REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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