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Marvin Kalt, Ph.D .

Marvin Kalt, Ph.D. Director Division of Extramural Activities National Institute of Allergy and Infectious Diseases National Institutes of Health. March 10, 2009. Topics. NIH – NIAID Overview Building a Sustainable Research Portfolio The NIH Extramural Support Process

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Marvin Kalt, Ph.D .

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  1. Marvin Kalt, Ph.D. Director Division of Extramural Activities National Institute of Allergy and Infectious Diseases National Institutes of Health March 10, 2009 Mississippi Delegation March 10, 2009

  2. Topics NIH – NIAID Overview Building a Sustainable Research Portfolio The NIH Extramural Support Process Types of Grant Applications The NIH Peer Review Process “Rules” fo Navigating the Peer Review System Identifying and Soliciting Collaborations Resources . Mississippi Delegation March 10, 2009

  3. NIH - NIAID OVERVIEW Mississippi Delegation March 10, 2009

  4. U.S. Department of Health and Human Services Mississippi Delegation March 10, 2009

  5. National Institutes of Health Mississippi Delegation March 10, 2009

  6. The NIH Mission “Science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability.” Mississippi Delegation March 10, 2009

  7. NIH - Campus Photo Mississippi Delegation March 10, 2009

  8. NIH Facts and Figures • Budget: ~ US $28 Billion • 2 year $10.4 Billion American Recovery and Reinvestment Act (ARRA) http://www.nih.gov/about/director/02252009statement_arra.htm NIH must spend all stimulus funds by September 2010 • 28,000 staff members • 27 Institutes and Centers, and the Office of the Director • 300 acres and 75 buildings on the Bethesda campus, off-campus sites- Maryland, North Carolina, Michigan, Montana, and Arizona • NIH Clinical Center - largest research hospital in the world • National Library of Medicine - world’s largest biomedical library Mississippi Delegation March 10, 2009

  9. NIAID ARRA funds - $1.12 B http://www.niaid.nih.gov/ncn/recovery/niaid.htm Mississippi Delegation March 10, 2009

  10. Scientific Areas Supported by NIAID • http://www3.niaid.nih.gov/topics/default.htm • http://www3.niaid.nih.gov/research/resources/ • HIV / AIDS • Microbiology and Infectious Diseases • Allergy, Immunology, Transplantation • Training, Basic & Clinical Research, Clinical Trials, Research Support • Vaccine Research Center – on campus • Biodefense BSL-3 Facility - on campus • Clinical Center – on campus • Rocky Mountain Laboratory (Montana) • Small scale Manufacturing facility – Vaccines / Biologics – Frederick, MD Mississippi Delegation March 10, 2009

  11. BUILDING A SUSTAINABLE RESEARCH PORTFOLIO Complementary Funding Sources to Support Research Training Opportunities Administration Mississippi Delegation March 10, 2009

  12. Mississippi Delegation March 10, 2009

  13. Build Capacity • Maintaining a sustainable research portfolio includes: • Securing research funds • Creating an administrative infrastructure to comply with the policies of the awarding organization • Each awarding organization has their specific requirements Mississippi Delegation March 10, 2009

  14. Complimentary Funding - Identify Scientific Resources • Define the scope of research goals • Individual • Group • Institution • Region • Identify sources of support • Each funding source has a mission • Funding sources have different mission • Select those sources that meet your needs • Apply to sources that in combination meet your research goals • Secure overlapping research support Mississippi Delegation March 10, 2009

  15. Identify Scientific Resources (cont.) • Identify individual, institutional, regional unique resources that can be leveraged • Identify available resources to supplement research support • Statistical support • Data Safety and Monitory Board • Invention and patent protection • Institutional Review Boards Mississippi Delegation March 10, 2009

  16. Seek Collaborations • Network and form coalitions with scientists worldwide to: • Increase scientific knowledge base • Increase access to new technology • Identify training opportunities for scientists at all levels • Gain access to established research/clinical networks Mississippi Delegation March 10, 2009

  17. Seek / Obtain Training • Training of scientists at all levels of development builds and sustains in-country research capacity • There are national, international and regional training programs • Research collaborations • Mentorship opportunities • Technical assistance opportunities Mississippi Delegation March 10, 2009

  18. Training Mechanisms • Intramural: Conducting research in the NIH laboratories. • Extramural: Supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the USA and in numerous countries. Mississippi Delegation March 10, 2009

  19. Intramural Training • 1,000 summer students • High School, College, Graduate and Medical • 600 post-baccalaureate trainees • 75 medical/dental students • 400 graduate students • 3,800 post-doctoral fellows Mississippi Delegation March 10, 2009

  20. Extramural Training • Generally institutional training grant to U.S. universities and non-profit research institutions in response to a specific Request For Applications (RFA) • Awardees are generally current NIH grant recipients with demonstrated research collaboration with foreign research institutions Mississippi Delegation March 10, 2009

  21. Administrative Support for Research • Establish infrastructure in support of research portfolio • Infrastructure should cover the spectrum of administrative responsibilities including: • Identification of relevant funding opportunities • Facilitation of the application process • Compliance with funding agency policy • Development of a sound financial management system Mississippi Delegation March 10, 2009

  22. Follow NIH Grants Policy Statement • The NIH Grants Policy Statement (GPS) summarizes all policy requirements that serve as terms and conditions of NIH grant awards. Mississippi Delegation March 10, 2009

  23. Part I: NIH Grants - General Information Part II: Terms and Conditions of NIH Grant Awards Subpart A: General Pre-Award Process Overview of Terms and Conditions Public Policy Requirements Ethical Conduct Individual Rights Human Subjects Animal Welfare Inclusion Requirements Civil Rights Environment Impact Availability of Information Other Policy Requirements (IND, etc.) Notice of Grant Award Payment Cost Considerations NIH Grants Policy Statement Parts I and II Mississippi Delegation March 10, 2009

  24. General Application preparation Policies and procedures Grant monitoring after award Standards of conduct Fiscal and scientific overlap Consortium arrangements Indirect costs Records management Banking arrangements Budget preparation and controls Accounting system Personnel Internal Controls Procurement Property/Asset Management Travel Systems and Managing an NIH Grant Mississippi Delegation March 10, 2009

  25. The NIH Extramural Support Process Mississippi Delegation March 10, 2009

  26. The NIH Extramural Support Process: Who do you work with? What do they do? How is it done? Mississippi Delegation March 10, 2009

  27. Typical NIH Institute/Center: Intramural (~10% of NIH funds) In-house scientists performing research Extramural Staff administering the research grant process: Scientific Review Administrator (SRA) Program Officer (PO) Grants Management Officer (GMO) Mississippi Delegation March 10, 2009

  28. OVERSIGHT • Program oversees the initiative and the progress of research after funding is awarded • Review oversees the rigorous scientific assessment by peers • Grants Management oversees fiscal administration of funds. Mississippi Delegation March 10, 2009

  29. Scientific Review Officer (SRO) Doctoral level scientist who: • Has expertise in peer-review policy, procedure and compliance • Provides scientific, administrative, and logistical oversight of the “peer-review” process – the hallmark of NIH Mississippi Delegation March 10, 2009

  30. The Grants Management Officer (GMO) • A business/finance professional who: • Negotiates, approves & awards all grants • Provides fiscal administration of grants • Is the government official on fiscal policy issues Mississippi Delegation March 10, 2009

  31. Program Officer (PO) Doctoral level scientist who: • Provides scientific stewardship; administers grants • Identifies areas of scientific priority • Serves as advocate for investigators • Provides guidance on resources for research and collaboration Mississippi Delegation March 10, 2009

  32. Before PIs write a grant application - seek PO advice on: Research priorities and areas of interest Grant mechanisms and FOAs (Funding Opportunity Announcements) Human subjects & other application issues After a grant application is reviewed, POs advise PIs on: Revision & resubmission Advisory Council & funding Progress reports & supplements Program Officer (PO) Mississippi Delegation March 10, 2009

  33. FOAs list responsible PO Unsolicited applications: POs by scientific area NIH eRA Commons https://commons.era.nih.gov/commons/ NIH and I/C communication offices Summary Statement and Notice of Grant Award Find A PO? Mississippi Delegation March 10, 2009

  34. Grant Review Cycle Applicants Council Applications Review Meeting Funding Plan $ Grant Award Summary Statement Council Meeting R R P P, G P, G Secondary Review Phase Initial Review Phase Negotiation Phase Post-Award Monitoring Phase P = Program, R = Review, G = Grants Management Mississippi Delegation March 10, 2009

  35. Scientists + Health Professionals + Advocates Performs second-level review of applications Advises I/C on policy Reviews programs Clears research concepts for I/C initiatives External Advisory Council Mississippi Delegation March 10, 2009

  36. Types of Grant Applications Mississippi Delegation March 10, 2009

  37. Unsolicited = investigator initiated Solicited = Funding Opportunity Announcement (FOA) Grant mechanisms - R, U, K, T, F, P Areas of funding - Training, Research, Conference, Equipment, Infrastructure Types of Grant Applications Mississippi Delegation March 10, 2009

  38. AREA Grants • Small research projects by students & faculty; • Eligibility: health professional schools that have not been major recipients of NIH research funds; • School/College of Medicine, Veterinary Medicine, Podiatry, Nutrition, Dentistry, Osteopathy, Pharmacy, Public Health, Optometry, Nursing, Chiropractic Medicine, & Allied Health •  The list of ineligible schools is updated annually. Mississippi Delegation March 10, 2009

  39. Solicited Grant Applications (FOA) • NIAID Funding Opportunities http://www.niaid.nih.gov/ncn/budget/default.htm • Written by Program Officer(s) at one or more I/C (Institute / Center) • Request applications in a specific area of interest • May have specific funds set aside • CALL or EMAIL the PO for details / clarifications • POs can assist in the application process • POs can / will answer questions. • Contact your PO before submitting an application - especially if it is your first. Mississippi Delegation March 10, 2009

  40. T = Institutional support to defer training costs F = Fellowship support for independent research K = Career development support Training and Career Awards • NIAID Training and Career support resources http://www.niaid.nih.gov/ncn/training/default.htm Mississippi Delegation March 10, 2009

  41. Investigator Initiated Awards – R series Based on Competitive Science Mississippi Delegation March 10, 2009

  42. THE NIH PEER REVIEW PROCESS Mississippi Delegation March 10, 2009

  43. THE NIH PEER REVIEW PROCESS • What is Peer Review? • What are the roles of NIH staff? • Who reviews my application? • What happens during a review meeting? • How are applications scored? • Rules for successful grantsmanship Mississippi Delegation March 10, 2009

  44. What is Peer Review? • Groups of scientific experts (peers) evaluate the scientific and technical merit of applications. • NIH staff recruit these experts and make sure that the review meeting is conducted within NIH review guidelines and federal regulations. • NIH staff may not influence the evaluation of applications. Mississippi Delegation March 10, 2009

  45. What are the roles of the NIH staff? • Scientific Review Administrators • Questions regarding peer review • Program Officers • Scientific aspects of grant before and after peer review • Grants Management Specialists • Handle business/budget functions of the grant Mississippi Delegation March 10, 2009

  46. Who reviews my application? • A panel of scientific experts recruited by the Scientific Review Officer (SRO). • Experts are chosen based on their: • scientific expertise • research background • review experience • lack of conflict of interest with applications Mississippi Delegation March 10, 2009

  47. Review is a Dual Process • Scientific Evaluation • Scientific Review Groups (SRGs) evaluate scientific merit and assign priority scores • CSR reviews 70% of all applications • Review divisions of funding institutes review the rest • Most NIAID reviews are Ad Hoc for RFAs & RFPs • Advisory Councils at funding institutes • May concur with priority score and recommend funding • Provide special consideration of proposal that address high program priorities • Consider investigator appeals Mississippi Delegation March 10, 2009

  48. CSR now receives most types of NIH grant applications electronically via Grants.Gov • eRA Commons is a web-based system for secure information exchange with applicants and applicant organizations • Applicants must establish personal commons accounts to track review progress and to retrieve scores and summary statements • http://www.grants.gov/ • http://commons.era.nih.gov/ Mississippi Delegation March 10, 2009

  49. Receipt and Referral • Referral officers assign applications to a Scientific Review Group for review • Applications are also assigned to one or more NIH institutes for funding consideration • A cover letter can help direct application toward appropriate SRG and institute assignments Mississippi Delegation March 10, 2009

  50. Scientific Review Groups • CSR has approximately 230 SRGs (or Study Sections) with specialized focus and appropriate expertise • Each SRG consists of about 20 regular members plus ad-hoc members as needed • Each SRG is run by a Scientific Review Administrator (SRA) • Special Emphasis Panels are established as needed • CSR web pages provide descriptions and rosters WWW.CSR.NIH.GOV Mississippi Delegation March 10, 2009

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