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  • Updated SOPP: SOPP, section 4.2, Categories of Action, has been updated to more specifically define the four categories an IRB can take when reviewing research and the procedures regarding the review of responses to Committee requests. These procedures include that if the response alters/affects risk/benefit to subject; equitable and non-coercive selection/recruitment of subject; privacy and confidentiality; process and documentation of consent/assent; and/or additional safeguards for vulnerable subjects, the response will be placed on an agenda for review at the next appropriate IRB meeting. This SOPP can be found on the SOPP page. (Released 5/11/12)
  • Updated Forms and SOPP: The Narrative Summary of Progress to Date for both Biomedical and Social and Behavioral studies has been revised include a separate section for more clearly provide a summary of any subject complaints since the last IRB review. In addition, SOPP, section 3.4, Informed Consent, page 5, has been updated to include ClinicalTrial.gov wording required by the FDA for applicable trials. The revised forms can be found on the Forms page. The updated SOPP can be found on the SOPP page. More information about the required FDA wording can be found here. (Released 4/23/12)
  • Updated Form: The Biomedical Standard Application Facesheets have been revised to include an additional Yes/No checkbox to indicate whether the study will recruit potential participants using ResearchMatch. The updated form is available on the Forms page. (released 03/27/12)
  • Updated SOPP: SOPP, section 3.10, Expedited Review, has been updated to include additional information regarding expedited review of sponsor provided annual reports and DMC/DSMB reports. This SOPP can be found on the SOPP page. (Release 2/3/12)
  • Updated SOPP: SOPP, section 3.2, Full IRB Review, has been updated to include procedures for rapid-cycle review of adult Cancer Cooperative group trials reviewed by the National Cancer Institute (NCI) Central Institutional Review Board (CIRB). This SOPP can be found on the SOPP page. (Released 01/31/12)
  • 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. (Released 01/17/12)
  • HIPAA (Health Insurance Portability and Accountability Act of 1996) information for researchers. Details here...
  • More...
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