Education on the protection of human subjects
Human Subject is required for any individual who will be involved in the conduct of NIH-supported human subjects research. OER has provided a Frequently Asked Questions document to help you determine whether this requirement applies to you and your co-investigators.
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction
any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102
and full 45 CFR 46
or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.
Your budget office must submit documentation that all personnel involved in the human subjects research have completed research training before ANY subjects can be enrolled in your study (and before your grant
Grant will be funded). Many institutions have a training program for research personnel conducting research at their institution. The NIH also provides a tutorial that satisfies this requirement called Protecting Human Research Participants . Upon course completion, a certificate can be printed for inclusion in your grant file.
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH
National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers
that conduct and support biomedical and behavioral research. NIH Homepage
Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.
Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov