Toward Evidence-Based Conflicts of Interest Training for Physician-Investigators
affiliation not provided to SSRN
Carl H. Coleman
Seton Hall University School of Law
Seton Hall School of Law; Seton Hall University - Center for Health & Pharmaceutical Law & Policy
Journal of Law, Medicine and Ethics, Forthcoming
Seton Hall Public Law Research Paper No. 2129247
The increased focus in recent years on the risks posed by conflicts of interest arising from financial relationships between physician-investigators and the pharmaceutical and medical device industries has led to a variety of measures that can broadly be described as “regulatory” interventions, including new federal and state laws, criminal prosecutions and private lawsuits, requirements attached to government funding, and institutional policies. Studies suggest, however, that physician-investigators have not internalized the message that financial conflicts of interest have the potential to influence their decision-making. Simply informing physician-investigators of the content of relevant rules and the consequences of noncompliance — as appears to be the practice in many existing compliance training activities — is unlikely to lead to lasting changes in norms or behavior. Instead, we theorize that, for trainings to be maximally effective, they must appeal to the complex intrinsic and extrinsic motivations that contribute to individuals’ willingness to comply with regulatory mandates. In addition, physician-investigators’ beliefs that the risks posed by conflicts of interest do not apply to them need to be challenged. Rigorous evaluation of the newly-designed training programs will help determine whether these theories are borne out in fact.
Number of Pages in PDF File: 29
Keywords: physicians, pharmaceutical and medical device industry, conflicts of interest, norms, training, empirical legal studies
Date posted: August 14, 2012 ; Last revised: September 18, 2012
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