Grantsmanship, Grant Opportunities, and the NIH Scientific Review Process Janice Benson Allen, PhD

Grantsmanship, Grant Opportunities, and the NIH Scientific Review Process

Janice Benson Allen, PhD

Scientific Review Officer

Division of Extramural Research and Training (DERT)

National Institute of Environmental Health Science (NIEHS)

National Institutes of Health (NIH)

Dept of Health & Human Services (DHHS)

Grantsmanship, Grant Opportunities, and the NIH Scientific Review Process

Janice Benson Allen, PhD

Scientific Review Officer

Division of Extramural Research and Training (DERT)

National Institute of Environmental Health Science (NIEHS)

National Institutes of Health (NIH)

Dept of Health & Human Services (DHHS)

The National Institute of Environmental Health SciencesThe National Institutes of Health

I am from the Government and am here to help you!

NIH

Overview of NIH Funding Mechanisms Important Personnel Overview of NIH Grant Process

Submission Receipt/Referral Review Award Post-award

The NIH Grant ProcessThe NIH Grant ProcessThe NIH Grant ProcessThe NIH Grant Process

NIH consists of 27 Institutes and Centers

= Extramural only

NEI

NCI

NHLBI

NLM NINDS

NIMH

NIAMS

NINR

NCCAM

CIT

CC

NHGRI

NIA

NIAAANIAID

NICHD

NIDCD

NIDCR

NIDDK

NIDA

NIEHS

OD

NIGMSNCRR

NIBIBNCMHD

FIC CSR

Within most ICs, there are separate and distinct Extramural and Intramural components.

At NIEHS, these are the Division of Intramural Research (DIR)

&Division of Extramural Research and Training

(DERT)

NIH Institutes

NIEHS -- National Institute of Environmental Health Sciences

Human health and human disease result from three interactive elements:

environmental factors

individual susceptibility

age

The mission of the NIEHS is to reduce the burden of human illness and dysfunction from environmental causes by understanding each of these elements and how they interrelate.

Assistance (Grant) MechanismsGrants – Assistance mechanism to stimulate research,

often unsolicited. If solicited, published in the NIH Guide to Grants and Contracts as:

– RFA – Request for Applications – one receipt date and funds set aside to fund (grants)

– RFP – Request for Proposal (contracts)– PA – Program Announcement– PAS – Program Announcement with set aside funds – PAR – Program Announcement reviewed by the

Institute/Center not Center for Scientific Review (CSR)

Grant Mechanisms“R”: Research Project

R01: Reseach GrantR03: Small Research GrantsR15: AREA GrantsR21: Exploratory/Developmental GrantsR43: Small Business Innovation Research

“P”: Multi-component projects

P01: Program ProjectsP30 & P50: Center Grants

“T”: Institutional

Training

T32: Institutional Training GrantsT35: Short-term Training

“F”: Individual

Fellowships (NRSA)

F30: MD/PhD Predoctoral FellowshipF31: Diversity Predoctoral FellowshipF32: Postdoctoral Fellowships

“K”: Career

Development

K99/R00: Pathways to Independence AwardK08: Mentored Clinical Scientist Develop AwardK12: Institutional Career Develop Program

Not all mechanisms are available at all Institutes under all circumstances.

R01 Characteristics

• “Traditional Research Grant”- supports a discrete, specified project to be performed by the Principal Investigator

• Up to five years of support• Budget potentially unlimited- modular up to $250K

per year• CSR or IC (Institute/Center) review• New Investigator status• Preliminary data

R03 - Small Grants

• Provision of limited funding for a short period of time

• Types of projects may be:– Pilot or feasibility studies

– Secondary analysis of existing data

– Small, self-contained research projects

– Development of research methodology

– Development of new research technology

• No preliminary data, but scientific plausibility

• Up to 2 years, up to $50,000/ year

R13 – Conference Grants

• A scientific meeting is defined as a gathering, symposium, seminar, conference, workshop or any other organized, formal meeting where persons assemble to coordinate, exchange, and disseminate information or to explore or clarify a defined subject, problem, or area of knowledge….focus must be scientific.

• $3000-10,000 support provided

• Apply 9 months prior to meeting

• Contact: Martha Barnes [email protected]

R15 – AREA Grants…Research Grants for non research Intensive Institutions

• Enable scientists at eligible institutions to receive support for small research projects, which might include, feasibility studies, pilot studies, and other small-scale research programs

• Maximum of $150,000 in direct costs plus facilities and administrative costs at the rate negotiated for the institution may be awarded for a period of up to three years

• Contact: Mike Humble [email protected]

R21 – Exploratory/Developmental Grant: High Risk/High Reward

• Fosters the introduction of novel scientific ideas, model systems, tools, and technologies that have the potential to substantially advance biomedical research.

• Intended to encourage new exploratory/developmental

research projects by providing support for the early stages of their development

• Supports small research projects to be carried out in a short period of time (2 years), with limited resources

• Preliminary data not required

Assistance (Grant) Mechanisms• Mentored Career Awards (Ks)

– K01 – Mentored Research Scientist Development Award– K02 – Independent Scientist Award– K07 – Academic Career Award– K08 – Mentored Clinical Development Scientist Award– K12 – Institutional Clinical Scientist Development Program Award– K23 – Mentored Patient-oriented Research Career Development

Award – K24 – Midcareer Investigator Award in Patient-Oriented research– K25 – Mentored Quantitative Research Development Award– K99/R00 – NIH Pathway to Independence Award

• Mentored career awardees may now hold concurrent support from an NIH career award and an NIH research grant

PURPOSE OF CAREER AWARDS

Provides support/protected time to junior, mid-career and established investigators to develop/further develop their research careers.

Provides bridge support to transition from mentored to independent career phases.

K01: PA-10-056 “Mentored Research Scientist Development” Purpose: Provide ‘protected time’ (3-5-yrs) for an intensive, supervised career development

experience in biomedical, behavioral, or clinical sciences leading to research independence. Some ICs use for training in new fields or returning from hiatus (illness, family circumstances) and increasing diversity in workforce.

Salary: Based on full-time, 12-month appointment at institute’s salary scale; devote 75% effort; NOT USED for salary supplementation or for extra duties.

Candidate: Work with mentor & institution to develop the application; US citizen or non-citizen national, or permanent resident card (USCIS Form I-551) or legal admission as permanent resident; possess research/health-professional degree; have full-time appointment.

Mentor: Recognized as an accomplished investigator in research area; posses independent research support; may be co-mentors.

Application: SF 424 (Grants.gov/apply); meet deadlines and submission criteria; cover letter; view in eRA Commons.

Candidate Information & Career Development Plan: Candidate’s Background; Career Goals & Objectives; Career Development/training activities; Training in the Responsible Conduct of Research.

Research Plan: Sound plan consistent with candidate’s research development/objectives; mentor’s research and proposed candidate’s plan must be described; (clinical trials).

Statements of Support: Mentor/Co-mentors, Consultants, Contributors (electronic submission) Environment & Institutional Environment: Description of environment; Institutional commitment

to Candidate’s research career development. Letters of Reference: 3-5 letters from well-established scientists not directly involved in the

application addressing candidate’s qualities/potential (may include advisory committee members).

Contact NIH staff & follow ‘specific’ review process

K02: PA-10-057 “Independent Scientist Award” (salary only award)

Purpose: Foster development and enable them to expand their potential to make significant contributions in their field; 3-5yrs of salary support and ‘protected time’ an intensive, supervised career development experience in biomedical, behavioral, or clinical sciences leading to research independence. Contact relevant IC for specific programmatic/budgetary information.

Salary: Based on full-time, 12-month appointment at institute’s salary scale; devote 75% effort; Sponsoring institution may supplement the NIH salary contribution consistent to existing salary structure; salary cap; not to be used for extra duties.

Candidate: 75% effort; possess new peer-reviewed research support (IC exceptions); Work with mentor & institution to develop the application; US citizen or non-citizen national, or permanent resident card (USCIS Form I-551) or legal admission as permanent resident; possess research/health-professional doctoral degree; have full-time appointment.


Candidate Information & Career Development Plan: Candidate’s Background; Career Goals & Objectives; Training in the Responsible Conduct of Research.


Statements of Support: Consultants & Contributors (electronic submission) Environment & Institutional Environment: Description of environment; Institutional commitment to

Candidate’s research career development.


K07 PA-10-057 “Academic Career Award” Purpose: Provide Support to increase academic/research expertise to become academic researchers and

enhance institution research capacity in a specific area of bimedical research: K07 Development Award: provides salary/research support/career curriculum; 3-5 yrs of salary/research

support; requires mentor; 75% effort; must have active NIH funding (R01/R03/etc) and in final 2 yrs of funding; statement of commitment from institution; environment considered ineligible criteria.

K07 Leadership Award: develop multidisciplinary curriculum to strengthen institute’s teaching program; 2-5 yrs for more senior PIs; 25-50 % effort; full-time appointment; statement of commitment from institution; ineligible criteria.

Contact relevant IC for specific programmatic/budgetary information. Salary: Based on full-time, 12-month appointment; salary may be supplemented by institute at institute’s salary

scale. Candidate: US citizen or non-citizen national, or permanent resident card (USCIS Form I-551) or legal admission

as permanent resident; possess research/health-professional doctoral degree; have full-time appointment; posses clinical/research/health-professional doctoral degree.


Candidate Information & Career Development Plan: Candidate’s Background; Career Goals & Objectives; Career development/Training activities; Training in the Responsible Conduct of Research. Curriculum Development Plan for K07 Leadership Award


Statements of Support: K07 Development Award; Mentor/Co-mentor; Consultants & Contributors; 3-5 letters of reference(electronic submission): K07 Leadership Award: Collaborator’s statement

Environment & Institutional Environment: Description of environment; Institutional commitment to Candidate’s research career development.


K08 PA-10-059 “Mentored Clinical Scientist Research Career Development Award” Purpose: Support/expand didactic study/mentored research of persons with clinical doctoral

degrees; includes translational research; appropriate for those with different levels of prior research training and career development; specific criteria. Contact relevant IC for specific programmatic/budgetary/eligibility information.

Salary: Based on full-time, 12-month appointment at institute’s salary scale; devote 75% effort; Sponsoring institution may supplement the NIH salary contribution consistent to existing salary structure; salary cap; not to be used for extra duties.

Candidate: 50 75% effort; possess active peer-reviewed research support (IC exceptions); Work with mentor & institution to develop the application; US citizen or non-citizen national, or permanent resident card (USCIS Form I-551) or legal admission as permanent resident; possess clinical doctoral degree; have full-time appointment; work with mentor.


Candidate Information & Career Development Plan: Candidate’s Background; Career Goals & Objectives; Career Development/Training Activities; Training in the Responsible Conduct of Research.


Statements of Support: Mentor/Co-mentors, Consultants, & Contributors (electronic submission) Environment & Institutional Environment: Description of environment; Institutional commitment to

Candidate’s research career development. Letters of reference: 3-5 letters from well-established scientists not directly involved in the

application addressing candidate’s qualities/potential (may include advisory committee members). Contact NIH staff & follow ‘specific’ review process

K24 PA-10-061 “Midcareer Investigator in Patient-Oriented Research”

Purpose: Provide support to mid-career health professional doctorates or equivalent at Assoc Prof level (or equivalent) for protected time to devote to patient oriented research (POR) and to act as research mentors to clinical faculty; expected to obtain funding and establish leadership roles in POR programs. Contact relevant IC for specific programmatic/ budgetary/eligibility information.

Salary: Based on full-time, 12-month appointment at institute’s salary scale; 3-5 yrs; devote 25-50% effort; Sponsoring institution may supplement the NIH salary contribution consistent to existing salary structure; salary cap; not to be used for extra duties.

Candidate: possess established record of independent, peer-reviewed research support; US citizen or non-citizen national, or permanent resident card (USCIS Form I-551) or legal admission as permanent resident; possess clinical doctoral degree; have full-time appointment; act as mentor to new clinical PIs.


Candidate Information & Career Development Plan: Candidate’s Background; Career Goals & Objectives; Training in the Responsible Conduct of Research; Plans to provide mentoring.

Research Plan: Currently supported research and new research to be specifically supported by this award to allow reviewers to evaluate research activities in POR and opportunities for mentoring. Must provide data & safety monitoring of clinical trials.

Statements of Support: Consultants & Contributors (electronic submission.) Environment & Institutional Environment: Description of environment; Institutional commitment to

Candidate’s research career development. Contact NIH staff & follow ‘specific’ review process

Ruth L. Kirschstein National Research Service

Awards• Training Grants - T32, T35

– Institutional – Predoctoral and postdoctoral

• Fellowships – Individual

• Predoctoral (F30, F31)• Postdoctoral (F32)• Senior (F33)

– http://grants.nih.gov/training/extramural.htm

Small Business Innovation Research (SBIR) & Small Business Technology Transfer (STTR) Programs: 3-Phase Program with set-aside funds to increase participation of small businesses in commercialization of technology through federal R&D Phase I (R43)

Feasibility Study $150K & 6months (SBIR) or $100K & 12

months(STTR) Phase II (R44)

Full R/R&D – results from Phase I 2 year award &$1M (SBIR) or $750K (STTR)

Phase IIICommercialization Stage (non-SBIR funds)

*Special requirements

http://grants1.nih.gov/grants/funding/sbirsttr_programs.htm

Grants vs. Contractshttp://grants.nih.gov

• GRANTS– Assistance– Government is a

Partner/Patron– Purpose is to support and

stimulate research– Benefit a public purpose

– Investigator initiated

• CONTRACTS– Acquisition

– Government is a purchaser

– Purpose is to acquire goods or services

– The direct benefit and use of the government

– Government initiated

Exciting Opportunities - 1

K99/R00: NIH-wide (intramural/extramural). Maintain strong cohort of NIH-supported investigators; transition from mentored postdoctoral to independent research positions; provides up to 5 yrs of support in 2 phases

Candidate: No more than 5 yrs of postdoctoral training at time of application; potential of independent research, based on experience level, research training, potential to contribute to health-related research field, evidence of research productivity (quality of peer-reviewed scientific publications), research creativity; reference letters, mentor’s (sponsor’s) statement, and statement from institutional training grant director (if applicable). Career Development Plan: Appropriateness of career development plan and likelihood that award will contribute substantially to the scientific development. Research Plan: Scientific and technical merit of the research question, design and methodology. Mentor: Appropriateness of the mentor’s research qualifications, scientific stature, experience and mentoring track record for career development needs. Environment and Institutional Commitment to the Candidate: Adequacy of facilities, availability of appropriate educational opportunities, and strength of institutional commitment to fostering career development of the candidate. Training in the Responsible Conduct of Research.

PA-10-063: NIH Pathway to Independence Award

http://grants.nih.gov/grants/guide/pa-files/PA-10-063.html

Exciting Opportunities - 2

Loan Repayment: NIH-wide. NIH Loan Repayment Programs Help Desk answers questions about programs/eligibility/benefits and provides assistance with online application. In exchange for a two-year research commitment, NIH will repay qualified educational debt up to $35,000 per year; reimburse Federal/state taxes resulting from repayment award; repay qualified educational debt after completion of the two-year commitment through competitive renewals - if you have student debt remaining at the completion of your award, you can apply for a competitive renewal provided you continue to meet NIH’s eligibility requirements. Applicants must have a Doctoral degree (M.D., Ph.D., or equivalent), funding for research at any domestic nonprofit, university, or government organization, educational loan debt equal to at least 20% of annual salary, conduct research an average of 20 hours/week, and be a US Citizen or permanent resident. (http://www.lrp.nih.gov)

ViCTER: NIEHS. The proposed new Virtual Program will allow researchers at remote locations to form a Virtual Consortia via an integration of their research and the identification of a center director who “houses” the ViCTER and coordinates monthly conference calls and annual update meetings. Any R01 ES funded researcher can develop a collaborative and integrative transdisciplinary and/or translational program with a focus on the role of environmental stressors in the etiology, trajectory and outcome of human disease and disorders with 2-3 other scientists. The Competitive Supplement mechanism will be used. (PAR ES-11-???)

Important Personnel

PROGRAMADMINISTRATOR

GRANTSMANAGEMENT

SPECIALIST

SCIENTIFICREVIEWOFFICER

When should/can I contact NIH/NIEHS Staff? ANY TIME!

PA: As soon as you begin to THINK of preparing an NIH application (or even sooner!); when receive summary statement; after Council meets; after award is made; during administration of project.

SRO: As soon as you receive an email from CSR as to which SRO is assigned to your application (CSR review) or when preparing your application (name provided in FOA).

GMS: When have budgetary/JIT (Just-in-Time) questions: preparing application; questions on summary statement (or contact PA); clarifications on FOA; JIT document submissions; fiscal administration during award period.

The NIH Grant ProcessThe NIH Grant Process

What happens in the Black Box ?

NIH Grant Process

Overview of NIH Grant Process

Referral

Review

Award

Post-award

Submission

WHAT IS AVAILABLE?To find out about

Funding Opportunity Announcements

(FOA)

NIH Guide for Grants and Contracts

http://grants.nih.gov/grants/guide/index.htm

www.gov.gov: Find, Apply, Submit

Bookmark!

http://grants.nih.gov/grants/guide/index.htm

http://www.gov.gov/

Applicants:Registration/Account CreationPersonal ProfileManage Professional BibliographyManage IC Profiles

Grantees:View Notice of AwardSubmit: eSNAP, Financial COI/Status Report/No-Cost Extension/Close out

Reviewers:How to access IAREnter scores & critiquesAccess grant apps & documents for review meeting

IC Training & Career DevelopmentxTrain (PDs/U Admin/Trainees submit/track paperwork

Bookmark! http://era.nih.gov/index.cfm

Electronic Research Administration: eRA Commons

Standard Deadlines: http://grants.nih.gov/grants/funding/submissionschedule.htm

R01 (new Research Grants): SF424 (R&R) February 5, June 5, October 5

R01 (renewal, resubmission, revision): SF424 (R&R)March 5, July 5, November 5

T Series: (Training): PHS 398January 25, May 25, September 25

K (new Career Grants): (PHS 398) February 12, June 12, October 12

K (renewal, resubmission, revision): (PHS 398)March 12, July 12, November 12Solicited Applications: See PA/RFA Problems? Contact SRO

Submission Dates

Where To Go For Help… General information on Electronic Submission and the SF424 (R&R):

http://era.nih.gov/ElectronicReceipt

Grants.gov registration, submission and ADOBE questions: Visit: http://www.grants.gov/CustomerSupport

Grants.gov Customer Service E-mail: [email protected] Phone: 1-800-518-4726

eRA Commons registration and post submission questions on Commons functionality

Web Support: http://ithelpdesk.nih.gov/eRA eRA Commons Help Desk

E-mail: [email protected] Phone: 1-866-504-9552 OR 301-402-7469

Forms transition and questions on NIH’s overall plan for electronic receipt NIH Grants Information

E-mail: [email protected] Phone: 301-435-0714

COVER LETTER

The cover letter should be used for a number of important purposes: Suggest Institute/Center Assignment Suggest review assignment Identify individuals in conflict Identify areas of expertise needed to

evaluate the application Discuss any special situations Required for an electronic

changed/corrected submission*It is not appropriate to use the cover letter to

suggest specific reviewers.

CRITICAL MESSAGE

If you do not see the application image in eRA Commons, the NIH does not see it either. You must follow up on the process and use eRA Commons to check. We need to know you have submitted an application in order to assign, review and award!


Receipt/Referral

Review

Award

Post-award

Submission

Prior to electronic submissions…..

ReferralReferralCenter for Scientific Review (CSR)

Division of Receipt and Referral

Receipt Check for completeness, enter information into database, assign number, etc.

ReferralTo a review group (“study section”)To a funding agency (e.g., NIEHS, NCI, etc.)

Note: You can request a certain institute for funding or a study section for review in your cover letter. Requests won’t always be honored – contact PA/SRO.

Grant Numbers

1 K99 ES 012345-01

Grant type

1 = new

2= competitive renewal

5 = noncompetitive renewal

Institute

Grant mechanism Sequential

number

Year of the grant

Contact SRO if you believe number is incorrect


Receipt/Referral

Review

Award

Post-award

Submission

Review and Award Cycles(Approximately)

App Submission Deadline: Jan/Feb May/JuneOct/Nov

Scientific Merit Review: June/July Oct/NovFeb/Mar

Advisory Council Review: Sept/Oct Jan/FebMay/June

Earliest Project Start Date: December April July

ReviewReviewReviewReviewCSR Study Sections (n = lots). Most

applications are reviewed here.

Study sections at the Institutions: SEPs

For special circumstances, e.g., RFAs & PAs (FOAs)

ViCTER applications are reviewed by a NIEHS SEP: (Janice B. Allen, SRO)

K99/R00 applications are reviewed by a NIEHS study section: The EHSR Committee

In addition to setting up the study sections, assigning applications to reviewers, etc., the SRO also does an “Administrative Review,” to make sure the application

• is administratively complete (e.g., Animal Welfare and Human Subjects)

• is formatted properly (e.g., page limits, fonts, etc.)

• meets the requirements of the RFA or PA, if appropriate

ReviewReview

Selecting Reviewers for SEPs Determine areas of expertise Determine number of reviewers Select peers:

mostly academics: peer-reviewed funding in appropriate

areas, review experience Currently NIH funded

Other reviewers ( e.g. government scientists; industry

scientists; community representatives) Representation of women, minorities, and

geographical distribution

Reviewers must….

adhere to strict conflict of interest, confidentiality and non-disclosure prior to seeing an application AND after review meeting

destroy all application materials after review meeting, or send back to SRO

Agree to not discuss proceedings of review meeting with ANYONE, and if asked to do so, should refer questions to SRO

NIH (and NIEHS) is very strict about conflicts/ confidentiality, and has convened an NIH committee to discuss consequences of misconduct

Know Your Audience - The Reviewers:

Accomplished, dedicated, Overly committed, tired,

inherently skeptical, overly critical

General understanding onlyUsed to reviewing R01

applications

http://cms.csr.nih.gov/ResourcesforApplicants/PolicyProcedureReview+Guidelines/OverviewofPeerReviewProcess/InsidetheNIHGrantReviewProcessVideo.htm

http://cms.csr.nih.govResources for applicantsNIH Grant Review Process videoLots of good information

2 videos

ENHANCING PEER REVIEW – CHANGES

IMPLEMENTED

NEW & EARLY STAGE INVESTIGATORS New PI Status calculated by IMPAC Early Stage Investigator Status

Subset of NI Within 10 years of last research degree/end of

residency Extension possible (not granted ahead of time)

Appropriate reasons for extension include clinical training, military service, family responsibilities, payback obligations, illness, disability, natural disasters

Reasons not appropriate include change of field, work in industry, visa complications

http://grants1.nih.gov/grants/new_investigators/index.htm

http://grants1.nih.gov/grants/new_investigators/index.htm

NEW FORMS, FORMAT, PAGE LIMITS

Applies to paper and electronic submissions (PHS 398 and SF 424 R&R)

Applies to applications intended for due dates of January 25, 2010.

For non-AIDS continuous submission change over date is January 25, 2010.

For AIDS continuous submission change over date is February 7,2010.

Not tied to a specific council round. Cannot mix two types of applications in the same

meeting.

NEW APPLICATION FORMAT Specific Aims – 1 page (all activities) Research Strategy generally 6 or 12 pages; 30 page

option needs OEP approval Training applications (Ts, K12) - 25 pages Multi-component applications use 6 or 12 page limit for

cores, projects, etc. Introduction is 1 page for applications 12 pages or less; 3

pages for others Personal statement in Biographical sketch; encouraged to

limit publications to 15 eRA validations will be set to check compliance No grandparenting clause – renewal and resubmission

applications must use new formathttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-149.html

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-149.html

MODIFIED SUBMISSION, REFERRAL, REVIEW

Eligible: appointed members of study sections (CSR and IC), NIH Boards of Scientific Counselors, NIH Advisory Boards or Councils, and the NIH Peer Review Advisory Committee, and reviewers with recent substantial service

R01, R21, and R34 applications for standard due dates may be granted extensions; no other activities; no RFAs or PARs with special dates

If multi-PI, only one need be a member CSR or IC review within 120 days

http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-09-155.html


RESUBMISSION POLICY A0 applications submitted for October 2009

council and beyond, only allowed an A1 Applications from submissions prior to

October 2009 council are allowed A2 by January 7, 2011 (AIDS date for May 2011 council)

Applies to all activity codes; no exceptions Applies to new (type 1), renewal (type 2), and

revision (type 3) applications; no exceptions. First major wave will be for October 2010

council (January to May 2010 due dates).

http://grants1.nih.gov/grants/guide/notice-files/not-od-09-016.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html

http://grants1.nih.gov/grants/guide/notice-files/not-od-09-016.html


WHAT CONSTITUTES A NEW APPLICATION?

Notice OD-07-015 Limits on Resubmission of an Application: Clarification of NIH Policy http://grants1.nih.gov/grants/guide/notice-files/not-od-07-015.html

A new application must have: Substantial changes in content and scope; more significant differences than

a resubmitted application. Fundamental changes in the questions being asked and/or the outcomes

examined. Insufficient change for a new application:

Rewording of the Title and Specific Aims Changes in response to previous Summary Statement Request for review by a different committee or funding consideration by a

different NIH institute Change of PA/PAS/PAR

http://grants1.nih.gov/grants/guide/notice-files/not-od-07-015.html

HOW WILL PROBLEM CASES BE HANDLED?

Applications may be identified at many steps in the referral/review process: DRR, SROs, Reviewers, Program or other IC

DRR will analyze each case. Straightforward cases will be handled directly. Knowledge management program is available to provide analysis. Additional input may be sought from CSR and/or IC staff. The PD/PI may be asked to provide input. Final determination of new or revised made by the DRR. When an application cannot be accepted or needs to be withdrawn

the PD/PI and AOR will be notified.

APPENDIX MATERIALS

Appendix requirements; Notice OD-10-077http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html

If publications allowed (PA/RFA), only 3 non-publicly available may be included

No submitted manuscripts Surveys, questionnaires, consent forms,

protocols allowed Color/glossy figures for paper submission only 5 CDs only for paper submissions (these are not

encrypted); PDF for electronic submissions Contact SRO if materials cannot be sent in PDF:

(medical devices, prototypes)


New Research Plan Components

IntroductionSpecific Aims

Background and SignificancePreliminary Studies/Progress Report Research Design and Methods

Inclusion Enrollment ReportBibliography and References CitedHuman Subjects Sections….

protections, women/minorities, enrollment, childrenOther Research Plan Sections….

animals, select agents, multi PD/PI, consortium, support, resource sharing

Appendix*

Research Strategy

Changes to Biographical Sketch

Personal Statement added: “Briefly describe why your experience and

qualifications make you particularly well-suited for your role in the project”

Publications revised: Limit the list of publications or manuscripts

to no more than 15 Applicant is encouraged to make selections

based on recency, importance to the field, and/or relevance to the application

Changes to Resources and Facilities

Instructions added to Resources: Provide a description of how the

scientific environment will contribute to the probability of success of the project

For Early Stage Investigators (ESIs), describe the institutional investment in the success of the investigator

New Policy on Post-Submission Application Materials

Expedite timely peer review, reduce burden on NIH staff & peer reviewers, and provide a uniform amount of materials for each grant

Provide information on unforeseen administrative issues

If allowed, sent to SRO 30 days prior to review meeting Post-submission is not required Unacceptable: updated Specific Aims/Research

Strategy pages; late-breaking research findings; supplemental pages (not contained in orig app); new LoS/collaboration that do not result from a change in key personnel due to loss of investigator

Allowed: RFAs with 1 due date; training grant apps; certain FOAs

All materials must be sent through AOR

Elimination of Error Correction Window: NOT-OD-10-123

On/after 01252011, error correction window will be eliminated – ensures consistent/fair deadlines for all applicants.

Submitted apps after 5:00pm on due date will be subject to ‘late policy’ & may not be reviewed.

Exceptions: system failure, natural disasters, etc; explain in cover letter.

Problems on applicant’s site are not considered. Applicants should submit in advance to view

application and reject/submit corrected application prior to deadline.

Submit early.

ReviewReviewReviewReview

Scores: 1 (best) to 9 (worst)

Non-numeric options: Not Recommended for Further Consideration, Deferred, Abstention, Conflict, Not present, Not discussed

• Applications are mailed to Reviewers (on CD)–(encryption)

• Reviewers read and evaluate applications, and prepare written comments (submitted to IAR)

• Review meeting: Reviewers discuss applications individually and give them a score

Enhanced Review Criteria for FY2010

Core Review Criteria

For research grant applications and cooperative agreements

Received for potential FY2010 funding

Will receive individual criterion scores from assigned reviewers & discussants

Significance

Investigator(s)

Innovation

Approach

Environment


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?



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?



Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project?

If Early Stage Investigators or New Investigators, 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*? (*Moved from Approach)


Enhanced Review Criteria for Enhanced Review Criteria for FY2010FY2010


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?

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?


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?


Overall Impact/Priority Score

Reflects the reviewers’ assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved

In consideration of:•Core criteria•Additional review criteria (RFA or PAR)•Additional review criteria – as applicable


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New Scoring Procedures

New Scoring Procedures for Evaluation


The new scoring system will utilize a 9-point scale (1 =exceptional, 9 = poor) This scale will be used for overall impact/priority scores and

for individual criterion scores Implemented for reviews of applications under funding

consideration beginning FY2010



9-point Scoring Descriptions

Weaknesses

Impact on applicants or PI/PDs

The scores provided for criteria that will:

1. emphasize areas of greatest strengths and weaknesses.

2. provide more information to aid in interpreting reviewer narratives – especially when the application was not discussed during the review meeting.

For a while, there may be confusion regarding the criterion scores vs. the impact/priority score.

72

Streamlining of Applications

Purpose: to identify applications that are least likely to be funded so that more time can be spent on the most scientifically meritorious applications

Goal: Set order of review: best – worst (score of 1 – 9 by assigned reviewers) Applications discussed by review committee Decision to streamline will ‘naturally’ fall about

halfway mark Decision to not discuss must be unanimous Streamlined applications receive a written

critique Discussed applications will also receive

summary of panel’s discussion at the meeting Verbiage of critiques must reflect

overall/criterion scores

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Key Facts- Final Scores

Final score provided by all eligible committee members (i.e. not in conflict), as is presently done

Overall impact/priority score is the mean score from all eligible reviewer scores, multiplied by 10

Final scores will range from 10 to 90, reported in whole numbers

End of ReviewSummary Statement

Written report compiled by SRA from written comments of the Reviewers and discussions at review meeting. (“Pink sheets”); shows score, reviewers comments, and summary of discussions

Streamlined applications also get summary statements, with critiques of assigned reviewers (no final scores)

Available to applicant on COMMONS (hard copy no longer mailed)

Made available to members of the National Council

What to do if disagree with Summary Statement

For a review issue: Contact SRO For a scientific issue: Contact PA For a budgetary issue: Contact GMS or PA PA will advise as to what occurs at this

point: Make plans for resubmission Discuss other opportunities Send a rebuttal letter to Advisory Council

(rare)

National Advisory Health Sciences Council

(“Secondary Review”)

Council accepts or rejects review of the study section

If recommendations are rejected, the Council may defer for a re-review. It can’t change the score.

Second Level of Review


Referral

Review

Award

Post-award

Submission

Funding Considerations

Recommendations for funding are based on:

Summary Statement: Score and review narratives

Programmatic Priorities

Budgetary Considerations

If the application is approved for funding: there are negotiations between NIH and applicant, if necessary, and an award is made.

If the application is not approved for funding, applicant can revise and resubmit (up to 1 more time, usually)


Referral

Review

Award

Post-award

Submission

Post-Award

Yearly Progress Reports

Competitive Renewal (for some mechanisms – not K99/R00)

Fame and Fortune

Initiates Research

Idea and Prepares

Application

INVESTIGATOR

GRANTEE

THE NATIONAL INSTITUTES OF HEALTH

Submits

Application

CSR Assigns

to IRG and Institute

Conducts

Research

Manages

Funds

Institute Evaluates

for Program Relevance

and Need

National Advisory

Council or Board

Recommends Action

IRG Evaluates

for Scientific

Merit

Institute Makes

funding Decisions

and Awards

Summary of NIH Grant Process

GrantsmanshipGrantsmanshipor or

How to swim with the How to swim with the sharks and survive!sharks and survive!

Setting the Stage….

Important Considerations Before Starting….

What to do…..What to do….. Start early! Learn to move from lab experiments to the big picture. Learn to think in terms of hypotheses to test and how to test

them….even in everyday lab work. Develop a specific niche research area of your own…you

need to be known as an expert in a specific area…think long term not just one application.

Check out the “competition”. Brainstorm ideas….match them to NIH. Novel, innovative, impact Check with NIH program directors Start with the end in mind: reviewers, review criteria Focus on specific aims page Think salesmanship/grantsmanship. Get help reviewing drafts and working through the entire process

It is not the will to win that’s important. Everyone wants to win! It is the will to prepare to win that makes the difference. Bobby Knight

BREAK…..

Common Problems with Common Problems with ApplicationsApplications

• Overly ambitious • Lack of innovation• Lack of linkage to human health

problem• Lack of focused/mechanistic hypothesis• Lack of focused aims that will prove and

only prove the hypothesis

• Unfocused research plan that does not test feasibility

• Questionable reasoning in approach• Lack of experimental detail• Lack of experience with methods

Begin with the End in Mind!Begin with the End in Mind!

Receipt and ReferralReview criteriaScoring System

Goal: To make everyone involved

in the process happy…to make their job easier.

The key to success in grant writing is to engender enthusiasm in the reviewer---who then becomes an advocate for the proposal!

Tell them what they want to hear, Tell them what they want to hear, not what you want to tell themnot what you want to tell them

Significance Investigators Innovation Approach Environment Further criteria are always

added by the reviewers!

Review Criteria Receiving Review Criteria Receiving ScoresScores

Overall Impact/Priority

5 Core Review Criteria: Significance Investigator(s) Innovation Approach Environment

Now that we know about.. Now that we know about.. Review assignment Reviewers Review criteria and Scoring system…we can use that information to

start at the beginning….. help develop the actual application.

A good idea is A good idea is necessary but not necessary but not

sufficientsufficient

Important Point to RememberImportant Point to Remember

There is an art to writing applications!

SCIENCE SALESMANSHIP

COMMUNICATION SKILLS

Grantsmanship: Sell Grantsmanship: Sell yourself and your ideas!yourself and your ideas!

What are you selling? Why is it important? Impact (who will benefit) How will you do it? Advantages/strengths/limitations Track record (can you do it?)

And put it in the proper form !

Principles of Successful Principles of Successful SellingSelling Make people like you…develop

rapport Find out what they need or want Get the other person’s point of view Know your product Show advantages of your product Develop a desire for your product Get people saying YES

Research Plan Research Plan ComparisonComparison

Introduction (Resubmissions

only) Specific Aims Background and

Significance Preliminary

Studies Research Design

Introduction (Resubmission Only)

Specific Aims Research Strategy

Significance Innovation Approach

Preliminary Studies (new)

Progress Report (Revision/Renewal)

NIH New Application NIH New Application GuidelinesGuidelines

Page limitationsSpecific Aims 1 PageResearch Strategy

R03/R21 6 pagesR01/R15 12 pages

Biographical Sketch 4 Pages

Research Plan Research Plan ComparisonComparison Introduction

(Resubmission Only) (1 page) Specific Aims (1 page) Research Strategy (12 pages)

Significance (1-2) IMPACT Innovation (1) Approach ( 10)

Specific aims ( 2-3 pages each)Preliminary Studies (new) (1-2)*Progress Report (Revision/Renewal)Timeline

Principles of Grantsmanship:Principles of Grantsmanship: Preparing an NIH Application Preparing an NIH Application

Title Abstract (200 words) Specific Aims Page Research Strategy

Significance InnovationApproach

Preliminary studies/Progress Report

Specific Aims PageSpecific Aims Page State concisely the goals of the proposed

research and summarize the expected outcome(s) including the impact that the results of the proposed research will exert on the research field(s) involved.

List succinctly the specific objectives of the research proposed, e.g. to test a specific hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field or develop a new technology.

Limited to one page.

Specific Aims PageSpecific Aims Page What, Why, Whom Paragraph

Human health problem Current status Background data…leading to hypothesis Hypothesis/problem addressed/new

technology Rationale

Aims Paragraph Payoff Paragraph

Innovation Expectations Impact

Specific Aims Page (One Page)Specific Aims Page (One Page)

Introductory Paragraph Statement of long term health problem (1

sentence) Background/significance of problem (1-2

sentences) Preliminary data/state of the art (2-3

sentences) Data gaps/controversy (1-2 sentences) Clearly defined hypothesis/specific goal

( 1-2 sentences)

Specific Aims Specific Aims (Cont’d)(Cont’d)

Specific Aims/Milestones 2-5 aims ( One sentence each) Specifically focused to prove

hypothesis/develop product Logical order with no dead ends

Summary Statement Emphasize novel product and innovative

approach and impact on field ( 2-3 sentences)

The aims should be endpoints…so it can be easily determined if they have been met!!

Aim 1. To determine if……

Aim 1. To characterize…..

HYPOTHESIS State what you are going to test

Be explicit One or two only Must be testable Do not rely on

reviewer to develop hypothesis

Do not wander about, stay aligned in logic

Idea and Hypothesis. Idea and Hypothesis. NOVEL!!!NOVEL!!!

New, innovative and novel ideas…paradigm shifters.

You need to be first….we don’t fund followers!

We don’t fund gap filling. We don’t fund verification/repetition.

Why is this application special….what singles out this application?

Research StrategyResearch Strategy Significance (1-2 pages)

Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. (Background)

Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more fields.

Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved. IMPACT!

Research StrategyResearch Strategy Innovation ( 1 page)

Explain how the application challenges and seeks to shift current research or clinical practice paradigms.

Describe any novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation or intervention(s).

Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions.

What is new or novel…what makes this application important and stand out from the rest?

Research StrategyResearch Strategy Approach (10 pages)

Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project.

Include how the data will be collected, analyzed, and interpreted as well as the resource sharing.

Discuss potential problems, alternative strategies and benchmarks for success anticipated to achieve the aims.

If project is in early states of development, describe any strategy to achieve feasibility, and address the management of any high risk aspects of the proposed work.

Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be used.

Research Strategy: ApproachResearch Strategy: Approach

For Each Aim/Milestone: (2-3 pages per aim) Rationale for approach Background or preliminary data related to aim Experimental design focusing on approach Data analysis and interpretation Potential difficulties/limitations… attention to high

risk Alternative approaches

Justify everything

Research Design and Research Design and MethodsMethods

Suggestion

NO experimental details unless Novel, controversial or of great interest

If relevant, explain why one approach or method will be used in preference to others. This establishes that the alternatives were not simply overlooked

Give not only the "how" but the "why"

Research Design and Research Design and MethodsMethods

Suggestions.

Include Timeline to demonstrate the objectives are attainable within the stated time frame.

Don't bite off more than you can chew. A small, focused project is generally better received than a diffuse, multifaceted project.

Preliminary StudiesPreliminary Studies

Discuss your preliminary studies, data, and/or experience pertinent to this application.

Early stage investigators should include preliminary studies…but for R01s reviewers will be instructed to place less emphasis on preliminary data for new investigators compared to the emphasis on preliminary data from more established investigators.

Preliminary ResultsPreliminary Results

Present unpublished studies by the applicants to establish:• the feasibility and importance of the

project• the applicants’ competence and

experience with the experimental techniques to be used in the project

Preliminary ResultsPreliminary ResultsSuggestions

• Organization: Link directly with Specific Aims (i.e. Use headings “Preliminary Data Supporting Aim 1: To determine…”)

• SUPPORT EACH AND EVERY AIM!

• Include all Tables and Figures necessary for the presentation of preliminary results.

ResourcesResources Describe how the scientific environment in which

the research will be done contributes to the probability of success ( e.g. institutional support, physical resources, and intellectual rapport).

Discuss ways in which the proposed studies will benefit from unique features of the scientific environment or subject populations or will employ useful collaborative arrangements.

For early stage investigators, describe institutional investment in the success of the investigator , e.g. classes, travel, training, career enrichment programs, organized peer groups, logistical support and best practices training and financial support such as protected time for research will salary support.

DO NOT write the application for the “Specialist”

You MUST convince the entire review committee

General IssuesGeneral Issues

Attention to details

Topic specific jargon

Layout and format

Common Problems with Common Problems with ApplicationsApplications

Lack of innovation Unconvincing case for commercial potential Lack of experience with methods Questionable reasoning in approach Lack of experimental detail Overly ambitious Unfocused research plan that does not test

feasibility

SummarySummary New/novel/innovative idea Impact Help and guidance Grantsmanship/salesmanship Start with the end in mind

Reviewers/review criteria/scoring system

Remember problems…We tell you how we will review it.

Grantsmanship Guidance at Grantsmanship Guidance at NIHNIH

http://www.niaid.nih.gov/ncn/grants/default.htm

http://grants1.nih.gov/grants/funding/sbir_policy.htm

http://grants1.nih.gov/grants/funding/sbirgrantsmanship.pdf

http://niaid.nih.gov/ncn/sbir/advice/advice.pdf

http://www.niaid.nih.gov/ncn/grants/default.htm





http://niaid.nih.gov/ncn/sbir/advice/advice.pdf

http://www.niehs.nih.gov/dert/home.htmhttp://www.niehs.nih.gov/dert/dertsrb/srb.htm

Thank you. QUESTIONS / INFORMATION

Janice B Allen, PhD 919-541-7556 [email protected]

mailto:[email protected]

Date post:	30-Dec-2015
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Grantsmanship, Grant Opportunities, and the NIH Scientific Review Process Janice Benson Allen, PhD

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