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12/17/2001

NIH Formalizes Educational Requirements for Conducting Human Research

Kate Traynor

A National Institutes of Health (NIH) policy that went into effect for the 2001 fiscal year requires researchers to obtain formal training in protecting people who are the focus of NIH-funded research.

The educational requirement holds true for all research involving human subjects, including some projects that are exempt from judgment by an institutional review board. NIH, in compliance with the Code of Federal Regulations, defines a human subject as a "living individual" about whom a researcher obtains data or "identifiable private information."

Research involving stored tissue samples or data that cannot be traced to their original source is not considered by NIH to involve human subjects.

According to a list of frequently asked questions compiled by NIH, everyone involved in planning or conducting research that involves human subjects must complete an educational program. Documentation, in the form of a letter signed by an official of the organization obtaining funding, must be submitted to NIH as proof that the educational requirement has been met.

NIH noted that it will delay grant and contract awards and renewals until such documentation has been received. Training grants administered by NIH agencies already meet the institution’s requirements for conducting research on human subjects and are exempt from the general educational mandate.

An online training module from NIH meets its requirements for educating researchers about protecting human research subjects. The module, which NIH said takes about an hour to complete, can be used alone or as a supplement to an institution’s existing educational program.