GRANTS 101: Everything you want to know about the NIH grants process but are afraid to ask David Armstrong, Ph.D. Chief, Scientific Review Branch, NIMH

Take-Home Message Communicate Communicate with NIH staff with NIH staff with investigators with investigators with institutional administrators with institutional administratorshttp://

National Institutes of Health Much of the biomedical research in the United States is supported by the Federal Government, primarily the National Institutes of Health (NIH) Much of the biomedical research in the United States is supported by the Federal Government, primarily the National Institutes of Health (NIH)

FY 2005 Funding By Mechanism (dollars in billions) Spending at NIH $4.7 Spending Outside NIH $24.1 Total budget $28.8 billion 16% supports 6,000 NIH scientists 84% supports 212,000 scientists At over 3,000 Universities And Institutes

Finding Your Way at NIH Comprised of 27 Institutes and Centers Comprised of 27 Institutes and Centers Similar in some ways, but not all Similar in some ways, but not all Each has its own mission, budget, activities, priorities, and ways of doing things. Each has its own mission, budget, activities, priorities, and ways of doing things.

A Typical Institute/Center Office of the IC Director National Advisory Council Board of Scientific Counselors ExtramuralIntramural Laboratory Studies Clinical Studies Review Program Grants Manage- ment

What is the Mission of NIMH? NIMH’s Mission is to reduce the burden of mental illness and behavioral disorders through research on mind, brain behavior. ■ Through the support and conduct of research on mental disorders and the underlying basic science of brain and behavior  Ensuring rapid and effective dissemination and use of research results to improve prevention, intervention, treatment, and policy

Multidisciplinary Research at NIMH is Supported PsychologistsPsychiatristsNeuroscientistsEpidemiologists Physician Scientists Anthropologists Social Workers SociologistsNursesNutritionistsNeurologists and more!

How do we set priorities? ■ Relevance – what do we need? ■ Traction – where are the opportunities? ■ Innovation – what is new? Relevance +Traction + Innovation = IMPACT

Overall Peer Review Process

What, Who, When What is the application process? What is the application process? Who is the right person to contact? Who is the right person to contact? When should I contact someone? When should I contact someone?

Dual Review System for Grant Applications First level of review Scientific Review Group - Provides initial scientific merit review of grant applications - Rates applications and makes recommendations concerning level of support and duration of award Second level of review Council - Makes recommendations to IC staff concerning funding - Evaluates program priorities and relevance - Advises on policy

WOW! What a great idea The NIH Grant Process Investigator initiated research is core to the NIH grant process

Preparation of the Application  Who at your home institution can help you Other investigators Institutional Officials/Administrators  Who at NIH can help you Project Officer/Program Chief Scientific Review Administrator (SRA) Grants Management Specialist/Officer

Who/What is a Project Officer/Program Chief?  Project Officer/Program Chief is a scientist and administrator manages grants, contracts, cooperative agreements identifies needs in scientific areas identifies scientific areas of special interest and communicates interest monitors scientific progress and reports program accomplishments advocates for the best science

Who/What is a Scientific Review Administrator?  Scientific Review Administrator is a scientist and administrator manages the review of grants, contracts, cooperative agreements appoints members to initial review groups/study sections/special emphasis panels responds to questions about review at Advisory Councils and Board meetings prepares summary statements reflecting IRG recommendations if Referral Officer, refers applications to study section for review and to Institute for acceptance into program

January/February June/July October/November The NIH Grant Process (cont) SF424 Writing a grant application can be very time consuming

Preparation of the Application  Help from other investigators Discuss ideas, critique application Discuss their experience w/ the NIH application process  Help from Institutional Officials/Administrators Register for eRA Commons for electronic submission Prepare budget Identify sources of funding in addition to NIH Identify electronic sources of information

Preparation of the Application  Help from NIH Project Officer/Program Chief Discuss science/proposed project Discuss NIH Institute’s degree of interest in proposed project Discuss application and review process Discuss funding mechanisms

Preparation of the Application Key Questions for Prospective Investigator Key Questions for Prospective Investigator 1. What do you intend to do? 2. Why is the work important? 3. What has already been done? 4. How are you going to do the work?

Preparation of the Application  Develop your idea Survey the literature Contact Investigators working on topic Prepare a brief concept paper Discuss with colleagues/mentors  Prepare to do the project Develop preliminary data Present to colleagues/mentors/students

Preparation of the Application  What makes a successful application? Significance (Does the study address an important problem?) Approach (conceptual framework, design, methods, analyses, problems and alternatives) Innovation (Is the project original and innovative?) Investigators (training, suitability for project) Environment (unique features, collaborations, institutional support)

The NIH Grant Process (cont) Center for Scientific Review receiving center Soon all grant applications will be received electronically Submission Website at: eceipt

The Future: Electronic Research Administration (eRA) NIH’s vision for the 21 st century. NIH’s vision for the 21 st century. Infrastructure for conducting interactive electronic transactions for the receipt, review, monitoring, and administration of NIH grant awards. Infrastructure for conducting interactive electronic transactions for the receipt, review, monitoring, and administration of NIH grant awards. Integrates the external system, NIH eRA Commons and the internal system, IMPAC II. Integrates the external system, NIH eRA Commons and the internal system, IMPAC II. sp

What is Grants.gov?  to electronically:  The Federal government’s single, online portal for any person, business, or State, Local and Tribal government to electronically: Find Grant Opportunities Apply for Grants   A cross-agency initiative involving 900 grant programs 26 grant-making agencies Over $350 billion in annual awards

Why transition? It’s the law…   Public Law (PL) Federal Financial Assistance Management Improvement Act of 1999 Improve the effectiveness and performance of Federal financial assistance programs Simplify Federal financial assistance application and reporting requirements Improve the delivery of services to the public

Preparing for Submission – Registration Grants.gov Applicant institutions must complete one time only registration Good for electronic submission to all Federal agencies Detailed instructions at: Grants.gov registration requires institutions to: Obtain a Data Universal Numbering System (DUNS) number Register in Central Contractor Registry (CCR) Registration not required to find funding opportunity or download application package, only to submit completed application

Preparing for Submission –Registration (cont) It is critical for institutions to begin this registration process at least 4 weeks before applications are due!  eRA Commons ■ PI’s must work through their institutions to register ■ Applicant institutions must complete one-time only registration ■ PI’s currently registered only for IAR must work through their institutions for full Commons registration

The NIH Grant Process (cont) 1 R01 MH A1 New Application Individual Research Grant Institute Serial number Grant Support Year Amended CSR’s x-ray security facility

The NIH Grant Process (cont) Scientific Review Administrator Reviewer Just ten more reviewers to recruit and the roster is complete. Just 5 more reviewers to recruit

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

The NIH Grant Process (cont) CritiqueIAR Finished! This is hard work.

The NIH Grant Process (cont) Score ( ) Human subject concerns Inclusion criteria Vertebrate animal concerns Budget First level of review

Confidentiality ■ ■ Review materials and proceedings of review meetings represent privileged information to be used only by consultants and NIH staff. ■ ■ At the conclusion of each meeting, consultants will be asked to destroy or return all review-related material. ■ ■ Consultants should not discuss review proceedings with anyone except the SRA. ■ ■ Questions concerning review proceedings should be referred to the SRA.

The NIH Grant Process (cont) Summary statement eRA Scientific Review Administrator

Summary Statement Overall resume and summary of discussion Overall resume and summary of discussion Essentially unedited critiques Essentially unedited critiques Priority score and percentile ranking Priority score and percentile ranking Budget recommendations Budget recommendations Administrative Notes Administrative Notes Animal/Human Subjects Concerns Animal/Human Subjects Concerns Concerns about Gender, Minority, Child Inclusion Concerns about Gender, Minority, Child Inclusion

The NIH Grant Process (cont) Second level of review National Advisory Mental Health Council Wow a 166 – Will I get paid?

Yippee!! Now I only have to worry about getting tenure.

When Preparing an Application Never assume that reviewers “will know what you mean” Never assume that reviewers “will know what you mean” Refer to literature thoroughly Refer to literature thoroughly State rationale of proposed investigation State rationale of proposed investigation Read instructions Read instructions Include well-designed tables and figures Include well-designed tables and figures Present an organized, lucid write-up Present an organized, lucid write-up Obtain pre-review from faculty at your institution Obtain pre-review from faculty at your institution

Common Problems in Applications Lack of new or original ideas Lack of new or original ideas Absence of an acceptable scientific rationale Absence of an acceptable scientific rationale Lack of experience in the essential methodology Lack of experience in the essential methodology Questionable reasoning in experimental Questionable reasoning in experimental approach approach Uncritical approach Uncritical approach Diffuse, superficial, or unfocused research plan Diffuse, superficial, or unfocused research plan Lack of sufficient experimental detail Lack of sufficient experimental detail Lack of knowledge of published relevant work Lack of knowledge of published relevant work Unrealistically large amount of work Unrealistically large amount of work Uncertainty concerning future directions Uncertainty concerning future directions