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May 22, 2020

COVID-19-Related Clinical Trials

For study teams preparing COVID-19-related clinical trials, please note that UC San Diego Health has established the COVID-19 Clinical Trials Review Committee (CCTRC). Clinical trials falling under the purview of the CCTRC must be approved by that committee before submission for IRB review.

Any new submission to the HRPP of an applicable clinical trial must include documentation of CCTRC review in order to continue through the IRB review process. This includes trials that will be reviewed by an external IRB (such as a commercial IRB or the IRB of a collaborating site).

The HRPP and the IRBs appreciate the urgency of COVID-19-related clinical trials and we are working with the CCTRC to coordinate our processes. This new step will improve study initiation by allowing the IRB to focus on its core responsibilities. This ultimately best serves our shared responsibility to protect UCSD patients and research subjects.

For more information about the CCTRC, its application form, and administrative contacts for questions, please visit the COVID-19 page on Pulse (AD login required), go to “Clinical Care Resources” and then expand the “Clinical Trials” section.
April 29, 2020

Clarification of IRB Approval Periods

A clarfication memo is available addressing questions and concerns about how the IRB database calculates and displays expiration dates and how approval and expiration are explained in IRB procedures and approval letters, all further complicated by the 2019 leap year. Despite the confusion, the UCSD IRB does conduct continuing reviews at intervals required by regulation.

This memo can be provided to sponsors or attached as a Note to File. We apologize for the inconvenience and confusion.
April 14, 2020

New Forms for Secondary Research

New forms have been created for studies that only propose the secondary use of data, records, or biospecimens. Secondary Use means the data/records/biospecimens to be used are/were initially collected for a purpose other than the proposed research. These forms are to be used regardless of the expected level of review. They replace both the Exempt Category 4 and Existing Medical Record Review forms. The new forms can be found here .
April 14, 2020

No Longer Acknowledging Key Personnel Changes

The HRPP/IRB will no longer acknowledge the submission of a completed “Cover Letter for Request Change/Modification to an Approved Study – Key Personnel Changes Only” form. Submitting the form or a copy of the signed delegation log with additions/removals highlighted will be considered sufficient to inform the IRB/HRPP of key personnel changes associated with the study. The HRPP database will be updated as soon as possible following the submission of the form/log. More information can be found here.
March 13, 2020 (Updated March 18, 2020)
Coronavirus (COVID-19) Guidance
The latest guidance information, updated March 18, 2020, regarding Coronavirus (COVID-19), the UCSD IRB, and human research studies can be found at https://irb.ucsd.edu/IRB-COVID-19-Guidance.pdf . Additional updates, as needed, will be posted on this website.
January 6, 2020

Federally Supported Multisite Projects - sIRB

Principal Investigators that have started new federally supported multisite projects since January 21, 2019 or are planning new proposals for such projects should especially be aware of the new requirement regarding single IRB (sIRB) review. More information about this requirement can be found here . For additional assistance, please contact the HRPP Office at irbrely@ucsd.edu .
June 21, 2019

Updated FWA Statement Letter

HRPP is making available an updated FWA statement letter. In addition to updating information, the letter now covers both UCSD and RCHSD and also addresses several common sponsor requests. This new content is intended to help UCSD and RCHSD PIs and Study Teams negotiate with sponsors about the standard HIPAA authorization for research or the standard consent language about treatment and compensation for injuries. To access the new letter, please see the About HRPP web page or click here .
January 19, 2019
Revised Common Rule
On January 21, 2019, a number of changes to the Federal Policy for the Protection of Human Subjects (aka the Common Rule) are scheduled to take effect. At this time, the UCSD IRBs and HRPP will only apply these changes to federally supported research that will receive initial IRB approval or initial certification of exemptions on or after January 21, 2019. Additional information for these changes can be found here and specifically for changes associated with the consent process, see here.
HIPAA (Health Insurance Portability and Accountability Act of 1996) information for researchers
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