July Updates
June 25, 2019
To: Investigators and Staff
Re: IRB News, Changes in requirements and reporting
The following notice provides updates regarding the new Common Rule requirements, Recombinant DNA Advisory Committee review, and iRIS (IRB submission system) guidance. Protocol Builder Pro Discontinuation (April 2019)
February 11, 2019
Common Rule & New Application
February 04, 2019
Human Research Protection Program
February 4th, 2019
To: Investigators and Staff
Revised Common Rule IRB Regulatory Changes coming January 21, 2019
December 03, 2018
Human Research Protection Program
December 19, 2018
To: Investigators and Staff
Re: IRB Regulatory Changes coming January 21, 2019
IRB Regulatory Changes coming January 21, 2019 Clinical Research Operations Update From Lindsey Criswell, Vice Chancellor of Research
June 29, 2018
Clinical Research Operations Update
From
Lindsey Criswell, Vice Chancellor of Research
June 2018
New IRB Form for Enrollment Exception Requests
January 10, 2018
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
December 01, 2017
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
April 20, 2017
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
November 10, 2015
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
February 27, 2015
Change Affecting New Greater-than-Minimal-Risk Studies