers' conflicts of interest, this paper disagrees with the numerous recommendations that such information become part of the informed consent process. Empirical research in several areas suggests that the provision of this information to prospective trial participants will too often cause information overload; further, few research participants understand the relevance of the information to them once provided. Because many clinical trial participants do not have viable alternatives to trial participation, the information is not facilitating exit from participation. In short, we conclude that embedding this complicated information will ultimately do more harm than good for most recipients.SSRN Electronic Journal 12/2010; DOI:10.2139/ssrn.1720564
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ABSTRACT: Perspectives of adolescent research participants regarding conflicts of interest (COIs) and their impact on trust in researchers have not been studied. This study evaluates views of adolescent patients in treatment for substance and conduct problems compared to controls enrolled in genomic addiction research. Participants included 273 (190 patients, 83 controls) adolescents. Participants consented or assented (with parental consent) to have their genomic information deposited in a NIH biobank that shares information globally with qualified investigators. As part of that study, participants completed a COI survey. Endorsement of each COI item was analyzed with multiple logistic regressions, evaluating group, age, sex, ethnicity, and highest grade completed. Patients and controls differed in gender, ethnicity and highest grade completed. In response to the survey, 38.4% of patients and 25.3% of controls "want to know" and 35.3% of patients and 37.3% of controls "might want to know" about COIs. Males were less likely to want/might want disclosure about COIs. Older patients were more likely to want disclosure about financial interests; patients were more likely to want disclosure about possible treatments; males were more likely to want information about monetary gains. Both groups requested between 1 paragraph and 1 page of information. Disclosure of COIs did not impact trust for most participants. Adolescent patients and controls in this study want comparable information for disclosure of COIs including monetary gains, salary, publications, grants, and professional awards. Notably, the majority of patients and controls report that disclosure will not undermine trust in researchers. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.Drug and Alcohol Dependence 12/2014; 147. DOI:10.1016/j.drugalcdep.2014.12.004 · 3.28 Impact Factor