Glossary

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C

Credential Field

Credential is a field on Grants.gov's R&R Senior/Key Person Profile form which is part of every competing grant application submitted through Grants.gov to NIH. Including the eRA Commons ID for the PD/PI, any multi-PD/PIs and Project Leads (for multi-project application components) is an NIH requirement and is critical to our ability to post errors, warnings and the assembled application image in eRA Commons. The credential field is not marked required on the federal-wide form since not all agencies that use the form need this field. NIH uses the Health and Human Services logo within the application guide to flag agency-specific instructions and clarifications for fields on federal-wide forms. Pay special attention to the HHS logo or you may miss key NIH requirements.

D

Data and Safety Monitoring Plan

Prior to award, this plan must be approved by the applicant’s IRB and the NIH awarding IC prior to the accrual of human subjects. The reporting of Adverse Events must be reported to the IRB, the DSMB (if applicable) or other monitoring entity, the NIH funding Institute or Center, and other required entities. This policy requirement is in addition to any monitoring requirements imposed by 45 CFR part 46.

Debarment and Suspension

The actions taken by a debarring official in accordance with OMB guidance at 2 CFR 180, "Non-procurement Debarment and Suspension," as implemented by HHS in 2 CFR 376, to exclude a person or organization from participating in grants and other non-procurement awards government-wide. If debarred or suspended, the person or organization may not receive financial assistance (under a grant, cooperative agreement, or subaward, or contract under a grant) for a specified period of time. Debarments and suspensions carried out pursuant to 2 CFR 376 are distinct from post-award suspension action by an awarding agency. (See NIH Grants Policy Statement: 4 Public Policy Requirements, Objectives and Other Appropriation Mandates 4.1.6 Debarment and Suspension).

Department of Health and Human Services (HHS)

Federal Executive Department of which the U.S. Public Health Service (PHS) is a component and the NIH is an agency of the PHS. Go to HHS.Previously DHHS.

Departmental Grants Appeals Board

The independent office established in the Office of the Secretary with delegated authority from the Secretary to review and decide certain disputes between recipients of HHS funds and HHS awarding agencies under 45 CFR Part 16 and to perform other review, adjudication and mediation services as assigned.

F

Federal-Wide Assurance (FWA)

The Federal-Wide Assurance is the only type of new assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance.

G

Grant Appeals

A DHHS policy providing for an appeal by the grantee institution of post award administrative decisions made by awarding offices. The two levels of appeal are an informal NIH procedure and a formal DHHS procedure. The grantee must first exhaust the informal procedures before appealing to the DHHS Appeals Board. (See Grant Appeals Procedures in the NIHGPS.)

H

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

The Privacy Rule is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information. It is administered and enforced by the Office for Civil Rights, HHS. Research organizations and researchers may or may not be covered by the HIPAA Privacy Rule. Decisions about applicability and implementation of the Privacy Rule reside with the researcher and the grantee organization. (See HIPAA Privacy Rule.)

HHSAR

Health and Human Services Acquisition Regulation

Human Subjects Assurance

A document filed by an institution conducting research on human subjects with the Office for Human Research Protections--HHS which formalizes its commitment to protect the human subjects prior to receiving any HHS grant funding.

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.

OHRP

Office for Human Research Protections - HHS office overseeing human subject protection for HHS-supported research.

ORIS

Office of Research Information Systems - Provides data and reporting support for grants processing for NIH and other agencies (HHS Operating Divisions and the Veterans’ Administration).

ORIS

Office of Research Information Systems - Provides data and reporting support for grants processing for NIH and other agencies (HHS Operating Divisions and the Veterans’ Administration).

P

Prior Approval

Written approval by an authorized HHS official, e.g., a designated IC GMO, evidencing prior consent before a recipient undertakes certain activities or incurs specific costs

R

Research & Development

All research activities, both basic and applied, and all development activities that are performed by HHS award recipients. The term research also includes activities involving the training of individuals in research techniques where such activities utilize the same facilities as other research and development activities and where such activities are not included in the instruction function. "Research" is defined as a systematic study directed toward fuller scientific knowledge or understanding of the subject studied. "Development" is the systematic use of knowledge and understanding gained from research directed toward the production of useful materials, devices, systems, or methods, including design and development of prototypes and processes.

S

Suspension of Award Activities

An action by the NIH awarding IC requiring the recipient to cease all activities on the award pending corrective action by the recipient. It is a separate action from suspension under HHS regulations (2 CFR 376) implementing Executive Orders 12549 and 12689. (See Public Policy Requirements and Objectives-Debarment and Suspension and Administrative Requirements-Enforcement Actions).

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Form Approved OMB# 0925-0648 Exp. Date 05/31/2021