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  • Additional FDA-required consent wording: Additional wording regarding a statement informing participants about the ClinicalTrial.gov trial registry for applicable clinical trials must be included in the consent of applicable trials initiated on or after March 7, 2012. For more information, please see the FAQ, Frequently Asked Questions--FDA Final Rule: Clinical Trials.gov Consent Wording.
  • Updated and new SOPPs: SOPP, section 3.15, Radition Exposure and Radioisotopes, has been updated to include that HERC approval may be obtained before, during, or after application to the IRB; the IRB has final approval of the wording regarding human subject radiation exposure in the consent/assent document(s); and wording regarding review documentation provided to the IRB by HERC. In addition, a new SOPP has been created, section 3.18, Review of Subject Complaints/Concerns/Questions. This section provided procedures for both the PI and the IRB/HRPP when a Subject has a complaint, concern, or question. These SOPPs can be found on the SOPP page.
  • Change In Fee Schedule For Commercially Sponsored Clinical Trials: For projects submitted after January 1, 2012, there will be a change in the fee schedule for IRB review of commercially sponsored clinical trials to reflect a flat rate of $2150 for an initual review and $2150 for each 7-year resubmission review (treated as a "new" projecct by the IRB) and $500 for each annual continuing review. For more information about this, please see the HRPP fact sheet "Institutional Review Board (IRB) Fees for Commercially Sponsored Projects" located here. (Released 11/28/11)
  • THE HRPP HAS MOVED: The HRPP Office has moved to the first floor of the "new" East Campus Office Building (ECOB). For our updated contact information, please see the Contact Us page. (Released 11/2/11; Updated 12/15/11)
  • FAQ-Common Qs: Ever wanted to know what "Expedited Review" means? Do you know what the specific requirements for font and font size for consent/assent and recruitment documents are? What do all those red boxes on the application Facesheets mean? Answers to these and other questions can be found on an HRPP FAQ available here. (Released 8/19/11).
  • Amendment/Compliance Reminder: The Department of Health and Human Services has notified UCSD that at least one UCSD IRB-approved research protocol was out of compliance with IRB-approved procedures. We remind all faculty and research staff that federal rules require IRB review and approval of all proposed changes in reseach activity prior to initiation of such change, except when necessary to eliminate apparent immediate hazard to subjects. Conducting research procedures without IRB approval can negatively impact the rights, welfare, and safety of human subjects who participate in research at this Institution. Any modification to an approved protocol must be reviewed and approved by the IRB prior to implementing the change, regardless of the nature of the modification. It is strongly recommended that faculty responsible for ongoing human subject research at UCSD discuss this requirement with your research staff and conduct periodic audits of your approved protocols to ensure compliance. Instances of non-adherence to IRB-approved protocols must be rectified and reported to the IRB immediately. Please remember, research compliance is a shared responsibility. (Released 03/08/11)
  • HIPAA (Health Insurance Portability and Accountability Act of 1996) information for researchers. Details here...
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