Peer Review of NIH Research Grant Applications Center for Scientific Review National Institutes of Health

Review Process for a Research Grant National Institutes of Health Research Grant Application School or Other Research Center Center for Scientific Review Assign to IC & IRG/ Study Section Initiates Research Idea Study Section Submits Application Review for Scientific Merit Institute Evaluate for Relevance Advisory Councils and Boards Allocates Funds Conducts Research Recommend Action Institute Director Takes final action

Dual Review System for Grant Applications First Level of Review Scientific Review Group (SRG) Provides Initial Scientific Merit Review of Grant Applications Rates Applications and Makes Recommendations for Appropriate Level of Support and Duration of Award Second Level of Review Council Assesses Quality of SRG Review of Grant Applications Makes Recommendation to Institute Staff on Funding Evaluates Program Priorities and Relevance Advises on Policy

National Institutes of Health Office of the Director National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Institute of Biomedical Imaging and Bioengineering National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine National Center on Minority Health and Health Disparities Clinical Center Center for Information Technology Center for Scientific Review

Center for Scientific Review (CSR)

Center for Scientific Review Referral Central Receipt Point for PHS Grant Applications Institute Assignment (Potential Funding Component) Assignment to Scientific Review Group in CSR or in an Institute Scientific Review More than 100 Study Sections that review: Research Grant Applications Postdoctoral Fellowship Application Academic Research Enhancement Award Applications Small Business Innovation Research Applications

Applications are Assigned to: Scientific review groups based on: Specific review guidelines for each scientific review group Institutes based on: Overall mission of the Institute Specific programmatic mandates and interests of the Institute

Assignment to CSR Study Sections Applications are assigned to Integrated Review Groups (IRGs) for review. IRGs are clusters of scientifically-related study sections The IRG assignment is based on specific referral guidelines for each IRG Each of the 20 IRGs within CSR has 5 - 8 standing study sections

Organization Chart of Review Divisions Center for Scientific Review National Institutes of Health Department of Health and Human Services Division of Molecular and Cellular Mechanisms Division of Biologic Basis of Disease Division of Physiology and Pathology Division of Clinical and Population-based Studies Bioengineering Sciences and Technologies AIDS and Related Research Cardiovascular Sciences Biobehavioral and Behavioral Processes Biological Chemistry and Macromolecular Biophysics Endocrinology, Metabolism, Nutrition and Reproductive Sciences Digestive Sciences Brain Disorders and Clinical Neuroscience Immunology Biology of Development and Aging AIDS and Related Research Health of the Population Hematology Infectious Diseases and Microbiology Risk, Prevention and Health Behavior Integrative, Functional and Cognitive Neuroscience Cell Biology Oncological Sciences Surgical Sciences, Biomedical Imaging and Bioengineering Genes, Genomes and Genetics Musculoskeletal, Oral and Skin Sciences Molecular, Cellular and Developmental Neuroscience Renal and Urological Sciences Respiratory Sciences Revised on April 16, 2003.

Assignment to CSR Study Sections (continued) Within an IRG, applications are assigned for review to Standing Study Sections when the subject matter of the application matches the referral guidelines for the study section Ad Hoc Special Emphasis Panels (SEPs) when the subject matter does not fit into any study section, or when assignment of an application to the most appropriate study section would create a conflict of interest. Also used for special mechanisms (e.g., fellowships, SBIRs, AREAS)

Musculoskeletal, Oral and Skin Sciences IRG [MOSS] The Musculoskeletal, Oral and Skin Sciences [MOSS] IRG will consider research applications that address structural systems that are prerequisite for physical form, mechanical function, movement, and integrity of the body. These structural systems and their components are the basis for the organization of the study sections of this IRG and are described according to the following topical areas: skeleton, spine, bone, connective tissue, extracellular matrix, and their related diseases/disorders; dental/oral and craniofacial and their related diseases/disorders; skeletal muscle, limb, and their related diseases/disorders; joints and their related diseases/disorders, including rheumatic diseases; skin and its related diseases/disorders. Autoimmune diseases are specifically included. For these topical areas, the studies considered range from molecular genetics and stem cell research to animal models and clinical trials. For each major topical area, the research applications may include studies of: basic biology, including growth, development, maturation, and aging; biomaterials for prostheses/orthotics and implants; pathogenesis and therapeutics; physical rehabilitation; exercise; mechanobiology/biomechanics; injury and repair, including adaptation, plasticity, degeneration, and regeneration; diagnostic markers and biomarkers; cell and gene-based therapies; and clinical outcomes and trials. The following Study Sections are included within the MOSS IRG: Oral, Dental and Craniofacial Sciences [ODCS] Skeletal Biology Development and Disease [SBDD] Skeletal Biology Structure and Regeneration [SBSR] Skeletal Muscle Biology and Exercise Physiology [SMEP] Musculoskeletal Rehabilitation Sciences [MRS] Arthritis, Connective Tissue, and Skin [ACTS] General Medicine B Study Section [GMB] Chronic Fatigue Syndrome/ Fibromyalgia Syndrome Special Emphasis Panel [CFS SEP] Urology Study Section [UROL SEP] Bioengineering Research Partnerships/Grants Special Emphasis Panel [SSS-M] MOSS Small Business Activities [SBIR/STTR SEPs]

Assignment to Institutes Applications are referred to an Institute or Center as the potential funding component: This assignment is based on a match between the research proposed and the overall mission of the Institute or Center Where applications are appropriate for more than one Institute or Center, multiple assignments are made

Peer Review in CSR CSR Study Sections are managed by a Scientific Review Administrator (SRA) who is a professional, usually at the Ph.D. level, whose scientific background is close to the expertise of the study section Each CSR standing study section has 12 - 24 members who are primarily from academia As many as 60 - 100 applications are reviewed at each study section meeting

Selection of Peer Reviewers Active and Productive Researchers Research Capability Non-Research Non-Doctoral Scientific Community

Criteria For Selection of Peer Reviewers Demonstrated Scientific Expertise Doctoral Degree or Equivalent Mature Judgment Work Effectively in a Group Context Breadth of Perspective Impartiality Interest in Serving Adequate Representation of Women and Minority Scientists

Review Process for a Research Grant Application

Review of Research Grants REVIEW CRITERIA: Significance Approach Innovation Investigator Environment Overall Evaluation & Score Reflects Impact on Field

Review Criteria (continued) Significance: Does the study address an important problem? How will scientific knowledge be advanced? Approach: Are design and methods well-developed and appropriate? Are problem areas addressed? Innovation: Are there novel concepts or approaches? Are the aims original and innovative? Investigator: Is the investigator appropriately trained? Environment: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment?

Research Involving Human Subjects Important Considerations Is the proposed study exempt from human subject review? Are there any apparent risks* to the human subjects? Are the protections adequate? What are the potential benefits to the subjects and to mankind? Are the inclusions of minorities and both genders adequately addressed? *”Risks” include the possibility of physical, psychological, or social injury resulting from research.

Research Involving Children Children must be considered for inclusion in all human subject research supported by NIH Effective for all new applications received after October 1, 1998 Child is defined as an individual under age 21 If children are included, Investigator must address age range expertise of investigative team facilities sufficient numbers

Animal Welfare Important Considerations Will the anticipated results be for the good of society? Will the work be planned and performed by qualified scientists? Will the animals be treated so as to avoid any unnecessary discomfort, pain, anxiety, or poor health? Species chosen Animals in short supply

Scientific Review Group or Study Section Actions Scored, Scientific Merit Rating (priority scores and percentiles) Unscored (lower half) Deferral

Summary Statement Once applications are reviewed, the results are documented by the SRA in a summary statement and forwarded to the Institute (and the PI) where a funding decision is made: The summary statement contains: Overall Resume and Summary of Review Discussion Essentially Unedited Critiques Priority Score and Percentile Ranking Budget Recommendations Administrative Notes

National Advisory Council or Board Review

Council Actions Concurrence with study section action Modification of study section action Deferral for re-review

What Determines Which Awards Are Made? Scientific merit Program Considerations Availability of funds

Information on the World Wide Web Selected Sites of Interest National Institutes of Health (http://www.nih.gov) Office of Extramural Research (http://www.nih.gov/grants/oer.htm) Grants Policy (http://www.nih.gov/grants/policy/policy.htm) Center for Scientific Review (http://www.csr.nih.gov) Referral and Review (http://www.csr.nih.gov/refrev.htm) Overview of Peer Review Process (http://www. csr.nih.gov/review/peerrev.htm) CSR Study Section Rosters (http://www.csr.nih.gov/committees/rosterindex.asp) NIH Peer Review Notes (http://www.csr.nih.gov/prnotes/prnotes.htm)