Grantsmanship101

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Grantsmanship 101: The Grant Application and Review Process Nita J. Maihle, Ph.D. Departments of Ob/Gyn, & Reproductive Sciences, Pathology, and Pharmacology Yale University School of Medicine nita.maihle@yale.edu November 7, 2006

Overview: 

Overview Introduction: Funding in 2007 The Application Process The Review Process “Dual Review” Scientific Peer Review Programmatic Review How to Use your Summary Statement Choice of Responses to Your Review Resubmission Process Concluding Remarks

2007: Tough Times Continue…?: 

2007: Tough Times Continue…?

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“During the last few years, there has been a slowly spreading realization within the biomedical research community that the enterprise not only has stopped growing but actually has begun a contraction of unpredictable duration. Competition for funds from the NIH and other sponsors, intensifying year by year, now stands at an unprecedented level, and shows no sign of abating. Never before have so many established investigators faced so much uncertainty about their longevity as active scientists. Never before have so many novices faced so many disincentives to entering or continuing a research career.” - Dr. William F. Raub, NIH Assoc. Director, Research and Training strategy paper, 7/26/82

The facts of life for researchers in 2007:: 

The facts of life for researchers in 2007: There are more applications for grant support than ever before There is more funding for research than ever before Approximately one application in ten is funded You CAN succeed - with perseverance

You need a good idea!!: 

You need a good idea!!

“I’m not sure what life is…but I know when my dog is dead.” Albert Szent-Györgi 1937 Nobel Laureate: 

“I’m not sure what life is…but I know when my dog is dead.” Albert Szent-Györgi 1937 Nobel Laureate

You Also Need To “Sell” Your Idea“Grantsmanship”: 

You Also Need To “Sell” Your Idea“Grantsmanship” Is not a dirty word You’re selling your ideas, whether in Academia Pharma Government It’s a way of getting busy people to notice and understand you and your ideas.

Why submit a grant application?: 

Grants allow you to do and enjoy your science (and keep your job!) Tackle an important problem Think through your ideas/plans carefully Are a GREAT learning opportunities! Why submit a grant application?

Types of NIH Grant Awards: 

NIH Grants – Office of Extramural Reseach http://grants1.nih.gov/grants/oer.htm National Research Service Awards (F_) Pre- and post-doctoral fellowships Career Development Awards (K_) Research Grant Programs (R_) Small Business Development (SBIR, STTR) SBIR (R41) – Small Business Innovation Res STTR (R43) – Small Business Tech Transfer Types of NIH Grant Awards

NIH Career Development Awards (K_): 

KO1 – Mentored Research Scientist Development Award Career development in a new area of research KO2 – Independent Scientist Award develop the career of the funded scientist KO5 – Senior Scientist Award for outstanding scientists w/ a sustained level of high productivity KO7 – Academic Career Award developmental/Leadership in academic instruction, research, administration KO8 – Mentored Clinical Scientist Developmental Award development of the independent clinical research scientist NIH Career Development Awards (K_)

NIH Research Grant Programs (R_): 

RO1 – Research Project Grant Program RO3 – Small Grant Program R21 – Exploratory / Developmental Research Grant R34 – Clinical Trial Planning Grant NIH Research Grant Programs (R_)

National Research Service Awards: 

National Research Service Awards

NRSA Sections: 

Scholastic Performance Background Research Experience / Training Plan Personal Data Form Biographical Sketch Facilities and Commitment Keys for evaluation: Potential of candidate, training plan, vibrancy of training program NRSA Sections

Preparing your grant application: 

Preparing your grant application

Mentoring: 

You are strongly encouraged to develop your proposal with the guidance of a senior colleague(s) Ideally an iterative process You should test your ideas and generate your hypotheses with a senior colleague(s) Mentoring for grantsmanship is also encouraged You likely have senior faculty colleagues with study section experience; ask them for help Mentoring

The RO1 Grant Application as a Paradigm : 

The RO1 Grant Application as a Paradigm

The basic elements of the proposal: 

State the hypothesis that you propose to test The rest of the proposal is focused on how you will test this hypothesis: Specific aims Background Preliminary Results Experimental Design The basic elements of the proposal

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Face Page

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First year detailed budget

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Budget for entire period

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Budget Justification

Budget Justification: 

Don’t be shy about asking for salaries, personnel, supplies, etc. If you need it to do the proposed work, ask for the funds to do it. However … Fully justify positions, equipment, supplies, animals, travel, other expenses (payments for use of machines, service contracts, phones, etc) Put in percent of your salary roughly equal to your percent effort Budget Justification

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Biographical Sketch Yours and all key individuals

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Other Support

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Resources Describe equipment and other items available in the Lab, in the Dept, and in the Institution (eg, core facilities, library, etc)

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Research Plan e. Human Subjects

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Research Plan f. Vertebrate Animals g. Literature Cited

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Page Limits Research Plan (sections a-d) limit = 25 pages including figures, tables, and diagrams

Page limits – Don’t exceed!: 

Sections a – d: 25 pages total, including figures, tables, drawings Don’t exceed the page limits, and use 12 point fonts. If you can’t say it within these 25 pages, with normal fonts, you’re not doing your job Specific aims: < 1 page Background and significance: ~3 pages Progress report / preliminary results: ~8-10 pages Experimental Methods and Procedures: remainder up to 25 pages (~10-12 pages) Page limits – Don’t exceed!

Before sending your grant application out:: 

Be sure you’ve had a senior colleage(s) read and critique a draft – MENTORING! Address a testable hypothesis Decide beforehand what study section you prefer – Center for Scientific Review: http://www.csr.nih.gov/ Write cover letter; decision ultimately made by NIH Referral Officer Get all local signatures Make sure you get your grant in on the deadline! FedEx is very reliable; e-submissions. Good luck! Before sending your grant application out:

So you’ve written your proposaland sent it out.What’s next?: 

So you’ve written your proposaland sent it out.What’s next?

The Grant Review Process: 

http:www.nichd.nih.gov/funding/peer_review/sld001.htm The Grant Review Process

The National Institutes of Health: 

The National Institutes of Health

The Review Process: 

The Review Process How do you know if something is a good idea…?

The Review Process: 

The Review Process Assess Yourself First Use Your Mentors The “Dual Review” Process

What happens to your grant application after you send it out?: 

What happens to your grant application after you send it out?

The “Dual Review” Process(NIH as an example): 

The “Dual Review” Process(NIH as an example) Center for Scientific Review (CSR) Assignment to Institute Scientific Review Group (SRG) SRG Review = Study Section Programmatic Review Understanding NIH priorities

The “Dual Review” Process(NIH as an example): 

The “Dual Review” Process(NIH as an example) Center for Scientific Review (CSR) Assignment to Institute Scientific Review Group (SRG) SRG Review = Study Section Programmatic Review Understanding NIH priorities

The “Dual Review” Process(continued): 

The “Dual Review” Process(continued) Programmatic Review Understanding NIH priorities Annual Reports Program Announcements (PA’s) Research Funding Announcements (RFA’s)

The “Dual Review” Process(Phase I-CSR): 

The “Dual Review” Process(Phase I-CSR) Pre-review Institute and SRG assignment by an NIH Referral Officer Information Used in Assignment Title Abstract Cover Letter Electronic record of the Institute and SRG assignment, referral number, and Program Director is sent to you.

The “Dual Review” Process(Phase I-CSR): 

Who comprises the Scientific Review Group? The “Dual Review” Process(Phase I-CSR)

Scientific Review Group(1946): 

Scientific Review Group(1946)

Scientific Review Group(2006): 

Scientific Review Group(2006)

The “Dual Review” Process(Phase I-CSR): 

SRA (Scientific Review Administrator) of the SRG receives the list of grant assignments and works with the Chair of the SRG to assign reviewers, typically: One “primary” reviewer One “secondary” reviewer “readers” (one to several) The “Dual Review” Process(Phase I-CSR)

The “Dual Review” Process(Phase I-CSR): 

Communications and submission of supplemental information/data Up until the time of the review, all communications occur via the SRA Once the review has been completed, all communications occur via your Program Director Often your Program Director will observe the proceedings of the SRG meeting. The “Dual Review” Process(Phase I-CSR)

The “Dual Review” Process(Phase I-CSR): 

SRG Review and Scoring Scientific and technical merit of proposed research/training Qualifications of PI and research team Availability of resources Reasonableness of proposed budget for work proposed Administrative issues, such as budget, human subjects/animal welfare The “Dual Review” Process(Phase I-CSR)

The “Dual Review” Process(Phase I-CSR): 

SRG Review and Scoring Your application will either have a score (>250) or be unscored (<250) If you have a score, this means that it is in the lower half of all grants reviewed You will get an integrated summary statement If unscored, it was viewed as ‘not competitive’ (upper 50%) You only get the raw written reviews of the SRG members The “Dual Review” Process(Phase I-CSR)

The “Dual Review” Process(Phase I-CSR): 

SRG Review and Scoring Outstanding 100-149 Excellent 150-199 Very Good 200-249 Good 250-299 Acceptable 300-500 NR not recommended The “Dual Review” Process(Phase I-CSR)

The “Dual Review” Process (Phase II: Programmatic Review): 

The SRA communicates your score and summary statement to your Institute’s Director All communications from here on are through your Program Director You access your score via the eRA Commons (http://commons.era.nih.gov/commons) The “Dual Review” Process (Phase II: Programmatic Review)

The “Dual Review” Process (Phase II: Programmatic Review, cont’d): 

How to Access and Interpret Your Summary Statement Scores are to be posted in eRA Commons ~5 days after the SRG meeting Summary Statements are to be posted in the eRA Commons within 8 weeks of the SRG meeting YOU AND YOUR INSTITUTION MUST BE REGISTERED IN THE eRA COMMONS The “Dual Review” Process (Phase II: Programmatic Review, cont’d)

The “Dual Review” Process: 

How to Interpret Your Summary Statement Priority Score: (100-500) Percentile Ranking: (1-100%) Project Summary: (abstracted from your application) Overall Evaluation: (one paragraph- for “scored applications usually a synopsis written by the SRA) The “Dual Review” Process

The “Dual Review” Process: 

How to Interpret Your Summary Statement Critiques (3 or more…): Significance Approach Innovation Investigator(s) Environment Overall Administrative notes The “Dual Review” Process

The “Dual Review” Process: 

You should contact your Program Director to help you: interpret your score determine your probability of funding help you reflect on your options The “Dual Review” Process

Choice of Responses: 

Choice of Responses Take some time to reflect/study your reviewers’ comments Consult your mentors - share your reviews with them Consult your Program Director If you decide to resubmit…

Choice of Responses: 

You have only two opportunities to resubmit (“A1”, “A2”) Choice of Responses

Resubmission: Responding to your critiques: 

Resubmission: Responding to your critiques Thank the reviewers for their efforts Write a careful rebuttal; address ALL the concerns of all of the reviewers Let them know that you appreciate their efforts and have seriously considered - and addressed - all of their concerns in the revised application

Resubmission: Responding to your critiques: 

If you agree with a particular criticism indicate how you have modified the point of concern in your proposal (and mark it in text). You don’t have to agree with everything, and you can state this, but… Explain why you disagree, and indicate how you have tried to make your point more clearly in the revised application. Resubmission: Responding to your critiques

Behind the Scenes at an NIH Study Section: 

Behind the Scenes at an NIH Study Section NIH Center for Scientific Review (CSR) Welcome to CSR…what happens to your application, FAQs on submitting applications http://www.drg.nih.gov/welcome.htm Descriptions of the Integrated Review Groups, Study Sections and Small Business Activities of the Center for Scientific Review http://www.drg.nih.gov/review/irgdesc.htm

Behind the Scenes at an NIH Study Section: 

NIH Center for Scientific Review (CSR) CSR Study Section Roster index http://www.drg.nih.gov/Committee/rosterindex.asp http://www.drg.nih.gov/Roster_proto/sectionI.asp Study Section Member Search (by last name, by institution) http://www.drg.nih.gov/Roster_proto/searchby.asp Fellowship Study Sections http://www.drg.nih.gov/EVENTS/fellowship_ss/fellow_ss.htm Behind the Scenes at an NIH Study Section

Common Reasons for Disapproval of Grant Applications(The NIH’s “Top Ten” List…): 

Common Reasons for Disapproval of Grant Applications(The NIH’s “Top Ten” List…) Lack of original ideas Diffuse, superficial or unfocused research plan Lack of knowledge of published, relevant work Lack of preliminary data and/or experience in essential methodologies Uncertainty concerning the future direction Questionable reasoning in experimental approach Absence of an acceptable scientific rationale Unrealistically large amount of work Lack of sufficient experimental detail Uncritical approach

In Conclusion…Successful Grant Applications Are:: 

In Conclusion…Successful Grant Applications Are: Clearly written Not beyond the capabilities of the investigator(s) Tackle an important problem Are innovative Help you enjoy and conduct your science Are A GREAT learning opportunity!

The Scientist’s Soul…: 

“Let what you observe penetrate your innermost soul, let it so warm and replenish you that your thoughts constantly refer to it, and then you will find true pleasure and delight in your intellectual labours.” - (Theodore Billroth, 1869) The Scientist’s Soul…