New IRB Form for Enrollment Exception Requests

The IRB has created a new “Protocol Enrollment Exception Request” submission form and it is now available in iRIS. When do I use the Protocol Enrollment Exception Request form?

HRPP Update from Brian Smith: Assoc. Vice Chancellor, Interim Chief Ethics & Compliance Officer

The message below is sent on behalf of Brian Smith, Associate Vice Chancellor, Interim Chief Ethics and Compliance Officer Dear Research Community,

Report Potential Breaches of Privacy or Confidentiality Within 48 Hours

Potential breaches of privacy or confidentiality of study participants’ Protected Health Information (PHI) are considered “major (reportable) incidents” that must be reported to the HRPP/IRB. The IRB collaborates with the UCSF Privacy Office to investigate these incidents to meet state and federal...

Guidance Updates

The HRPP has made the following changes to guidelines that pertain to IRB submissions.   New Definition for Key Study Personnel PI Eligibility for Post Docs, Clinical Fellows and Residents Submission Guidelines for Just-In-Time Awards New Definition for Key Study Personnel  

New Greater-than-minimal-risk Studies Require a Scientific Protocol Starting 5/1/15

Change Affecting New Greater-than-Minimal-Risk Studies

Bulletins from 2012

Review archived announcements from 2012, including bulletins on these topics:   Relying on Western IRB Research Online to Be Decommissioned December 31, 2012 UCSF Treatment and Compensation for Injury Consent Form Paragraph Updated Holiday Schedule Announcement (October)