Grantsmanship, Grant Opportunities, and the NIH Scientific Review Process Janice Benson Allen, PhD

1. The National Institute of Environmental Health Sciences The National Institutes of Health Grantsmanship, Grant Opportunities, and the NIH Scientific Review Process Janice Benson Allen, PhD Scientific Review Officer Division of Extramural Research and Training (DERT) National Institute of Environmental Health Science (NIEHS) National Institutes of Health (NIH) Dept of Health & Human Services (DHHS)

2. NIH I am from the Government and am here to help you!

3. The NIH Grant Process • Overview of NIH • Funding Mechanisms • Important Personnel • Overview of NIH Grant Process • Submission • Receipt/Referral • Review • Award • Post-award

4. NIH consists of 27 Institutes and Centers NHLBI NINR OD NCCAM NIEHS NCI NIAMS CIT NIDA NEI NIMH CC NIDDK NLM NINDS NHGRI NIDCR NCMHD NIBIB NIA NIDCD NIAAA NICHD NIAID CSR NCRR NIGMS FIC = Extramural only

5. NIH Institutes Within most ICs, there are separate and distinctExtramuralandIntramuralcomponents. At NIEHS, these are the Division of Intramural Research (DIR) & Division of Extramural Research and Training (DERT)

6. NIEHS -- National Institute of Environmental Health Sciences • Human health and human disease result from three interactive elements: • environmental factors • individual susceptibility • age • The mission of the NIEHS is to reduce the burden of human illness and dysfunction from environmental causes by understanding each of these elements and how they interrelate.

7. Assistance (Grant) Mechanisms • Grants – Assistance mechanism to stimulate research, often unsolicited. If solicited, published in the NIH Guide to Grants and Contracts as: • RFA – Request for Applications – one receipt date and funds set aside to fund (grants) • RFP – Request for Proposal (contracts) • PA – Program Announcement • PAS – Program Announcement with set aside funds • PAR – Program Announcement reviewed by the Institute/Center not Center for Scientific Review (CSR)

8. Grant Mechanisms Not all mechanisms are available at all Institutes under all circumstances.

9. R01 Characteristics • “Traditional Research Grant”- supports a discrete, specified project to be performed by the Principal Investigator • Up to five years of support • Budget potentially unlimited- modular up to $250K per year • CSR or IC (Institute/Center) review • New Investigator status • Preliminary data

10. R03 - Small Grants • Provision of limited funding for a short period of time • Types of projects may be: • Pilot or feasibility studies • Secondary analysis of existing data • Small, self-contained research projects • Development of research methodology • Development of new research technology • No preliminary data, but scientific plausibility • Up to 2 years, up to $50,000/ year

11. R13 – Conference Grants • A scientific meeting is defined as a gathering, symposium, seminar, conference, workshop or any other organized, formal meeting where persons assemble to coordinate, exchange, and disseminate information or to explore or clarify a defined subject, problem, or area of knowledge….focus must be scientific. • $3000-10,000 support provided • Apply 9 months prior to meeting • Contact: Martha Barnes barnes@niehs.nih.gov

12. R15 – AREA Grants…Research Grants for non research Intensive Institutions • Enable scientists at eligible institutions to receive support for small research projects, which might include, feasibility studies, pilot studies, and other small-scale research programs • Maximum of $150,000 in direct costs plus facilities and administrative costs at the rate negotiated for the institution may be awarded for a period of up to three years • Contact: Mike Humble humble@niehs.nih.gov

13. R21 – Exploratory/Developmental Grant: High Risk/High Reward • Fosters the introduction of novel scientific ideas, model systems, tools, and technologies that have the potential to substantially advance biomedical research. • Intended to encourage new exploratory/developmental research projects by providing support for the early stages of their development • Supports small research projects to be carried out in a short period of time (2 years), with limited resources • Preliminary data not required

14. Assistance (Grant) Mechanisms • Mentored Career Awards (Ks) • K01 – Mentored Research Scientist Development Award • K02 – Independent Scientist Award • K07 – Academic Career Award • K08 – Mentored Clinical Development Scientist Award • K12 – Institutional Clinical Scientist Development Program Award • K23 – Mentored Patient-oriented Research Career Development Award • K24 – Midcareer Investigator Award in Patient-Oriented research • K25 – Mentored Quantitative Research Development Award • K99/R00 – NIH Pathway to Independence Award • Mentored career awardees may now hold concurrent support from an NIH career award and an NIH research grant

15. PURPOSE OF CAREER AWARDS • Provides support/protected time to junior, mid-career and established investigators to develop/further develop their research careers. • Provides bridge support to transition from mentored to independent career phases.

16. K01: PA-10-056 “Mentored Research Scientist Development” • Purpose: Provide ‘protected time’ (3-5-yrs) for an intensive, supervised career development experience in biomedical, behavioral, or clinical sciences leading to research independence. Some ICs use for training in new fields or returning from hiatus (illness, family circumstances) and increasing diversity in workforce. • Salary: Based on full-time, 12-month appointment at institute’s salary scale; devote 75% effort; NOT USED for salary supplementation or for extra duties. • Candidate: Work with mentor & institution to develop the application; US citizen or non-citizen national, or permanent resident card (USCIS Form I-551) or legal admission as permanent resident; possess research/health-professional degree; have full-time appointment. • Mentor: Recognized as an accomplished investigator in research area; posses independent research support; may be co-mentors. • Application: SF 424 (Grants.gov/apply); meet deadlines and submission criteria; cover letter; view in eRA Commons. • Candidate Information & Career Development Plan: Candidate’s Background; Career Goals & Objectives; Career Development/training activities; Training in the Responsible Conduct of Research. • Research Plan: Sound plan consistent with candidate’s research development/objectives; mentor’s research and proposed candidate’s plan must be described; (clinical trials). • Statements of Support: Mentor/Co-mentors, Consultants, Contributors (electronic submission) • Environment & Institutional Environment: Description of environment; Institutional commitment to Candidate’s research career development. • Letters of Reference: 3-5 letters from well-established scientists not directly involved in the application addressing candidate’s qualities/potential (may include advisory committee members). • Contact NIH staff & follow ‘specific’ review process

17. K02: PA-10-057 “Independent Scientist Award” (salary only award) • Purpose: Foster development and enable them to expand their potential to make significant contributions in their field; 3-5yrs of salary support and ‘protected time’ an intensive, supervised career development experience in biomedical, behavioral, or clinical sciences leading to research independence. Contact relevant IC for specific programmatic/budgetary information. • Salary: Based on full-time, 12-month appointment at institute’s salary scale; devote 75% effort; Sponsoring institution may supplement the NIH salary contribution consistent to existing salary structure; salary cap; not to be used for extra duties. • Candidate: 75% effort; possess new peer-reviewed research support (IC exceptions); Work with mentor & institution to develop the application; US citizen or non-citizen national, or permanent resident card (USCIS Form I-551) or legal admission as permanent resident; possess research/health-professional doctoral degree; have full-time appointment. • Application: SF 424 (Grants.gov/apply); meet deadlines and submission criteria; cover letter; view in eRA Commons. • Candidate Information & Career Development Plan: Candidate’s Background; Career Goals & Objectives; Training in the Responsible Conduct of Research. • Research Plan: Sound plan consistent with candidate’s research development/objectives; mentor’s research and proposed candidate’s plan must be described; (clinical trials). • Statements of Support: Consultants & Contributors (electronic submission) • Environment & Institutional Environment: Description of environment; Institutional commitment to Candidate’s research career development. • Contact NIH staff & follow ‘specific’ review process

18. K07 PA-10-057 “Academic Career Award” • Purpose: Provide Support to increase academic/research expertise to become academic researchers and enhance institution research capacity in a specific area of bimedical research: • K07 Development Award: provides salary/research support/career curriculum; 3-5 yrs of salary/research support; requires mentor; 75% effort; must have active NIH funding (R01/R03/etc) and in final 2 yrs of funding; statement of commitment from institution; environment considered ineligible criteria. • K07 Leadership Award: develop multidisciplinary curriculum to strengthen institute’s teaching program; 2-5 yrs for more senior PIs; 25-50 % effort; full-time appointment; statement of commitment from institution; ineligible criteria. • Contact relevant IC for specific programmatic/budgetary information. • Salary: Based on full-time, 12-month appointment; salary may be supplemented by institute at institute’s salary scale. • Candidate: US citizen or non-citizen national, or permanent resident card (USCIS Form I-551) or legal admission as permanent resident; possess research/health-professional doctoral degree; have full-time appointment; posses clinical/research/health-professional doctoral degree. • Application: SF 424 (Grants.gov/apply); meet deadlines and submission criteria; cover letter; view in eRA Commons. • Candidate Information & Career Development Plan: Candidate’s Background; Career Goals & Objectives; Career development/Training activities; Training in the Responsible Conduct of Research. Curriculum Development Plan for K07 Leadership Award • Research Plan: Sound plan consistent with candidate’s research development/objectives; mentor’s research and proposed candidate’s plan must be described; (clinical trials). • Statements of Support: K07 Development Award; Mentor/Co-mentor; Consultants & Contributors; 3-5 letters of reference(electronic submission): K07 Leadership Award: Collaborator’s statement • Environment & Institutional Environment: Description of environment; Institutional commitment to Candidate’s research career development. • Contact NIH staff & follow ‘specific’ review process

19. K08 PA-10-059 “Mentored Clinical Scientist Research Career Development Award” • Purpose: Support/expand didactic study/mentored research of persons with clinical doctoral degrees; includes translational research; appropriate for those with different levels of prior research training and career development; specific criteria. Contact relevant IC for specific programmatic/budgetary/eligibility information. • Salary: Based on full-time, 12-month appointment at institute’s salary scale; devote 75% effort; Sponsoring institution may supplement the NIH salary contribution consistent to existing salary structure; salary cap; not to be used for extra duties. • Candidate: 50 75% effort; possess active peer-reviewed research support (IC exceptions); Work with mentor & institution to develop the application; US citizen or non-citizen national, or permanent resident card (USCIS Form I-551) or legal admission as permanent resident; possess clinical doctoral degree; have full-time appointment; work with mentor. • Application: SF 424 (Grants.gov/apply); meet deadlines and submission criteria; cover letter; view in eRA Commons. • Candidate Information & Career Development Plan: Candidate’s Background; Career Goals & Objectives; Career Development/Training Activities; Training in the Responsible Conduct of Research. • Research Plan: Sound plan consistent with candidate’s research development/objectives; mentor’s research and proposed candidate’s plan must be described; (clinical trials). • Statements of Support: Mentor/Co-mentors, Consultants, & Contributors (electronic submission) • Environment & Institutional Environment: Description of environment; Institutional commitment to Candidate’s research career development. • Letters of reference: 3-5 letters from well-established scientists not directly involved in the application addressing candidate’s qualities/potential (may include advisory committee members). • Contact NIH staff & follow ‘specific’ review process

20. K24 PA-10-061 “Midcareer Investigator in Patient-Oriented Research” • Purpose: Provide support to mid-career health professional doctorates or equivalent at Assoc Prof level (or equivalent) for protected time to devote to patient oriented research (POR) and to act as research mentors to clinical faculty; expected to obtain funding and establish leadership roles in POR programs. Contact relevant IC for specific programmatic/ budgetary/eligibility information. • Salary: Based on full-time, 12-month appointment at institute’s salary scale; 3-5 yrs; devote 25-50% effort; Sponsoring institution may supplement the NIH salary contribution consistent to existing salary structure; salary cap; not to be used for extra duties. • Candidate: possess established record of independent, peer-reviewed research support; US citizen or non-citizen national, or permanent resident card (USCIS Form I-551) or legal admission as permanent resident; possess clinical doctoral degree; have full-time appointment; act as mentor to new clinical PIs. • Application: SF 424 (Grants.gov/apply); meet deadlines and submission criteria; cover letter; view in eRA Commons. • Candidate Information & Career Development Plan: Candidate’s Background; Career Goals & Objectives; Training in the Responsible Conduct of Research; Plans to provide mentoring. • Research Plan: Currently supported research and new research to be specifically supported by this award to allow reviewers to evaluate research activities in POR and opportunities for mentoring. Must provide data & safety monitoring of clinical trials. • Statements of Support: Consultants & Contributors (electronic submission.) • Environment & Institutional Environment: Description of environment; Institutional commitment to Candidate’s research career development. • Contact NIH staff & follow ‘specific’ review process

21. Ruth L. Kirschstein National Research Service Awards • Training Grants - T32, T35 • Institutional • Predoctoral and postdoctoral • Fellowships • Individual • Predoctoral (F30, F31) • Postdoctoral (F32) • Senior (F33) • http://grants.nih.gov/training/extramural.htm

22. Small Business Innovation Research (SBIR) & Small Business Technology Transfer (STTR) Programs: 3-Phase Program with set-aside funds to increase participation of small businesses in commercialization of technology through federal R&D • Phase I (R43) • Feasibility Study • $150K & 6months (SBIR) or $100K & 12 months(STTR) • Phase II (R44) • Full R/R&D – results from Phase I • 2 year award &$1M (SBIR) or $750K (STTR) • Phase III Commercialization Stage (non-SBIR funds) *Special requirements http://grants1.nih.gov/grants/funding/sbirsttr_programs.htm

23. Grants vs. Contracts • http://grants.nih.gov • CONTRACTS • Acquisition • Government is a purchaser • Purpose is to acquire goods or services • The direct benefit and use of the government • Government initiated • GRANTS • Assistance • Government is a Partner/Patron • Purpose is to support and stimulate research • Benefit a public purpose • Investigator initiated

24. Exciting Opportunities - 1 K99/R00:NIH-wide (intramural/extramural). Maintain strong cohort of NIH-supported investigators; transition from mentored postdoctoral to independent research positions; provides up to 5 yrs of support in 2 phases Candidate: No more than 5 yrs of postdoctoral training at time of application; potential of independent research, based on experience level, research training, potential to contribute to health-related research field, evidence of research productivity (quality of peer-reviewed scientific publications), research creativity; reference letters, mentor’s (sponsor’s) statement, and statement from institutional training grant director (if applicable). Career Development Plan: Appropriateness of career development plan and likelihood that award will contribute substantially to the scientific development. Research Plan: Scientific and technical merit of the research question, design and methodology. Mentor: Appropriateness of the mentor’s research qualifications, scientific stature, experience and mentoring track record for career development needs. Environment and Institutional Commitment to the Candidate: Adequacy of facilities, availability of appropriate educational opportunities, and strength of institutional commitment to fostering career development of the candidate. Training in the Responsible Conduct of Research. PA-10-063: NIH Pathway to Independence Award

25. Exciting Opportunities - 2 • Loan Repayment: NIH-wide. NIH Loan Repayment Programs Help Desk answers questions about programs/eligibility/benefits and provides assistance with online application. In exchange for a two-year research commitment, NIH will repay qualified educational debt up to $35,000 per year; reimburse Federal/state taxes resulting from repayment award; repay qualified educational debt after completion of the two-year commitment through competitive renewals - if you have student debt remaining at the completion of your award, you can apply for a competitive renewal provided you continue to meet NIH’s eligibility requirements. Applicants must have a Doctoral degree (M.D., Ph.D., or equivalent), funding for research at any domestic nonprofit, university, or government organization, educational loan debt equal to at least 20% of annual salary, conduct research an average of 20 hours/week, and be a US Citizen or permanent resident. (http://www.lrp.nih.gov) • ViCTER: NIEHS. The proposed new Virtual Program will allow researchers at remote locations to form a Virtual Consortia via an integration of their research and the identification of a center director who “houses” the ViCTER and coordinates monthly conference calls and annual update meetings. Any R01 ES funded researcher can develop a collaborative and integrative transdisciplinary and/or translational program with a focus on the role of environmental stressors in the etiology, trajectory and outcome of human disease and disorders with 2-3 other scientists. The Competitive Supplement mechanism will be used. (PAR ES-11-???)

26. Important Personnel PROGRAM ADMINISTRATOR SCIENTIFIC REVIEW OFFICER GRANTS MANAGEMENT SPECIALIST

27. When should/can I contact NIH/NIEHS Staff? ANY TIME! PA:As soon as you begin to THINK of preparing an NIH application (or even sooner!); when receive summary statement; after Council meets; after award is made; during administration of project. SRO:As soon as you receive an email from CSR as to which SRO is assigned to your application (CSR review) or when preparing your application (name provided in FOA). GMS:When have budgetary/JIT (Just-in-Time) questions: preparing application; questions on summary statement (or contact PA); clarifications on FOA; JIT document submissions; fiscal administration during award period.

28. The NIH Grant Process NIH Grant Process What happens in the Black Box ?

29. Submission • Referral • Review • Award • Post-award Overview of NIH Grant Process

30. WHAT IS AVAILABLE? To find out about Funding Opportunity Announcements (FOA) NIH Guide for Grants and Contracts http://grants.nih.gov/grants/guide/index.htm www.gov.gov: Find, Apply, Submit Bookmark!

31. Electronic Research Administration: eRA Commons Applicants: Registration/Account Creation Personal Profile Manage Professional Bibliography Manage IC Profiles Grantees: View Notice of Award Submit: eSNAP, Financial COI/Status Report/No-Cost Extension/Close out Reviewers: How to access IAR Enter scores & critiques Access grant apps & documents for review meeting IC Training & Career Development xTrain (PDs/U Admin/Trainees submit/track paperwork Bookmark! http://era.nih.gov/index.cfm

32. Submission Dates Standard Deadlines: http://grants.nih.gov/grants/funding/submissionschedule.htm R01 (new Research Grants): SF424 (R&R) February 5, June 5, October 5 R01 (renewal, resubmission, revision): SF424 (R&R) March 5, July 5, November 5 T Series: (Training): PHS 398 January 25, May 25, September 25 K (new Career Grants): (PHS 398) February 12, June 12, October 12 K (renewal, resubmission, revision): (PHS 398) March 12, July 12, November 12 Solicited Applications: See PA/RFA Problems? Contact SRO

33. Where To Go For Help… • General information on Electronic Submission and the SF424 (R&R): http://era.nih.gov/ElectronicReceipt • Grants.gov registration, submission and ADOBE questions: Visit: http://www.grants.gov/CustomerSupport • Grants.gov Customer Service • E-mail: support@grants.gov • Phone: 1-800-518-4726 • eRA Commons registration and post submission questions on Commons functionality • Web Support: http://ithelpdesk.nih.gov/eRA • eRA Commons Help Desk • E-mail: commons@od.nig.gov • Phone: 1-866-504-9552 OR 301-402-7469 • Forms transition and questions on NIH’s overall plan for electronic receipt • NIH Grants Information • E-mail:grantsinfo@nih.gov • Phone:301-435-0714

34. COVER LETTER The cover letter should be used for a number of important purposes: • Suggest Institute/Center Assignment • Suggest review assignment • Identify individuals in conflict • Identify areas of expertise needed to evaluate the application • Discuss any special situations • Required for an electronic changed/corrected submission *It is not appropriate to use the cover letter to suggest specific reviewers.

35. CRITICAL MESSAGE If you do not see the application image in eRA Commons, the NIH does not see it either. You must follow up on the process and use eRA Commons to check. We need to know you have submitted an application in order to assign, review and award!

36. Submission • Receipt/Referral • Review • Award • Post-award Overview of NIH Grant Process

37. Prior to electronic submissions…..

38. Referral Center for Scientific Review (CSR) Division of Receipt and Referral • Receipt Check for completeness, enter information into database, assign number, etc. • Referral To a review group (“study section”) To a funding agency (e.g., NIEHS, NCI, etc.) Note: You can request a certain institute for funding or a study section for review in your cover letter. Requests won’t always be honored – contact PA/SRO.

39. Grant Numbers 1 K99 ES 012345-01 Grant mechanism Grant type 1 = new 2= competitive renewal 5 = noncompetitive renewal Year of the grant Sequential number Institute Contact SRO if you believe number is incorrect

40. Submission • Receipt/Referral • Review • Award • Post-award Overview of NIH Grant Process

41. Review and Award Cycles(Approximately) App Submission Deadline: Jan/Feb May/June Oct/Nov Scientific Merit Review: June/July Oct/Nov Feb/Mar Advisory Council Review: Sept/Oct Jan/Feb May/June Earliest Project Start Date: December April July

42. Review Study sections at the Institutions: SEPs • For special circumstances, e.g., RFAs & PAs (FOAs) • ViCTER applications are reviewed by a NIEHS SEP: (Janice B. Allen, SRO) • K99/R00 applications are reviewed by a NIEHS study section: The EHSR Committee CSR Study Sections (n = lots). Most applications are reviewed here.

43. Review In addition to setting up the study sections, assigning applications to reviewers, etc., the SRO also does an “Administrative Review,” to make sure the application • is administratively complete (e.g., Animal Welfare and Human Subjects) • is formatted properly (e.g., page limits, fonts, etc.) • meets the requirements of the RFA or PA, if appropriate

44. Selecting Reviewers for SEPs • Determine areas of expertise • Determine number of reviewers • Select peers: • mostly academics: • peer-reviewed funding in appropriate areas, • review experience • Currently NIH funded • Other reviewers • ( e.g. government scientists; industry scientists; community representatives) • Representation of women, minorities, and geographical distribution

45. Reviewers must…. • adhere to strict conflict of interest, confidentiality and non-disclosureprior to seeing an application AND after review meeting • destroyall application materials after review meeting, or send back to SRO • Agree to not discussproceedings of review meeting with ANYONE, and if asked to do so, should refer questions to SRO • NIH (and NIEHS) is very strict about conflicts/ confidentiality,and has convened an NIH committee to discuss consequences of misconduct

46. Know Your Audience - The Reviewers: Accomplished, dedicated, Overly committed, tired, inherently skeptical, overly critical General understanding only Used to reviewing R01 applications

47. http://cms.csr.nih.gov/ResourcesforApplicants/PolicyProcedureReview+Guidelines/OverviewofPeerReviewProcess/InsidetheNIHGrantReviewProcessVideo.htmhttp://cms.csr.nih.gov/ResourcesforApplicants/PolicyProcedureReview+Guidelines/OverviewofPeerReviewProcess/InsidetheNIHGrantReviewProcessVideo.htm http://cms.csr.nih.gov Resources for applicants NIH Grant Review Process video Lots of good information 2 videos

48. ENHANCING PEER REVIEW – CHANGES IMPLEMENTED

49. NEW & EARLY STAGE INVESTIGATORS • New PI Status calculated by IMPAC • Early Stage Investigator Status • Subset of NI • Within 10 years of last research degree/end of residency • Extension possible (not granted ahead of time) • Appropriate reasons for extension include clinical training, military service, family responsibilities, payback obligations, illness, disability, natural disasters • Reasons not appropriate include change of field, work in industry, visa complications http://grants1.nih.gov/grants/new_investigators/index.htm

50. NEW FORMS, FORMAT, PAGE LIMITS • Applies to paper and electronic submissions (PHS 398 and SF 424 R&R) • Applies to applications intended for due dates of January 25, 2010. • For non-AIDS continuous submission change over date is January 25, 2010. • For AIDS continuous submission change over date is February 7,2010. • Not tied to a specific council round. • Cannot mix two types of applications in the same meeting.