Letter to NIH Regarding Investigators' Education
on the Protection of Human Subjects
NIH now requires, for each research proposal involving human subjects, that the Principle Investigator prepare, and that a university official countersign, a letter attesting to the education the Principle Investigator and all "key personnel" involved in the proposed research have had regarding the ethical conduct of human subjects research.
The NIH GUIDE Notice of June 5, 2000 requires this letter accompany the following submittals to NIH :
- J-I-T responses on IRB review for all competitive proposals submitted after 10/1/00 (Please note that it need not be attached to a grant proposal at the time of original submission, but only at the time that the certification of IRB review is submitted),
- all noncompeting proposal which involve human subjects research submitted after 10/1/00,
- all annual reports for R&D contracts which involve human subjects research submitted after 10/1/00.
Attached is a recommended form for this letter. The Principle Investigator should complete this letter on letterhead and sign it, and attach it to each of the documents in the list above, so VCU's authorized official can sign it as the document flows through OSPA.
There is an NIH FAQ on this subject.
Please click here to download a copy of this letter.
|
