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A Conflict-of-Interest Policy for Epidemiology

Gilman, Paul

doi: 10.1097/01.ede.0000200464.05103.2d

From the Oak Ridge Center for Advanced Studies, Oak Ridge, TN.

Correspondence: Paul Gilman, Oak Ridge Center for Advanced Studies, P.O. Box 2008, Building 5100, MS-6173, Oak Ridge, TN 37831-6173. E-mail: PAUL.GILMAN@ORAU.ORG.

When I arrived at the Environmental Protection Agency (EPA) as the Assistant Administrator for Research and Development, I was faced with a report from the General Accounting Office titled “EPA's Science Advisory Board Panels: Improved Policies and Procedures Needed to Ensure Independence and Balance.” The EPA's Science Advisory Board was in the midst of revising a form from the Office of Government Ethics for federal employees to determine whether their activities constituted a conflict of interest. The Science Advisory Board had used that same form and now it was apparent that something more detailed was necessary.

The evaluation of conflict of interest was not new to me. As a nominee going through Senate confirmation, I had filled out forms for the White House, the Senate, and the EPA. I had also overseen these evaluations as a staff person for the National Research Council (NRC) where all participants in NRC activities have these evaluations. A new form was eventually developed and extended throughout the various advisory boards of the EPA. It was then incorporated into the peer review activities for all major science activities at the EPA. These peer reviews, done through independent contractors along with the work of the formal advisory boards, results in over 600 reviews in any given year. Thus, reporting and evaluations related to conflict of interest are now done not just for federal employees engaged in the conduct and use of science in federal agencies, but for peer reviewers of that science as well.

How does any of this relate to whether Epidemiology should have a conflict-of-interest policy for its authors? Ralph Waldo Emerson should have included policymakers when he said “A foolish consistency is the hobgoblin of little minds, adored by little statesmen and philosophers and divines.” So we will abandon a justification based on consistency. How about going back to the basics?

The EPA and other regulatory agencies are constantly urged to use the best available science in formulating environmental and human health regulations. Most of that science is not generated internally. Most of it comes from research conducted outside federal agencies. During my time inside the EPA, a new set of guidelines was developed for determining what information is used in the formulation of regulations (the “Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies”). These guidelines place a premium on the use of peer-reviewed literature as a mechanism for quality assurance.

Organizations who view themselves as watchdogs of the regulatory process have for some time opposed the use of science funded by entities that are the object of regulation. This applies to science performed by a corporate scientist or even an academic who has been funded by a corporate entity. In their view, this research is tainted even if it appears in a peer-reviewed journal. There is also a growing movement among these watchdog groups to restrict the participation of scientists and engineers as reviewers of regulation-related science if they have been funded by entities that are the object of the regulation. Is all this concern misplaced?

Perhaps it is, and, then again, perhaps it is not. Take the example of a recently published epidemiologic study of a compound that has been the subject of intense regulatory interest. Should the journal publishing the paper have refused to review it because one of the principal authors was a staff scientist of a potentially regulated corporation? In my opinion—no. Should the journal have refused to review it because the work was funded by a potentially regulated corporation? Again, in my opinion—no. Should the journal have refused to review it because the authors reanalyzed select data after a statistically “significant” relationship between dose and response was found with the result that a “nonsignificant” dose–response relationship was reported? Again, in my opinion—no. Should the journal have required a disclosure of funding and financial interest so that special care could be taken in selecting peer reviewers? Yes. Should the reviewers have been asked to disclose information allowing a conflict-of-interest evaluation? Yes.

Why place this additional burden on authors and even reviewers? Because, if processes like these are not put in place, the credibility of peer-reviewed journals will become the focus of future debates. Regulatory agencies such as the EPA, which have an obligation to evaluate the quality of the science used in their regulatory activities, will begin to consider whether such a review is part of the journal's process.

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PAUL GILMAN, Director of the Oak Ridge Center for Advanced Studies, was the EPA's Science Advisor and Assistant Administrator for Research and Development. He also served as the Executive Director of the Life Sciences at the National Research Council of the National Academies and the Associate Director of the Office of Management and Budget for Natural Resources, Energy, and Science.

© 2006 Lippincott Williams & Wilkins, Inc.