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  • New "Medical Device" Fact Sheet. A new fact sheet regarding projects associated with medical devices including policy for review and information required for review can be found here. (Released 3/5/09; Updated 4/2/09)
  • Exemption from IRB Review Application. The "Common Rule" (45 CFR 46 subpart A) defines a set of research activities that may be exempt from its purview. Research that is exempt from IRB review has very little, if any, associated risk. More information about projects that may be exempt from IRB review at UCSD can be found here. (Released 2/6/09)
  • Updated Form and Fact Sheet. The form, Continuing Review Narrative Summary of Progress to Date, has been updated to include an additional section to report adverse events (non-URPs) at this site to the IRB. This updated form can be found here. In addition, the fact sheet, Submitting an Amendment/Modification to a Research Plan (Protocol), has been updated including a more specfic description of information required in association with an amendment request. The updated fact sheet can be found here. (Released 1/26/09)
  • Pre-screening of all "new" applications. As of September 24, 2008, the HRPP will be pre-screening all new applications submitted for review. This pre-screening is designed to comply with federal rules by ensuring the documentation necessary for an accurate and thorough review of the application is obtained prior to the IRB review. As noted in a prior announcement, incomplete applications will not be placed on an IRB meeting agenda. HRPP staff will notify PIs of incomplete submissions and provide information regarding missing documentation. When an application is found to be complete, it will be assigned to the next appropriate IRB meeting. It is important to note that incomplete applications cannot attain final approval by the IRB. A copy of the IRB pre-screening form can be found here. (Released 9/19/08)
  • SDSU/UCSD Agreement for Joint Doctoral Program Research Review. The students enrolled in a SDSU/UCSD Joint Doctoral Program (JDP) who plan to involve human subjects in research are required to obtain approval from both the SDSU and UCSD Institutional Review Boards in advance of initiating research. We are pleased to announce that an agreement between SDSU and UCSD is now in place allowing for a cooperative review of research protocols involving SDSU/UCSD JDP students. Under this agreement, one campus will serve as the "reviewing" IRB and the other as the "relying" IRB. More information about this agreement and application submitting procedures can be found here. (Released 9/19/08)
  • As a reminder, please ensure that complete continuing review materials are submitted approximately 45 days prior to expiration (check the most recent approval letter) to avoid any lapse in approval or the need to submit a NEW application should the study's approval expire. Also, if there is no lapse in approval, a study may receive up to 4 IRB reviews. A study may undergo an Initial and 3 Continuing Reviews. Please check the status of the study carefully before submitting Continuing Review materials.
  • HRPP announces new guidelines for reporting adverse events to the IRB. Guidance for Prinicipal Investigators and research staff when reporting unanticipated problems or adverse events to the IRB is provided in this fact sheet.
  • HIPAA (Health Insurance Portability and Accountability Act of 1996) information for researchers. Details here...
  • More...
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