Glossary

2 A B C D E F G H I K M N O P R S T U X

Institutional Review Board

An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the organization with which it is affiliated.

A

A1 application

The A1 suffix is typically seen as part of an application identification number or grant number and "A1" is often used to refer to a new, renewal, or revision application that is amended and resubmitted after the review of a previous application with the same project number.

B

Bridge Awards

Bridge awards provide continued but limited interim support (bridge funding) for meritorious investigators who just miss the funding cutoff and have minimal support from other sources. The continued funding will permit the PD/PI additional time to strengthen a resubmission application. A Bridge award recipient usually will receive an R56 award for a single year. Investigators may not apply for R56 grants. Applications for conversion to an R56 will be selected by IC staff from reviewed applications that fall at or near the payline margins.

C

Competing Applications

Competing applications are applications for a new, renewal, or resubmission research project grants(RPG), including R01s, R21s, and related mechanisms, that require competitive peer review

Competitive Revision

A request for (or the award of) additional funds during a current project period to support new or additional activities which are not identified in the current award that reflect an expansion of the scope of the grant-approved activities. Competitive revisions require peer review.

Council Round

At the NIH, there are at least three, and sometimes four, council rounds each fiscal year: October, January, May, and sometimes August. Application receipt dates, initial review dates, and council review dates all fall within one of these council rounds.

D

Data and Safety Monitoring Board (DSMB)

A formal, independent board of experts including investigators and biostatisticians that advise study investigators regarding the safety progression of a study. In general, NIH requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risk to the participants and for all Phase III clinical trials. As necessary, a DSMB may be appropriate for Phase I and Phase II or other clinical trials if the studies are blinded (masked), employ high-risk interventions, or involve vulnerable populations.

Direct Costs

Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. (See NIH Grants Policy Statement 7.3 Direct Costs and Facilities and Administrative Costs)

G

Grant Number

Sample Grant Number 1 R01 AI 183723 -01 A1 S1

Grants Management Officer (GMO)

An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition.

H

High Risk/High Impact (HR/HI)

A category of applications identified by a scientific review group as having a high degree of uncertainty in approach but also a high potential for impact. NIH tracks how many of these applications are identified and funded.

I

IDeA

Institutional Development Awards (IDeA) enhance biomedical and behavioral research in specific geographic areas.

Impact Score

The impact score is the rating which is assigned to an individual application by an SRG, and designates the reviewers' assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of established review criteria. The impact score is one mechanism by which the SRG makes a recommendation to the funding component concerning the application's scientific and technical merit. Impact scores may be numeric (10 – 90) or alphabetical (ND, for example).

Independent Clinical Trial

An independent clinical trial is one for which the researcher proposing the study has primary or lead responsibility for conducting and executing the trial. NIH policy permits individual career development awardees and individuals appointed to institutional career development awards to be involved in a range of clinical trial activities, including leading independent clinical trials. For NRSA trainees or fellows, however, NIH policy precludes leading an independent clinical trial as part of their training experience. Instead, NRSA trainees and fellows interested in clinical trials may gain clinical trial research experience by working on a trial led by their mentor or another investigator.

Institute or Center (IC)

The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC" or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.

Acronym Full Name Organizational Code
CC Clinical Center CC
CSR Center for Scientific Review RG
CIT Center for Information Technology CIT
FIC John E. Fogarty International Center TW
NCATS National Center for Advancing Translational Sciences (NCATS) TR
NCCIH National Center for Complementary and Integrative Health AT
NCI National Cancer Institute CA
NCRR National Center for Research Resources (dissolved 12/2011) RR
NEI National Eye Institute EY
NHGRI National Human Genome Research Institute HG
NHLBI National Heart, Lung, and Blood Institute HL
NIA National Institute on Aging AG
NIAAA National Institute on Alcohol Abuse and Alcoholism AA
NIAID National Institute of Allergy and Infectious Diseases AI
NIAMS National Institute of Arthritis and Musculoskeletal and Skin Diseases AR
NIBIB National Institute of Biomedical Imaging and Bioengineering EB
NICHD Eunice Kennedy Shriver National Institute of Child Health and Human Development HD
NIDA National Institute on Drug Abuse DA
NIDCD National Institute on Deafness and Other Communication Disorders DC
NIDCR National Institute of Dental and Craniofacial Research DE
NIDDK National Institute of Diabetes and Digestive and Kidney Diseases DK
NIEHS National Institute of Environmental Health Sciences ES
NIGMS National Institute of General Medical Sciences GM
NIMH National Institute of Mental Health MH
NIMHD National Institute on Minority Health and Health Disparities MD
NINDS National Institute of Neurological Disorders and Stroke NS
NINR National Institute of Nursing Research NR
NLM National Library of Medicine LM
OD Office of the Director OD

Institutional Review Board

An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the organization with which it is affiliated.

IRG

Integrated Review Group

N

NRFC

An application may be designated Not Recommended for Further Consideration (NRFC) by the Scientific Review Group if it lacks significant and substantial merit; presents serious ethical problems in the protection of human subjects from research risks; or presents serious ethical problems in the use of vertebrate animals, biohazards, and/or select agents. Applications designated as NRFC do not proceed to the second level of peer review (National Advisory Council/Board) because they cannot be funded.

O

Office of Research Integrity

(ORI) - HHS office promoting integrity in biomedical and behavioral research supported by the Public Health Service by monitoring institutional investigations of scientific misconduct and facilitating the responsible conduct of research.

P

Payline

The percentile rank is based on a ranking of the impact scores assigned by a peer review committee. The percentile payline is a conservative cutoff point for funding applications.

Peer Review

The process that involves the consistent application of standards and procedures that produce fair, equitable, and objective examinations of applications based on an evaluation of scientific or technical merit or other relevant aspects of the application. The review is performed by experts (Peer Reviewers) in the field of endeavor for which support is requested. Peer review is intended to provide guidance and recommendations to the NIH individuals responsible for making award decisions.

Peer Review Criteria

The reviewers judge the overall impact for the project to exert a sustained, powerful influence on the research field(s) based on five criteria: Significance, Investigator(s), Innovation, Approach, and Environment.

Phase IIB Competing Renewal

An application requiring competitive peer review and Institute/Center action to continue beyond the SBIR/STTR Phase II award.

Program Announcement

A PA is a formal statement about a new or ongoing extramural activity or program. It may serve as a reminder of continuing interest in a research area, describe modification in an activity or program, and/or invite applications for grant support. Most applications in response to PAs may be submitted to a standing submission date and are reviewed with all other applications received at that time using standard peer review processes. NIH may also make funds available through PARs (PAs with special receipt, referral, and/or review considerations) and PASs (PAs with set-aside funds).

PAs may be used for any support mechanism other than construction awards. Unless otherwise specified in the PA, new applications (and associated renewal and revision applications) submitted in response to PAs are treated as investigator-initiated. PAs also are used to annually solicit applications for the SBIR and STTR programs. Those applications must be received by the dates specified in the PA.

Program Announcements (PA) are published in the NIH Guide for Grants and Contracts. Go to Program Announcements. Learn more about types of funding opportunity announcements.

R

Renewal Application

An application requesting additional funding for a period subsequent to that provided by a current award. Renewal applications compete for funds with all other peer reviewed applications.

Review Committee

The terms Study Section and Review Committee are normally used for continuing Scientific Review Groups in the Center for Scientific Review or NIH Institute, respectively. These are groups with members who have been appointed for multi-year terms of service; at any given meeting there are also usually a number of temporary members present to provide the expertise needed to review the applications.

Review Cycle

Refers to the Center for Scientific Review's thrice yearly initial peer review cycle, from the receipt of applications to the date of the review. See Standard Receipt Dates

S

Scientific Review Group

A peer review committee group of primarily non-government experts (peer reviewers), qualified by training or experience in particular scientific or technical fields, or as authorities knowledgeable in the various disciplines and fields related to the applications under review, to evaluate and give expert advice on the scientific and technical merit of the applications. No more than one-fourth of the members of any SRG may be Federal employees, as noted in 42 CFR 52(h).

Scored Review Criteria

For research grant applications, and most other types of applications, reviewers judge the overall impact to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, taking into account five criteria, among other pertinent factors: Significance, Investigator(s), Innovation, Approach, and Environment. These scored review criteria may not be applicable for some types of applications. When these criteria are not applicable, the FOA will include the specific review criteria. Reviewers will consider each of the five criteria in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have a major scientific impact. See Peer Review Process/Scoring for additional information.

Special Emphasis Panel (SEP)

Scientific Review Groups formed on an ad hoc basis to review applications requiring special expertise or when a conflict of interest situation occurs.Scientific Review Groups formed on an ad hoc basis to review applications requiring special expertise or when a conflict of interest situation occurs.

Streamlined Review

In the peer review process, applications not considered by the Scientific Review Group to be in the more meritorious half are 'streamlined' and designated Not Discussed. Streamlined applications are not discussed at the review meeting and will not be assigned a numerical overall impact/priority score, but the applicants do receive the reviewers' critiques. Streamlined applications will receive criterion scores from the assigned reviewers in addition to the reviewers' critiques to help applicants assess whether or not they should submit a resubmission application.

Success Rate Base

The basis for computing the Research Project Grant (RPG) success rate. It includes the total number of competing applications reviewed (the number of applications subjected to a streamlined review process).

Summary Statement

A combination of the reviewers' written comments and summary of the members' discussion during the study section meeting. It includes the recommendations of the study section, a recommended budget, and administrative notes of special considerations.

X

xTrain

xTrain provides program directors/principal investigators, university administrators, and trainees the ability to electronically prepare and submit PHS 2271 Statement of Appointment forms and PHS 416-7 Termination Notices associated with institutional research training grants, institutional career development awards, individual fellowships and research education awards.