Required Education in the Protection of
Human Subjects
- SUBJECT: Correction
to Documentation Procedures
The letter will need to be signed
by Grants and Contracts rather than the Office of Education.
When NIH (or entities awarding subawards under NIH
grants) requests this letter for key personnel, please:
- prepare the letter
with signature blocks for the principal investigator
and Jennifer Silverthorne, Manager, PreAward, Grants
and Contracts, include the information requested
in the September 14 NIH e-mail - see samples (sample
1and sample
2);
- obtain signature of
the principal investigator;
- forward the letter to
Grants and Contracts for institutional endorsement; Grants
and Contracts will verify completion of training prior
to signature.
The following is the
NIH announcement of September 14, 2000:
This is to clarify the
June 5, 2000 NIH Guide announcement* on Required Education
in the Protection of Human Research Participants. The
NIH has received a large number of inquires regarding
the recent announcement requiring investigators to document
their education in the protection of human subjects.
This notice is intended to clarify two issues: (1) what
constitutes documentation and (2) when documentation
should be submitted to the NIH.
With respect to the type
of documentation, the NIH requires a letter that includes
the names of the key personnel who are responsible for
the design and conduct of the study; the title of the
education program completed by each named personnel
plus a one sentence description of the program. This
letter must be signed by the principal investigator
and co-signed by an institution official.
The timing of submission
of documentation is in keeping with just-in-time procedures.
Thus, the NIH will request this letter documenting education
before an award is issued.
*June 5, 2000 NIH Guide
original announcement is at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html
For more information,
NIH's Frequently Asked Questions are at: http://grants.nih.gov/grants/policy/hs_educ_faq.htm
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