National Institute of Health (NIH)

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1 National Institute of Health (NIH) Funding Presented by: Samantha J. Taylor Senior Research Officer Wyss Institute for Biologically Inspired Engineering, Harvard University

2 What is NIH s primary mission? To improve the health of the Nation How is that mission accomplished? By supporting and conducting research How do they support extramural Research? By issuing grants and contracts How do you apply for grants? Grants.gov or paper applications (this is rare) Who is involved in the application process and what are their roles? Applicant and NIH staff

3 What s the Difference Between Grants and Contracts? GRANT $ CONTRACT Assistance Government is Patron or Partner Purpose: support and stimulate research Benefit a public purpose Investigator initiated $ $ $ $ $ $ $ $ $ $ $ $ Acquisition Government is Purchaser Purpose: acquire goods or services Benefit and use of the government Government initiated

4 Grants, First steps! ERA Commons USER name! (Club Membership) You Need the Goods! -Good Idea - Good Timing - Good Presentation - Good Reviewers - Good Grantsmanship

5 Good Grantsmanship Knowing and Understanding: Who, what, when, where, how. Willingness: Requires approximately 22 hours to collate a grant (not including the science). Commitment: On the part of the PI first & his team to get it done. (We can do it!)

6 Funding Opportunity Announcements (FOA) published through NIH Guide ( Grants.gov Type of FOA General Description Parent Announcements Investigator initiated for basic mechanisms Program Announcements highlights areas of focus ideal institutional use of funds Requests for Applications (RFA) a one-time call with set-aside funds

7 What should I apply for? R01 Too difficult! R03 Too much work, not enough funding! R21 They re saying no! R01 Time &Innovation R03 Start somewhere! R21 They never say no when they re excited!

8 Developing the Application: NIH Interests NIH Institute Program Priorities Search RePORTERto learn what research is supported Search Institute Web Sites Contact Institute Staff Identify Relevant RFA or PA in NIH Guide

WHO: Finding Your Way at NIH Office of the Director National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National

9 WHO: Finding Your Way at NIH 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 Center on Minority Health and Health Disparities National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine National Institute of Biomedical Imaging and Bioengineering NIH Clinical Center Center for Information Technology Center for Scientific Review No funding authority

10 NIH Research Programs Institutes and Centers Divisions Branches Programs Where do I find a guide?

11 Getting Started: Contact a Program Official Why? They can direct you to: The appropriate Institute - 24 institutes have granting authority The appropriate Division/Office - Basic, clinical, behavioral, translational The appropriate Program Official - Extramural research portfolio

12 Officials you Should You Program Official Scientific Review Officer Grants Specialist

13 Program Official [aka Program Director or Project Officer] Responsible for the programmatic, scientific, and technical aspects of a grant

14 Who/What is a Program Official? The Program Official is both: a Scientist and an Administrator

15 Responsibilities of the Program Official Manages scientific research portfolio of grants, contracts, and cooperative agreements Identifies opportunities and needs of science specific to an Institute s mission Stimulates interest in scientific areas of emphasis for each Institute Communicates program priorities -Program Announcements (PA) -Request for Applications (RFA)

16 Responsibilities of the Program Official Provides technical assistance to applicants Observes scientific review meetings Discusses review issues with applicant Evaluates the programmatic merit and mission relevance of applications Prepares funding recommendations Reviews annual research progress of grantees Reports on scientific progress and program accomplishments

17 Program Official Principal liaison between investigators and the NIH Your most important contact Call them early Contact them often!

18 Must I contact NIH before applying? Yes under certain circumstances it is MANDATORY Applications with budgets >$500,000 (direct cost) for any single year IC must agree to accept the application Request must be six weeks before receipt date NIH Guide NOT-OD (10/16/2001) R13 Conference Grant Applications IC must agree to accept the application

19 Must I contact NIH before applying? Usually, it s just a smart idea When RFA s request Letter of Intent If you have questions about grant mechanisms or budget limitations or eligibility or... When you are considering applying for any grant -whether you are a new or experienced investigator - contact with program staff is always highly recommended Prior contact with a program official will always save you time!

20 Contact before submission has benefits Two more important reasons: Develop a relationship with a potential program official Assure that your application has a home (appropriate Institute)

21 Your Program Official Can Help... During Application Development and Preparation During Scientific Review After Peer Review After the Grant Award

22 Developing the Application: Your Idea Your Research Needs and Interests My research interests focus on the link between A & B My need is for additional research training or career development

23 Develop Your Application: For NIH A Program Official can discuss Your ideas -Match your scientific interests with the mission and focus of NIH Institutes NIH ideas -Research initiatives and priorities already established by ICs

24 Organize your thoughts for productive discussion with a Program Official Grant Purpose Briefly, you want a grant from which institute/agency to do what? Problem/Background Explain why you to think this topic needs study. Demonstrate you know the institute priorities.or ask! Significance Explain why this is important to the field. Question What hypotheses will you test and what model will guide your hypotheses? Design/Analysis What is the study design that will enable testing your hypotheses? What statistical approach? Team Who will be the key participants (co-investigators and organizations) on the project? Miscellaneous Other issues that may be relevant to your plans

25 Remember the INSTITUTE DIRECTOR makes the final funding decisions But

26 Program Officials... Give advice and encouragement! The cape, Larry! Go for the cape!

27 Writing a Grant Application Research plan answers 4 essential questions What do you intend to do? Why is the work important? What has already been done? How are you going to do the work? Successful applications typically are: Well-focused and explicitly written Not overly ambitious Understandable by a naïve reader

28 Time to write!!! Cover Letter Science CV (Biosketch) Personnel Budget (Along with your administrator) Subcontracts Resources (Institutional) Letters of Support

29 The NIH Peer Review Process Cover Letter Cover letter of application Application title FOA# and title Request: Assignment to particular SRG or study section Assignment to particular IC for funding consideration Disciplines involved, if multidisciplinary Explanation for late application Typically written last SRG rosters are posted 30 days before the SRG meeting:

30 The NIH Peer Review Process - Science Scored Review Criteria Significance Investigator(s) Innovation Approach Environment (FOA-specific criteria) See Review Criteria at a Glance (

31 The NIH Peer Review Process - Science Scored Review Criteria Significance Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

32 The NIH Peer Review Process Science Scored Review Criteria Investigator(s) Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-pd/pi, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

33 The NIH Peer Review Process Science Scored Review Criteria Innovation Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

34 The NIH Peer Review Process - Science Scored Review Criteria Approach Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

35 The NIH Peer Review Process Science Scored Review Criteria Approach If the project involves clinical research, are the plans for: 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

36 The NIH Peer Review Process - Science Scored Review Criteria Environment Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

37 The NIH Peer Review Process - Science Additional Review Criteria As applicable for the project proposed, reviewers: Consider in determining scientific and technical merit Do not give separate scores for these items. FOA-specific criteria Protections for Human Subjects Inclusion of Women, Minorities, and Children Vertebrate Animals Resubmission Applications Renewal Applications Revision Applications Biohazards

38 The NIH Peer Review Process -Other Additional Review Considerations As applicable for the project proposed, reviewers: Address each item Do not give scores for these items Should not consider them in providing an overall impact/priority score but!!!! FOA-specific considerations Select Agent Research Applications from Foreign Organizations Resource Sharing Plans Budget and Period Support

40 The NIH Peer Review Process SRG Meeting Procedures If 60 applications/srg meeting ~ 50% streamlined, 30 applications to discuss and score If 9 hour SRG meeting ~ ½ hour introduction, streamlining ~ 1 hour lunch, 2 x 15 minute breaks Leaves ~ 14 minutes on average/application ~ 3-4 minutes/reviewer Clarity and brevity are essential!

41 New Investigator: New Investigator Definition A Program Director or Principal Investigator (PD/PI) is considered a New Investigator if he/she has not previously competed successfully as a PD/PI for a significant independent NIH research grant (like an R01).

42 New Investigator Definition Significant independent NIH research grant: Any NIH research project grant other than the following small or early stage research grants: Pathway to Independence Award-Research Phase (R00) Small Grant (R03) Academic Research Enhancement Award (R15) Exploratory/Developmental Grant (R21) Research Education Grants (R25, R90, RL9, RL5) Clinical Trial Planning Grant (R34) Dissertation Award (R36) Small Business Technology Transfer Grant-Phase I (R41) Small Business Innovation Research Grant-Phase I (R43) Shannon Award (R55) NIH High Priority, Short-Term Project Award (R56) Competitive Research Pilot Projects (SC2, SC3) Additionally, the PD/PI is not excluded from consideration as a New Investigator if he/she has been the PD/PI of, or received an award from, any of the following classes of awards: Training-Related and Mentored Career Awards All Fellowships (F awards) All individual and institutional career awards (K awards) Loan repayment contracts (L30, L32, L40, L50, L60) All training grants (T32, T34, T35, T90, D43) Instrumentation, Construction, Education, Health Disparity Endowment Grants, or Meeting Awards G07, G08, G11, G13, G20 S10, S15, S21, S22 R13 Note regarding grants with Multiple PD/PIs: In the case of a grant application that involves more than one PI, all PD/PIs must meet the definition of New Investigator to check Yes in the New Investigator box

43 Early Stage Investigators NIH created a new Early Stage Investigator (ESI) category designed to accelerate the early transition of new scientists to research independence by receiving their first R01 earlier. A Program Director/Principal Investigator who qualifies as a New Investigator is considered an Early Stage Investigator (ESI) if he/she is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent).

44 Implementation of ESI definition The NIH modified the collection of information on degree dates and medical residency within the personal profile of the era Commons. PD/PIs must update their personal profile in the eracommons in order to be considered for the ESI classification. Investigators who enter degree and residency completion dates will be notified of their ESI status by . A procedure and guidelines for requesting an extension of the period of ESI eligibility is in place to accommodate individuals with various medical concerns, disability, pressing family care responsibilities, or active duty military service (instructions in Commons).

45 Implementation of ESI definition (cont d) Applications from ESIs and New Investigators are identified to reviewers so that appropriate consideration of their career stage can be applied during review. Applications from ESIs and New Investigators are clustered during review to enable evaluation as a group and distinguish from Established Investigators. An application with more than one Principal Investigator is identified for consideration of ESI/NI by reviewers only if ALL of the listed Principal Investigators qualify as New Investigators. Staff in the NIH institutes and centers are apprised of ESI and New Investigator status and this factor is considered when applications are selected for award. New Investigators are eligible for the Full Implementation to Shorten the Review Cycle for New Investigator R01 Applications Reviewed in Center for Scientific Review (CSR) Recurring Study Sections. ( )

46 NIH New Investigators FY 2006 R01-Equivalent awards include R01, R23, R29, and R37 grants.

47 NIH New Investigator Results FY 2009 FY 2006 R01-Equivalent awards include R01, R23, R29, and R37 grants.

48 Receipt and Referral of Applications Electronic SF424 R&R submitted through grants.gov to an NIH Institute (IC) CSR Referral Office assigns the application a unique identifier (application number) Application assessed for completeness & eligibility Notice of assignment available in era Commons in 4 weeks. to Integrated Review Group (IRG) and then a study section (SRG) 1 st Month 2 nd Month

49 Review System for Grants Scientific Review Group (SRG) Independent outside review Evaluate scientific merit, significance 1st level Recommend length and level of funding Output: Priority Score and Summary Statement 3-7 months Output: Funding Recommendations Advisory Council assess quality of SRG process offers recommendation to Institute Staff evaluates program priorities and relevance advises on policy 2nd level 1-3 months Output: Awards or Resubmission Institute Director makes final decision based on Council input, programmatic priorities Must also Pass Administrative Review

50 Review Who Reviews Grant applications? Scientist peers with appropriate expertise -- recruited by the Scientific Review Officer Assigned to specific applications based on content 4 year term typical Temporary reviewers sought as needed

51 1 st Level Review Standing study sections typically have members: scientist peers 3 face-to-face meetings per year, and a 4 year term of service applications to review at each meeting 3 rd Month 4 th Month

52 After 1 st Level Review Priority Scores recorded Summary Statements prepared Overall Resume and Summary of Review Discussion Essentially Unedited Critiques Priority Score and Percentile Ranking Budget Recommendations Administrative Notes Viewable 4-6 weeks after review meeting Only available through the era Commons 5 th Month 6 th Month 7 th Month

53 2 nd Level Review National Advisory Council or Board assesses quality of 1 st level review Concurs with or modifies IRG recommended action Reads summary statements only Can also designate application as High or Low program priority 8 th Month

54 Funding Decisions The Institute Director has the final funding decision. Factors Considered in Funding Selections: Scientific Merit Contribution to Institute Mission Program Balance Availability of Funds

55 Timeline: New Applications Receipt Date Scientific Review Council Review Award Date February 5 July October December June 5 October January April October 5 March May July

56 Revise and Resubmit Write A Clear Introduction Section Address All Criticisms Thoroughly Respond Constructively Acknowledge and Accept the Help of Reviewer Comments Don t Be Argumentative! Don t be Abrasive or Sarcastic!

57 Revise and Resubmit Prepare a REVISION COVER LETTER For Revisions, Indicate Review History Request Same or Different Study Section Provide Justification for your request Don t be Argumentative! Never! Don t be Abrasive! Never!

58 Questions? Thank you for attending All the best with your applications!

Fundamentals of the NIH. Erica Brown, PhD Director, NIH AREA Program Extramural Policy Coordination Officer National Institutes of Health

Fundamentals of the NIH. Erica Brown, PhD Director, NIH AREA Program Extramural Policy Coordination Officer National Institutes of Health Fundamentals of the NIH Erica Brown, PhD Director, NIH AREA Program Extramural Policy Coordination Officer National Institutes of Health 1 Overview The big picture Finding funding opportunities Interacting