Conflict of Interest: A National Perspective


Description of the Research
COI has currently become a popular issue in both lay and medical publications. A recent study by the Association of American Medical Colleges reported a rise in significant financial interests following implementation of the 2011 COI regulations (Pierce, 2015). After an event at our institution, we proposed to look at how other institutions deal with this issue. 

Our aim was to see, nationwide, the scope of this issue from prevention to reaction to incidence. To accomplish this we contacted all US Association for the Accreditation of Human Research Protections Programs (AAHRPP)-accredited institutions and sent an anonymous online IRB approved questionnaire aimed at the IRB chairman. We sent out 270 surveys with 124 responses (46%). Of these institutions, 93% were from academic or university medical centers. Of the respondents, 86% believed there was a COI in biomedical research and almost 98% had a COI policy. However, only 84% had a COI committee or knew that they had one. Interestingly, although 92% thought they monitored COI adequately, only 76% checked the accuracy of COI forms. Seventy-five percent of the respondents said their institutions had COI situations. This number may have been higher because almost 13% said they did not know. Seventy-six percent of respondents said they had anywhere from one to 10 issues per year. Interestingly, 67% of COI was self-disclosed, 19% caught by a monitor, and 3% were discovered by whistleblowers. As far as institutional integrity, 51% said their institution had potential COI in regard to biomedical research. Seventy-six percent said no pressure had been made on them to alter the decision on COI, 8.4% said pressure was exerted, and 16% did not know. Most corrective action (67%) was monitored reeducation. Eighty-five percent of the people believed the institutions' COI was handled properly. Finally, almost 20% of the respondents felt that an adverse decision by them in regards to COI would terminate their committee appointment. 

In conclusion, COI is an issue faced by medical research institutions throughout the country. The conflict has been dealt with, but the effectiveness of which has yet to be determined. The limitation of our study was outreach as we were only able to contact AAHRPP-accredited institutions. Our hope in the future is to expand our base and also to include commercial IRBs, and to further investigate the nature, seriousness, and outcomes of particular instances of COI in an effort to define a more effective national policy towards this problem.