Current Directions in NIEHS Extramural Programs J. Patrick Mastin, Ph.D. Chief, Cellular, Organs, and Systems Pathobiology Branch Division of Extramural.

Current Directions in NIEHS Current Directions in NIEHS Extramural ProgramsExtramural Programs

J. Patrick Mastin, Ph.D.J. Patrick Mastin, Ph.D.Chief, Cellular, Organs, and Systems Pathobiology BranchChief, Cellular, Organs, and Systems Pathobiology Branch

Division of Extramural Research & TrainingDivision of Extramural Research & TrainingNIEHSNIEHS

[email protected]

NIH Grants Process

NIEHS Strategic Plan (more tomorrow morning, 7:30)

New Investigators Pathway to Independence

(K99/R00) ONES Award NIH New Investigators Policy

Training / Career Development Funding Opportunities

OverviewOverview

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

What happens in the Black Box ?

NIH Grant Process

Funding Mechanisms Important Personnel Overview of NIH Grant Process

Submission Referral Review Award Post-award

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

Grant MechanismsGrant Mechanisms“R”: Research Project

R01R03 (Small Research Grants)R21 (Exploratory/Developmental Grants)R43 (Small Business Innovation Research Grants)

“P”: Multi-component projects

P01 (Program Projects)P30 & P50 (Center Grants)

“T”: Institutional Training

T32T35: Short-term Training

“F”: Fellowships F30 (MD/PhD)F31 (Diversity pre-doctoral)F32 (National Service Research Award)

“K”: Career Development

K99/R00 (Pathways to Independence Award)

Although there are many mechanisms, not all mechanisms are available at all Institutes under all

circumstances.

http://grants.nih.gov/grants/funding/ac.pdf

Important PersonnelImportant Personnel

PROGRAMADMINISTRATOR

GRANTSMANAGEMENT

SPECIALIST

SCIENTIFICREVIEW

ADMINISTRATOR

Important PersonnelImportant Personnel

Responsible for the programmatic, scientific and/or technical aspects of a grant

Program Administrator (PA)

Develop research programs

Provide guidance and assistance to applicants

Attend study section meetings

Communicate results of review

Make funding recommendations

Post-award administration

GRANTSMANAGEMENT

SPECIALIST

SCIENTIFICREVIEW

ADMINISTRATOR

PROGRAMADMINISTRATOR

Manages activities of a scientific review group

Important PersonnelImportant Personnel

Scientific Review Administrator (SRA)

Performs an initial administrative review of applications

Assembles study section panel and assigns applications to individual reviewers

Serves as the overall point of contact with applicants

Prepares Summary Statements

PROGRAMADMINISTRATOR

GRANTSMANAGEMENT

SPECIALIST

SCIENTIFICREVIEW

ADMINISTRATOR

Responsible for the business management aspects of grants

Important PersonnelImportant Personnel

Grants Management Specialist (GMS)

Evaluate grant applications for administrative content and compliance with statutes, regulations and guidelines

Negotiates grants

Provides consultation and technical assistance

Administers and closes out grants

PROGRAMADMINISTRATOR

GRANTSMANAGEMENT

SPECIALIST

SCIENTIFICREVIEW

ADMINISTRATOR

Note: There are 3 “Council Rounds” per year.

These correspond to the times when the institutes’ Advisory Councils meet.

• “September Council” (“October”)

• “January Council” (“February”)

• “May Council”

Overview of NIH Grant ProcessOverview of NIH Grant Process

Overview of NIH Grant ProcessOverview of NIH Grant Process

Review

Award

Post-award

SubmissionReceipt and ReferralReview

Award

SubmissionTypes of applications

SubmissionTypes of applications

Unsolicited“Investigator-Initiated”

Program Announcements (PA)Request for Applications (RFA)

SolicitedUsed when NIH wants to solicit

applicationsin a particular area or on a particular topic

or using a particular grant mechanism

Funding Opportunity Announcement (FOA)

Majority of applications, e.g., most R01s

All applications, even the “unsolicited” ones, have FOA numbers

SubmissionTypes of applications

SubmissionTypes of applications

To find out aboutFunding Opportunity

Announcements(FOA)

NIH Guide for Grants and Contractshttp://grants.nih.gov/grants/guide/index.html

What to submit: Application Forms

All applications must besubmitted on

PHS 398SF424

PastNow Most electronically

•http://era.nih.gov/ElectronicReceipt/

Electronic SubmissionElectronic Submissionhttp://era.nih.gov/ElectronicReceipt/

Electronic SubmissionElectronic Submissionhttp://era.nih.gov/ElectronicReceipt/

Electronic SubmissionElectronic Submissionhttp://era.nih.gov/ElectronicReceipt/

Recommendation

Contract an appropriate Program Administrator in an appropriate institute before submitting (and preferably before you finishing the writing) your application.

Overview of NIH Grant ProcessOverview of NIH Grant Process

Receipt and Referral

Review

Award

Post-award

Submission

Receipt and Referral

Receipt and Referral

Center for Scientific ReviewDivision of Receipt and Referral

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

Referral (assignments)1. To a review group (“study section”)2. To a funding agency (e.g., NIEHS,

NCI, etc.)

Note: You can request a certain institute for funding or a study section for review. Requests won’t always be honored.

Overview of NIH Grant ProcessOverview of NIH Grant Process

Referral

Review

Award

Post-award

Submission

ReviewReview

Study sections at the Institutions For special circumstances

e.g., RFAs & PAs (FOAs)

Center for Scientific Review Study Sections(n = lots)

Most applications reviewed here

ReviewReview

1. “Streamlined”: Lower half; “Unscored”2. Scored: 100 (best) to 500 (worst)3. “Not Recommended for Further

Consideration” (“nerfed”)

Applications are mailed to Reviewers (on CD)

Reviewers read and evaluate applications, and prepare written comments

Review meeting: Reviewers discuss applications individually and give them a rating

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.

ReviewReview

Overview of NIH Grant ProcessOverview of NIH Grant Process

Referral

Review

Award

Post-award

Submission

Funding ConsiderationsFunding Considerations

Recommendations for funding are based on

Summary Statement: Score and summary statement 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 not approved for funding, applicant can revise and resubmit (up to 2 more times).

Overview of NIH Grant ProcessOverview of NIH Grant Process

Referral

Review

Award

Post-award

Submission

Post-AwardPost-Award

Yearly Progress Reports

Competitive Renewal (for some mechanisms)

Fame and Fortune

NIEHS 2006-2011 Strategic Plan

New Frontiers in Environmental Sciences

and Human Health

The Plan, The Vision

• Input from the public and discussions at a Strategic Planning Forum resulted in development of three major Challenges and seven major Goals that are put forward in the Strategic Plan.

• These Challenges and Goals are in fulfillment of the NIEHS vision:

The NIEHS vision is to prevent disease and improve human health by using environmental sciences to understand human biology and human disease.

Goals

1. Expand the role of clinical research in environmental health sciences.

2. Use environmental toxicants to understand basic mechanisms in human biology.

3. Build integrated environmental health research programs to address the cross-cutting problems in human biology and human disease.

4. Improve and expand community-linked research.

Goals

5. Develop sensitive markers of environmental exposure, early (preclinical) biological response, and genetic susceptibility.

6. Recruit and train the next generation of environmental health scientists.

7. Foster the development of partnerships between the NIEHS and other NIH institutes, national and international research agencies, academia, industry, and community organizations to improve human health.

Recent Requests for ApplicationsRecent Requests for ApplicationsGene-Environment Initiatives (GEI)

DISCOVER: Disease Investigation through Specialized Clinically-Oriented Ventures in Environmental Research

Comparative Biology Elucidation of Environmental Pathways and Susceptibility

Manufactured Nanomaterials: Physico-chemical Principles of Biocompatibility and Toxicity

Institutional Patient-Oriented Career Development Programs in the Environmental Health Sciences

http://www.niehs.nih.gov/dert/announce.htm

http://grants2.nih.gov/grants/new_investigators/

New Investigators are identified in post-council funding discussions by program administrators at NIEHS, and are given preferential consideration. NIEHS has established the Outstanding New Environmental Health Scientist (ONES) award, a first time R01 grant for scientists in the early, formative stage (less than 8 years from the doctoral degree) of their career.

New Investigators are identified in post-council funding discussions by program administrators at NIEHS, and are given preferential consideration. NIEHS has established the Outstanding New Environmental Health Scientist (ONES) award, a first time R01 grant for scientists in the early, formative stage (less than 8 years from the doctoral degree) of their career.

Transition from post-doc to facultyTransition from post-doc to facultyK99/R00K99/R00

Outstanding New Environmental Scientist (ONES) Award

Outstanding New Environmental Scientist (ONES) Award

Outstanding New Outstanding New Environmental Scientists Environmental Scientists (ONES)(ONES)

Goals of the ONES Program: Identify outstanding scientists who are in

the early, formative stages of their careers and who intend to make a long term career commitment to research in the mission areas of the NIEHS

Assist them in launching an innovative research program focusing on problems of environmental exposures and human biology, human pathophysiology and human disease.

Provide R01 support Highly competitive review process Provide support for resource

development and career enhancement, separate from research funding Can be used for training, sabbaticals, etc. Can be used as for resource development:

equipment, staff, cohort development, etc.

Unique Features of ONES awards

Outstanding New Outstanding New Environmental Scientists Environmental Scientists (ONES)(ONES)

To be qualified, applicants Must be New Investigator: < 8 years

postdoctoral experience Must be Assistant, Research Assistant

Professor, or equivalent, and must show evidence of independent productivity and facilities

Must show a long-term commitment to Environmental Health Sciences research

Must show strong departmental and institutional support for their career development

ONES award would be first R01 Support

Outstanding New Outstanding New Environmental Scientists Environmental Scientists (ONES)(ONES)

2007 NIH Director's New Innovator 2007 NIH Director's New Innovator Award ProgramAward Program

New investigators who have not yet obtained an NIH R01 or similar grant

Must have received a doctoral degree or completed a medical internship and residency in 1997 or later

Up to $1.5 million in direct costs over five years Application period opens on April 25 and closes

on May 22, 2007 NIH expects to make at least 14 awards in

September 2007 http://grants.nih.gov/grants/new_investigators/

innovator_award/

Outstanding New Environmental Scientist Award (ONES) (Recurring RFA)

NIH Director's New Innovator Award Program (RM-07-009)

NIH Pathway to Independence (PI) Award (K99/R00) (PA-07-297)

Human Genes and the Environment Research Training Program (ES07-002) -- Application Receipt Date June 29, 2007

Short Term Educational Experiences for Research (STEER) in the Environmental Health Sciences for Undergraduates and High School Students (R25) (ES06-009)

Administrative Supplements to Support High School Student and College Undergraduate Research Experiences

Research Supplements to Promote Diversity in Health-Related Research (PA-05-015)

Current Training Funding OpportunitiesCurrent Training Funding Opportunities

http://www.niehs.nih.gov/dert/announce.htm

Current Directions in NIEHS Current Directions in NIEHS Extramural ProgramsExtramural Programs

J. Patrick Mastin, Ph.D.J. Patrick Mastin, Ph.D.Chief, Cellular, Organs, and Systems Pathobiology BranchChief, Cellular, Organs, and Systems Pathobiology Branch

Division of Extramural Research & TrainingDivision of Extramural Research & TrainingNIEHSNIEHS

[email protected]