Scientists and policy experts from industry, government, and various nonprofit sectors worked on a report released recently by the Research Integrity Roundtable, designed to offer ways to improve the scientific analysis and independent expert reviews which underpin many important regulatory decisions. The primary audience for the report is federal agencies and their scientific advisory committees, but the ideas in the report may be relevant to others who work at the intersection of science and regulatory policy, including in Congress, the judiciary, and readers of MassTortDefense. These issues can have important implications for persons interested in issues associated with chemicals, energy, land use, natural resources, agriculture, pharmaceuticals, and other areas in which science informs public policy.
Critics of the manner in which science is used in regulatory decision-making processes tend to raise two kinds of concerns. They question the composition of committees that are empaneled to recommend or review the science behind a possible regulatory decision and they question the way an agency or committee has reviewed the relevant scientific literature, charging that the reviewers used or omitted the wrong studies, and/or that the studies were not appraised appropriately. Obviously, some disputes over the “politicization” of science actually arise over differences about policy choices that science can inform, but not determine.
With that in mind, this report attempts to lay out some broad principles, guidelines, and practices designed in the view of the authors to limit the battling over conflict of interest and bias, and systematic reviews. Accordingly, this report focuses on:
How should panels be composed and the qualifications of prospective advisory panelists be vetted?
How should concerns about biases and conflicts of interest of advisory panelists be handled?
Which studies should agencies review when examining the scientific literature related to a regulatory policy issue?
How should contending views regarding the relevance of particular scientific results to a regulatory issue and the credibility of those results be addressed?
For panel formation, the report concludes that a reasonable balance must be established between transparency and privacy. In the realm of qualifications, for example, balancing how much personal information should be revealed to the public by a prospective panelist who may be willing to serve in an advisory capacity, but may not want every aspect of his or her personal life or financial status released to the public.
In dealing with scientific studies, the report suggests a balance must be established in developing and applying objective and transparent criteria for establishing data relevance and reliability between the desire for complete data-sets and the reality that the relevant scientific literature is populated with studies from a wide variety of sources with varying degrees of data availability. In some cases, when proprietary information is involved, an appropriate balance must be struck between the public’s right to know and the legally based need to protect proprietary formulas, production processes, and related intellectual property.