Sutter Health Institutional Review Board (SHIRB):
The IRB at Sutter Health
The Sutter Health Institutional Review Board (SHIRB) is established in accordance with federal law to protect the safety, rights, and welfare of human subjects involved in research at Sutter Health and its affiliated entities. SHIRB has the institutional authority to approve, modify, or disapprove such research. Unless specifically exempted by the IRB from further review, every research project involving humans must be SHIRB-approved prior to initiation and re-approved at least once a year (or more often, as determined by the IRB). SHIRB’s primary responsibility is the protection of human subjects from undue risk and from deprivation of personal rights and dignity.
SHIRB is currently comprised of two panels each of which meets monthly and shares equal authority and responsibility for reviewing research in any area or specialty. SHIRB operates in compliance with relevant state and federal regulations (including 45 CFR 46 and 21 CFR 50 and 56) and with the Federalwide Assurances (FWAs) of the Sutter Health affiliates. Each SHIRB panel is registered with the Office of Human Research Protection (OHRP): registration #00009826 and #00009827. SHIRB also serves as the Privacy Board for Sutter Health and its affiliates.
Important information to know before submitting a research project to SHIRB
Required: Sutter Health Research Institute administrative review prior to IRB submission
In accordance with Sutter Health policy, any research project involving Sutter Health and its affiliated entities must be reviewed and cleared for IRB review by one of the Sutter Health Research Institutes prior to entry into the SHIRB electronic submission system and submission to the IRB. The purpose of this review is to determine the level of administration and oversight required to ensure that Sutter Health meets its federal, state, local, and institutional obligations and a source of funding for the IRB review is identified (see fee schedule below). SHIRB will not consider an application complete—and will not initiate IRB review—without the appropriate sign-off from the applicable Research Institute.
Prior to submitting to SHIRB, please contact the applicable Research Institute for information about pre-IRB requirements.
Required: IRB Training
Sutter Health has standardized the training required to conduct human subject research, which is based upon the type of research being conducted (e.g. data only, or active interventions or consenting of subjects). New investigators will need to complete training via the CITI web-based tool. Established investigators will require updated training every 3 years. Please contact your regional research institute for additional information.
How to submit to SHIRB: IRBNet
SHIRB uses a web-based, electronic protocol management and online submission system called IRBNet. All submissions (e.g., new studies, progress reports, modifications) to the IRB are made electronically through the IRBNet system. In addition, all necessary IRB documents—including IRB application forms and instructions, review fees, rosters and meeting schedules, IRB policies and procedures, and other such information—are accessible through IRBNet.
Fee Waivers: According to current policy, fee waivers are eligible only for (1) residents, fellows, and other students conducting research as a required part of their curriculum or training at a Sutter Health-affliated program; and (2) government funded or private foundation grant proposals that do not include funds for IRB review. However, a fee waiver is not automatic: Requests for fee waivers must be reviewed and approved by the applicable Sutter Health Research Institute prior to submission to SHIRB. Please follow the instructions above to contact the applicable Sutter Health Research Institute and obtain further information regarding IRB fee waivers.
Patti Young, IRB Regulatory Affairs Lead
David Gill, PhD, CIP, HRPP Manager
Sutter Health IRB
633 Folsom St., 7th Floor
San Francisco, CA 94107