Proposed Rules Would Lower the Amount of Industry Money that Constitutes a Conflict for Researchers

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A newly proposed rule on conflict of interest in medical research would reduce the monetary amount that qualifies as a conflict for researchers from $10,000 to $5000. Issued by the National Institutes of Health (NIH) in May, the rule is designed to help strengthen the current rules governing conflicts of interest between researchers and industry.

In addition to changing the definition of “significant financial interest” by reducing it to a total of $5000, the rule supports creating a website for public reporting of significant financial interests among researchers and placing increased responsibility on individual institutions to monitor potential conflicts of interest among their researchers.

The relationship between research and industry has always been complex. Industry support is crucial to the success of research. This support, however, must be balanced with the fundamental need for researchers to remain impartial when carrying out their research and interpreting results. Key to the public’s trust in the medical profession and confidence in new treatments is this belief in impartiality. NIH grants remain the foremost vehicle for government to help fund medical research. NIH accounts for almost a third of all medical research spending at 27 percent. Industry accounts for the majority of funding at 58 percent (1). The important role NIH plays in funding medical research underscores the significance of this proposed rule.

Before issuing final recommendations, NIH solicited feedback from the research community on its proposals. The American Society of Nephrology (ASN) submitted a comment letter supporting a number of proposals included in the rule. These comments were crafted with the assistance of Thomas Hostetter MD, Dwight McKinney MD, Bruce Molitoris MD, FASN, John R. Sedor, MD, and John Stokes III MD, FASN.

In particular, ASN backs the new definition of significant financial interest. ASN also agrees with new guidelines that expand the definition of significant financial interest to include income from non-higher education nonprofits. ASN further commended the idea to create a public site for reporting significant financial interest. ASN views these changes as reasonable and not overly onerous for researchers.

ASN voiced concern over the burden placed on individual academic institutions to monitor conflict of interest. Placing responsibility largely at a facility level may result in disparate standards across research facilities, potentially to the detriment of researchers at institutions that enforce more stringent polices. ASN recommends that NIH develop clear guidelines for enforcement and administration of conflict of interest to help create a level playing field across all institutions nationwide, alleviating institutional differences in enforcement of conflict of interest rules. ASN also recommends NIH keep in mind the administrative burden increased conflict of interest reporting may have on researchers and institutions alike, taking this into consideration when issuing final recommendations.

“Any new conflict of interest guidelines should help institutions educate their faculty and make the rules more uniform, not decrease the amount of research done in universities because of onerous paperwork,” said Sedor.

The Society continues to monitor NIH recommendations regarding conflicts of interest to ensure the regulations reflect the best interests of researchers and patients. Read ASN’s comment letter and learn more about research-related issues in nephrology on the Society’s Medical Research Policy page at http://asn-online.org/policy_and_public_affairs/medical-research.aspx.

Reference

1. Dorsey, et al. Funding of U.S. Biomedical Research, 2003–2008. JAMA 2010; 303:137–143.