Vitalant Research Institute (VRI) Institutional Biosafety Committee (IBC)

Overview

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 Biosafety Policy for Research Involving Biohazards  (“Guidelines”), and the Biosafety in Microbiological and Biomedical Laboratoriesexternal site, 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 which is defined as research involving known or potential risk to human health and any of the following:

  1. Wild-type biological agents (i.e., bacteria, viruses, fungi, or parasites) that cause disease in humans.
  2. Cells, viruses, or organisms, other than plants, which have been genetically modified;
  3. Toxins, prions, and other self-aggregating proteins; or 
  4. 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 - first Friday of June and December, 11:00AM to 12:00PM PST

  • Friday, October 9th at 1:00 PM PT
  • 2026 Meetings: June 5 and December 4

VRI IBC Meeting Minutes:

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
Roberts@Vitalant.org
Steven Sweet, MSM, BS
VP, Research Administration

For IBC meeting minutes or other inquiries, please contact Patrick Roberts at proberts@vitalant.org.