Transition of IRB Review for Research Conducted at UCSF Benioff Children’s Hospital Oakland
Beginning May 1st, 2020, the UCSF HRPP will start receiving transfers of IRB approvals from UCSF Benioff Children’s Hospital Oakland (BCH Oakland) into the iRIS system.
New Oakland IRB Committee
A new Oakland IRB Committee is currently being convened. The new committee will be based at the Oakland campus and will be primarily staffed with IRB Members whose main work site is the Oakland campus.
Lynne Neumayr, M.D., who specializes in Pediatric Hematology/Oncology and has Chaired the BCH Oakland IRB for the last two years, will serve as Chair of the new Oakland Committee. Art D’Harlingue, M.D. is a Neonatologist and will serve as the Vice Chair. Diane Wara, M.D., a Pediatric Immunologist and Vice Chair of the UCSF Laurel Heights IRB Committee, has volunteered to also serve as a member of the new Oakland IRB Committee.
Most of the new Oakland IRB members have served on the BCH Oakland IRB and bring a wealth of knowledge and experience in human subject protection and the regulatory review of research with them.
As the committee is first being brought on-line, their work will initially be limited to review of ongoing and new research that is being conducted primarily at the Oakland campus. The long-term plan is that the Oakland Committee will become the main committee for review of research involving pediatric populations and childhood diseases, as capacity allows.
Transition Process and Priorities
The transition process is mapped out to occur over a 9-month period. First priority will be given to studies involving full committee
interventional research and minimal risk
research involving subject contact. No-subject-contact research, such as studies that ONLY involve chart reviews or specimen analysis, as well as studies involving a reliance will be processed according to expiration date.
Changes to the Initial Review Form
In order to route new and transferring UCSF Benioff Children’s Hospital Oakland studies to the Oakland Committee in iRIS, some minor changes have been made to the Initial Review Submission Packet Form.
If UCSF Benioff Children’s Hospital Oakland is checked as an institution in the Sites section in the Study Application Form, the Initial Review Submission Packet Form will display questions relating to site status and prior IRB review.
1.9 * BCH OAKLAND STUDY: You checked UCSF Benioff Children's Hospital Oakland (BCH Oakland) as a site. Is BCH Oakland the PRIMARY study site:
* Has this study already been approved by the BCH Oakland IRB:
* What is the original BCH Oakland IRB number: ______________________________
If your study is being conducted at both the San Francisco and Oakland campuses and the Oakland campus is not the primary site, you should check ‘No’ to 1.9.
BCH Oakland IRB Integration Resources
The HRPP has a new webpage for IRB integration
information and resources. The site includes instructions for submission pre- and post-transfer as well as information about consent form and HIPAA requirements for transferred studies.
Contact Brigid Roy at [email protected] if you have questions about transferring BCH Oakland research to the new Oakland IRB Committee.