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NIDCR Clinical Terms of Award (CToA) Policy

Guidance for grantees about conducting research involving human subjects.

Final

Issued by: National Institutes of Health (NIH)

Issue Date: January 01, 2020

NIDCR Clinical Terms of Award

1. Introduction

The National Institute of Dental and Craniofacial Research (NIDCR) Clinical Terms of Award (CToA) policy applies to all grants and cooperative agreements conducting human subjects research that have been determined by NIDCR to need additional oversight (as defined in Section 2). The NIH defines clinical research as research with human subjects that is:

  • patient-oriented research: research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects
  • epidemiological and behavioral studies
  • outcomes research and health services research. 1

The NIDCR clinical research portfolio includes interventional clinical trials, observational studies, and studies involving analysis of existing data or specimens. The level of oversight for each study varies depending on the risk to human subjects and the complexity of the study. The NIDCR CToA policy helps to ensure that studies supported by NIDCR are well designed, conducted with rigor, monitored at a level commensurate with risk and complexity, and that the Institute is kept informed of study progress through reporting.

Recipients must comply with the CToA policy, which will be incorporated into the Notice of Award (NoA) and applies throughout the course of the research. For studies subject to the NIDCR CToA policy, NIDCR will request specified study documentation that is not included or fully developed in the application, and compliance with certain start-up activities prior to starting human subjects research. In addition, to ensure that standards of Good Clinical Practice (GCP) are followed while the study is ongoing, NIDCR may request further study documentation and compliance with oversight activities.

The CToA policy outlined here is in addition to and not in lieu of other federal regulations regarding human subjects research. Please see the Department of Health and Human Services (DHHS) regulations (45 CFR 46).

See also other applicable NIH and NIDCR policies and guidelines and federal regulations regarding grant administration:

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