Vitalant Research Institute (VRI) Institutional Biosafety Committee (IBC)
Overview
The Institutional Biosafety Committee meets to discuss and address various safety concerns.
Institutional Biosafety Committee meets on the second Wednesday of each month from 9:00-11:00 am. Please refer to the meeting schedule for exact dates.
BUA review process may take up to 1-2 months, including EH&S site review, Biosafety Officer pre-review and Institutional Biosafety Committee review.
Federal law requires the establishment of an Institutional Biosafety Committee (IBC) at institutions where recombinant biological materials are used in research. At VRI, the IBC consists of a Chair, Vice Chair, and members of the VRI Faculty with expertise in a wide variety of biological disciplines. At least two community members with no VRI affiliation other than membership on the IBC are required and are responsible for representing the surrounding community’s interests regarding health and environmental protection. VRI IBCmembers include a Biological Safety Officer (BSO), and the Director of the Animal Care Facility. The IBC membership represents collective expertise and research experience in recombinant DNA, infectious agents, toxins, and biological safety, which are applied to the evaluation of appropriate safety measures needed for experiments that may pose potential risks to health or the environment.
The VRI IBC is also specifically authorized to limit or suspend any research that is not in compliance with VRI biosafety policies and procedures. The VRI IBC advises and works with EH&S in administering the various aspects of the Biological Safety Program.
The IBC is responsible for 1) ensuring that research conducted at VRI is in compliance with the NIH Guidelines for Research Involving Recombinant DNA Moleculesexternal site (opens in a new window) (“Guidelines”), and the Biosafety in Microbiological and Biomedical Laboratoriesexternal site (opens in a new window), 6th edition (“BMBL”); 2) drafting biosafety policies and procedures; and 3) reviewing individual research proposals for biosafety concerns. The IBC meets bi-annually to review proposals from all VRI faculty members, including those who work off-site. The IBC does not oversee biosafety policies for other Vitalant locations but does provide consultation when requested.
Principal Investigators (PIs) who wish to perform research using biological materials must submit a Biological Use Authorization (BUA) application to the VRI IBC for approval prior to beginning work. The Committee reviews applications that involve research including biohazards is defined as research involving known or potential risk to human health and any of the following:
- Wild-type biological agents (i.e., bacteria, viruses, fungi, or parasites) that cause disease in humans.
- Cells, viruses, or organisms, other than plants, which have been genetically modified;
- Toxins, prions, and other self-aggregating proteins; or
- Cells or organisms, other than plants, containing 1, 2, or 3 above.
The IBC review includes an independent assessment of the containment levels required by the NIH Guidelines for the proposed research, an assessment of the laboratory facilities, procedures and practices, and a review of the training and expertise of personnel.
While the IBC cannot alter the Risk Group of an organism, it is within the IBC’s authority to raise or lower containment for the work involving the organism based upon a full risk assessment of the work being done. Recommendations for the biosafety level (BSL) of laboratory operation are often modified according to the number of infectious particles encountered in the project and the usual route of infection.
Meeting Schedule will fall on:
The first Friday of June and December from: 11:00 AM to 12:00 PM
- December 4, 2026
Voting Members
| Name/Affiliation |
|---|
| Graham Simmons, PhD, IBC Chair Senior Investigator, Virology GSimmons@Vitalant.org |
| Satish Pillai, PhD, IBC Vice Chair Senior Investigator, Viral Pathogenesis SPillai@Vitalant.org |
| Pamela Millani, PhD Director, Molecular Technology and Genomics (MTG) Vitalant Research Institute |
| Marcus Muench, PhD Director, Cell Therapy Core Vitalant Research Institute |
| Shawn Keil Manager, Research Support Services Vitalant Research Institute |
| Rachel Martinelli, BSO Manager, Research Laboratories RMartinelli@Vitalant.org |
| Nora Hirschler, Community Member, Former CEO of Blood Centers of the Pacific |
| Laura L. Flores, Community Member U.C. Berkeley |
| Bozena Krystyna Kozakiewicz, Community Member U.C. Berkeley |
Non-Voting Members
| Name/Affiliation |
|---|
| Patrick Roberts, BA, Committee Coordinator Clinical Research Coordinator PRoberts@Vitalant.org |
| Steven Sweet, MSM, BS VRI Senior Director, Operations |