Guidance Updates

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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 that your JIT IRB application is handled expeditiously, e-mail the UCSF IRB Expedited and Exempt Coordinator Manager (Joanne.Mickalian@ucsf.edu) with JIT in the subject line as soon as NIH issues a JIT notice. In the e-mail text, provide the study number, summarize the JIT request including the due date, and indicate whether this is a single site protocol (i.e., data collection solely at UCSF sites) or whether UCSF is also serving as a coordinating center or data center for a study that includes two or more data collection sites. Also attach a complete copy of the grant application to the email.
 
When preparing your iRIS submission, fill out item 1.9 of the Initial Review Submission Packet noting “NIH JIT” and the due date. Also attach a complete copy of the grant application in the “Other Study Documents” section of the initial submission.