NIAID Workshop on Grantsmanship, Funding, and Peer Review

NIH Structure and Grantsmanship Alison Deckhut Augustine, Ph.D. Basic Immunology Branch Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases

Presentation Outline NIH Structure and Grantsmanship (Alison) Funding Opportunities (Lawrence Prograis, MD) Grant Application Process/Peer Review (B. Duane Price, PhD)

NIH – 27 Institutes and Centers Office of the Director National Library of Medicine Center for Information Technology Scientific Review Fogarty International Center National Institute of Arthritis and Musculoskeletal and Skin Diseases of Diabetes and Digestive and Kidney Diseases of Dental and Craniofacial Research National Institute on Deafness and Other Communication Disorders National Eye Institute National Heart, Lung, and Blood on Alcohol Abuse and Alcoholism National Cancer on Drug Abuse of Environmental Health Sciences of Mental Health of Neurological Disorders and Stroke of Allergy and Infectious Diseases National Center on Minority Health and Health Disparities on Aging of Child Health and Human Development National Human Genome Research of General Medical Sciences of Nursing Research National Center for Complementary and Alternative Medicine for Research Resources Clinical Center National Institute of Biomedical Imaging and Bioengineering no funding authority Component of the Department of Health and Human Services (DHHS) 27 Institutes and Centers and the Office of the Director (Francis Collins M.D., Ph.D.) over 18,000 Employees Headquartered in Bethesda, MD. Off-campus sites in Rockville and Bethesda, MD; North Carolina; Michigan; Montana; and Arizona National Institute on Minority Health and Health Disparities Different Missions, Responsibilities and Constituencies

A Typical NIH Institute/Center Office of the IC Director Board of Scientific Counselors National Advisory Council Extramural Intramural Biomedical Research Grants Biomedical Research Contracts Basic & Clinical Research Clinical Trials

Understanding/Navigating the NIH NIH Extramural Programs

NIH Extramural Staff Program Officer (PO) Scientific Review Officer (SRO) Grants Management Specialist (GMS)

Program Officer A science professional, usually Ph.D./M.D. level, who: Serves as an advocate for investigators Provides scientific stewardship and administration of grants & contracts awarded by NIH Identifies areas of scientific priority and develops funding opportunities for extramural researchers Provides guidance on NIH extramural policy/procedures, research resources, and funding opportunities to extramural investigators

Scientific Review Officer A science professional, usually M.D. or Ph.D. level, who: Is based at an NIH Institute or Center (IC), or at the Center for Scientific Review (CSR) Manages Study Sections and review panels for grants and contracts Selects review panel members Assigns reviewers to applications Compiles application summary statements

Grants Management Specialist Business/finance professional who: Negotiates and awards all grants Provides fiscal administration of grants Is the government official on fiscal and policy issues and approvals

Types of NIH Funding Opportunity Announcements (FOAs) FOA: Call for applications in a particular research area of interest to one or multiple NIH Institutes. Contracts RFP BAA Grants Request for Application (RFA) Program Announcement (PA)

Types of NIH Funding Opportunity Announcements (FOAs) Request for Application (RFA) One application receipt date Set-aside funds Areas of scientific interest indicated, also includes areas not supported by the RFA Awards may have a budget cap Programmatic, Review, and Grants Management contacts

Types of NIH Funding Opportunity Announcements (FOAs) Program Announcement (PA) – 3 types PA – general type. No set-aside funds or special review. Reviewed in standing study sections, paid with IC “payline” funds PAR – Special review (Special Emphasis Panel) convened, no set-aside funds (paid with IC “payline” funds) PAS – Set-aside funds, may include review by a Special Emphasis Panel

When will I get my grant funded? (well, sometimes it just feels that way…)

Grant Writing 101: The Big Three Can your research move your field forward? Is the field important – will progress make a difference in human health? Can you and your team conduct the work (expertise, resources)?

Grant Writing 101 Read FOA instructions thoroughly Never assume the reviewers will “know what you mean” Refer to literature thoroughly State rationale of proposed studies Include well-designed tables and figures Present an organized, clear story

Common Grant Writing Mistakes Lack of new or original ideas; incremental advances Absence of a solid scientific rationale Insufficient knowledge of relevant published work Diffuse, superficial or unfocused research plan or experimental approach Proposed studies are too broad or too narrow Limited/no experience in essential techniques, no collaborators with required expertise Lack of discussion of possible pitfalls and alternative approaches Uncertainty concerning future directions

A Little Help From Your Friends NIH extramural staff: SRO – advice about appropriate study sections; submission requirements PO - advice about research focus (before review), appropriate study sections, discussion of review results and applicant responses Colleagues: read your application, well in advance of the application due date GRIP: Grant Review for Immunologists Program Matches new PIs with established PIs in same area Obtain expert advice on grant application http://www.aai.org/Education/GRIP/index.html

Mechanisms (Funding Opportunities) Lawrence Prograis, M.D. Division of Allergy, Immunology and Transplantation

PhD Career Track and NIAID Funding Mechanisms T32 - Institutional training grant (NRSA)-has pre- & postdoc slots F31 - Individual (diversity) predoc fellowship (NRSA) F31 – Individual Predoctoral Fellowship (NRSA) [FY2015 available] F32 - Individual postdoc fellowship (NRSA) K01- Mentored Research Scientist Award K22 - Research Scholar Development Award K99/R00 - Pathway to Independence Award Ph.D. Faculty Position Award Types Career Stage High School Student Graduate Independent Investigator T32 Diversity Supplements F32 K22 K99 or R00 K01 Postdoc Phase F31

MD Career Track and NIAID Funding Mechanisms T35 - NRSA Short Term Institutional Research Training Grant F30 - Individual predoctoral MD/PhD and Other Dual Doctoral Degree Fellows (NRSA) T32 - Institutional training grant (NRSA)-has pre-& postdoc slots F32 - Individual postdoc fellowship (NRSA) K01 - Mentored Research Scientist Award K08 - Mentored Clinical Scientist Research Career Development Award K23 - Mentored Patient-Oriented Research Career Development Award K24 - Mid-Career Investigator Award in Patient-Oriented Research K22- Research Scholar Development Award M.D. Faculty Position Award Types Medical Student Clinical Training Phase Research Independent Investigator T35 T32 Diversity Supplements F32 K24 K01 K08 K23 F30

NIAID Fellowship Awards (Fs) F30: started FY14 Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral MD/PhD and Other Dual Doctoral Degree Fellows (Parent F30) F31 (Div): Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships to Promote Diversity in Health-Related Research (Parent F31 - Diversity) F32: Ruth L. Kirschstein National Research Service Awards (NRSA) for Individual Postdoctoral Fellows (Parent F32) FY15: Sign on to F31: Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellows

Individual Fellowship Awards (Fs) Individual awards Cannot change the scope, move fellowship, or change mentor without prior NIH approval NIH determines stipend levels and limited tuition reimbursement, training related expenses; F&As 8% Review at CSR (currently 24 SS) http://public.csr.nih.gov/StudySections/Fellowship/Pages/def ault.aspx Success rate < 20%

NIAID Career Development Awards (Ks) Mentored Clinical Scientist Research Career Development Award (Parent K08)  K23: Mentored Patient-Oriented Research Career Development Award (Parent K23) K24: Midcareer Investigator Award in Patient-Oriented Research (Parent K24) K22 (PAR): NIAID Career Transition Award (K22) K99/R00: NIH Pathway to Independence Award (Parent K99/R00) NIAID supports only 1 year of a mentored phase (K99) and 2 years of the independent (R00) phase. This is a deviation from the support from all the other ICs. K01: Mentored Research Scientist Development Award (Parent K01) NIAID Career Development (K01) Awards in Epidemiology, Modeling, and Outcomes Research http://grants1.nih.gov/grants/guide/notice-files/NOT-AI-08-040.html K25: Mentored Quantitative Research Development Award (Parent K25)

Career Development Awards (Ks) Individual awards MDs (K08 and K23) to support development to become independent investigators K24 (associate professor)**supports mentoring of young clinical investigators Salary for K08/23 awards: $90K/$50K research support; F&A 8% Most are mentored, others are not PhDs (MDs): Mostly K22 and K99/R00: transition awards; also K01 and K25 Review at NIAID SRP by 4 chartered committees (AIDS, AITC, MID and MID-B) Candidate, Career Dev. Plan, Research Plan, Mentor(s), Env./Inst. Com. Success rates about 30+%

Postdoc (PhD/MD) – Should I apply for a K22 or a K99/R00? NIAID Research Scholar Development Award (K22) Transition award (postdoc-to-assistant professor) NIAID’s Pathway to Independence Award (K99/R00) 2 year award Transition award (postdoc-to asst. professor) No mentored phase. Fundable score, s/he has one year to find a position as assistant professor 3 year award (other ICs 5yrs) 1 yr mentored phase ($90K/yr) Phase 2: Awardee becomes assistant professor (internal approval similar to K22 phase 2) Assistant Professor position Own lab space Significant start-up funds 2 yr independent R00 phase ($249K/yr TC) Little teaching/ no administrative responsibilities $150K (Year 1) + $100K (Year 2) No US citizenship required Success rate: >25% Success rate: ca. 7-18%

NIAID Transition Awards (K22 or K99/R00) Postdoc with less than 4 years of postdoc experience Assistant Professor +/- 1 year Secures a faculty Position & Submits the K22 phase II or R00 application Submits a K22 or K99 application and receives a fundable score NIAID makes the award to the new institution/candidate.

Success Rates for NIAID Training and Career Grants, FY2012 Grant Type Applications Awards Success Rate F32 Awards 240 47 19.6% K08 38 15 39.5% K22 51 29.4% K23 32 17 50.1% K99 33 6 18.2% T Awards 72 23 31.9%

NIAID Training Pay lines FY Overall Impact Score F31 F32 K (not K99) T32 2013 30 25 26 14 2012 24 22 16 2011 31 2010 28

Loan Repayment programs (LRP) NIH wants to encourage outstanding health professionals to pursue careers in biomedical, behavioral, social, and clinical research. If you commit at least two years to conducting qualified research funded by a domestic nonprofit organization or U.S. federal, state, or local government entity, NIH may repay up to $35,000 of your qualified student loan debt per year. Loan repayment benefits are in addition to the institutional salary you receive for your research. Clinical Research Pediatric Research Health Disparities Research Contraception and Infertility Research Clinical Research LRP for Individuals from Disadvantaged Backgrounds General LRP site: http://www.lrp.nih.gov/index.aspx A recorded overview webinar from the LRP Office: http://go.usa.gov/aHx

NIH WEBSITES Training at NIH NIH Research Training Opportunities http://www.training.nih.gov NIH Research Training Opportunities http://grants1.nih.gov/training/extramural.htm NIH Guidelines and Forms http://www.nih.gov/grants/documentindex.htm NIAID Advice on Training http://www.niaid.nih.gov/ncn/training/default.htm How to Write a Grant http://www.niaid.nih.gov/ncn/grants/write/index.htm

Non-NIH Research Funding Websites Fogarty International Center: http://www.fic.nih.gov/funding/index.htm National Science Foundation (NSF): http://www.nsf.gov/ FastLane: http://www.fastlane.nsf.gov/fastlane.jsp Defense Advanced Research Projects Agency (DARPA) http://www.darpa.mil/ The Congressionally Directed Medical Research Programs (CDMRP) http://cdmrp.army.mil/

Research Support Funding Websites Bill and Melinda Gates Foundation: http://www.fgatesfoundation.org/default The Wellcome Trust: http://www.wellcomefund.ac.uk/ The Global Fund to Fight AIDS, Tuberculosis and Malaria: http://www.theglobalfund.org/en/ amfAR, the American Foundation for AIDS Research:http://www.amfar.org/   The International AIDS Vaccine Initiative: http://www.iavi.org/ The Alfred P. Sloan Foundation: http://www.sloan.org/ Centers for Research Libraries (includes dissertations): http://www.crl.edu/catalog/index.htm

Private Funding Sources: (National and International) A short list of NIAID's List of Foundations and Other Funding sources at: http://www.niaid.nih.gov/researchfunding/ann/Pages/found.aspx

NIH Peer Review B. Duane Price, PhD Senior Scientific Review Officer Immunology Review Branch, Division of Extramural Activities, NIAID

Application Processing * CSR assigns applications to study section (review) & NIH Institute (funding) Researcher writes and Institution submits application to NIH Summary Statement and Priority Score transmitted to applicant (Commons) and NIH extramural staff Study section composed of 20-30 reviewers – review/discuss applications 3- 4 reviewers assigned to read and write critiques for each application

Mock Peer Review Sample R01 Applications and Summary Statements http://www.niaid.nih.gov/researchfunding/grant/pages/appsamples.aspx NIH Grant Review Process YouTube Videos http://cms.csr.nih.gov/ResourcesforApplicants/InsidetheNIHGrantReviewProcessVideo.htm

NIH Scoring Range

Understanding the Summary Statement Impact/Priority Score: 1-9 scale Percentile: Approximate percentage of applications receiving an impact/priority score from the study section during one year (3 review cycles), NOT all types of grants receive a percentile Resume: Official summary of review meeting discussion, for scored applications only Critiques: Reviewers written comments

What to Do After Review Talk to your NIH Program Officer Attends the Study Section (most cases) Provide insights to discussion (unofficial) and possible funding options Read the Summary Statement Official document providing scientific merit score and summarizing reviewers comments First paragraph (Resume) is the official summary of the meeting discussion Strategize Next Steps Talk to your NIH program officer again, after both of you have read the summary statement Discuss with colleagues, mentors