UPDATED POLICY GUIDANCE FOR INVESTIGATORS
IMPLEMENTATION OF THE NIH POLICY
ON INSTRUCTION ON THE PROTECTION OF
HUMAN RESEARCH SUBJECTS

POLICY July 31, 2003
On August 21, 2000, Executive Vice Chancellor Daniel Neuman wrote about the National Institutes of Health (NIH) policy which requires that grant applications or contract proposals for research involving human research subjects certify that all key personnel have received training on the protection of human subjects.

Under the regulations, UCLA is required to provide NIH with assurance that key personnel on all NIH-supported research projects involving human subjects research have completed mandatory training.

TRAINING PROGRAM
UCLA has developed a Web-based certificated training program to satisfy this educational requirement. Information about the course is available at http://www.training.arc.ucla.edu/index.htm.

TO WHOM DOES IT APPLY?
For the purposes of the NIH policy, "key personnel" is defined as individuals who contribute in a substantive way to the scientific development or execution of the project and are identified as such within the proposal. This can include UCLA personnel as well as consultants and key personnel at subrecipient institutions.

Under UCLA implementation, all UCLA personnel listed as key personnel on all NIH research projects involving human subjects research are required to complete the UCLA-specific course at least once every two years.

For program project and center grants, key personnel participating in projects that involve human subjects research must complete the training. Key personnel working on projects in which there is no human subjects research are not required to complete the training.

Non-UCLA affiliated key personnel including consultants (when none of their work is performed at UCLA) and personnel participating on subgrants or subcontracts may complete either the UCLA-specific program, the educational program specified by their home institutions, or the course developed by the NIH.

ASSURANCE TO NIH
The UCLA Office of Contract and Grant Administration (OCGA) must provide NIH assurance that all key personnel on proposals for new contracts or grants have completed a mandatory educational program.

• FOR NEW APPLICATIONS: This assurance will be incorporated into a letter to be submitted by OCGA in keeping with the Just-In-Time process. NIH will request an assurance letter before an award is issued. Principal Investigators (P.I.s) should forward copies of the certificates of training to OCGA. OCGA will prepare and submit the assurance letter when requested by NIH.
• For program project or center grants, the P.I. will need to provide OCGA with written guidance about which projects involve human subjects research and a list of key personnel on those projects. As appropriate, this information should also be included in the assurance letter.
  
  
• FOR CONTINUATION APPLICATIONS FOR GRANTS OR INCREMENTALLY FUNDED CONTRACTS: The following description of the UCLA educational program should be incorporated into the progress report:

  "The UCLA Program on Education on the Protection of Human Research Subjects, "Protecting Human Research Subjects," is comprised of six modules: (1) Introduction; (2) Multiple Project Assurance; (3) IRB Review; (4) Informed Consent; (5) Biomedical Research; and (6) Case Studies. UCLA Investigators and other key personnel may either attend a live session given on the UCLA campus (2 hours) or complete an on-line course (http://www.training.arc.ucla.edu/index.htm). In both instances, certificates of completion are issued after participants take and pass a short quiz."

The narrative should also list the names of all key personnel and indicate that the P.I. and all key personnel have either completed UCLA's educational program or, for those investigators who are not at UCLA, a training program at their home institution(s). Certificates of completion for the P.I. and all other key personnel, and when applicable, assurance letters from subrecipients, should be provided to OCGA when the proposal and other supporting materials are forwarded for review and submission to NIH.

For more information, please contact the OCGA contact assigned to your department.

Proposal Preparation || OCGA || RESEARCH@UCLA

Last updated August 19, 2002