(This e-mail was sent out with the request that it be disseminated widely. Hence I am posting it on the web site. The blue highlighting is mine. - Vic Schoenbach.)

From: Osborne, Scott (CSR) [mailto:osbornes@csr.nih.gov]

Sent: Thursday, October 04, 2001 4:42 PM

Subject: EDC: Boundaries Panel Recommendations

Greetings. Please do not let this intrude on the valuable time before the meeting, and the issues addressed below can be discussed at the meeting. However, I want to inform you of an emerging situation and ensure that you have an opportunity to comment on a potential restructuring of study sections which may affect the manner in which some epidemiology applications are reviewed.

Two points for clarification of these materials are as follow:

(1) Background information follows in this email from the Chief of the SNEM IRG (Social Sciences, Nursing, Epidemiology and Methods Integrated Review Group), Dr. Robert Weller; and

(2) I am also attaching both (a) the note he sent to the behavioral and social sciences community as the SRA of the SNEM-3 Study Section and (b) the note which Dr. David Monsees, SRA for EDC-2, sent to the EDC-2 community. These are attached as Word documents at the end of this email; whereas Dr. Monsees is retiring, his remarks (prior to Dr. Weller's in the EDC2 note appended below) are quite candid.

You are encouraged to share this information with others in the epidemiology community so that the broadest possible response and consideration can be given to the potential effects of the proposed changes on the review of some epidemiology applications. The fundamental issue appears to pertain to whether some epidemiology applications would be reviewed in a group composed primarily of epidemiologists, which is the current practice, or whether they would be reviewed in a restructured system organized by organs or physiological systems where some epidemiology applications would be reviewed with non-epidemiologic applications relevant to the particular organ or physiological system in question.

The implementation process is just beginning, and you should consider whether such changes could affect (disadvantage?) the quality of review for epidemiology applications in the areas undergoing implementation. Another important issue to consider is that this approach would set a precedent from the start which, if adopted, could affect the approach to the review of epidemiology applications in other areas as the implementation process continues.

If you have any questions prior to the meeting, please let me know. I urge you to consider the implications of these matters with respect to the most appropriate review of applications in the field of epidemiology.

Best wishes, Scott Osborne

J. Scott Osborne, Ph.D., M.P.H. Health Scientist Administrator Scientific Review Administrator, Epidemiology & Disease Control-1 Study Section Center for Scientific Review, National Institutes of Health

Telephone: (301) 435-1782 FAX: (301) 480-3962 Email: osbornes@csr.nih.gov

NIH/CSR/EDC-1 6701 Rockledge Drive, Room 3154 (Fedex/Courier) or MSC-7770 (regular mail) Bethesda, MD 20817 (Fedex/Courier) or 20892-7770 (regular mail)

Comments from Dr. Weller (see attachment for full unrevised text):

As the second phase in implementing the recommendations of the Panel on Scientific Boundaries of Peer Review, individual Study Section Boundary Teams are reviewing and making recommendations on the organization of CSR Study Sections. This process is similar to the reorganization efforts two years ago that resulted in the IRG and Study Sections in which the EDC study sections are administratively located.

I invite you to review the proposed recommendations for the review responsibilities of study sections within the:

(1) Musculoskeletal, Oral, and Skin Sciences (MOSS) IRG, in particular, selected specific areas covered by the Skeletal Muscle, Exercise, and Rehabilitation (SMER) Study Section and Arthritis, Connective Tissue, and Skin (ACTS) Study Sections http://www.csr.nih.gov/PSBR/MOSS/MOSS.htm , and

(2) Biology of Development and Aging (BDA) IRG, http://www.csr.nih.gov/PSBR/BDA/BDA.htm for providing input via the WEB is in particular selected specific areas covered by the Aging Systems and Geriatric (ASG) Study Section,

If these study sections are created as described the potential exists that some research grant research applications currently reviewed in the EDC Study Sections http://www.csr.nih.gov/review/irgdesc.htm (then click on SNEM and then on EDC of choice) may end up being assigned to one of these new Study Sections.

As has been the practice, investigators may request assignment to any existing Study Section. However, dispersing epidemiology research applications across multiple Study Sections would decrease the value placed on the significance of the proposed research to moving the field forward and would decrease the pool of eligible reviewers with appropriate expertise.

Here are some comments I have prepared to suggest areas you consider and examine closely. There may be others. The more comments received on the web sites, the more effective they are likely to be.

A little over two years ago, a panel of representatives primarily from the three institutes (NIMH, NIDA and NIAAA) most affected by the integration of their review into the NIH review system recommended creation of three IRGs containing close to 20 study sections to review applications for research grants that are primarily behavioral or social science in their approach to the phenomenon being studies. These were named the Biobehavioral and Behavioral Processes (BBBP), Risk Prevention and Health Behavior (RPHB) and Social Sciences, Nursing, Epidemiology and Methods (SNEM) Integrated Review Groups (IRGs). Each IRG contains a number of study sections that concentrates on a specific area of scientific inquiry in the behavioral and social sciences. About six to nine months later, the Director of CSR, Ellie Ehrenfeld, established a panel of blue ribbon scientists to recommend a new IRG and study section structure for the rest of CSR, excluding the newly created IRGs in the behavioral and social sciences. This was called the Panel on Scientific Boundaries for Review, or PSBR for short.

PSBR finished its job and recommended establishment of a number of IRGs, based on the principal that IRGs should be focused upon organs or physiological systems and that all applications concerning that organ or system belongs in a study section within that IRG. By contrast, the three behavioral and social science IRGs, which were largely unaffected by the original PSBR recommendations, place the primary emphasis upon the approach to the phenomenon being studied. Thus a given study section will review applications covering a variety of subjects areas but which have a commonality based upon approach to that subject area. When PSBR was established, assurances were given repeatedly to the rest of NIH and to the scientific community that BBBP, RPHB and SNEM would not be included in the Boundaries Panel's domain and that these three IRGs would not be affected.

Subsequently, a number of trans-NIH committees were established to develop implementation plans of the PSBR recommendations. To date, three sets of implementation plans have been published, and in two of the cases the implementations go beyond the actual PSBR recommendations in a way that would adversely affect the epidemiology, behavioral and social science IRGS, as well as the SNEM Study Sections. The three sets of implementation guidelines that have been published for new IRGs are: (1) Hematology; (2) Biology and Development of Aging (BDA), and (3) Musculoskeletal, Oral and Skin Sciences (MOSS).

BDA and MOSS are still available for public comment, MOSS until October 19 and BDA until November 12. There is material in the guidelines for these two IRGs that I believe directly affects one or more of the behavioral IRGs by including coverage in areas that are currently reviewed by one of the three IRGs. Given the large number of IRGs proposed by the Boundaries Panel whose guidelines have not yet be presented for public comment, I fear that the impact on BBBP, RPHB and SNEM may be substantial, and I have prepared some material showing the basis of this impact for BDA and MOSS.

The period for comments on the implementation plans for BDA and the Cellular Mechanisms in Aging and Development (CMAD) Study Section in this IRG is still open, but the appropriate sites are not found easily and the casual reader of the CSR home page would not even know they exist. The URL for BDA is www.csr.nih.gov/PSBR/BDA/bda.htm and the URL for MOSS is www.csr.nih.gov/PBSR/MOSS/MOSS.htm. The rosters of the implementation committees are also on-line. One is hard-pressed to find a behavioral or social scientist on either committee. These are made up of physical scientists.

Here are some potential impacts on the Social Science, Nursing, Epidemiology and Methods (SNEM) IRG that occur to me. In the proposed Biology and Development of Aging (BDA) IRG (website www.csr.nih.gov/PSBR/BDA/bda.htm) one of BDA's review areas is identified as: Determinants of longevity; age-related changes in physiological functions; geriatric syndromes and diseases; animal models of aging; predictive markers of biological health and aging; and mechanisms of exceptional aging. This has a great deal of overlap with applications reviewed by SNEM.

For example, under the referral guidelines proposed for the Cellular Mechanisms in Aging and Development (CMAD) Study Section, the following types of applications would be referred to CMAD: "Genetic and environmental determinants of longevity and age-related functional changes, including: fetal origins of adult disease; mechanistic aspects of metabolic imprinting; dietary restriction; and mechanistic aspects of genetic and hormonal manipulation of organismal longevity. Evolution of aging, including comparative studies of mechanisms of aging. This study section appropriately reviews fundamental mechanistic studies that relate to both developmental disorders and the pathobiology underlying aging and degeneration. Studies designed to address only general principles, not related to a temporal dynamic or to a developmental or aging process, should be considered by the appropriate organ-focused IRG."

SNEM3 currently reviews applications pertaining to age-related functional changes, mortality and morbidity, and EDC-3 currently reviews applications to study aspects of the epidemiology of aging. These referral guidelines make no mention of overlap with the IRG 7 (which is SNEM, retitled as "Health of Populations").

Under the proposed reorganization, one of the review areas for the Aging Systems and Geriatrics (ASG) Study Section (another study section in the BDA IRG) would be applications involving aging humans or animals, in particular studies of postmaturational changes, which transcend single organ systems or disciplines, and which may require integrated experimental, genetic or observational approaches. Also included would be geriatric syndromes (i.e., age-related conditions involving multiple systems and/or multifactorial mechanisms) and their prevention or treatment. These include: falls, syncope, frailty, immobility, delirium, incontinence, polypharmacy, malnutrition, mood disorders, sarcopenia, chronic pain, loss of functional independence, and failure to thrive. Interventions may include exercise, hormones, nutrition, medications, technology, and lifestyle modifications. Another specific area is descriptive, mechanistic, and intervention studies of geriatric diseases affecting multiple body systems that are unique or highly prevalent in elderly people or aging animals. The focus should be on an aging population, the role of comorbid health conditions, or complex outcomes relating to overall functional status and multiple systems. Examples include congestive heart failure (especially, diastolic dysfunction), atrial fibrillation, hypertension (especially systolic hypertension), type 2 diabetes and its complications, osteoarthritis, osteoporosis and related bone fractures. Development and validation of predictive markers of biological health and aging. Studies of mechanisms of exceptional aging, including premature aging syndromes, extreme longevity and factors contributing to sustained health without significant diseases or disability into advanced age.

Again, there is potential overlap with SNEM Study Sections, especially SNEM1 (which reviews applications related to interventions to change health-related behavior), SNEM 3 (which reviews applications related to mortality and morbidity), EDC1 (which reviews applications related to the epidemiology of cardiovascular health), and EDC3 (which studies epidemiology of aging, including dementia, pulmonary disease and musculoskeletal conditions).

In the overlap statements, there is acknowledge of an overlap with IRG 7 (the new, renamed SNEM), but the nature of this overlap is not described. Overlap is also noted with regard to IRG 8 (the new RPHB) and IRG 9 (the new BBBP). The nature of the overlap with IRG8 is not described, but the following statement appears concerning overlap with IRG-9 (the new BBBP): Applications with a primary focus on behavioral interventions should be reviewed by ASG when the endpoints are physiological or biological in nature, and an aging population is specifically studied.

In the proposed guidelines for the Musculoskeletal Oral and Skin Sciences (MOSS) IRG (website www.csr.nih.gov/PBSR/MOSS/MOSS.htm), the Skeletal Muscle Exercise, and Rehabilitation (SMER) Study Section would review applications related to integrative and functional studies on human mobility and exercise, physical rehabilitation, and health. Currently SNEM1 reviews applications pertaining to community based interventions to increase exercise as a means to promote health.

Also, the SMER SS would review applications related to therapeutic and preventive interventions as they relate to skeletal muscle function. Presumably at least some of these, if not most, would involve an approach utilizing the behavioral and social sciences approach. These currently are reviewed within BBBP, RPHB or SNEM.

The SMER SS would review applications related to use of exercise and other physical rehabilitation modalities in treatment and prevention of aging and/or diseases related to skeletal muscle wasting and maintenance of functional capacity, increased health in the general population, and as a therapy. These currently are reviewed within SNEM, either by NURS, SNEM1 or SNEM4.

Under the proposed implementation plan, the Arthritis, Connective Tissue and Skin (ACTS) Study section would review applications related to clinical research in arthritis and related rheumatic diseases: epidemiology and studies on natural history of disease; outcomes research, developmental therapeutics and interventions; genetic linkage studies; imaging, diagnostics, and biomarkers; psychological aspects, pain, disability, physical rehabilitation, fatigue, and functional measures of clinical outcomes. EDC-3 currently reviews applications related to many of these factors, yet no mention of overlap with SNEM or EDC-3 is made in the overlap statement for ACTS.

There are 24 IRGs being proposed. What is presented above is what we have after only three sets of implementation guidelines have been prepared. Cannibalization by organ or biological system will result in the placement of 1 or 2 behavioral scientists on study sections that are dominated by physical scientists, with predictable results. It will also reduce the review load in the behavioral and social science IRGs to the extent that continuation of some of the existing study sections may not be feasible.

Comment from the scientific public is highly desirable and much more importance is attached to it than to comments from CSR staff such as myself. So people and professional societies need to take a look and see if they like what they see and what it represents. And they need to make comments.

-----------------------

Corinne C. Aragaki, Ph.D. Assistant Professor, Epidemiology and Biometry School of Public Health,
Dallas regonal campus at University of Texas Southwestern Medical Center
University of Texas Health Science Center at Houston (main campus)
5323 Harry Hines Blvd. V8.112
Dallas, TX 75390-9128 Corinne.Aragaki@UTSouthwestern.edu http://www2.utsouthwestern.edu/publichealth/Aragaki
Ph: (214)648-1054, (214)648-1080
FAX: (214)648-1081

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Posted 10/9/2001