Janice Benson Allen, PhD Scientific Review Officer

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 Sciences The National Institutes of Health

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

The NIH Grant Process Overview of NIH Funding Mechanisms
Important Personnel Overview of NIH Grant Process Submission Receipt/Referral Review Award Post-award

NIH consists of 27 Institutes and Centers
NHLBI NINR OD NCCAM NIEHS NCI NIAMS CIT NIDA NEI NIMH CC NIDDK NLM NINDS NHGRI NIDCR NCMHD NIBIB NIA NIDCD NIAAA NICHD NIAID CSR NCRR NIGMS FIC = Extramural only

NIH Institutes 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)

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) Mechanisms
Grants – 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 Grant
R03: Small Research Grants R15: AREA Grants R21: Exploratory/Developmental Grants R43: Small Business Innovation Research “P”: Multi-component projects P01: Program Projects P30 & P50: Center Grants “T”: Institutional Training T32: Institutional Training Grants T35: Short-term Training “F”: Individual Fellowships (NRSA) F30: MD/PhD Predoctoral Fellowship F31: Diversity Predoctoral Fellowship F32: Postdoctoral Fellowships “K”: Career Development K99/R00: Pathways to Independence Award K08: Mentored Clinical Scientist Develop Award K12: 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. $ ,000 support provided Apply 9 months prior to meeting Contact: Martha Barnes

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

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. 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; 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: 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

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; % 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. 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. Curriculum Development Plan for K07 Leadership Award 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: 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. Contact NIH staff & follow ‘specific’ review process

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. 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

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. 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; 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)

$150K & 6months (SBIR) or $100K & 12 months(STTR) Phase II (R44)
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 III Commercialization Stage (non-SBIR funds) *Special requirements

Grants vs. Contracts CONTRACTS GRANTS http://grants.nih.gov
Acquisition Government is a purchaser Purpose is to acquire goods or services The direct benefit and use of the government Government initiated GRANTS Assistance Government is a Partner/Patron Purpose is to support and stimulate research Benefit a public purpose Investigator 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 : NIH Pathway to Independence Award

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. ( 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 PROGRAM ADMINISTRATOR SCIENTIFIC REVIEW OFFICER
GRANTS MANAGEMENT SPECIALIST

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 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.

What happens in the Black Box ?
The NIH Grant Process NIH Grant Process What happens in the Black Box ?

Overview of NIH Grant Process
Referral Review Award Post-award Submission

WHAT IS AVAILABLE? NIH Guide for Grants and Contracts
To find out about Funding Opportunity Announcements (FOA) NIH Guide for Grants and Contracts Find, Apply, Submit Bookmark!

Electronic Research Administration: eRA Commons
Applicants: Registration/Account Creation Personal Profile Manage Professional Bibliography Manage IC Profiles Grantees: View Notice of Award Submit: eSNAP, Financial COI/Status Report/No-Cost Extension/Close out Reviewers: How to access IAR Enter scores & critiques Access grant apps & documents for review meeting IC Training & Career Development xTrain (PDs/U Admin/Trainees submit/track paperwork Bookmark!

Solicited Applications: See PA/RFA Problems? Contact SRO
Submission Dates Standard Deadlines: 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 398 January 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 12 Solicited Applications: See PA/RFA Problems? Contact SRO

Where To Go For Help… General information on Electronic Submission and the SF424 (R&R): Grants.gov registration, submission and ADOBE questions: Visit: Grants.gov Customer Service Phone: eRA Commons registration and post submission questions on Commons functionality Web Support: eRA Commons Help Desk Phone: OR Forms transition and questions on NIH’s overall plan for electronic receipt NIH Grants Information Phone:

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…..

Center for Scientific Review (CSR)
Referral Center for Scientific Review (CSR) Division of Receipt and Referral Receipt Check for completeness, enter information into database, assign number, etc. Referral To 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.

Contact SRO if you believe number is incorrect
Grant Numbers 1 K99 ES Grant mechanism Grant type 1 = new 2= competitive renewal 5 = noncompetitive renewal Year of the grant Sequential number Institute 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/June Oct/Nov Scientific Merit Review: June/July Oct/Nov Feb/Mar Advisory Council Review: Sept/Oct Jan/Feb May/June Earliest Project Start Date: December April July

Review CSR 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

Review 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

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 only Used to reviewing R01 applications

Resources for applicants NIH Grant Review Process video
Resources for applicants NIH Grant Review Process video Lots 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

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 format

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

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).

WHAT CONSTITUTES A NEW APPLICATION?
Notice OD Limits on Resubmission of an Application: Clarification of NIH Policy 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

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-10-077
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
Introduction Specific Aims Background and Significance Preliminary Studies/Progress Report Research Design and Methods Inclusion Enrollment Report Bibliography and References Cited Human Subjects Sections…. protections, women/minorities, enrollment, children Other Research Plan Sections…. animals, select agents, multi PD/PI, consortium, support, resource sharing Appendix* Research Strategy Research Plan to align with Significance, Innovation, and Approach Enhanced Review criteria.

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 The Biographical Sketch corresponds to the Investigator(s) criterion.

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 These two sections correspond to the Environment criterion. Early Stage Investigator (ESI): An individual who is classified as a New or First-Time Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent) is considered an Early Stage Investigator (ESI).

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 These two sections correspond to the Environment criterion. Early Stage Investigator (ESI): An individual who is classified as a New or First-Time Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent) is considered an Early Stage Investigator (ESI).

Elimination of Error Correction Window: NOT-OD-10-123
On/after , 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. These two sections correspond to the Environment criterion. Early Stage Investigator (ESI): An individual who is classified as a New or First-Time Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent) is considered an Early Stage Investigator (ESI).

Review 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 Scores: 1 (best) to 9 (worst) Non-numeric options: Not Recommended for Further Consideration, Deferred, Abstention, Conflict, Not present, Not discussed

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 508 text is behind picture 63 63

Enhanced Review Criteria for FY2010 Core Review Criteria
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? 508 text is behind picture 64 64

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? 508 text is behind picture 65 65

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) 508 behind photo 66 66

Enhanced Review Criteria for FY2010
Core Review Criteria 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? 508 text is behind picture 67

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? 508 text is behind picture 68 68

Overall Impact/Priority Score
Enhanced Review Criteria for FY2010 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 508 text is behind picture 69 69

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 70

9-point Scoring Descriptions
Right column displays two corresponding triangles. One triangle is labeled “strengths” and gets progressively smaller from 1 to 9. The second triangle is labeled “weaknesses” and gets progressively larger from 1 to 9. IMPACT SCORE DESCRIPTOR High Impact 1 Exceptional 2 Outstanding 3 Excellent Moderate Impact 4 Very Good 5 Good 6 Satisfactory Low Impact 7 Fair 8 Marginal 9 Poor Weaknesses 71 71

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. Funding lists currently demarcate a pay limit based on percentile or priority score, e.g., through 147, but now it will be through, say, 45. 72 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

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 74

End of Review Summary 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
Second Level of Review 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.

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)

Competitive Renewal (for some mechanisms – not K99/R00)
Post-Award Yearly Progress Reports Competitive Renewal (for some mechanisms – not K99/R00) Fame and Fortune

Summary of NIH Grant Process
Initiates Research Idea and Prepares Application INVESTIGATOR GRANTEE THE NATIONAL INSTITUTES OF HEALTH Submits 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

Grantsmanship or How to swim with the sharks and survive!

Setting the Stage…. Important Considerations Before Starting….

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 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 Applications
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!
Receipt and Referral Review criteria Scoring 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, not what you want to tell them
Significance Investigators Innovation Approach Environment Further criteria are always added by the reviewers!

Review Criteria Receiving Scores
Overall Impact/Priority 5 Core Review Criteria: Significance Investigator(s) Innovation Approach Environment

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 necessary but not sufficient

Important Point to Remember
There is an art to writing applications! SCIENCE SALESMANSHIP COMMUNICATION SKILLS

Grantsmanship: Sell 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 Selling
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 Comparison
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 Guidelines
Page limitations Specific Aims 1 Page Research Strategy R03/R21 6 pages R01/R15 12 pages Biographical Sketch 4 Pages

Research Plan Comparison
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: Preparing an NIH Application
Title Abstract (200 words) Specific Aims Page Research Strategy Significance Innovation Approach Preliminary studies/Progress Report

Specific 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 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)
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 (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. 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 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 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 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: 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 Methods
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 Methods
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 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 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 Results Suggestions
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.

Resources 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 Issues Attention to details Topic specific jargon
Layout and format

Common Problems with Applications
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

Summary 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 NIH

Thank you. QUESTIONS / INFORMATION
Janice B Allen, PhD

Janice Benson Allen, PhD Scientific Review Officer

Similar presentations

Presentation on theme: "Janice Benson Allen, PhD Scientific Review Officer"— Presentation transcript:

Similar presentations

About project

Feedback

Log in

Auth with social network:

Janice Benson Allen, PhD Scientific Review Officer

Similar presentations

Presentation on theme: "Janice Benson Allen, PhD Scientific Review Officer"— Presentation transcript:

Similar presentations

About project

Feedback