Release Date:  September 5, 2001

NOTICE:  NOT-OD-01-061  

Update: The following update relating to this announcement has been issued:

September 24, 2010 - See Notice NOT-OD-10-139 Spanish On-line Tutorial on Human Research Participants Protections Launched by NIH Office of Extramural Research. (Also see Notice NOT-OD-08-054) National Institutes of Health Policy: Beginning on October 1, 2000, NIH implemented a policy requiring education on the protection of human research participants for all key personnel submitting NIH applications for grants or proposals for contracts or receiving new or non-competing awards for projects involving human research participants (see June 5, 2000 NIH Guide Notice). Before funds are awarded for applications or contract proposals involving human subjects, documentation must be submitted that all key personnel have received training in the protection of human subjects. In a follow-up to the June 5, 2000 Guide Notice, it was announced that the letter documenting completion of the education required signatures of both the official authorized to represent the applicant institution and the principal investigator. In an effort to streamline the submission of the required documentation, NIH staff will now accept a letter signed by the official authorized to represent the institution. It is not required that the principal investigator also sign the letter. The letter should continue to be submitted in accordance with Just-in-Time procedures. The education requirement also applies to key personnel at consortium institutions or performance sites if they are participating in research that involves human subjects. If the grantee organization is having difficulty obtaining this documentation, NIH staff may consider issuing awards that restrict the third party participation until the documentation has been received. This will streamline issuing awards in situations where the third party participation is not essential to the start of the project.

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