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Medicine grapples with COI reporting


 

Enforcement questions

Some experts believe that institutions should maintain public databases of disclosures and/or that disclosure requirements should be better enforced in-house.

“There often are no clear guidelines in institutions about how to respond to people who are negligent in how they’re managing their disclosures,” said Jeffrey R. Botkin, MD, MPH, professor of pediatrics and associate vice president for research at the University of Utah, Salt Lake City, who has served on a variety of ethics committees and is an elected member of the Hastings Center. Dr. Botkin proposed in a Viewpoint published last October in JAMA that failure to disclose significant COIs should be considered research misconduct (JAMA 2018;320[22]:2307-8).

Dr. Jeffrey R. Botkin, professor of pediatrics and associate vice president for research at the University of Utah, Salt Lake City

Dr. Jeffrey R. Botkin

At the University of Utah, “we’re getting better at saying, ‘show us that you’ve disclosed,’ ” he said. “In some cases we’ll do spot checks of journal articles to make sure [researchers have] followed through with their disclosures.”

John Abramson, MD, a lecturer in the department of health care policy at Harvard Medical School, Boston, contends that incomplete declarations of COI have been shown to correlate with reporting of manufacturer-friendly research results. Journals should have “zero tolerance” standards for incomplete or inaccurate COI declarations and should, among other things, “inform academic institutions of breaches of integrity.”

At JAMA, which in 2017 published a theme issue on COI and COI declarations, editors have been discussing whether they will contact an author’s institution “if there’s a pattern involved [with disclosure problems] or if there’s a lack of declaration of multiple COIs,” Dr. Bauchner said.

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