The NIH Grant Review Process

Hiram Gilbert, Ph.D. Dept. of Biochemistry, Baylor College of Medicine

Xander Wehrens, M.D. Ph.D.Dept. of Molecular Physiology & Biophysics, and Medicine, BCM

Overview of This Presentation

• Introduction into NIH grant review process• Review criteria• NIH review cycles

• VIDEO of mock study section

• Recent changes at the NIH (application, scoring, revision, new investigator)

Review Process

• All applications are reviewed• But streamlined process:– Top applications: brief discussion– Bottom application: unscored (full critiques– Mid-range: 10-15 min discussion

• ‘Peer review’

Center for Scientific Review

• CSR handles review of NIH grant applications• Handles 55,000 – 70,000 grant applications /yr• Only 20-30% receive funding (recently <20%)

• Grants are reviewed by study sections

http://cms.csr.nih.gov/

CSR - Study Sections

• Study section clusters:

Study Section Description

http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescriptionNew/CVRSIRG/LIRR.htm

Roster of Study Section

Study Section

• Goal: to provide thorough and objective reviews of all applications

• Chair – guides discussion• SRO – scientific review officer, federal official,

provides orientation about NIH policies and regulations

• Up to 20-30 members

Conflict of Interest

• A reviewer shall not review an application if:• A reviewer has a professional, personal, or

financial interest in an application• If an application is submitted by the reviewer,

a relative, close friend, or a collaborator.• If the reviewer is listed on a budget page.

Confidentiality

• Everything associated with the review process and committee is confidential.

• Reviewers may not take home applications or unpublished papers.

• Applicants may not contact study section members to discuss critiques.

Review Criteria (1/5)

• Significance– Address important problem?– If aims achieved, how will scientific knowledge

advance?– Effects of proposed studies on concepts or

methods that drive field?

Review Criteria (2/5)

• Innovation– Novel concepts, approaches, methods?– Aims original and innovative?– Challenge paradigms or develop new methods?

Review Criteria (3/5)

• Approach– Conceptual framework, design, methods and

analyses adequately developed?– Well integrated and appropriate for aims?– Potential problem acknowledged?

Review Criteria (4/5)

• Investigator– Appropriately trained?– Work appropriate to experience level PI and

collaborators?

• Environment– Contribute to success– Take advantage to unique scientific environment

Review Criteria (5/5)

• Human and Vertebrate Animal Subjects– Compelling rationale for using humans/ animals?– Humans: adequacy protections against risk,

benefits of research for subjects and others?– Inclusion age groups, different ethnicities, etc.

MOVIE

[6:48 - 34:06]

Changes in Application Structure

• Restructured application forms, page limits.

Changes in Scoring System

• Old system 1.0 - 5.0 (only 41 discriminations)• New system 1.0 - 9.0• Not recommended for further consideration• Percentile ranking

Changes in Scoring System

http://enhancing-peer-review.nih.gov/scoring&reviewchanges.html

Changes in Revisions

• Beginning with original new and competing renewal applications submitted for the January 25, 2009 due dates and beyond, the NIH will accept only a single amendment (A1) to the original application.

• Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2).

Changes in Revisions

http://www.nhlbi.nih.gov/funding/policies/operguid.htm

Early Stage & New Investigator

• New investigator: PI who has not previously successfully competed for a significant NIH research award. Exempt: R00, R21, et al.

• 2009: Early Stage Investigator (ESI): New investigators who are <10 years from completing their terminal research degree or medical residency

Early Stage & New Investigator

Questions ?