1 che594 lect24 proposals to nih. all information and opinions are those of mark a. shannon, 2007...

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Che594 Lect24

Proposals To NIH

All information and opinions are those of Mark A. Shannon, 2007

Objective For Today

Overview Of NIH Grants How Grants Are Scored

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All information and opinions are those of Mark A. Shannon, 2007 3

National Institutes of Health

The NIH is not a single institute. It is actually a collection of 20 institutes and 7 centers (next page).

The individual Institutes are funded at very different levels: The level plays a large role in whether or not your proposal is funded or not.

Programs in each institute are also funded at very different levels.

You have the choice to send your proposal to different programs and institutes

Do your homework to find out which program has both money and fits your proposal best. TALK TO PROGRAM MANAGERS!


National Cancer Institute - Est. in 1937

National Eye Institute - Est. 1968

National Heart, Lung, and Blood Institute - Est. 1948

National Human Genome Research Institute - Est. 1989

National Institute on Aging - Est. 1974

National Institute on Alcohol Abuse and Alcoholism - Est. 1970

National Institute of Allergy and Infectious Diseases - Est. 1948

National Institute of Arthritis and Musculoskeletal and Skin Diseases - Est. 1986

National Institute of Biomedical Imaging and Bioengineering - Est. 2000

National Institute of Child Health and Human Development - Est. 1962National Institute on Deafness and Other Communication Disorders - Est. 1988

National Institute of Dental and Craniofacial Research Est. 1948National Institute of Diabetes and Digestive and Kidney Diseases - Est. 1948

National Institute on Drug Abuse - Est. 1973

National Institute of Environmental Health Sciences - Est. 1969

National Institute of General Medical Sciences - Est. 1962National Institute of Mental Health - Est. 1949

National Institute of Neurological Disorders and Stroke - Est. 1950National Institute of Nursing Research - Est. 1986

National Library of Medicine - Est. 1956

Center for Information Technology - Est. 1964

Center for Scientific Review - Est. 1946

John E. Fogarty International Center - Est. 1968

National Center for Complementary and Alternative Medicine - Est. 1999

National Center on Minority Health and Health Disparities - Est. 1993

National Center for Research Resources - Est. 1962

NIH Clinical Center - Est. 1953


National Cancer Institute - Est. in 1937

National Eye Institute - Est. 1968

National Heart, Lung, and Blood Institute - Est. 1948

National Human Genome Research Institute - Est. 1989

National Institute on Aging - Est. 1974

National Institute on Alcohol Abuse and Alcoholism - Est. 1970

National Institute of Allergy and Infectious Diseases - Est. 1948

National Institute of Arthritis and Musculoskeletal and Skin Diseases - Est. 1986

National Institute of Biomedical Imaging and Bioengineering - Est. 2000

National Institute of Child Health and Human Development - Est. 1962National Institute on Deafness and Other Communication Disorders - Est. 1988

National Institute of Dental and Craniofacial Research Est. 1948National Institute of Diabetes and Digestive and Kidney Diseases - Est. 1948

National Institute on Drug Abuse - Est. 1973

National Institute of Environmental Health Sciences - Est. 1969

National Institute of General Medical Sciences - Est. 1962National Institute of Mental Health - Est. 1949

National Institute of Neurological Disorders and Stroke - Est. 1950National Institute of Nursing Research - Est. 1986

National Library of Medicine - Est. 1956

Center for Information Technology - Est. 1964

Center for Scientific Review - Est. 1946

John E. Fogarty International Center - Est. 1968

National Center for Complementary and Alternative Medicine - Est. 1999

National Center on Minority Health and Health Disparities - Est. 1993

National Center for Research Resources - Est. 1962

NIH Clinical Center - Est. 1953

You apply to individual institutes in response to

calls for proposals or with unsolicited

proposals. Proposals reviewed and ranked by

Center for Scientific Review (CSR).


NIH Funding Levels

Total NIH funding over $29 Billion a year! Total is misleading for basic and applied research

Most of money goes to hospitals and clinics who enrolled patients into treatment modality studies, including pharmaceuticals

Money dominated by physician side of NIH Total funding for applied, and basic research on order of $6B

This is the only pot universities can apply to NIH has only a very small educational mission. Hence, Universities do NOT dominate basic and applied research funding.

Most of this goes to medical research centers, the NIH Institutes (themselves) and companies. Universities compete head on with these.

Competition among University research intense: < 1 in 10 is funded, similar to NSF

Reported 15 to 20% funding levels misleading: > 20% in SBIR/STTR


Main Types of NIH Grants

Largest is “Center-like” Research Grants (in response to Program Announcements (PAs)

Very, very hard to get (much less than 5% funded). Evaluated exactly the same as smaller grants, but much more complex, so tends to have worse scores (more later).

$ much larger, order $1 million/yr or more in direct costs

RO1 - Main funding instrument. Can be up to 5 years funding.

Order of $250 to $500 k/yr direct funding for 1 to 4 investigators. MUST HAVE STRONG PRELIMINARY DATA…i.e. the evaluators must be convinced you will be successful

R21 - Higher risk, impact, 2 yr. Order $125 k/yr direct. No Prelim data needed, however,

it is highly desired. SBIR/STTR for Small Companies - Easiest to get,

highest funding ratio. $100k Phase I, $750 k phase II. Phase III possible, but

improbable. STTRs have University participation RO3, R15 - Special University focused proposals with

educational content $30 to 80 k/yr. Easier to get but still must be

evaluated by CSR.


Center for Scientific Review (CSR)

All proposals from all institutes evaluate proposals, and are given a score or are unscored (a lot more later on scoring). The score is almost everything.

There are many, many Study Sessions, which is the group that does the scoring (more on Study Sessions later).

Each proposal is handled by a CSR Official, who is NOT a PM. One typically CANNOT select the CSR Official or Study Session, but there are ways to help influence this MOST IMPORTANT decision by CSR. Talk to PM and research CSR S.S. These are online.

If you want a particular S.S., get intellectual area right


Study Sessions (S.S.)

S.S. is determined by intellectual content, NOT INSTITUTE!

Large number of members 20 to 26, each with one vote Varied backgrounds, including MD’s, scientists, and a few engineers.

Bulk are Charter members, which means they serve a 2 to 6 year term giving the S.S. memory of previous proposals. 25% are rotators or ad hoc panelists. Only 7% are allowed to be junior faculty or scientists. Charter members must be nominated by CSR Officers and undergo a tenure review by CSR upper management. Good for Junior to do at least once.

Meets 3 to 4 times a year to review 80 to 100 proposals at a time

3 or 4 of the S.S. members read and evaluate proposal Each proposal that is scored considered for about 15 minutes

Panel votes on proposal based on evaluation of readers


Connection of S.S. to Institutes

Network of S.S., Programs, and Institutes The same PM can send proposals to different S.S., even for the same BAA. Different institutes send to the same S.S. Determined by what area/intellectual content is within the proposal, NOT INSTITUTE!

Scores normalized within and across S.S., which is normalized by the scores of the total S.S. mean and StDev.

PM 1

PM 2

PM 3

PM 4

S.S. A

S.S. B

S.S. C

Institutes CSR

InstituteI

InstituteII


Scoring

Streamlining (triage) 60% at every S.S. is now streamlined based on the Primary (P), Secondary (S), and Discussant (D) scores

If streamlined, the proposal is UNSCORED, thus you do NOT know where you are with respect to the mean.

Low-score is better Scale is from 1 to 5 (old scale from 100 to 500)

1 is considered perfect (typically not permitted by CSR), 3 average, 5 does not allow resubmission

Scores and Range 40% remaining are scored. Highest and lowest of P, S, and D score sets range. S.S. members can vote outside range if they speak up before vote. Average of all votes is the score.


Fundable Range

Depends on the NORMALIZED Score, Type of Grant, and $ that PM has in a program Everything here is subject to change…moving target

RO1 < 5th percentile is considered in fundable range

Depends on Institute (Cancer yes, facial cranial, probably no), and if PM has money in program

R21 < 10th percentile is considered fundable

R03/R15 < 15th percentile R43/44 SBIR/STTR < 25th percentile Training Grants for Young Investigator Development Highly competitive, but good opportunity to look into


How Evaluators Tend to Rank Criteria

1. Medical and/or biological significance: Do not underestimate this

2. Hypothesis-driven specific aims: Can be lost right here, not won.

1. Note: No longer required for engineering or instrumentation proposals, but reviewers still desire them

2. Adequate number, but not too many1. Need to be related, but common mistake is to have one depend on

another2. R21 - 2 to 3 are good…5 or more too many3. RO1 - 3 to 5 are good….7 or more too many

3. Ideas: Is the approach to solve the problem innovative and exciting, but still sound? This is what wins proposals.

4. Strength of investigators: Can they do the work proposed?1. Strong CV and number of papers published essential2. Preliminary data and previous impact of investigators work

5. Money and timeline1. Can’t be considered until after scoring, but it still

matters. Don’t ask for full 5 years for an RO1, keep budget modular if possible.

Given in order of importance that S.S. members look for.


CSR Suggested Format of Reviews

SUMMARY AND RECOMMENDATION State briefly the objective of the research plan. Indicate the specific gaps or areas that the proposed plan is going to address. Then, summarize the major strengths and weaknesses. Finally, provide your assessment by assigning one of the flexible priority scores (The range is 1.0 to 5.0, Examples 1.8, 3.5).

The aim of the evaluation is the generation of strengths and weaknesses. Limit descriptive comments and emphasize evaluative comments for the following criteria:



Criteria Significance

Evaluate the importance and impact of the proposed plan on human health, biodiversity conservation, and sustainable economic opportunities and for contributions to scientific advancement in the field.

Evaluate the capacity building on research and training for host country.

Evaluate progress of the existing project (For relevant applications only), including accomplishments made and published results.



Criteria Approach

Evaluate whether the methods and analysis are appropriately designed to provide clear answers to the specific aims of the proposed plan and whether the potential problems are addressed and alternatives considered.

Innovation Evaluate the creativity of the proposed plan

Investigators Evaluate the research competence and evidence of productivity for both US and foreign investigators, in the relevant field of research plan.

Environment Evaluate the adequacy of both existing and proposed facilities and resources for the planned research.



Other Considerations

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISKS: Evaluate the application with reference to the following criteria: risk to subjects, adequacy of protection against risks, potential benefit to the subjects and to others, importance of the knowledge to be gained. (If the applicant fails to address all of these elements, notify the SRA immediately to determine if the application should be withdrawn.) If all of the criteria are adequately addressed, and there are no concerns. Write "Acceptable Risks and/or Adequate Protections." A brief explanation is advisable. If one or more criteria are inadequately addressed, write, "Unacceptable Risks and/or Inadequate Protections" and document the actual or potential issues that create the human subjects concern. If the application indicates that the proposed human subjects research is exempt from coverage by the regulations, determine if adequate justification is provided. If the claimed exemption is not justified, indicate "Unacceptable" and explain why you reached this conclusion. Also, if a clinical trial is proposed, evaluate the Data and Safety Monitoring Plan. (If the plan is absent, notify the SRA immediately to determine if the application should withdraw.) Indicate if the plan is "Acceptable" or "Unacceptable", and, if unacceptable, explain why it is unacceptable.


Other ConsiderationsGENDER, MINORITY AND CHILDREN SUBJECTS: Public Law 103-43 requires that women and minorities must be included in all NIH-supported clinical research projects involving human subjects unless a clear and compelling rationale establishes that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. NIH requires that children (individuals under the age of 21) of all ages be involved in all human subjects research supported by the NIH unless there are scientific or ethical reasons for excluding them. Each project involving human subjects must be assigned a code using the categories "1" to "5" below. Category 5 for minority representation in the project means that only foreign subjects are in the study population (no U.S. subjects). If the study uses both then use codes 1 thru 4. Examine whether the minority and gender characteristics of the sample are scientifically acceptable, consistent with the aims of the project, and comply with NIH policy. For each category, determine if the proposed subject recruitment targets are "A" (acceptable) or "U" (unacceptable). If you rate the sample as "U", consider this feature a weakness in the research design and reflect it in the overall score. Explain the reasons for the recommended codes; this is particularly critical for any item coded "U".



Other ConsiderationsGENDER, MINORITY AND CHILDREN SUBJECTS:


Category Gender (G) Minority (M) Children (C)

1 Both Genders Minority & non-minority Children & adults

2 Only Women Only minority Only children

3 Only Men Only non-minority No children included

4 Gender Unknown

Minority representation unknown

Representation of children unknown

5 Only Foreign Subjects

NOTE: To the degree that acceptability or unacceptability affects the investigator's approach to the proposed research, such comments should appear under "Approach" in the five major review criteria above, and should be factored into the score as appropriate.


Other ConsiderationsGENDER, MINORITY AND CHILDREN SUBJECTS:ANIMAL WELFARE: Express any comments or concerns about the appropriateness of the responses to the five required points, especially whether the procedures will be limited to those that are unavoidable in the conduct of scientifically sound research.

BIOHAZARDS: Note any materials or procedures that are potentially hazardous to research personnel and indicate whether the protection proposed will be adequate. BUDGET: Evaluate the direct costs only. Do not focus on detail. Determine whether the total budget is appropriate for the project proposed. Provide a rationale for suggested modification in amount or duration of support. OTHERS (for Administrative Notes in the Summary Statement): These comments are useful to NIH but should not influence your overall score. FOREIGN: If the applicant organization is foreign, comment on any special talents, resources, populations, or environmental conditions that are not readily available in the United States or that provide augmentation of existing U.S. resources. In addition, indicate whether similar research is being performed in the U.S. and whether there is a need for such additional research. These aspects do not apply to applications from U.S, organizations for projects containing a significant foreign component.



Allowed up to three submissions on same topic PM’s and CSR Officials determine if proposal is on same topic

and content. Reviews returned within 2 weeks of CSR Review

Wants to have quick turnaround so resubmission can occur. Pay close attention to reviews, take at face value,

and respond as affirmatively as possible Since goes back to same S.S. at least one of the previous

reviewers will see. Also, all on panel can read and comment. There is institutional memory. Reviewers want to see their comments taken seriously and responded to. Else scores will worsen, not become better on subsequent reviews.

New reviews There will be at least one new review each time, which means

that addressing previous reviews may not be sufficient. New ideas, innovations, and data can strengthen.

What to do With Reviews


Elements Of An NIH Proposal

Executive Summary (1/2 page) Introduction Literature review Specific Aims

1-2 for R21, 3-5 for R01 Detailed Research Plan

Methods Preliminary data Risk mitigation strategy

References cited Biosketches Current and pending support Supporting Letters

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The Executive Summary

Shorter version (30 lines max) of the introductions you have already been writing

Must cover the Heilmeier Criteria Explain exactly what you are going to do with absolutely no jargon

Explain Who cares? If you're successful, what difference will it make?

What's new in your approach and why do you think it will be successful?

No citations (you do not have to cite an expert)

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Elements Of An NIH Budget

NIH Uses “Modular budgets” up to $250,000/yr Ask for fixed increments of 25K in direct costs

Flat budgets for all years

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Typical NSF Budget For Starting Faculty Member

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Year 1 Year 2 Total

PI 0 0 0 0Others 0 0 0others 0 0 0 0Grad Students 1 @ 50% 23,500 24,675 48,175Fringe Benefits 1,206 1,266 2,471Total Salary and Fringe 24,706 25,941 50,646

supplies 10,000 10,000 20,000travel 3,000 3,000 6,000equipment 0tuition remission 13,160 13,818 26,978Total Direct Costs 50,866 52,759 103,624F&A 20,738 21,417 42,156

Total Costs 71,604 74,176 145,780


Typical NIH R21 Budget For Starting Faculty Member

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Year 1 Year 2 Total

PI 2 months 15,000 15,750 30,750

Others 0 0 0 0

others 0 0 0 0

Grad Students 1 @ 50% 23,500 24,675 48,175

Fringe Benefits 6,547 6,874 13,421

Total Salary and Fringe 45,047 47,299 92,346

supplies 13,793 10,883 24,676

travel 3,000 3,000 6,000

equipment 0tuition remission 13,160 13,818 26,978

Total Direct Costs 75,000 75,000 150,000

F&A 34,012 33,650 67,662

Total Costs 109,012 108,650 217,662


NIH Hints For New Investigators

Start with an R21 (2 years of support) Instructions say no preliminary data needed, but it IS needed

Make budget low ($75K of Direct Costs)

Be sure to follow the rules

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Questions?

1 che594 lect24 proposals to nih. all information and opinions are those of mark a. shannon, 2007...

Documents

nih institutes

applied research funding

nihtotal funding

kyr direct funding

years funding

funding levels misleading

individual institutes

research grants