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Michelle M. Timmerman, Ph.D. Director, AREA Program National Institutes of Health

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Page 1: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Michelle M. Timmerman, Ph.D.

Director, AREA Program

National Institutes of Health

Page 2: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

• Overview of AREA (R15) program

• R15-specific instructions

• Review of R15 applications

Page 3: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Goals of AREA program

• Support meritorious research

• Expose students to research

• Strengthen the research environment of the

institution

Page 4: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Key features

• Project period is limited up to 3 years

• Direct cost limited to $300,000 over entire

project period

• Multiple PIs are allowed, if all eligible

• Research Strategy limited to 12 pages

• Grants are renewable

• Preliminary data not required but can be

provided

Page 5: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Eligibility

Eligibility = applicant institution and PI only

Eligibility ≠ collaborators

Eligibility

Institution Principal

Investigator

Page 6: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Institution eligibility

• US institutions only

• Baccalaureate or advanced degree in

biomedical or behavioral science

• Degree granting & accredited

• Receives less than $6 million per year in NIH

support in 4 out of last 7 years

Page 7: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

There is no “eligible” list

• Ineligible list is on AREA Program website ▫ http://grants.nih.gov/grants/funding/area_ineligible.htm

• “Other Academic” = sum of everything that is not

an R15-defined Health Professional School

• Updated in April; university should check

Page 8: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

PI eligibility

• Primary appointment at eligible institution

• Multiple PI OK if all eligible

• R15 supports small scale projects

▫ Eligible:

Also serve as consultant (e.g., Key Personnel) on

another grant

▫ Not Eligible:

Also serve as PI of other NIH research grants at

time of award

Also serve as Multiple PI on another NIH research

grant at time of award

Page 9: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Application logistics

• Funded through the R15 grant mechanism ▫ Program Announcement (PA) Number: PA-13-313

• All NIH ICs participate in the PA-13-313 except

FIC and NCATS

Page 10: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Timeline for R15 applications

10

Scientific Review:

Jun/July

Oct/Nov

Feb/Mar

Council Review:

October

January

May

Earliest Award Date:

December

April

July

Receipt/Due Date:

Feb 25 May 7 AIDS

Jun 25 Sept 7 AIDS

Oct 25 Jan 7 AIDS

Page 11: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

There is no winning formula

No one can give specifics of what will score well

Do not treat a successful [or not] application as

an iron-clad template [of what not to do]

▫ How much experience supervising students

▫ How many students

▫ How many papers

▫ What % of a collaborator

▫ What % of special facilities

▫ What amount or type of institutional support

▫ What type of environment

Page 12: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

R15-specific instructions:

Biosketch • Personal statement addresses your experience

supervising students doing research

▫ Potentially includes:

Numbers and length of experience

Inclusion of students in publication

Student outcomes

• Specifies which pubs/patents involved your

students

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Page 13: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

R15-specific instructions: Budget

• Must include undergraduate (preferably, if

available) and/or graduate students

• Specify which parts of research students will be

involved in

• List number & level (e.g., undergraduate, junior)

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Page 14: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Budget: Justify ineligible collaborators

• FAQ: Can I have a collaborator who is not at an

AREA-eligible institution, at home campus or

another site?

• Eligibility answer: Yes

• Merit answer: But keep the unique goals and

criteria of the R15 in mind

▫ No one can predict what level of involvement will

be seen as counter to the R15 goals

▫ Pre-PA-12-006, unique attributes not included as

strongly in review criteria

Page 15: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

R15 instructions:

Facilities & Other Resources

• For institution; not PI’s mentoring experience

• Profile of students

• Estimate of # who obtained Bachelor & pursued

doctoral degree in last 5 years

• Special characteristics that make it appropriate

for 3 goals of AREA

• Impact of R15 on PI & institution

• Any institutional support

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Page 16: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Research Strategy • Address research-related AREA goals

▫ Support small-scale meritorious research projects Research should contribute to the field

Results should be publishable

Hypothesis should be provable with budget requested

▫ Expose students to research How students will be incorporated into the research

project

How students will benefit from this research experience

Project should stimulate students’ interest in research

• Don’t include fellowship-style training plans

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Page 17: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Additional advice

• Include a collaborator or consultant if you don’t have

the necessary expertise or resources • Note caveat for ineligible collaborators

• Understand the review criteria and the review

criteria questions

▫ Each question should be addressed in the

application

• In A1, respond thoroughly and diplomatically to

all of the reviewer comments

17

Page 18: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Talk to a Program Officer

• Before you write

▫ Is your project appropriate for R15?

▫ Does your project fit in Institute/Center’s mission?

• After your Summary Statement is released

▫ More context for Resume and Summary of

Discussion

▫ Resubmit?

▫ Timeline for funding decisions

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Page 19: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Electronic submission hints

• Obtaining or renewing registrations can take 6

weeks

• Start e-submission 3 business days early

• Follow process for system errors ▫ http://grants.nih.gov/grants/ElectronicReceipt/support.htm#guidelines

• Correct errors & “address” warnings on time

▫ Error = NIH does not get application

▫ Warning = application gets to NIH and will be

manually validated

• Use the 2 day viewing window

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Page 20: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

News & resources • Annotated sample R01, R21 applications ▫ http://www.niaid.nih.gov/researchfunding/grant/pages/

appsamples.aspx

• AREA Program evaluation underway

▫ Assessing Program’s success in meeting its goals

▫ Surveys & interviews by Westat

• AREA Program Facebook page

▫ Like us on Facebook

▫ https://www.facebook.com/NIHAreaProgram

• AREA Program FAQs

▫ http://grants.nih.gov/grants/funding/area_faq.htm

• AREA mailbox

[email protected]

Page 21: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Peer Review of Research Applications at the

NIH

Vonda Smith, Scientific Review Officer (SRO) Small Business: Biological Chemistry, Biophysics, and Drug Discovery Study Section February 19, 2015

American Association of State Colleges and Universities:

2015 GRC Funding Competitiveness Conference

Page 22: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Center for Scientific Review

Page 23: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Center for Scientific Review

• Serves as central receipt point for grant applications

submitted to NIH and some other DHHS agencies

• Assigns applications to CSR review groups/study

sections or Institute scientific review groups

• Assigns applications to NIH Institute(s)/Center(s) as

potential funding component(s)

• Conducts initial scientific merit review of most

research applications submitted to the NIH in about 240

Study Sections and regularly recurring Special Emphasis

Panels

Page 24: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Your Scientific Review Officer Takes Charge

Your SRO is a doctoral-level scientist with expertise relevant to

your field who manages the overall peer review of your application.

Page 25: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Your SRO Assigns at Least Three Reviewers to

Your Application

Page 26: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

What Your SRO Looks for When Recruiting Reviewers

• Demonstrated scientific expertise/research support

• Doctoral degree or equivalent

• Mature judgment

• Work effectively in a group context

• Breadth of perspective

• Impartiality

• Diversity

• Geographic distribution

Page 27: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

The Study Section Meeting

Your SRO Convenes the Study Section Meeting

Page 28: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

At the Meeting: Application Discussion

• Any member in conflict with an application leaves the room

• Reviewer 1 introduces the application and presents critique

• Reviewers 2 and 3 highlight new issues and areas that

significantly impact scores

• All eligible members are invited to join the discussion and then

vote on the final overall impact score

Page 29: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

• Reviewers typically discuss the top half of the

applications

• The panel will discuss any application a reviewer wants

to discuss

Discussions Focus on the Best Applications

Page 30: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Main Review Criteria

• Overall Impact

The likelihood for the project to make an important

scientific contribution to the research field(s) involved, to

provide research opportunities to students, and to

strengthen the research environment of the institution,

• Core Review Criteria

Page 31: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Core Review Criteria

• Significance: Does the project address an important problem

or a critical barrier to progress in the field, or have the ability

to improve knowledge, technical capability or clinical practice?

Does the project advance the field?

• Investigator(s): Are they qualified? If ESI or NI , for an R01

application, do they have appropriate experience and

training?

• Innovation: Does it challenge and seek to shift current

research or clinical practice paradigms by utilizing something

novel? Is it novel to one field of research or novel in a broad

sense? Is it a refinement, improvement, or new application?

Page 32: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Core Review Criteria

• Approach: Is it well-reasoned and appropriate to accomplish

the specific aims of the project? Are potential problems/

alternative /benchmarks for success presented? If in the early

stages of development, will the strategy establish feasibility and

will particularly risky aspects be managed?

• Environment: Will it contribute to the probability of success?

Are the institutional support/equipment/other physical resources

available to the investigators adequate? Will the project benefit

from unique features of the scientific environment, subject

populations, or collaborative arrangements?

Page 33: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Additional Criteria Contribute to Overall Impact

Scores

• Protections for human subjects

• Inclusions of women, minorities and children

• Appropriate use of vertebrate animals

• Management of biohazards

Page 34: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

R15/AREA Grant Review

• Reviewed together

o Clustered

o SEP

Page 35: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Main Review Criteria

• Overall Impact

Overall Impact : How likely is it that the project will make

an important scientific contribution to the research field(s)

involved, to provide research opportunities to students,

and to strengthen the research environment of the

institution?

• Core Review Criteria

Page 36: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Core Review Criteria R15/Area Grants

• Significance: How well could the grant strengthen the

research environment and expose students to research?

• Investigator(s): Do the PD(s)PI(s) have suitable

experience in supervising students in research?

• Innovation: No specific difference from assessing

innovation in R01 grant applications.

• Approach: Can the project stimulate students’ interest so

they might consider a biomedical/behavioral science

career?

• Environment: Are qualified students available? Is there

evidence that students have pursued or will pursue

biomedical/ behavioral science careers?

More on the AREA/R15 Program

http://grants.nih.gov/grants/funding/area.htm

Page 37: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

9-Point Scoring Scale

Impact Score Descriptor

High Impact

1 Exceptional

2 Outstanding

3 Excellent

Medium Impact

4 Very Good

5 Good

6 Satisfactory

Low Impact

7 Fair

8 Marginal

9 Poor

Page 38: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Scoring

• Each panel member provides an overall impact score.

Range of Scores

• After discussion, assigned reviewers state final Overall Impact

Scores, defining the score range.

• Panel members may vote outside this range although any intent

to do so must be declared.

Page 39: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Other Considerations that Do Not Affect Overall

Impact Scores

• Resource Sharing Plans:

– Data

– Model Organisms

– Genome Wide Association Studies

• Foreign Organizations

• Select Agents

• Budget

Page 40: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Electronic reviews are used to facilitate reviewer participation

Electronic Review Platforms

• Telephone Assisted Meetings

• Internet Assisted Meetings

• Video Assisted Meetings

Your Application Could Be Reviewed Electronically

Page 41: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

View the Video

http://www.csr.nih.gov/video/video.asp

Page 42: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

After Your Review

Your SRO

• Prepares summary statements

• Provides information to NIH Institutes and Centers

Page 43: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

• Scores for each review criterion

• Critiques from assigned reviewers

• Administrative notes if any

If your application is discussed, you also will receive:

• An overall impact/priority score and percentile

ranking

• A summary of review discussion

• Budget recommendations

Your Summary Statement

Page 44: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Check the Status of Your Application in NIH Commons

Page 45: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Cover Letter

The cover letter should be used for a number of important

purposes:

• Suggest Institute/Center assignment

• Suggest review assignment

• Identify individuals in potential conflict and explain why

• Identify areas of expertise needed to evaluate the application

• Discuss any special situations

It is NOT appropriate to use the cover letter to suggest specific

reviewers.

Page 46: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

What Reviewers Look for in Applications

• Impact

• Exciting ideas

• Clarity

• Realistic aims and timelines -- Don’t be overly

ambitious

• Brevity with things that everybody knows

• Noted limitations of the study

• A clean, well-written application

Page 47: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Key NIH Review and Grants Web Sites

NIH Center for Scientific Review

http://www.csr.nih.gov

NIH Office of Extramural Research

http://grants.nih.gov/

Page 48: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Who Can Answer Your Questions?

Before You Submit Your Application

• A Program Officer at an NIH Institute or Center

• Scientific Review Officer

After You Submit

• Your Scientific Review Officer

After Your Review

• Your Assigned Program Officer

Page 49: Michelle M. Timmerman, Ph.D. Director, AREA Program ...• Resource Sharing Plans: – Data – Model Organisms – Genome Wide Association Studies • Foreign Organizations • Select

Meet the Experts in NIH Peer Review Webinars

www.csr.nih.gov/webinar

For Researchers Seeking:

• R01 Grants

• Fellowship Awards

• AREA/R15 Grants

• Small Business Grants