Toward Evidence-Based Conflicts of Interest Training for Physician-Investigators

Abstract

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.

Clinician, student and faculty perspectives on the audiology-industry interface: implications for ethics education

“…Recognising something as an ethical issue is a necessary first step to ethical deliberation. In a review of physician-investigators and the medical device industry, ethical sensitivity and awareness of conflicts of interest were not always raised by education that provided content and facts (Greenwood, Coleman, and Boozang 2012). An ethical "lens" may require education that goes beyond provision of content knowledge in the classroom; it may require an integrated approach with workplace experiences if we wish to engender ethical sensitivity in everyday practice.…”

“Get the Consent”—Nonfinancial Conflict of Interest in Academic Clinical Research

“…7 This is probably a result of highly publicized historical scandals involving investigators receiving monetary gains from sponsoring pharmaceutical companies, 8-13 inaccurate publication of results on the basis of financial (dis)-incentives, 14-16 and evidence suggesting that pharmaceutical sponsorship in medical education induces biases. 15,17-21 For these reasons, ASCO and other organizations, including the National Institutes of Health, the US Food and Drug Administration, and the Institute of Medicine, have all made the disclosure of financial COI mandatory. 13,22-26 …”

Insights from a National Conference: “Conflicts of Interest in the Practice of Medicine”

“…For example, Kate Greenwood and colleagues describe a process of externallyorganized training and compliance programs for physician-scientists, and conclude that such requirements could help promote a culture of openness and greater understand of the importance of accounting for potentially conflicting relationships. 23 However, legal regulation has drawbacks too. It can become too complicated and generate unintended consequences.…”