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  • Holiday Schedule and Closure: Dear UCSD Researchers and staff: In a September Campus Notice, the Office of the Executive Vice Chancellor-Academic Affairs and the Office of the Vice Chancellor and Chief Financial Officer, notified the UC San Diego community that UC San Diego will officially close four (4) working days in December, 2015 (28th, 29th, and 30th) and January, 2016 (1st). The HRPP will be closed between Thursday, December 24, 2015 and Sunday January 3, 2016, reopening Monday, January 4, 2016. Please keep this in mind when preparing your IRB submissions. The IRB meeting dates are available here. On behalf of the HRPP staff and IRB members, we wish you all the best. Happy Holidays! (Released 11/23/15)
  • New Fact Sheet and Updated SOPP: A new Fact Sheet has been created regarding research methods courses in the Social and Behavioral Sciences. In addition, SOPP, section 3.4 Informed Consent, has been updated to include links to the UCSD short form and Experimental Subject's Bill of Rights translated into Spanish, Vietnamese, Chinse (both Simple and Traditional), Arabic, and Somali. The Fact Sheet can be found on the Fact Sheets page. The updated SOPP can be found on the SOPP page and information regarding procedures associated with the use of the short form (also found in the SOPP) can be found at https://irb.ucsd.edu/short_form_consent.shtml. (Released 11/17/15)
  • New Fact Sheet and New Cover Letter Form: A new Fact Sheet has been created regarding procedures for PI-initiated clinical trials and IND applications. In addition, a new form has been created for a Cover Letter that can be used for making changes to "key personnel" only that are associated with a study. The Fact Sheet title "Investigator Initiated Clinical Trials/IND Applications" can be found on the Fact Sheets page. More information about the Cover Letter form can be found here. (Released 10/27/15)
  • Let your voice be heard -- NPRM: The US Department of Health & Human Services has announced a Notice of Proposed Rule Making (NRPM) for changes to the "Common Rule" for protection of human subjects and is requesting public comment about those changes. The public comment period for the proposed changes will be open for approximately 2 more months. For more information about the NPRM and submitting your comments, please see the OHRP web site at http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html. The HRPP Office is also providing a Word document that includes a table of questions associated with the NPRM as well as a PDF that provides a more easily readable NPRM to allow for greater ease in providing your comments. (Released 10/13/2015)
  • November and December Meeting Dates: As is customary, the schedule for the IRB meeting dates changes during the months of November and December because of University holidays and the need to ensure quorum. The updated schedule is available on the Dates page. (Released 10/8/15)
  • 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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