Conflict Disclosures for Regulatory Science: Slow but Steady Progress at Last

by Wendy Wagner

March 18, 2014

Basic disclosures of conflicts of interest have been required by the top science journals for decades. Yet most regulatory agencies – despite strong urging from a variety of bipartisan sources – have failed to require these disclosures for private research submitted to inform regulatory decisions. This omission is particularly alarming since, unlike journals, agencies used this research to determine the appropriate standards for protection of public health and welfare. If anything, one would expect the agencies to apply higher scientific standards and insist on greater transparency for privately submitted research as compared to journal editors.

The failure of agencies to meet these bare minimum standards of science has not gone unnoticed. Recently, the Administrative Conference of the U.S. recommended that agencies should, where possible, require these basic disclosures of conflicts, including “whether the experimenteror author had the legal right without approval of the sponsor of the research to: design the research; collect the data; interpret the data; and author, publish or otherwise disseminate the resulting report or fulldataset.”   See Recommendation #11. Both the Bipartisan Policy Center (p.42) and the Keystone Center (p.20,24) preceded the ACUS recommendation with similar calls for basic conflict disclosures for private research that informs regulation. An editor of Nature recently called for such disclosures, noting:

It was the 1976 film All the President’s Men, about the uncovering of the Watergate political scandal by two Washington Post reporters, that popularized the phrase: “Follow the money.” He who pays the piper calls the tune. Science combats the undue influence of commercial interests — or at least tries to — by using a different guideline, illustrated by a popular catchphrase from another film: “Show me the money.” Give us transparency.

Even members of Congress recognize the need for basic conflict disclosures in environmental in reform legislation (see § 4(b)) that is otherwise considered by environmentalists to be far too lax.  

At last, one federal agency has begun to show leadership on this issue. Last November, in a proposed rule that would set standards for silica exposure, OSHA requested that commenters voluntarily disclose funding sources in the course of submitting their comments. While this is simply a voluntary request by OSHA (and compliance with this request may prove disappointing), it is still a step in the right direction. Hopefully other agencies and Congress will follow suit and make the disclosure requirements mandatory for new research submissions that inform public and environmental regulation, holding this regulatory science to at least the minimum standards of the scientific community. 

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Also from Wendy Wagner

Wendy E. Wagner is the Joe A. Worsham Centennial Professor at the University of Texas School of Law, Austin Texas. Prior to joining the University of Texas Law faculty, Professor Wagner was a professor at the Case Western Reserve University School of Law and School of Management, and was a visiting professor at the Columbia Law School and the Vanderbilt Law School.

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