SUBJECT:

The UCSD Human Research Protections Program Announces New Policies and Procedures for Human Subjects Research

The UCSD Human Research Protections Program (HRPP) and the Clinical and Translational Research Institute (CTRI) are pleased to announce innovations in policy and procedures for 2011. They are designed to enhance compliance and facilitate human subjects research at UCSD, and include:

1. Increase in life span for Institutional Review Board (IRB) projects to 7 years: All active human research projects (those with valid IRB approval) will now enjoy a 7-year life span. In 2004, HRPP extended the life span from 2 to 4 years of continuing approval. HRPP is now extending this life span to 7 years. This means that once approval is granted for a project, the investigator may submit up to six (instead of three) annual continuing review applications in order to ensure ongoing IRB approval. Investigators are still required to submit their annual (within 365 days of IRB approval) continuing review applications 45 days before project expiration to ensure that the study remains active.

2. Exemptions from IRB Review: Most research on existing tissue samples or data for which personal identifiers or records are not needed would qualify as exempt from IRB review. IRB exemption means that the project does not undergo IRB review. Furthermore, once certified as exempt, the project will not require continuing review applications. A certification process is required to determine if the project satisfies the criteria for IRB exemption. The following link provides more information on IRB exemption for certain categories of human subjects research: http://irb.ucsd.edu/Exemption_fact_sheet.pdf

3. Rapid Cycle Review: For some industry-sponsored clinical trials, HRPP has developed a “Rapid Cycle Review” IRB process to reduce approval delay for these trials. Rapid Cycle Review ensures that all federal and local regulatory requirements governing IRB approval are met, while taking steps to facilitate approval within 3 weeks of a complete IRB submission. Qualifying trials are those that include the following attributes: (1) Phase III or IV, multi-site, non-VA clinical trial; (2) industry-sponsored study; (3) a Data and Safety Monitoring Board (DSMB) or Plan (DSMP) in place; and (4) no participants with cancer or under the age of 18 years. If you believe your IRB submission qualifies for this rapid review process, include a Request for Rapid Cycle Review in the cover letter accompanying your new IRB application.

4. Tracking the Status of a Submission Online: In early 2011, HRPP will begin implementing an online resource that permits research staff to track the status of their submission in the review process.

5. New IRB Documents and Instructions: HRPP posted an updated biomedical application Research Plan and instructions as well as other updated documents. The update to the Research Plan is a significant expansion of the existing Research Plan and includes requests for information now required to comply with Federal and accreditation guidelines.

For further information, please contact Dr. Michael Caligiuri (mcaligiuri@ucsd.edu)

Gary S. Firestein, M.D. Director, CTRI, and UCSD Institutional Official Michael P. Caligiuri, Ph.D. Director, UCSD HRPP