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March 19, 2018 (Updated March 26, 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 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.
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 .
June 14, 2017

Updated Form

The Biomedical Standard Application Facesheets have been updated. Specifically, the Project Title section has been updated to allow for the specific collection of the Sponsor's protocol number, if such a number is associated with the study. In addition, the Project Characteristics section has been updated to include an indication for the involvement of DURC agents. As noted on the form, for more information about DURC agents, please contact EH&S . The updated form can be obtained on the Biomedical Forms page and/or directly here.
June 13, 2017

Updated SOPPs

The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 3.2, 3.10 and 3.13 have been updated. Section 3.2, page 1 has been updated to reflect "Convened" rather than "Full" IRB review, and page 14, the header has changed from "Approval and Documentation" to "Review and Documentation." Section 3.10, page 5, has been updated regarding review of modification required to secure approval. And section 3.13, page 2, has been updated to include two additional events that meet the definition of a UPR, that all UPRs will be reviewed by a convened IRB, and clarified that the UPR will be presented to the IRB by the Primary Discussant; page 3 updated to reflect "10-year" timing for resubmission and page 4 has been updated to clarify that FDA clinical trials, the review will be of participants enrolled at sites under the direct purview of the UC San Diego IRB. The updated SOPPs can be found on the SOPPs page .
May 22, 2017

Updated SOPPs

The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 1.4, 2.1, and 2.2 have been updated. Section 1.4, page 1, has been updated to include additional documents that are part of adequate documentation; pages 1 and 2 have been updated to include that deliberations will be separate for each action, approval period, and category of expedited initial/continuing review approval is provided in the meeting minutes; and page 3, update indicates that IRB records will allow for the reconstruction of the complete history of IRB records. Section 2.1, page 1 has been updated to include that in general, an unaffiliated IRB member, and an IRB member who represents the general perspective of subjects, will attend 10 of 12 IRB meetings. And section 2.2, page 2 has been updated to include IRB membership will be evaluated and adjusted to meet regulatory and organizational requirements and page 4 has been updated to address stipends provided to various IRB members. The updated SOPPs can be found on the SOPPs page .
April 11, 2017

Updated SOPP, Fact Sheet, and Form, and New Form for Exempt Studies

The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP) and the Fact Sheet regarding studies that are exempt from IRB review have been updated. The updates include an updated SOPP with a definition of "existing" data and a link for an exempt sample informed consent, as well as, links to the updated Cover Sheet for Exempt Status Application and the "new" Exempt Status Facesheets. The updated SOPP, section 3.9, can be found on the SOPPs page , the updated Fact Sheet on the Fact Sheets page , and the updated forms on the Exempt Status forms page .
January 6, 2017

Multiple Document Uploads

The HRPP website has been enhanced to allow for multiple document uploads through "e-IRB Services." In addition, the "Document Type" is now selected using a dropdown menu. Further information can be found on the document upload page via "My Protocols at a Glance."
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 .
November 28, 2012
Secondary Use of Existing Data/Specimens Requires IRB Approval or Certificate of Exemption Reminder
Investigators and study staff are reminded that the secondary use of existing data/specimens including review of existing medical records, student records, accessing computer databases that have been produced from previous studies, etc., requires IRB approval or Certification of Exemption from IRB review. For more information about this, please see the HRPP Fact Sheet, Research Involving the Use of Existing Data/Specimens .
August 24, 2012
Submitting Documents to the IRB/HRPP Reminder
The IRB/HRPP does not accept study-related documents by e-mail. All documents must be uploaded to the appropriate project number through "My Protocols at a Glance" using e-IRB services on the HRPP website or may be provided hard copy only if the document requires the signature of the PI, Department Chair and/or Submitter. Or if a copy of the stamped, approved consent/assent that is currently in use is being provided for Continuing Review. If the PI has appropriate means to convert each document into a PDF, such as a document scanner, then each document can be submitted via the web.
HIPAA (Health Insurance Portability and Accountability Act of 1996) information for researchers
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