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December 6, 2018

Dear UC San Diego Researchers and Staff

UC San Diego, including the HRPP Office, will be closed starting Monday, December 24, 2018 and will re-open Wednesday, January 2, 2019. Please keep this in mind when preparing your IRB submissions. As always, upcoming IRB meeting dates are available here . On behalf of the HRPP staff and IRB members, we wish you all the best. Happy Holidays!

Note: You may implement changes to research to eliminate an apparent immediate hazard to a subject without obtaining prospective IRB approval. Changes made in those circumstances must subsequently be reported to the IRB.

You may make emergency treatment use of investigational products according to the appropriate instructions for drugs or devices (including permission from the FDA as required). Links to consent templates are included in these guidance documents. Such emergency uses must be reported to the IRB within 5 days.
October 26, 2018

November and December Meeting Dates

As is customary, the schedule for the IRB meeting dates changes during the months of November and December because of University holidays and the need to ensure quorum. The updated schedule is available on the IRB Meeting Dates page.
September 26, 2018

Circumstances Beyond Our Control

Shared ACTRI resources, including e-IRB Services, are experiencing intermittent network connection problems. If you are unable to connect, please wait 15 minutes and try again. IT staff are working to correct the issues and we apologize for any inconvenience.
July 19, 2018

Final Rule Compliance Delay

The U.S. Office for Human Research Protections has announced a further 6-month delay of the Revised Common Rule. The changes are now expected to take effect on January 21, 2019. At this time the UCSD IRB/HRPP is reviewing its plans for implementing the changes. Please continue to monitor our website for upcoming announcements.
May 9, 2018

New and Updated Fact Sheets

A new Fact Sheet has been created titled, Expanded Access - Investigational Device . The updated Fact Sheet is titled, Investigator Initiated Clinical Trials/IND Applications . The new and the updated Fact Sheet provide updated information regarding expanded access investigational treatment including single patient treatment in both non-emergency and emergency situations. The Fact Sheets also provide links to sample treatment consent/permission/assent documents. The new and updated Fact Sheets can also be found on the Fact Sheets page .
March 19, 2018 (Updated May 4, 2018)

HRPP Process Improvements

The HRPP has made modifications for protocol review to improve efficiency. Please note there are "Rapid-Cycle Review" procedures available for Phase 2b, 3, and 4 industry-sponsored clinical trials. Also, non-federally funded research in the Expedited Category may receive a 3-year initial review approval. Additional changes include broader eligibility for non-federally funded Exempt Category research. The Amendment Request Cover Letter form , which has been available and demonstrated to improve communication with the HRPP Office, will be required for amendment submissions in April or submissions may be considered incomplete. For more information about Rapid-Cycle Review, please see SOPP, section 3.2 , page 6. A checklist for Rapid-Cycle Review can be found here . For more information about the 3-year initial review approval, please see SOPP, section 3.10 , page 3. A checklist for 3-year initial review approval can be found here . For more information about the broader eligibility for exempt category research, please see SOPP, section 3.9 , page 2. Also, longer approval periods for studies reviewed by a convened IRB will result from making the initial approval date based upon the "last touch" date rather the date of the first Committee review. In addition, there is a new Fact Sheet for NIH Issuing Certificates of Confidentiality (see Fact Sheets webpage and here ). And there is an additional FAQ, number 16, that addresses pregnant partners/pregnant participants (please see FAQs webpage ).
February 6, 2018

New Fact Sheets and Updated Biomedical Facesheets

Two new Fact Sheets have been created. One Fact Sheet is regarding the NIH definition of a clinical trial. The other Fact Sheet is regarding the return of research and/or incidental findings. The Biomedical Facesheets have been updated to include an indication whether a study involves dual use research of concern (DURC) agents (more information about DURC agents can be found here ). The new Fact Sheets can be found on the Fact Sheets page. and the updated Facesheets can be found on the Biomedical Research Forms page. .
December 22, 2017 (Updated January 18, 2018)
Final Rule Effective Date and General Compliance Date Delay
An Interim Final Rule (IFR) has been announced that delays the effective date and general compliance date for the Final Rule to July 19, 2018. Additional information about the IFR can be found here . As noted previously, the Final Rule compliance and effective date was January 19, 2018, and the Final Rule was only effective for federally supported/conducted studies initially approved on or after that date. Researchers should continue to monitor and review the HRPP website to learn of "new" information regarding the IFR and changes in policies and procedures as they become operational.
October 31, 2017

Updated SOPPs

The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 1.5 and 3.12 have been updated. Section 1.5, page 1, has been updated to revise wording regarding who can be a PI on a study. Section 3.12, page 2, has been updated to reflect the use of the Amendment Request Cover Letter form and the Cover Letter for Request Change/Modification - Key Personnel Change Only form. The updated SOPPs can be obtained on the SOPPs page
September 11, 2017

Updated SOPPs

The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 3.8 and 8.2 have been updated. Section 3.8 has been updated including wording regarding conflict of interest and who may serve as an IRB member (page 1). And section 8.2 has been updated to provide the definition of "Enrolled" and clarify the definition of "Generalizable Knowledge" (page 3). The updated SOPPs can be found on the SOPPs page.
June 26, 2017

Updated SOPPs

The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 3.16, 3.17, 3.20, 4.2, and 5.2 have been updated. Section 3.16, page 4, has been updated to clarify wording regarding reuse and storage of data/specimens and agreements. Section 3.17, page 2 has added two additional items that cannot be part of advertisements. Section 3.20, page 3, has been updated include wording regarding data collection and participant withdrawal. Section 4.2, page 2, has been updated to include addition information regarding disapproval and page 4 has been updated to include additional information regarding review of response to a disapproved study. And section 5.2, page 1, has been updated to define suspension and termination and page 4 has been updated to include additional information regarding informing current participants and a termination or suspension. The updated SOPPs can be found on the SOPPs page .
March 18, 2013

One-on-One Advising Sessions

The HRPP is introducing 15-minute, One-on-One advising sessions. These sessions will be done once a month and are designed for investigators, study staff, and students conducting research involving human subjects to obtain guidance from HRPP staff. For more information, please see the Training page .
HIPAA (Health Insurance Portability and Accountability Act of 1996) information for researchers
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