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Following is an important message from Executive Vice Chancellor Rory Hume regarding NIH requirements for training key personnel in Human Subjects Research.

August 21, 2000

TO: Investigators involved in human subjects research

FROM: Executive Vice Chancellor Hume

RE: NIH requirement for training key personnel

Many of you are aware that NIH recently instituted a policy that requires that all proposals for contracts and grants for research involving human subjects submitted after October 1, 2000 certify that all key personnel have received education on the protection of human research subjects. This requirement applies to all applications for grants or proposals for contracts submitted to NIH after October 1st and to all new and all non-competing grants for which an award is issued after October 1st. NIH has posted a web series of "frequently-asked questions" regarding these new requirements. The frequently asked questions can be accessed at: http://grants.nih.gov/grants/policy/hs_educ_faq.htm. Please note that the "computer based training module" mentioned at the end of the frequently asked questions is the module for NIH, not the module for UCLA.

UCLA is initiating two mechanisms whereby key personnel on NIH grants involving human subjects can meet this mandated requirement for education:

1. Live two-hour training sessions will be held at Covel Commons in the Grand Horizons room. The sessions will be offered three times. The sessions have been scheduled for

Tuesday, August 29 (2:00-4:00pm)
Wednesday, September 6 (9:00-11:00am)
Saturday, September 16 (9:00-11:00am).

Each Principal Investigator and all key personnel are asked to pre-register for any of these sessions at http://training.arc.ucla.edu. During each session the trainees will answer questions to be turned in at the end of the session to document their understanding of key provisions of the educational requirement. Personnel attending these sessions will be issued a certificate of training by e-mail.

2. Alternatively, individuals can complete the training by using a web-based training program that uses some materials available from NIH and some materials specifically developed for UCLA. This program is in the final stages of development and will be posted at http://training.arc.ucla.edu/. Training and testing may be accomplished on-line and a certificate will be printed out at completion of the training and testing.

Because this is a rapidly evolving area the initial certification for training will be in force for two years.

As of October 1st (2000) for all new and competing grants and contracts, which involve human subjects, UCLA will be required to provide NIH with assurance that all key personnel (identified as such in the proposal) have completed a mandatory educational program. Principal Investigators will need to provide the Office for Protection of Research Subjects with copies of the UCLA certificates of completion when the proposal and supporting materials are submitted for review. Copies of the UCLA certificates of completion for the Principal Investigator and all other key personnel should also be submitted to the Office of Contract and Grant Administration (OCGA) when the proposal and other supporting materials are forwarded to that office for review and submission to the NIH, so that an appropriate cover letter can be prepared.

After October 1st (2000), investigators submitting continuation applications or grants or annual reports for incrementally funded contracts that involve human subject research must include a description of the education program within the progress report. That narrative should list the names of all key personnel and indicate that the Principal Investigator and all key personnel have completed UCLA's educational program on the protection of human research subjects. In addition, Principal Investigators should assemble certificates for all key personnel and forward them to the Office of Contract and Grant Administration with the proposal package.

In those cases where grant applications and contract proposals were submitted previously without this information but the award date is after October 1st (2000), UCLA will need to provide NIH with assurance that all key personnel have completed the mandated educational training before NIH will issue an award. In these instances, packages of certificates of completion for the PI and all key personnel should be forwarded to OCGA as soon as they are available so appropriate assurances can be submitted to NIH.

Questions on these policies can be forwarded to Martha Hansen by e-mail (mhansen@resadmin.ucla.edu) or telephone (x40236); or by e-mail to speckman@oprs.ucla.edu or left on voice-mail at Steve Peckman, OPRS, 825-5344.