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

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

3. Dual Review System for Grant Applications Second Level of Review Second Level of ReviewCouncil  Assesses Quality of SRG  Review of Grant Applications  Makes Recommendation to  Institute Staff on Funding  Evaluates Program Priorities  and Relevance  Advises on Policy 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

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

5. Center for Scientific Review (CSR)

6. 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: u Research Grant Applications u Postdoctoral Fellowship Application u Academic Research Enhancement Award Applications u Small Business Innovation Research Applications

7. 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

8. Assignment to CSR Study Sections Applications are assigned to Integrated Review Groups (IRGs) for review. IRGs are clusters of scientifically-related 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

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

10. Assignment to CSR Study Sections (continued) Within an IRG, applications are assigned for review to 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)

11. 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] Musculoskeletal, Oral and Skin Sciences IRG [MOSS]

12. Assignment to Institutes Applications are referred to an Institute or Center as the potential funding component: 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

13. 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

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

15. 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

16. Review Process for a Research Grant Application

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

18. 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?

19. Research Involving Human Subjects Important Considerations 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.

20. Research Involving Children  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 Children must be considered for inclusion in all human subject research supported by NIH

21. Animal Welfare Important Considerations 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

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

23. 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: 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: The summary statement contains:  Overall Resume and Summary of Review Discussion  Essentially Unedited Critiques  Priority Score and Percentile Ranking  Budget Recommendations  Administrative Notes

24. National Advisory Council or Board Review

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

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

27. 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)