NIH Training Requirements

M E M O R A N D U M

September 27, 2000

To: NIH Investigators with funding to do Human Subjects Research

From: Tony G. Waldrop, Vice Chancellor for Research; Janet H. Glaser, Associate Vice Chancellor for Research and Executive Secretary, Institutional Review Board; Jack Kamerer, Director, Office of Grants and Contracts

RE: NIH Requirement for Education in the Protection of Human Subjects Research

The purpose of this memo is to provide further guidance on how the University of Illinois at Urbana–Champaign (UIUC) campus will implement the NIH requirement for documentation of training in the protection of human subjects.

NIH requirement: All NIH investigators who receive funding after October 1, 2000, 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.

Frequently asked questions: Consult the NIH Web site for answers to frequently asked questions.

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.

• A UIUC Web-based training module has been available since September 1, 2000. A certificate of completion is provided.
• NIH has an intramural Web-based training program that is medically oriented but presents basic information on the ethics of human subject research. It provides a certification of completion.
• For subcontracts and consultants, completion of either a training program at their home institution or completion of the UIUC training module will be sufficient. Principal investigators should maintain documentation of completion.
• Other organized educational programs are acceptable to NIH (see their Web site), but 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: (also see the IRB Web site)

"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 UIUC Office of Grants and Contracts. The required institutional signature will be coordinated through that office.

Top