Abstract
The Center for Scientific Review's (CSR) Panel on Scientific Boundaries released a draft of its Phase 1 report this past August (full text of the draft is available at http://www.csr.nih.gov/bioopp/select.htm). The “Boundaries Panel” continues to work at examining the structure of the review process carried out by the CSR, with the self-described purposes of positioning “the CSR peer review system to foster the expanded research opportunities created by the stunning successes of the biomedical enterprise,” and enabling “the review system to keep pace with the accelerating rate of change in the way biomedical research is now performed.”
The primary job of the Panel at this first stage was the development of a set of Integrated Review Groups (IRGs) to be used in Phase 2 (expected to begin in “early 2000” and continue for the next two years) to serve as umbrellas for the study sections that will be created. In releasing the draft, the Panel noted perceptions that the peer review process is not functioning as effectively as it should. One of the Panel's aims, in creating new IRGs, was to remedy perceptions “that there are no appropriate study sections for many newly emerging fields; that applications describing some of the most productive, highest impact work may be assigned to too few study sections, causing too much of the “best science” to compete with itself; that the scope of some study sections is restricted to science with relatively low impact, resulting in undeserved “entitlements;” and that the breadth of knowledge needed to assess the importance and potential impact of research proposals may often be sacrificed in composing narrowly focused review committees.” It also called attention to the more specific complaint that clinical researchers and others “believe that they are inadequately served by the existing system.” The release of the draft of the Phase 1 report was accompanied by a request for comments.
In conjunction with this restructuring of the IRGs, there is an ongoing initiative to change the underlying culture of the peer review process. This attempt includes an emphasis on clarifying or further defining issues like peer reviewer roles, who a peer is, the role of preliminary data, and the appropriate relationship between study sections and disciplines. “The Panel believes that the key to maximizing the health of peer review in CSR lies in instilling in the applicants, reviewers and administrators a shared perception of their roles and responsibilities. .. concerning not only what reviewers should be doing, but also how they should be doing it.”
Included in the original draft was a plan to provide support for research with no “immediate or specific application to human health,” allowing for such research to be reviewed “in a fundamental context, without regard to a specific organ, biological system, or disease.” Five new IRGs were created with the express purpose of fostering this type of review. At the same time, the Panel made it clear that basic research “that more directly underlies clinical or applied studies on specific diseases, organs, physiological systems, or general health problems, should be reviewed within the broader biological and medical context to which it will ultimately be applied.” The Panel further decided that research related to a given system or disease should be clustered in an IRG devoted to that system or disease. In an unexpected adjunct to this decision, however, the AIDS and Related Research IRG was removed, shifting possible HIV-related topics to the Infectious Diseases and Microbiology IRG.
While criticisms of the Panel's report were tempered with praise for their efforts, some issues of concern did make it to the forefront. Removal of the AIDS IRG received a good deal of attention. Likewise, the proposed definition of a peer reviewer as an “active researcher, who is fully aware of (or can easily learn about [italics added for emphasis]) both the research goals and the research means being proposed” caused some to wonder how the high standards outlined in the draft could be achieved with inexpert reviewers. In a letter to the Chairman of the Boundaries Panel, AFMR urged the Panel to offer concrete examples of how they will “counter the conservatism” of the peer review system and cited the need for better and more appropriate reviews of clinical research.
Errol Crook, Public Policy Cochair for AFMR, called the Panel draft “a big step forward,” but added, “It will be important that the clinical investigator community respond to calls to serve on review panels and that we continue to train clinical investigators. Clinical investigators will remain skeptical until they see some results in terms of better outcomes for funding.”
An update posted on the NIH website in November listed three additional IRGs to be added to the 21 previously released in the draft. AIDS and AIDS-Related Research was created as a stand-alone IRG, as were Biology of Development and Aging, and Renal and Urological Sciences. A final Phase 1 report is expected in January 2000.