Gastroenterology Utilization of Tissue (GUT) Committee

Committee

The UCSF Gastroenterology Utilization of Tissue (GUT) Committee provides guidance, approval, and letters of support for research studies involving the collection of research-only biospecimens during 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.

Overview

Endoscopic procedures typically yield smaller biospecimens and require additional “research-only” tissue sampling that is beyond minimal risk for patients.

  • 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 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 research-only procedures, biopsies, or tissue sampling by proceduralists in the UCSF Division of Gastroenterology are included. This committee does not oversee research studies involving surgical specimens. Studies with pre-existing IRB approval as of 11/30/21 are exempt from retroactive guidance or approval by the UCSF GUT committee. Studies that involve minimal risk only, such as collection of feces, saliva, blood, or urine samples are also excluded from UCSF GUT committee approval.

Membership

Members include three general gastroenterologists, two hepatologists, one advanced endoscopist, and one nursing unit director.

Expected outcomes

The UCSF GUT committee serves both an advisory and approving role. Researchers proposing a study involving additional research-only sampling during endoscopic or liver biopsy procedures first identify collaborator(s) within the Division of Gastroenterology at UCSF. Draft IRB applications can be sent to the UCSF GUT committee ([email protected]) 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 takes into consideration existing studies and anticipated impact on procedural times, clinical workflow, and study participants. Ultimately, a letter of support from the UCSF GUT committee will be required prior to IRB submission. This letter of support serves as the unit director/patient care manager letter of support required by the UCSF IRB. UCSF IRB approval will still be required.

Meetings

The committee meets monthly to discuss proposed research studies.

Additional considerations

Currently, the UCSF GUT committee does not provide resources, personnel support, or facilities to assist with patient recruitment, biospecimen acquisition, or biobanking.

Tissue distribution

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.

Contact

Draft IRB applications (in pdf format) and/or pre-submission inquiries can be submitted by email to [email protected]