grant-admin-arch: Grant-Admin-News: NIH Training Requirement for Human Subjects Research

[Research Services <Research_Services@orsa.uoregon.edu>]

The National Institutes of Health has implemented a new training policy for
researchers with human subjects effective October 1, 2000.  For applications
submitted to NIH on or after 10/1/00, and for new or continuation awards
funded in FY 2001 beginning October 1, principal investigators and their key
personnel must complete and certify training for protection of human
subjects in research.  A letter with details on this new requirement has
been sent by the UO Human Subjects Compliance office to UO PIs and key
personnel on NIH projects with human subjects.  Following is a summary of
the requirement and instructions for preparing applications.

Before an award will be made by NIH on FY 01 funds, certification of
training by key personnel is required in a signed cover letter from the PI.
Since most new NIH awards are under the "just-in-time" process, NIH will
request final documentation just before the award is issued, including the
letter of certification.  The just-in-time period for the next new award
cycle (project start dates of December 1 or after) begins in September, so
there is some urgency for training personnel on these awards.    Awards for
non-competing continuation applications  (includes SNAP applications) will
not be issued until this certification is submitted to NIH, as well.

Applications submitted on or after October 1 for new grants or contracts,
and non-competing continuation applications or annual reports on contracts,
must include a description of the training completed or to be completed
prior to award.  Be sure to include training for any new key personnel added
during the project.  Below are instructions on where this information should
be located in the application.  


INSTRUCTIONS FOR DOCUMENTING TRAINING TO NIH:

Both the just-in-time cover letter for awards and all new or non-competing
continuation applications with human subjects should indicate that "the
training completed at the University of Oregon is the NIH Protection of
Human Subjects: Computer-Based Training Program" and the date the training
was completed or will be completed by each key personnel.  It is the
responsibility of the PI to verify all key personnel listed on a proposal or
progress report have completed the training.   

DOCUMENTATION OF TRAINING IN APPLICATIONS: 

1.  New or renewal proposals (PHS 398):  the statement should be included in
the Research Plan (Item 9e.).  
2.  Continuations (PHS 2590 - includes SNAP): include the statement in the
Progress Report Summary (Item 6d).
3.  Individual fellowships (NRSA):  the statement should be included in
Research Training Plan (Form Page 6-FF) of the Individual National Research
Service Award (PHS 416-1).
4.  Fellowship continuations (PHS 416-9):  the statement should be indicated
in the Research Training Plan section. 

For questions concerning the training, contact the UO Human Subjects
Compliance office at 6-3106 or see the training module on the web at
http://darkwing.uoregon.edu/~humansub/NIH_Certification.html.  For questions
on preparing applications or certifying training for just-in-time awards,
contact ORSA at 6-5131.  


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