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NIH Training Requirements

NIH requirement: All NIH investigators who receive funding, including new awardees, and those who receive continuing or competing renewals for projects involving human subjects, must provide a description of education completed in the protection of human subjects for each individual identified as "key personnel" in the proposed research.

Key personnel: All individuals responsible for the design and conduct of the study are considered "key personnel." This may include personnel from subcontractor institutions, consultants, fellowship applicants, and training grant trainees if they are involved in the design and conduct of research involving human subjects. Individuals do not necessarily have to be paid on the NIH award to be considered "key personnel" if they are involved in the design and conduct of the study.

Competing proposals and competing renewals: Just-in-time procedures will be followed. If a proposal is in a fundable range, NIH will request a letter documenting education (see below) and IRB approval. These will need to be provided before an award can be issued.

Noncompeting renewals: A statement should be included in the annual progress report identifying key personnel for purposes of the education requirement along with a description of the education completed (see below).

Meeting the training requirement: NIH will permit several options to satisfy the training requirement.

  • The completion of CITI at their home institution or BYU will be sufficient. Principal investigators should maintain documentation of completion.
  • It will be the principal investigator's responsibility to maintain documentation of content and completion by all key personnel.

Letter to NIH documenting training: The principal investigator should prepare a letter with the following format:

"In compliance with NIH Notice OD-00-039, the required education in the protection of human subjects has been completed by the key personnel listed below. The description of the education that each named personnel received is also included."

The principal investigator must sign the letter and submit it with other material required for a proposal renewal or award to Brigham Young University’s Research Administration Office. The required institutional signature will be coordinated through that office.