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

 
The HRPP has implemented a change to the definition of Key Study Personnel (KSP) for human subjects research applications. Individuals who meet this definition should be listed in section 4 of the IRB application along with a description of their responsibilities and qualifications.
 
The HRPP also requires that all Key Study Personnel complete Human Subjects Protection Training through CITI prior to approval of a new study, or a modification in which KSP are being added. More information on the CITI training requirement can be found on our website.
 
New Definition
 
Key Study Personnel include the Principal Investigator, other investigators and research personnel who are directly involved in conducting research with study participants or who are directly involved in using study participants’ identifiable private information during the course of the research. Key Personnel also include faculty mentors/advisors who provide direct oversight to Postdoctoral Fellows, Residents and Clinical Fellows serving as PI on the IRB application.
 

PI Eligibility for Post Docs, Clinical Fellows and Residents

 
The criteria for who can serve as PI on applications submitted to the IRB has been revised to include Clinical Fellows and Residents in addition to Postdoctoral Fellows, as long as the following conditions are met.
 
  1. A UCSF faculty member who would otherwise qualify as a Principal Investigator is identified as the Co-PI on the application, and
  2. A cover letter from the Co-PI faculty member is attached to the application stating that he or she agrees to serve as faculty support and/or a mentor to the Fellow or Resident listed as PI on the IRB application.

Submission Guidelines for Just-In-Time Awards

 
NIH Just-in-Time Requests
 

To ensure your JIT IRB application is handled expeditiously, please complete item 1.15 of the Initial Review Submission Packet only—this section is not available for Continuing Reviews, Modifications, or other submission types. In item 1.15, note “NIH JIT” and provide the due date.

Click the link in item 1.15 to send an email to the IRB front desk ([email protected]) with your NIH JIT award notice and answer the questions included. Attach any requested documents, including a copy of your grant application, in the "Other Study Documents" section of the Initial Review Submission Packet.

Important:
The Initial Review Submission Packet is not made available for Modifications or Continuing Reviews. If your JIT is associated with a Modification or Continuing Review, the Principal Investigator should email [email protected] with the study number, stating that the submission is related to a JIT and providing the JIT due date