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REFERRAL PHILOSOPHY AND PRACTICE Suzanne E. Fisher, Ph.D. Director, Division of Receipt and Referral, Center for Scientific Review Jean Noronha, Ph.D. Referral Officer, National Institute of Mental Health
REFERRAL PHILOSOPHY AND PRACTICE – CSR PERSPECTIVE Suzanne E. Fisher, Ph.D Director, Division of Receipt and Referral, Center for Scientific Review
DIVISION OF RECEIPT AND REFERRAL FUNCTIONS Receipt, processing, data entry, policy compliance, corrections, etc. - logistics and workflow are not the focus of this talk Referral Grant mechanism Primary Institute/Center (IC) and appropriate dual ICs Review location – CSR or IC CSR review – assign to IRG and IRG decides on Study Section/SEP
HISTORICAL PERSPECTIVE Initially Division of Research Grants (DRG) was responsible for receipt, review, award, and management of all scientific areas except cancer (only NCI established in 1946) Logically this led to a central receipt and assignment role for DRG As more ICs established, DRG relinquished role in awards process (ended in 1958) and concentrated on receipt/referral/review
HISTORICAL PERSPECTIVE (continued) Referral function needed from the beginning of the Division of Research Grants. Ten Study Sections in 1946: Antibiotics, Biochemistry and Nutrition, Cardiovascular, Dental, Hematology, Malaria, Pathology, Physiology, Virus and Rickettsial Diseases, Syphilis First mention of a Referral Branch in 1974 Many studies of review, few of referral and those mainly focus on workflow/logistics, making process faster
ROLE OF REFERRAL Central Receipt point Convenient for applicants Economies of scale Assignment to IC and review location based on guidelines, not considering other factors such as payline, portfolio balance, IC specific rules, etc. Honest broker, ensuring equitable treatment for all applicants Also gate keeper and enforcer of policies Information source for applicants and NIH staff
CRITICAL FEATURES OF REFERRAL PROCESS Information available to all potential applicants about opportunities Trans NIH policies and procedures must be followed Neutral, not show favoritism to ICs IC specific variations have been established over time that limit options for assignment of some applications
COMPLICATIONS OF THE REFERRAL PROCESS Twenty-four funding components of NIH have different missions, budgets, priorities, ways of achieving goals ICs established through political process, not by scientific principles ICs organized around different schemes – disease, organ systems, life stage, cross cutting issues Overlap/shared interests on almost every major topic
COMPLICATIONS (continued) Wealth of opportunities Different grant mechanisms used in by ICs Grant mechanisms may be used in different ways by different ICs Constant tension between consistency/uniformity and specific intent/needs of ICs
CASE STUDY IN VARIATION: SMALL GRANT (R03) 20 ICs participate; NIAMS, NIGMS, NCMHD, and NCRR do not Number of revisions allowed: 1 or 2 (general NIH standard) $ requested/years: $25,000 for 1 year; $32,000 a year for 3 years; $50,000 for 1 year; $50,000 a year for 2 years; $50,000 a year for 3 years; $75,000 for 3 years; $100,000 a year for 2 years; $100,000 a year for three years; $150,000 a year for 2 years Eligibility: new investigators only, new investigators and those changing research focus; only K08 and K23 recipients; all investigators Page limits for Research Plan: 8 pages;10 pages; 15 pages; 25 pages Page limits for Introduction: 1 page; 1 ½ pages; 3 pages Appendix Material: only figures and no publications; figures and up to 3 publications; figures and up to 5 publications; figures and up to 10 publications No renewal allowed; one renewal allowed Receipt dates: standing receipt dates; special receipt dates Review: CSR review; IC review Standard review cycle; expedited review All topics appropriate to IC; limited scientific areas
CASE STUDY IN VARIATION: R21 22 ICs participate; NCMHD and FIC do not $ requested/years: $150,000 for 1 year; $100,000 a year for 2 years; $100,000 a year for 3 years; $125,000 a year for 2 years; $250,000 for 1 year; $275,000 over 2 years; $400,000 over 3 years Page limits for Research Plan: 10 pages; 15 pages; 20 pages; 25 pages Appendix material: figures plus up to 5 publications; figures plus up to10 publications Receipt dates: standing receipt dates, special receipt dates Review: CSR review; IC review All topics appropriate to IC; limited scientific areas Purpose: Exploratory/developmental; high risk; limited scope projects; preliminary data; feasibility; clinical trial planning grant; pilot clinical data
CASE STUDY IN LIMITED OPPORTUNITIES: K01 MENTORED SCIENTIST DEVELOPMENT AWARD 18 of 24 ICs utilize for unsolicited applications (NIDCD, NIDCR, NEI, NLM, and NCMHD do not; NHLBI for RFAs only) 6 of the 18 ICs have specifications (NICHD only for Medical Rehabilitation, Child Abuse and Neglect, and Population Research)
CASE STUDY IN LIMITED OPPORTUNITY: PREDOCTORAL FELLOWSHIP (F31) All NIH ICs and AHRQ participate in the predoctoral program for minority students All NIH ICs participate in the predoctoral program for students with disabilities Only 10 ICs accept unsolicited predoctoral fellowship applications; 2 have very specific conditions (NCI and NIGMS) DRR regularly has to return F31 applications that do not fit any of the participating ICs
REVIEW IN CSR OR IC Overall paradigm CSR reviews the common, universally used grant mechanisms: R01, F32, Small Business ICs review grant mechanisms that have IC specific spin: Program Project (P01), Centers, Training Reality is IC by IC agreement based on historical precedent and negotiation Result is 42 page Cheat Sheet Greatest variation occurs for: R03, R21, fellowships Greatest discrepancies occur for: Ks, P01, R24, R25, S10, T35 Change of primary IC may lead to change in review location
EFFORTS FOR SIMPLIFICATION Consolidation of Career Award Mechanisms: Lasted only a short time and now have 14 different flavors, including K26, Mid career investigator award in mouse pathology Cassman Report (1995) suggested that mission related research should be reviewed by ICs, broad areas of basic research reviewed by CSR. In practice difficult to apply, all applications should be mission related.
WHO IS RESPONSIBLE FOR REFERRAL FUNCTIONS DRR 7 full time staff – value broad scope, quick learners, ability to evaluate, synthesize, and make decisions 16 Referral Officers- also experienced SRAs, broad science, flexible, able to manage additional responsibilities IRGs – use different methods: IRG Chief, Deputy Chief, rotate among SRAs, discussions ICs – Jean will address soon
LOGISTICS OF REFERRAL PROCESS Referral Officers responsible for about 1000 applications per round – one or more IRGs Referral Officers do not necessarily assign to their own IRG Breakout – first cut, not binding; separate IC review applications here Considerable movement of applications between Referral Officers Carefully consider PI requests; capture data to check for future changes Have process for ICs to request assignment Discussion with IRG Chiefs, SRAs, Review Division Directors, ICs Final decisions made by DRR staff For RFAs/PARs assignment is generally predetermined
THOUGHT PROCESSES IN REFERRAL Is the application assignable? If not assignable in present form, is it fixable? What is the real focus of the application; what kind of scientists care about this research; what expertise needed to evaluate? Grant mechanism IC – primary and dual Interplay mechanism and ICs that support If CSR review, what IRG?
ASSIGNMENT TO OTHER HHS COMPONENTS Main customers Agency for Healthcare Research and Quality (AHRQ) National Institute of Occupational Safety and Health (NIOSH) Minor customers CDC for small business FDA for small business Overall very small part of workload but may increase Some discussion of CSR/NIH doing referral for all of HHS
CHANGES WITH ELECTRONIC RESEARCH ADMINISTRATION Fundamental function of providing neutral, unbiased referral will not change Many of the routine functions (checking/fixing, data entry) will be gone Extensive variation (page limits, budget) will limit ability of electronic submission to do automated checking/policy enforcement Knowledge management may offer suggestions for assignments, but generally not make final decisions Need to develop tracking/reporting systems Need to ensure equity during transition from paper to electronic
CONCLUSIONS The good news – NIH provides a wealth of funding opportunities for investigators at many stages in their career and across the entire spectrum of biomedical and behavioral research The bad news - NIH provides a wealth of funding opportunities for investigators at many stages in their career and across the entire spectrum of biomedical and behavioral research. Thus, it is challenging for investigators to understand the differences and pick the most appropriate one.
CONCLUSIONS NIH strives to find a balance between uniformity/conformity and specific needs/desires of the initiatives of the ICs. The referral process is challenged by the inherent complexity and continually increasing workload