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

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

Dear Research Community,

I am writing to introduce myself as the newly-appointed Interim Chief Ethics and Compliance Officer, overseeing the HRPP (Human Research Protection Program) office among others. This office has a critical role in helping you protect participants and initiate studies in a timely fashion so as to keep UCSF investigators at the forefront of clinical research while offering our patients the most promising and innovative therapies. I am aware that we are not meeting the expectations of our research community with respect to protocol approval times. The primary reasons for this are vacant staff positions and an increased volume of protocol submissions. HRPP staff and IRB reviewers are working tirelessly to reduce the backlog. In addition, the following are a few of the steps we are proposing to begin to address the situation.

HRPP Office Staffing

We are recruiting to fill vacancies in the HRPP office staff and expect to soon identify a finalist candidate for the Director position. We appreciate the efforts of Laurie Herraiz of the HRPP staff along with Michael Roach, a consultant who continues to serve as the Interim Director as he has over the past eight months. We also recognize and appreciate the support you have given them in the interim period.

External IRB Use

Effective December 1, 2017, UCSF Phase II and foundation-funded trials may temporarily use external IRBs (e.g., WIRB). Such use is temporarily being opened through the end of June 2018. We will then reevaluate such use on a longer-term basis. We understand that this change will not improve processing for all trials, but it is a small part of our broader efforts.

Single IRB Use for Multi-Site Studies

After January 25, 2018, NIH expects that all sites participating in multi-site studies will use a single Institutional Review Board (sIRB). Our staff are engaged in UC-wide discussions of sIRB implementation. We are working on UCSF-specific guidance and will distribute it in December.

Stakeholder Involvement: Town Hall Meetings and IRB Policy Group

We are planning town hall meetings as we seek input to refine our IRB systems. We will also restart the “IRB Policy Group”-- an advisory group for the Chief Ethics and Compliance Officer. The group (Chairs and Vice-Chairs of each of the IRB panels, HRPP leadership, Legal, VA, and non-IRB faculty representatives) will be asked to meet regularly to facilitate and expedite changes that can improve UCSF policies for the protection of human subjects and human research at UCSF.

Our goals

Guided by stakeholder input, we will strive to prioritize timely review of IRB applications and provide metrics for your use; ensure a transparent protocol review and approval process; maintain direct communication with stakeholders; and engage in process improvements to address other critical elements in the research infrastructure necessary to support the UCSF mission.

Please let me know if you have any questions at this point, and we look forward to working with you in partnership.

Best regards,

Brian Smith
Associate Vice Chancellor, Research Infrastructure & Operations
Interim Chief Ethics and Compliance Officer