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  • 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)
  • Updated SOPP: UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), section 3.21, IRB Oversight by Non-UCSD "Centralized" IRBs, has been updated to reflect additional wording regarding submission of amendment documentation to ensure appropriate information is available for UCSD departments/committees including Investigational Drug Service. The updated SOPP can be found on the SOPPs page. (Released 5/14/14)
  • Life Span of Projects Increased: As of March 1, 2014, the life span of a project has been increased from 7 years (i.e., up to 6 cycles of Continuing Review after initial approval) to 10 years (i.e., up to 9 cycles of Continuing Review after initial approval). The PI is reminded that continuing review documents must be submitted to the HRPP approximately 45 days prior to the project expiration date (365 days from the initial approval /continuing review approval or as outlined in the approval letter) to ensure that there is no lapse in study approval. IRB/HRPP web pages and documents including SOPPs sections 3.11 and 3.13 have been revised to reflect the increase in life span. (Released 3/3/14)
  • Updated Biomedical Research Application Facesheets, Research Plan Instructions, and "New" Supplement: The Biomedical Research Application Facesheets have been revised to remove requests for information regarding the VA San Diego and to include requests for information regarding whether a project involves an infectious agent; meets criteria for an IND exemption; involves a non-significant risk or significant risk device; and to indicate the "Phase" of a clinical trial, as appropriate. The Research Plan instructions have been updated to include that if a study is requesting an IND exemption, the IND exemption supplement to the Research Plan must be completed and submitted. And a "new" supplement for IND exemption requests has been created. The updated Facesheets, instructions and the new supplement, as well as the other supplements to the Research Plan, can be found on the Biomedical Research Forms page (Released 2/3/14)
  • 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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