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Policy

Reporting Conflicts Of Interest

Ethics: Requirements outlined by the Department of Health and Human Services raise concerns

by Britt E. Erickson
September 1, 2011

Criticism from Capitol Hill greeted the Aug. 23, release of an updated rule meant to strengthen conflict of interest oversight of NIH and other Department of Health and Human Services grantees. The rule closely mirrors a proposal issued last year by HHS (C&EN, May 31, 2010, page 12), but dilutes one key aspect.

Under the new rule HHS-funded investigators must now disclose financial interests, including payments from industry and equity interests, to their institutions when they receive more than $5,000 in a one-year period. The original rule, which dates back to 1995, set that threshold at $10,000. Another change requires institutions to determine when a financial conflict exists and to report those conflicts to NIH. Under the previous regulation, researchers determined when they had a financial conflict.

The criticism concerns public access to the conflict of interest information. Unlike the proposed rule, NIH will not require institutions to make conflict-of-interest information publicly accessible on a website. Instead, institutions will have the option of providing this information in writing within five business days to people who request it—in writing.

Sen. Charles E. Grassley (R-Iowa), who has been pushing for biomedical researchers to disclose payments from drug companies, says the rule will hurt public access. “An institution that doesn’t want to disclose information readily will be able to opt for the written request, knowing that requiring a request in writing is a barrier,” he says. “This is a missed opportunity to inject transparency where it’s really needed.”

Giving institutions a choice gives them “maximal flexibility to decide which is the least burdensome way to approach this while still achieving the goal of making information accessible to all,” counters Sally Rockey, NIH Deputy Director for Extramural Research.

NIH Director Francis S. Collins acknowledges that the new rule will put additional burdens on institutions that employ NIH grantees. “But we are confident that the results of this will further add to the public’s sense of confidence in the scientific process and the results that come out of NIH-funded research,” he says.

Institutions have one year to comply with the new regulation.

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