HUMAN SUBJECTS PROTECTION TRAINING

Campus Procedures for NIH Grants, Contracts, and Fellowships - Human Subjects Protection Training Certification

New and Competing Renewal Awards

When submitting Just-In-Time (JIT) material to NIH to document human subjects protection training on those projects involving human subjects (including projects considered "exempt" under HRPP rules), all UCSF Key Personnel listed are required either to take the newly posted Collaborative Institutional Training Initiative (CITI) hosted by UCSF as described on the Human Research Protection Program (HRPP) webpage or to have taken the UCSF Human Subjects Protection: Basic Course.  The Human Subjects Protection: Basic Course training certifications will be valid until February 2009 and at that time all Key Personnel will be required to take the CITI training. Please see the HRPP Frequently Asked Questions for further information about the CITI training.

Subcontractors who are listed as Key Personnel on UCSF NIH applications may supply either a letter or other documentation which indicates that they have received training which meets all NIH requirements; they are not required to take the UCSF Basic Course or CITI course. NIH has stated that the training requirement applies to all individuals identified as Key Personnel on awards that involved human subjects, with the exception of Key Personnel on program project grants who may be working on sub-projects which do not involve human subjects.

When submitting JIT material to C&G for submittal on to NIH, the following material must be supplied:

• Certification Letter for NIH documenting training of all Key Personnel, signed by the Principal Investigator with a concurrence line for C&G signature
• Documentation of completion of the Collaborative Institutional Training Initiative (CITI) hosted by UCSF or UCSF Human Subjects Protection: Basic Course for UCSF Key Personnel
• Documentation of training for subcontractor's Key Personnel

Note: Previously, in response to the NIH announcement of June 5, 2000 UCSF Key Personnel were allowed to take a variety of training courses and provide evidence of training via completion of the UCSF HSPT Certification Form. However, as of November 1, 2003, UCSF Key Personnel listed on NIH applications who have not previously submitted JIT material for a particular award to NIH must take the UCSF Human Subjects Protection Basic Course or CITI Course.

Note: If Key Personnel have changed for any reason since the new or renewal proposal submission, this information should be relayed to NIH within the certification letter. Identify all deleted or new Key Personnel, and provide the reason for the change.

NIH Continuation Proposals

If Key Personnel are added to an award in a non-competing year, documentation that they have received the required human subject education should be included in the non-competing progress report.

Subcontract Awards

For subcontract awards made to UCSF, requests for Key Personnel training certification will most likely come from the prime awardees when they are contacted by NIH prior to award. UCSF Principal Investigators should submit all letters to the prime awardees that document training certification via C&G for review and authorization, along with documentation of training for all Key Personnel who are involved with human subjects on the subcontract. The template letter used for NIH awards can also be used as a certification letter for subcontracting agencies, with a modification changing the address to the awarding agency rather than NIH.

Additionally, if there are changes in Key Personnel or new Key Personnel are added to a subcontract, certification of the human subject training should be submitted to the prime awardees either when a progress report is submitted or as changes in Key Personnel occur.  Forward all continuation or change of Key Personnel material through C&G along with the completed template letter and evidence of training for addition of an institutional signature and forwarding on to the prime awardee.

If you have questions about the new procedures or requirements relating to contract and grant award or proposals, please contact Joan Kaiser at joan.kaiser@ucsf.edu or the appropriate C&G Analyst listed on the C&G assignment page.

Updates:

The campus has received further information from NIH on the new requirement for training in the protection of human subjects.  Additionally there are now Human Subject Training FAQs available on the NIH homepage.
T Awards:  The training certification requirement does not apply to T type awards (Institutional National Research Service Awards) as training requirements for Institutional NRSA are already covered under the current proposal guidelines which state that all Institutional NRSA trainees must receive instruction in the responsible conduct of research.

F Awards: The training certification requirement does apply to F type awards (Individual National Research Service Awards) where the project involves human subjects. For these types of awards, the human subjects training certification material is required for both the trainee and mentor at the time of submittal of a continuation, or on a just-in-time basis for new F awards.

Training Requirements for Projects with Exempt Approvals:  NIH projects that involve human subjects research that is considered exempt from IRB (Institutional Review Board) review and approval (six exempt categories defined in 45 CFR part 46.101(b)) must comply with this education requirement.  See the CHR website for the exempt categories.   While many of the studies that use human tissue or involve the review of medical records may be able to be certified as exempt, most do not.  Turnaround time for review of exempt studies is typically less than one week.