1

NIH Clinical Center,CTSAsNIH Molecular

Libraries Initiative

Disease Target

IDAssay Dev.

HTSProbe

to Lead

Pre-Clinical

FDA IND

Ph. I Ph. II Ph. IIIFDA

Review

NIH

RA

ID

NIH

T

RN

D

New NIH FDA Partnerships

CAN Provides a Framework for IntegrationAnd for Process Engineering

Cures Acceleration Network

2

Predoctoral Individual NRSA (F31)Predoctoral Individual MD/PhD NRSA

(F30)

Postdoctoral Institutional Training Grant (T32)

Postdoctoral Individual NRSA (F32)

Small Grant (R03)

Research Project Grant (R01)

Independent Scientist Award (K02)

Senior Scientist Award (K05)

Approx. Stage of ResearchTraining and Development Mechanism of Support

GRADUATE/MEDICALSTUDENT

POSTDOCTORAL

EARLY

MIDDLE

SENIOR

CA

RE

ER

Predoctoral Institutional Training Grant (T32)

NIH Pathway to Independence (PI) Award (K99/R00)Mentored Research Scientist Development Award (K01)Mentored Clinical Scientist Development Award (K08)Mentored Patient-Oriented RCDA (K23)Mentored Quantitative RCDA (K25)

Midcareer Investigator Award in Patient-Oriented Research (K24) Exploratory/

Development Grant (R21)

NIH Offers Funding Programs to Support Scientists at Every Stage of Their Career

*Graph represents a small sample of NIH funding mechanisms available.

3

• NIH Director’s ARRA Funded Pathfinder Award to Promote Diversity – Supports investigators who intend to pursue new research directions

related to workforce diversity– Total funding ~ Up to $2M total costs over 3 year period

• New Innovator Award– Supports small number of exceptionally creative new investigators– Provides up to $300,000 in direct costs

• Transformative R01– Common Fund initiative for exceptionally innovative, high risk, original

and/or unconventional research projects– Supports both individuals and collaborative investigative teams– Total funding ~ Up to $25 million total costs for 5 year period

• NIH Director’s Pioneer Award– Supports exceptionally creative individual scientists– Total funding ~ $5 million for 5 year period

Opportunities for Tomorrow:Investing in Innovative Researchers

4

EARLY STAGE & NEW INVESTIGATORS

NIH fosters research independence of early career investigators.

5

NEW DIRECTIONS IN PEER REVIEW

6

Enhancing Peer Review

A Self-Study by the NIH in Partnership with the Scientific Community to Strengthen Peer Review in Changing Times

Keeping the Goal in Mind:

“Fund the Best Science, by the Best Scientists, with the Least Administrative Burden.”

Former NIH Director, Dr. Elias A. Zerhouni

7

Summary of Recommendations

More at: http://enhancing-peer-review.nih.gov

8

Enhancing Peer Review at NIH: Timeline

January 2009

May/June 2009

January 2010 Submissions

ChangesSO FAR

• Phase out of A2 applications• Identification of Early Stage Inv. applications

• Enhanced review criteria• New scoring system• Criterion scoring• Structured critiques• Clustering of New Inv. Applications• Score order review

ChangesNOW

• Alignment of applications & review criteria• Shorter Research Plans

9

Executive Order 13505 Removing Barriers to Responsible Research Involving Human Stem

Cells - March 9, 2009

Human Embryonic Stem Cells

10

NIH Guidelines for Human Stem Cell Research

Effective July 7, 2009 • Establish criteria for NIH review of Human Embryonic Stem Cells (hESCs) to be

included in new Registry as eligible for use in NIH funding

• All hESCs must be:• Derived from embryos created by IVF for reproductive

purposes and no longer needed for that purpose• Donated by individuals who sought reproductive treatment and who

gave voluntary written consent for human embryos to be used for research purposes

• Centralize processes and procedures for NIH reviews of hESCs

• 64 lines now approved on the Registry including H7 & H9

• Applicants will cite hESCs from the Registry in grant applications

• NOT-OD-10-056 - Review Considerations for Applications and Awards under the New NIH Guidelines for Human Stem Cell Research

• NOT-OD-10-063 - Status of Certain Human Embryonic Stem Cell Lines http://hescregapp.od.nih.gov/comments/FR_Notice_2-23-2010.pdf

More at: http://stemcells.nih.gov

11

Financial Conflict of Interest(FCOI)

12

Federal Regulation on Financial Conflict of Interest (FCOI)

42 CFR Part 50, Subpart F

Purpose: The regulation promotes objectivity by NIH-

funded research by ensuring that the research is not biased by an Investigator’s conflicting financial interests.

Who is Responsible? Investigator Responsible for complying with

his/her Institution’s policies and procedures and for disclosing the necessary financial information.

Institution Responsible for compliance including developing, maintaining, and communicating a written and enforced FCOI plan.

NIH As the grantor agency, NIH has primary is responsible for oversight and compliance by reviewing all Institutional reports of FCOI.

13

Major Areas Addressed in the NPRM

• Significant Financial Interest (SFI)• Investigator Disclosure • Reporting to PHS Awarding Component

(NIH)• Public Notice• Scope • Investigator Training

14

Future Challenges for NIH

• Translation of Basic Science• Scientific Workforce• Emerging Technologies and Data Needs• Ethical and Social Implications of Research • Economic Impact of Research• Academic/Biomedical Industry Relationships• Post-ARRA Funding Issues• Accountability and Transparency – making the case

1515

NIH encourages applicants to describe their research in terms that are easily understood by:

u Congress u Public u Scientists u Administrators u Peer Reviewers ____________________________________

Titles, abstracts and statements of public health relevance should:

• Convey the value of the research in plain language – clear, succinct, and professional

• Be comprehensible to both scientists and the public• Relay the potential impact of the research on health

This information on funded grant applications is publicly available on NIH’s RePORTER Web Site at http://ProjectRePORTER.NIH.gov.

Communicating Research Intent