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Who needs human subjects protection training?

Education on the protection of human subjects 

Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction 
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.
is required for any individual who will be involved in the conduct of NIH-supported human subjects research. OER 
Office of Extramural Research (OER)
a NIH office that supports extramural research by providing policy and guidance to the NIH ICs that award grants and assisting investigators through the process of attaining grants funding and helping them understand and navigate through federal policies and procedures. OER Homepage
has provided a Frequently Asked Questions document to help you determine whether this requirement applies to you and your co-investigators.

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
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.
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.



Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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