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  • Updated SOPPs and Forms: UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 3.9, Exemption from IRB Review; and 3.21, IRB Oversight by Non-UCSD "Centralized" IRBs; the WIRB checklist; and the Research Plan associated with exemption category 4 have been updated. Section 3.9 has been updated to more clearly indicate that the IRB Chair and/or the IRB Chair's designee may determine whether a submitted research project meets the requirements for exemption from IRB review. Section 3.21 has been revised to reflect the addition of Copernicus Group IRB (CGIRB) oversight (specific Facesheets and checklist have been provided) and a change in the eligibility criteria for WIRB IRB oversight to include that a multicenter study is defined as 5 sites including UCSD, Phase II studies and Phase I studies that meet criteria as well as provide documentation of approval for the project from the UCSD Institutional Official. The WIRB checklist has been revised to reflect these changes. The Research Plan associated with exemption category 4 has been updated to reflect conditions required to grant waiver of individual HIPAA authorization. The updated SOPPs can be found on the SOPPs page. The updated Research Plan can be found on the Exemption forms page. (Released 9/11/14)
  • Updated SOPPs: UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 1.1, Responsibility and Authority; 2.2, Member Appointment, Compensation and Responsibilities; 3.10, Expedited Review; and 4.2, Categories of Action, have been updated. Section 1.1 has been updated to more clearly reflect 45 CFR 46.112 and to include procedures associated with reporting/reviewing attempted undue influence of UCSD IRB, HRPP Administration, and/or HRPP staff. Section 2.2 has been updated in regards to the appointment of an IRB Chair. Section 3.10 has been updated to reflect extended approval, up to 3 years, of minimal risk studies that meet specific criteria. Section 4.2 has been updated to include procedures for assigning a response to an approved pending letter from the Committee requesting review of the response to another Committee with the approval of the IRB Chair and HRPP Director. These updated SOPPs can be found on the SOPPs page. (Released 9/8/14)
  • Change In Fee Schedule for Commercially Sponsored Clinical Trials: For projects submitted after July 1, 2014, there will be a change in the fee schedule for UCSD IRB review of commercially sponsored clinical trials to reflect a flat rate of $2700 for an initial review and $2700 for each 10-year resubmission (treated as a "new" project review by the IRB) and $1000 for each annual continuing review. More information can be found on the HPPP Fact Sheet, "Institutional Review Board (IRB) Fees for Commercially Sponsored Projects" located here. (Released 6/25/14)
  • Updated CIRB Consents Boilerplate Language Approved: Updated CIRB consent/permission/assent boilerplate language has been approved by the CIRB. As noted in the approval documentation from CIRB, "The Signatory Institution Principal Investigator has the responsibility for ensuring that CIRB-approved boilerplate language is appropriately inserted into the CIRB-approved consent form(s) and institutional requirements are met." The updated, approved boilerplate language can be found here. (Released 5/22/14)
  • 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. (Released 3/18/13)
  • 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/specmens 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. (Released 11/28/12)
  • 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. (Released 8/24/2012)
  • HIPAA (Health Insurance Portability and Accountability Act of 1996) information for researchers. Details here...
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