The NIH definition of clinical research is quite broad and will impact a large fraction of Berkeley campus NIH research involving human subjects. Principal Investigators on projects involving human subjects research and all personnel who are directly responsible for the design and conduct of the human subjects part of the project must be trained prior to working with human subjects. This includes key foreign and domestic personnel on subcontracts and consultants and applies whether or not these individuals are compensated from the award.
Training is required only once during the project period.
See this link for the required Human Subjects Training Certification Form, the Berkeley Campus Procedures document that includes the NIH definition of clinical research, and the campus deans and directors memorandum. NIH made several important changes to requirements for modular grant applications effective September 1, 2000. The original guidance requested budget narrative only for key personnel. The second important change is that applications not in compliance with the modular application instructions will be returned to the applicant institution. The NSF GPG continues the Small Grants for Exploratory Research supplementation and extension process that was scheduled to expire on October 1, 2000.