The Phase 1 report by the Panel on Scientific Boundaries for Review (PSBR) was presented to the CSR Advisory Committee at its meeting on January 10-11, 2000. By accepting the report, the Advisory Committee launched CSR into phase 2. Phase 2 represents the creation of specific study sections that will comprise the Integrated Review Groups (IRGs) proposed in the Panel's Phase 1 report.  We anticipate that some changes will be made to the proposed IRG structure during Phase 2. The Phase 2 implementation process will be gradual and will involve all stakeholders: scientific research communities, NIH program and review staff, and the members of the PSBR.

IMPLEMENTATION PLAN

Mock Referral

In designing the proposed set of IRGs, the PSBR was guided by the principle that the IRG organization should be flexible enough to adjust to the rapid changes in scientific opportunities and emerging fields expected in the years ahead. While the applications submitted today may not be a good indicator of the future, a starting point is needed. The first step in Phase 2 is to see how a typical round of applications distributes among the 24 Integrated Review Groups (IRGs) proposed by the Panel in Phase 1. CSR staff is assessing a "mock referral" of all applications being reviewed for the May 2000 Council meetings based on the Panel's recommendations. The abstracts from these applications will form the working material to be used when considering IRG and study section structure throughout this process. The definitions of the IRGs will be refined. Additional definition and modification will occur later in Phase 2 when applications are considered for assignment to specific study sections.

Steering Committees

The purpose of the Steering Committees will be to create Study Section Boundaries Teams (SSB Teams) for each of the IRGs to be created or reorganized. The Steering Committees will ensure that all stakeholders are appropriately represented on the SSB Teams through outreach activities to professional societies and other scientific leaders, and to CSR and other NIH staff. There will be multiple Steering Committees. A Steering Committee may be created for one IRG or a group of IRGs depending on the science in the IRGs. The membership of each Steering Committee will include senior CSR and other NIH staff.  A Steering Committee will terminate when the CSR Advisory Committee accepts their SSB Teams' recommendations.

Study Section Boundaries Teams

SSB Teams are unique groups convened for the single purpose of designing new study sections.  They should not be confused with IRG Working Groups, which are convened on a regular (every 5 years) cycle to assess the performance of the study sections in an IRG.  These latter reviews are an ongoing activity that will likely provide information to SSB Teams, but they are a distinct and separate activity, part of our program for periodic monitoring and review of study section function.   SSB Teams will consist of research scientists from the relevant scientific communities, a member of the PSBR, CSR staff, and other NIH staff. Members will convene to sort the abstracts of applications for the May 2000 Council round assigned to their given IRG into new study sections. By sorting the applications into groups suitable for study sections and exchanging views, the SSB Team will determine the scientific boundaries for each study section within the IRG. At this stage, there is likely to be some additional movement of topics from one IRG to another. After each SSB Team completes its proposal for the study sections, input from the broader research community will be sought by posting the descriptions of the proposed IRG and study sections on the web for public comment. After comments are received the Steering Committees and SSB Teams may refine the recommendations. The responsibilities of the SSB Team will end when the CSR Advisory Committee accepts their report.

Timetable

Steering Committees for all of the IRGs will begin their activities within the next two years with full implementation within three years. CSR will begin by establishing a SSB Team for a single IRG, Hematology. Teams for up to three more IRGs will be initiated approximately every four months thereafter until Teams for all 17 IRGs being considered for formation or reorganization have been established. It is estimated that the work of each team will require approximately 9 months. As an intermediate step, applications coming from two or more existing study sections may be brought together in a temporary special study section (SEP). At any one time, CSR will have no more than 6 active SSB Teams. A SSB Team's term will end when their report is submitted to their Steering Committee and, similarly, a Steering Committee's term will end when their report is submitted to the PSBR.

Evaluation

To ensure that the review process continues to evolve to accommodate the ongoing emergence of new scientific opportunities and practices, the PSBR recommended that formalized evaluations be carried out at regular intervals to assess the structure and function of the CSR peer review process. Thus, the study section design produced in Phase 2 will be reviewed on approximately a five-year basis by ad hoc external advisory groups for each IRG that report to the CSR Advisory Committee. This process is already being implemented for current IRGs. In addition to this intra-IRG evaluation, the PSBR recommended a periodic global assessment of the study sections, based on input from applicants, reviewers, and NIH staff. Plans for these assessments are in progress.

THE RECOMMENDED IRGs

The PSBR recommended 24 IRGs for CSR. Six IRGs are new, and their applications will be taken from existing IRGs. Although eleven IRGs already exist in name, they will be reorganized around their major organ or disease systems.

Seven IRGs have recently been reorganized and, therefore, will not be involved in this reorganization. They are:

Health of the Population (formerly Social Sciences, Nursing, Epidemiology and Methods)
Risk Prevention, and Health Behavior
Behavioral and Biobehavioral Processing
AIDS and AIDS-Related Research
Molecular, Cellular, and Developmental Neuroscience
Integrative, Functional, and Cognitive Neuroscience
Brain Disorders and Clinical Neuroscience

New IRGs that have no current counterpart will be amongst the first to be created and populated with study sections. These include the following six IRGs:

Biology of Development and Aging
Fundamental Bioengineering and Technology Development
Hematology
Digestive Sciences
Pulmonary Sciences
Renal and Urological Sciences

Existing IRGs that will be modified are:

Immunology
Infectious Diseases and Microbiology
Oncological Sciences
Cardiovascular Sciences
Endocrinology, Metabolism, and Reproductive Sciences
Bone, Muscle, Connective Tissue, and Skin
Surgery, Applied Imaging, and Applied Bioengineering.

The remaining four basic science IRGs will be amongst the last to be organized:

Biological Chemistry and Macromolecular Biophysics
Molecular Approaches to Gene Function
Molecular Approaches to Cell Function and Interactions
Fundamental Genetics and Population Biology

CONCLUSION

A comprehensive assessment of the organization and composition of CSR's study sections has never been attempted before and will certainly be a challenge. We will try to move slowly and carefully, with as much input and discussion as possible, so that we do the best possible job in trying to align the review process with the rapidly moving scientific landscape. Perfection is not achievable; however, science is changing, and the challenge to CSR is to respond and to provide the best reviews possible. The transition may be difficult but, with participation of all parts of the scientific enterprise, we are determined to develop a system that provides the world's best peer review of health-related research.

To ensure that the review process evolves to accommodate the ongoing emergence of new scientific opportunities and practices, the PSBR recommended that formalized evaluations be carried out at regular intervals to assess the structure and function of the CSR peer review process. Thus, they recommended that the study section design produced in Phase 2 should be reviewed on approximately a five-year basis by the ad hoc external advisory groups for each IRG that are being established to report to the CSR Advisory Committee. In addition to this intra-IRG evaluation, the PSBR recommended a periodic global assessment of the study sections, based on input from applicants, reviewers, and NIH staff. When phase 2 is complete, plans for intra-and inter-IRG evaluations will begin.