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University of Colorado Denver

Office of Grants and Contracts

Required Education in the Protection of Human Subjects

Office of Grants and Contracts


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:

  1. 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 letter 1 (DOC) and sample letter 2 (DOC);
  2. obtain signature of the principal investigator;
  3. 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:

For more information, NIH's Frequently Asked Questions are at:

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