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  • 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)
  • Updated SOPPs: UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPPs), Sections 1.1; 1.3; 1.4; 1.5; 2.1; 2.2; 2.3; 3.1; 3.3; 3.4; 3.6; 3.7; 3.9; 3.14; 3.17; 3.18; 8.1;and 8.2 have been updated to reflect that the UCSD IRBs are no longer the San Diego VA Healthcare System IRBs of record. The updated SOPPs can be found on the SOPPs page. (Released 1/31/14)
  • New Fact Sheet: A new Fact Sheet has been created regarding a CSUSM/UCSD agreement for review of human subject research associated with students enrolled in joint CSUSM/UCSD programs and CSUSM graduate programs conducting research at UCSD facilities. The new Fact Sheet can be found on the Fact Sheets page. (Released 10/30/13)
  • Updated Social and Behavioral Sciences Research Consent/Permission/Assent Examples and Research Plan Instructions: The Social and Behavioral Sciences (SBS) Research consent/permission/adolescent assent examples have been updated to include wording regarding reporting rules associated with child and elder abuse. The SBS Research Plan Application instructions have been updated to reflect this information as well (item 15). The updated examples and instructions can be found on the SBS Forms page. (Released 10/14/13)
  • Updated SOPP: Section 3.14, Protocol and Regulatory Violations and Exceptions , has been revised to provide definitions for Serious Non-compliance and Ongoing Non-compliance. The SOPP has also been updated to request additional information regarding previous protocol exceptions. The updated SOPP can be found on the SOPPs page. (Released 10/14/13)
  • New Fact Sheet, Oral History/Journalism Projects: A new Fact Sheet has been created regarding review of oral history/journalism projects. The new Fact Sheet can be found on the Fact Sheets page. (Released 10/1/13)
  • Updated Biomedical Research Consent/Permission/Assent Examples: The Biomedical Research consent/permission/assent examples have been updated to reflect wording regarding reporting rules and GINA/CALGINA. In addition, the provided Cost language should be used for all studies that involve billable events not only cancer studies. The updated examples can be found on the Biomedical forms page. (Released 10/1/13)
  • Updated HIPAA Authorization: As of September 23, 2013, newly enrolled participants who need to sign a HIPAA authorization must "opt-in" to allow the use of their PHI for optional sub-studies and future secondary use of PHI. The HIPAA authorization has been updated to include a checkbox to indicate the participant has agreed to this use. The updated HIPAA authorization should be used for all participants who require completing a HIPPA authorization and can be found on the Biomedical Forms page. (Released 9/23/13)
  • 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, VA Service Chief 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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