Gastroenterology Utilization of Tissue (GUT) Committee
The Gastroenterology Utilization of Tissue (GUT) committee is a standing tissue utilization committee for the Division of Gastroenterology that provides guidance, approval, and letters of support for research studies involving the collection of research-only biospecimens during adult endoscopic or liver biopsy procedures prior to submission to the UCSF IRB. The goal of the committee is to maintain patient care and safety as the highest priority, while also supporting research endeavors.
Patient-derived biospecimens are being increasingly utilized in research studies. Surgical procedures often yield surplus tissue that can be provided to researchers with minimal risk to study participants. In contrast, endoscopic procedures typically yield smaller biospecimens and require additional “research-only” tissue sampling that is beyond minimal risk for patients. Patients undergoing endoscopic procedures should be recruited for research studies in a consistent and coordinated manner to minimize interruptions to clinical workflow and to avoid additional stress for study participants.
- Procedures and tissue sampling: This committee provides advice and approval for all procedures performed by the Division of Gastroenterology at UCSF, including but not limited to adult upper endoscopy, colonoscopy, sigmoidoscopy, pouchoscopy, ileoscopy, liver biopsy, endoscopic retrograde cholangiopancreatography (ERCP), and endoscopic ultrasound (EUS). Tissue sampling techniques include but are not limited to forceps biopsy, snare, brushing, and fine-needle aspiration.
- Research studies included: All research studies that involve additional adult research-only procedures, biopsies, or tissue sampling by proceduralists in the UCSF Division of Gastroenterology and Hepatology are included.
- Research studies excluded: Studies with pre-existing IRB approval as of 11/30/21 are exempt from retroactive guidance or approval by the UCSF Gastroenterology utilization of tissue (GUT) committee. This committee does not oversee research studies involving surgical specimens, or studies performed by Pediatric Gastroenterology & Hepatology. Studies that involve minimal risk only, such as collection of feces, saliva, blood, or urine samples are excluded from committee approval.
The members include general gastroenterologists, hepatologists, one advanced endoscopist, and one nursing unit director.
The UCSF GUT committee serves in both an advisory and approving role. Researchers proposing a study involving additional research-only sampling during endoscopic procedures identify collaborator(s) within the Division of Gastroenterology at UCSF. They create a draft IRB application and send it to the UCSF GUT committee for review and feedback prior to submission to the IRB. The committee provides feedback regarding feasibility, number of study participants, and safety of the number and types of biospecimens to be collected. The committee will take into consideration existing studies and the anticipated impact on procedural times, clinical workflow, and study participants. Ultimately, a letter of support from this committee is required prior to IRB submission. The letter of support generated by the UCSF GUT committee will suffice as the unit director/patient care manager's letter of support for the UCSF IRB. UCSF IRB approval is still required.
The committee meets ad hoc to discuss proposed research studies.
Committee members proposing research studies will exclude themselves from the discussion of their proposals.
All requests for tissue are reviewed by the GUT committee for feasibility, appropriate use of tissue, and priority.
- Priority of tissue use is as follows:
- UCSF investigators
- Non-UCSF academic investigators
- Private, non-academic companies
- Tissue distribution to private companies and/or academic institutions outside of UCSF requires an approved Material Transfer Agreement.
- IRB approval is still required for all tissue use.
Draft IRB applications (in pdf format) and/or pre-submission inquiries can be submitted by email to [email protected]