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May 22, 2017

Updated SOPPs

The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 1.4, 2.1, and 2.2 have been updated. Section 1.4, page 1, has been updated to include additional documents that are part of adequate documentation; pages 1 and 2 have been updated to include that deliberations will be separate for each action, approval period, and category of expedited initial/continuing review approval is provided in the meeting minutes; and page 3, update indicates that IRB records will allow for the reconstruction of the complete history of IRB records. Section 2.1, page 1 has been updated to include that in general, an unaffiliated IRB member, and an IRB member who represents the general perspective of subjects, will attend 10 of 12 IRB meetings. And section 2.2, page 2 has been updated to include IRB membership will be evaluated and adjusted to meet regulatory and organizational requirements and page 4 has been updated to address stipends provided to various IRB members. The updated SOPPs can be found on the SOPPs page .
April 11, 2017

Updated SOPP, Fact Sheet, and Form, and New Form for Exempt Studies

The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP) and the Fact Sheet regarding studies that are exempt from IRB review have been updated. The updates include an updated SOPP with a definition of "existing" data and a link for an exempt sample informed consent, as well as, links to the updated Cover Sheet for Exempt Status Application and the "new" Exempt Status Facesheets. The updated SOPP, section 3.9, can be found on the SOPPs page , the updated Fact Sheet on the Fact Sheets page , and the updated forms on the Exempt Status forms page .
January 6, 2017

Multiple Document Uploads

The HRPP website has been enhanced to allow for multiple document uploads through "e-IRB Services." In addition, the "Document Type" is now selected using a dropdown menu. Further information can be found on the document upload page via "My Protocols at a Glance."
November 18, 2016

New Forms for Amendment Requests and Key Personnel Changes

Two new forms have been created for amending an approved study and requesting changes to key personnel associated with a study. The Amendment Request Cover Letter was created to formalize the means for providing the IRB/HRPP with sufficient information for an appropriate review of an amendment request. The Request Key Personnel Changes Only form can be used for making changes to key personnel associated with a study only where those changes do not require revision of the consent/permission/assent form(s) and/or the change is not to the PI of the study. The Amendment Request form and information about the using the form can be found here. The Request Key Personnel Changes Only form and information about using the form can be found here.
November 18, 2016

New Forms for Existing Medical Record Review Studies

New forms have been created for studies that propose to only review pre-existing medical records. These forms may only be used when a retrospective medical record review study that is reviewing pre-existing medical records is being proposed. Pre-existing means the medical records are collected prior to this research use for the purpose other than the proposed research, and the only information accessed in the medical records must be present at the time the Existing Medical Record Review (EMRR) Application Facesheets are submitted to the HRPP via the web. These forms include EMRR Application Facesheets and an EMRR Research Plan. These forms and information about using these forms can be found here.
March 18, 2013

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 .
November 28, 2012
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/specimens 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 .
August 24, 2012
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.
HIPAA (Health Insurance Portability and Accountability Act of 1996) information for researchers
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