# Presentation: 376461

## National Institutes of Health

**National Institute**
**on Alcohol Abuse**
**and Alcoholism**

**National Institute**
**of Arthritis and**
**Musculoskeletal**
**and Skin Diseases**

**National Cancer**
**Institute**

**National Institute**
**of Diabetes and**
**Digestive and**
**Kidney Diseases**

**National Institute**
**of Dental and**
**Craniofacial**
**Research**

**National Institute**
**on Drug Abuse**

**National Institute**
**of Environmental **
**Health Sciences**

**National Institute**
**on Aging**

**National Institute**
**of Child Health**
**and Human**
**Development**

**National Institute on**
**Deafness and Other**
**Communication**
**Disorders**

**National Eye**
**Institute**

**National Human**
**Genome Research**
**Institute**

**National Heart,**
**Lung, and Blood**
**Institute**

**National Institute**
**of Mental Health**

**National Institute**
**of Neurological**
**Disorders and**
**Stroke**

**National Institute**
**of General**
**Medical Sciences**

**National Institute**
**of Nursing Research**

**National Library**
**of Medicine**

**Center for **
**Information**
**Technology**

**Center for **
**Scientific Review**

**National Center**
**for Complementary**
**and Alternative**
**Medicine**

**National Institute**
**of Allergy and**
**Infectious Diseases**

**Fogarty**
**International**
**Center**

**National Center**
**for Research**
**Resources**

***National Institutes of Health***

** **
**Clinical Center**

**National Center on **
**Minority Health and**
**Health Disparities**

**National Institute of **
**Biomedical Imaging**
**and Bioengineering**

## A Typical Institute/Center

**Office of the IC**
**Director**

**National**
**Advisory**
**Council**

**Board of**
**Scientific**
**Counselors**

**Extramural**

**Scientific**
**Programs**

**Grants**

**Contracts**

**Intramural**

**Laboratory**
**Studies**

**Clinical**
**Studies**

## NIH Extramural Awards

**Grant****	****Patron**
**                   ****	****(assistance, encouragement)**
**Cooperative****	****Partner**
**Agreement****	****(assistance but substantial**
**                        ****	****program involvement)**
**Contract****	****Purchaser**
**                      ****	****(procurement)**

## NIH Funding in FY 2004: By MechanismTotal = $27B

## Program Announcement (PA)

**Invites grant applications in a given  research area**
**May describe new or expanded interest in a particular extramural program**
**May be a reminder of a continuing interest in a particular extramural program**
**Generally has no funds set aside**
**Applications reviewed in CSR along with unsolicited grant applications**

## Request for Applications (RFA)

**Invites grant applications in a defined research area for a one-time competition**
**Usually targets a perceived area of scientifically needed information for which the technology is available**
**Single receipt date designated**
**Specifies amount of funds set aside and expected number of awards**
**Applications reviewed by an Institute SEP**

## Request for Proposals (RFP)

**Invites contract proposals in a given  research area**
**Describes specific need(s) to be met by contractor and lists milestones for progress**
**Single receipt date designated**
**Projected costs are estimated and funds are set aside**
**Proposals are reviewed by Institute Contract Review Committee**

## Dual Review System for Grant Applications

***Dual Review System for Grant Applications***

**  ****Second Level of Review**
**    ****National Advisory Council**
**Assesses Quality of  SRG**
** ****Review of Grant Applications**
**Makes Recommendation to**
**Institute Staff on Funding**
** ****Evaluates Program Priorities**
** ****and Relevance**
** ****Advises on Policy**

**     ****First Level of Review**
**Scientific Review Group**
**Provides Initial Scientific Merit**
**Review of Grant Applications**
**Rates Applications and Makes       Recommendations for Appropriate Level of Support and Duration of Award**

## Types of Scientific Review GroupsWhere are Applications Reviewed?

**CSR IRGs**

**Study Sections**

**Special Emphasis Panels**

**  ****INSTITUTES**

**Scientific Review Groups**

**Contract Review Committees**

**APPLICATIONS REVIEWED**

**Research Projects**

**  ****Academic Research   **

**Enhancement Awards**

**Postdoctoral Fellowships**

**Small Business Innovation **

**Research**

**Shared Instrumentation**

**Program Projects**

**Centers**

**Institutional Training Grants**

**Conference Grants**

**Career Awards**

***Types of Scientific Review Groups******Where are Applications Reviewed?***

**Small Grants**

**RFAs**

**Contracts**

** **

## Center for Scientific  Review

**Serves as central receipt point for most PHS grant applications**
**Assigns applications to CSR Integrated Review Groups/Study Sections or Institute Scientific Review Groups**
**Assigns applications to NIH Institute(s) as potential funding component(s)**
**Conducts initial scientific merit review of most research applications submitted to the NIH in more than 100 Study Sections **

## Applications Submitted to NIH

**Over  60,000 grant applications are submitted to NIH each year, of which 25-30% are funded**
**Competing grant applications are received for three review cycles per year**

## Competing Applications Reviewed By:

**NOTE: Starting in FY93, NIDA, NIAAA, and NIMH are included in NIH totals**

## Applications are Assigned to:

**Scientific review groups based on:**
**Specific review guidelines for each scientific review group**
**Institutes based on:**
**Overall mission of the Institute**
**Specific programmatic mandates and interests of the Institute**

## Assignment to CSR Study Sections 

**Applications are assigned for review to**
**Standing Study Sections ****when the subject matter of the application matches the referral guidelines for the  study section**
**Ad Hoc Special Emphasis Panels (SEPs) ****when the subject matter does not fit into any study section, or when assignment of an application to the most appropriate study section would create a conflict of interest.  Also used for special mechanisms (e.g., fellowships, SBIRs, AREAS)**

## Peer Review in CSR Study Sections

**CSR Study Sections are managed by a Scientific Review Administrator (SRA) who is a professional, usually at the Ph.D. level, whose scientific background is close to the expertise of the study section**
**Each CSR standing study section has 12 - 24 members who are primarily from academia**
**As many as 60 - 100 applications are reviewed at each study section meeting**

## Scientific Review Administrator

**Performing administrative and technical review of applications to ensure completeness and accuracy**
**Selecting reviewers based on broad input**
**Managing study section meetings**
**Preparing summary statements**
**Providing any requested information about study section recommendations to Institutes and National Advisory Councils/Boards**

**Designated Federal official with overall **
**     ****responsibility for the review process, including:**

## Criteria For Selection of Peer Reviewers

**Demonstrated Scientific Expertise**
**Doctoral Degree or Equivalent**
**Mature Judgment **
**Work Effectively in a Group Context**
**Breadth of Perspective**
**Impartiality**
**Interest in Serving**
**Adequate Representation of Women and Minority Scientists**

## Certification of No Conflict of Interest

**This will certify that in the review of applications and proposals by **_**(study section**_**)**** on **_**(date)**_**, I did not participate in the evaluation of any grant or fellowship applications from (1) any organization, institution or university system in which a financial interest exists to myself, spouse, parent,child, or collaborating investigators; (2) any organization in which I serve as officer, director, trustee, employee or collaborating investigator; or (3) any organization which I am negotiating or have any arrangements concerning prospective employment or other such associations.**
**   ****__________________     __________________**
**   ****__________________     __________________**
**   ****__________________     __________________**
**   ****__________________     __________________**

**SIGNATURES**

## Confidentiality

**Review materials and proceedings of review meetings represent privileged information to be used only by consultants and NIH staff.**
**At the conclusion of each meeting, consultants will be asked to destroy or return all review-related material.**
**Consultants should not discuss review proceedings with anyone except the SRA.**
**Questions concerning review proceedings should be referred to the SRA.**

## Review of Research Grants

_**	**__**	**__**	**_
**REVIEW CRITERIA:**
**  ****Significance **
**  ****Approach**
**  ****Innovation**
**  ****Investigator**
**  ****Environment**
**  ****Overall Evaluation**

## Review Criteria (defined)

**Significance: ****Does the study address an important problem?  How will scientific knowledge be advanced?**
**Approach: ****Are design and methods well-developed and appropriate?  Are problem areas addressed?**
**Innovation: ****Are there novel concepts or approaches?  Are the aims original and innovative?**
**Investigator: ****Is the investigator appropriately trained?**
**Environment: ****Does the scientific environment contribute to the probability of success?  Are there unique features of the scientific environment?**

## Research Involving Human Subjects

**     ****Important Considerations**
**Is the proposed study exempt from human subject review?**
**Are there any apparent risks* to the human subjects?**
**Are the protections adequate?**
**What are the potential benefits to the subjects and to mankind?**
**Are the inclusions of minorities and both genders adequately addressed?**

***”Risks” include the possibility of physical, psychological,**
** ****or social injury resulting from research.**

## Common Problems in Applications

**Lack of new or original ideas**
**Absence of an acceptable scientific rationale**
**Lack of experience in the essential methodology**
**Questionable reasoning in experimental approach**
**Uncritical approach**
**Diffuse, superficial, or unfocused research plan**
**Lack of sufficient experimental detail**
**Lack of knowledge of published relevant work**
**Unrealistically large amount of work**
**Uncertainty concerning future directions**

## Scientific Review Group or Study Section Actions

**Scored, Scientific Merit Rating (priority scores and percentiles)**
**Unscored (lower half; Streamlined)**
**Deferral**

## Action

**Scored - Scientific Merit Rating 1.0 to ****	****   approximately 3.0**
**Based on the relevant review criteria,  the application is judged to be in the upper half of applications reviewed by the study section or scientific review group.  The recommendation can be for the requested time and amount or for an adjusted time and amount.  A priority score is provided, and a summary statement prepared that incorporates the written critiques plus a resume and summary of the discussion.**

## Action

**Unscored**
**Application is unanimously judged to be in the lower half of applications reviewed by the study section or scientific review group.  No priority score is assigned.  The summary statement provided to the applicant is a compilation of reviewers’ comments prepared prior to the meeting.**

## Calculation of Percentiles

**Based on the priority score, the percentile is the rank of an application relative to others reviewed over three cycles. It indicates the percentage of applications with better priority scores.**
**Percentile = (**_**relative rank – 0.5)**_**  x 100**
**                         ****# of applications**
**__________**
**For Special Emphasis Panels, the percentile values are intercalated on a table of all-CSR review**

## Summary Statement

**Once applications have been reviewed, the results are documented by the SRA in a summary statement and released to the NIH Commons (available to Institutes and applicants)**
**The summary statement contains:****	**
**Resume and Summary of Discussion**
**Minimally-edited Critiques**
**Priority Score and Percentile Ranking**
**Budget Recommendations**
**Administrative Notes**

## Dual Review System for Grant Applications

***Dual Review System for Grant Applications***

**  ****Second Level of Review**
**    ****National Advisory Council**
**Assesses Quality of  SRG**
** ****Review of Grant Applications**
**Makes Recommendation to**
**Institute Staff on Funding**
** ****Evaluates Program Priorities**
** ****and Relevance**
** ****Advises on Policy**

**     ****First Level of Review**
**Scientific Review Group**
**Provides Initial Scientific Merit**
**Review of Grant Applications**
**Rates Applications and Makes       Recommendations for Appropriate Level of Support and Duration of Award**

## Extramural Program Mission

**Identify scientific opportunities**

**Foster the best **
**science**

**Ensure proper stewardship**

**Promote effective communication**

**Manage a portfolio of investments to**
**improve health through science**

## Council Actions

**Concurrence with study section action**
**Modification of study section action**
**Deferral for re-review**

## What Determines Which Awards Are Made?

**Scientific merit**
**Program considerations**
**Availability of funds**