IRB FAQs & Postponement of non-essential research uses of iohexol

May 10, 2022

*This message is sent on behalf of Associate Vice Chancellor of Clinical Research Harold Collard.*

*Please read the IRB FAQs prior to contacting the IRB.*

To All UCSF Research Faculty and Staff:

As recently communicated by Josh Adler, there is a severe nationwide shortage of Omnipaque (iohexol) iodinated contrast media for use in computed tomography, cardiology, interventional radiology, and endoscopic examinations. The shortage is due to a COVID-related shutdown of one major vendor production facility; a resolution to the supply-chain limitations is not expected until the end of June 2022. The UCSF Health pharmacy department, procurement, and contracting teams are working to purchase all acceptable alternatives and distribute them adequately across the UCSF enterprise.

As such, the Office of Research requests that research faculty postpone all non-essential research uses of iohexol, with immediate effect.

Iohexol contrast studies deemed essential to the health and well-being of the participant by the principal investigator are EXEMPT from this request and may proceed. Contrast studies deemed NOT essential should be reviewed with the IRB before postponement. To consult with the IRB, please use the Ask Andy form or email [email protected].

Ordering providers should consult this Google doc or a radiologist regarding alternative imaging examinations for specific indications. Study teams that do not already have a Radiology Department contact may email Kimberly Kallianos, MD.

The UCSF community must do all that is possible to preserve the limited iohexol contrast supplies for urgent/emergent exams for which there are no alternatives. We recognize the impact this hold of non-essential contrast enhanced radiography for clinical research may have on important research projects. The supply of iohexol contrast media is dynamic; UCSF Health will be providing updates to this plan as mitigation tactics change, and we will adjust accordingly.

We appreciate your understanding and patience. For general queries, please email [email protected].

Thank you,

Harold R. Collard, MD, MS

Professor of Medicine and Health Policy

Associate Vice Chancellor of Clinical Research

Director, Clinical and Translational Science Institute

University of California San Francisco

________________________________________________________________________________________________________________________

IRB FAQs Regarding Research Use of Iohexol

1. Who is responsible for deeming the use of Omnipaque (iohexol) iodinated contrast media essential?

  • The Principal Investigator.

2. The Principal Investigator has deemed the use of iohexol essential. Do I need to consult the IRB?

  • No. Continue the study as planned.

3. The Principal Investigator has deemed the use of iohexol NOT essential. Do I need to consult the IRB?

  • If UCSF IRB is the IRB of Record: Yes. The Principal Investigator must use the Ask Andy form or email [email protected] and include the following information: IRB study number, study population, rationale for why the use of iohexol is NOT essential. This request must come from the Principal Investigator. An IRB chairperson will review the request and discuss with the Principal Investigator as needed.
  • If UCSF IRB is NOT the IRB of Record: Consult the IRB of Record or study sponsor.

4. The Principal Investigator has deemed the use of iohexol is NOT essential and an IRB chairperson has agreed. Do I need to submit any forms in iRIS for IRB review?

  • If UCSF IRB is the IRB of Record: Yes. You must submit a Protocol Violation/Incident Report form in iRIS that describes what procedures were not performed or were altered (e.g., MRI instead of CT with contrast).
    • Mark the type of report as Incident and indicate in the form that the changes were made in order to preserve the limited supply of iohexol per University request, and that an IRB Chair has agreed with your assessment.
    • You can submit one Protocol Violation/Incident Report form that captures all procedures not performed or were altered once the University lifts the request that research faculty postpone all non-essential research uses of iohexol. The IRB’s 10-day reporting timeline does not apply to this situation.
  • If UCSF IRB is NOT the IRB of Record: Consult the IRB of Record.