CHARGE TO THE ADMINISTRATIVE PANEL ON BIOSAFETY
(Revised July 2008)
The Administrative Panel on Biosafety reviews all University research and
teaching activities involving the use of biohazardous agents and recombinant
DNA molecules that require approval ("biosafety activities"), as defined below.
Through these reviews, the Panel ensures that the activities described in the
previous sentence and the related facilities are in compliance with applicable
University policies and external regulations.
The Panel advises the University and recommends policies to guide investigators
and the Department of Environmental Health & Safety (EH&S) in carrying out the
University’s Biosafety Program in the acquisition, use, training, transfer, storage,
disposal, and emergency response procedures for all biosafety activities. The
Panel’s objective shall be to ensure that such activities meet standards of good
practices consistent with safety of personnel and the general public in ways that
best facilitate relevant research or teaching activities of the University.
The Panel is responsible for reviewing all University projects conducted by
Stanford faculty, staff, students and/or visiting scientists which involve biosafety
activities at Stanford facilities. In addition, the Panel may be asked by the
University administration to review research protocols on behalf of other
institutions with which Stanford has formal affiliation agreements. Under
Stanford's current “Institutional Biosafety Committee” agreement with the
Veterans Affairs Palo Alto Health Care System (VAPAHCS), the Panel shall
review all biosafety protocols from Stanford researchers located at the
VAPAHCS and from VAPAHCS researchers not otherwise affiliated with Stanford
The Panel shall function so as to discharge the University’s obligations placed
upon the Panel by current governmental requirements, including those described
in the NIH Guidelines, the Centers for Disease Control and Prevention (CDC)
Guidelines, and Occupational Health & Safety Administration (OSHA)
Regulations. To this end, the Panel shall assist protocol directors in meeting
All biosafety activities involving the use of Class 2 or 3 agents OR non-exempt
recombinant DNA molecules as defined by the National Institutes of Health (NIH)
shall be reviewed by the Panel regardless of the source of funding for the project.
The Panel may approve research protocols with or without modifications, or
withhold approval of all or any portion of a protocol. The Panel may delegate
review and approval of protocols that meet specific requirements to a voting
member of the panel. This subset of protocols must be agreed upon by the full
Panel and approved by the Dean of Research.
All human subjects’ protocols involving gene transfer or gene therapy, as defined
in the NIH Recombinant DNA Research Guidelines, shall be reviewed by the
Panel in coordination with the Administrative Panel on Human Subjects in
Medical Research. (See Review Process for Biosafety and Human Subjects
Gene Transfer or Gene Therapy Experiments.)
The Panel shall assess suspected or alleged violations of protocols, external
regulations, or University policies which involve biosafety activities. Activities in
which serious or continuing violations occur may be suspended by the Panel or
the Institutional Biosafety Officer. In such cases, the Panel will immediately
notify the affected investigator(s), the relevant school dean, the Vice Provost and
Dean of Research, appropriate University officers, and others as required by
University policies and external regulations.
Upon request, the Panel shall review and comment on proposed external
regulations dealing with biosafety. When appropriate, the Panel will formulate
draft policies and procedures for approval by the appropriate University bodies
and promulgation by the Vice Provost and Dean of Research.
A. Infectious/pathogenic agents classified in the following categories: Class 2, 3, and 4 bacterial, fungal, parasitic, viral, rickettsial or chlamydial agents or,
B. Other agents that have the potential for causing disease in healthy individuals, animals, or plants.
Recombinant DNA Molecules:
A. Molecules which are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell or,
B. DNA molecules that result from the replication of those described in "A" above.
Delivery of exogenous genetic material (DNA or RNA) to somatic cells for the
purpose of modifying those cells.
All biosafety protocols shall be available for review by any member of the Panel.
The Panel shall maintain records of research protocol reviews, minutes of
meetings, including records of attendance and Panel deliberations. The activities
of this Panel are subject to the Guidelines on Confidentiality of Administrative
The following guidelines are established to aid the Panel in the exercise of its
Protocols involving Class 2 and Class 3 biohazardous agents must be
reviewed and approved by the Panel prior to the initiation of use of agent.
Approval of Class 3 agents may be granted for no more than one year after
review at a convened meeting of a quorum of the Panel (i.e., a majority of the
voting members) with the affirmative vote of a majority of those present.
Class 2 protocols are approved for 3 years
Protocols involving Class 1 agents that do not involve recombinant DNA, are
not reviewed by the Panel.
Research using Class 4 agents is not currently being carried out at Stanford.
The routine use of most toxins will not require APB review and approval.
However, the Panel will notify the Department of Environmental Health and
Safety (EH&S) if any experiments involve the isolation and production of
certain toxins (from live biological organisms) that are listed in the CDC
Standard, Select Agent Regulation (42 CFR 73).
Recombinant DNA experiments involving certain Class 1 agents and all Class
2 and Class 3 agents require Panel approval before initiation. In addition,
Panel approval is required prior to the commencement of any proposed
recombinant DNA project that involves pathogenic agents, human subjects,
live animals, plants, and/or planned release of recombinant DNA organisms
into the environment.
Human Subjects protocols involving gene transfer or gene therapy must be
reviewed and approved by the Panel prior to initiation of protocol. Approval
may be granted for no more than one year after review at a convened
meeting. RAC review occurs before final Panel approval in order to inform
that Panel of the RAC's recommendations before the Biosafety Panel makes
its final determination.
Experiments classified as "Exempt" in the NIH Guidelines do not require
Conflict of Interest
In accordance with the NIH Guidelines, no member of an IBC may be
involved (except to provide information requested by the IBC) in the review or
approval of a project in which he/she has been or expects to be engaged or
has a direct financial interest.
In cases of dispute with respect to procedures or decisions of the Panel, appeals
may be made to the Vice Provost and Dean of Research for mediation.
The Panel is appointed by the Vice Provost and Dean of Research and shall be
made up of at least five members with expertise in general issues of laboratory
biosafety, use of infectious materials, and recombinant DNA technology.
Individuals on the Panel include faculty and staff, one student nominated by the
ASSU Committee on Nominations who is either an upperclassman or preferably
a graduate student with previous biosafety experience, two members from the
local community not otherwise affiliated with the University, and any others who
may be invited to serve when their expertise is required.
Voting ex officio members shall include representatives of the: Department of
Environmental Health & Safety (Biosafety Officer) and Department of
Comparative Medicine (a veterinarian). Non-voting ex officio members shall
include representatives of the: Department of Environmental Health & Safety
(Associate Vice Provost), Office of Vice Provost and Dean of Research and
Office of General Counsel (consultation basis).
The term of membership on the Panel is a 12-month renewable period beginning
October 1 through September 30.
The Panel reports to the Vice Provost and Dean of Research. The Biosafety
Officer is the institutional official responsible for the day-to-day operation of the
biosafety program and reports to the Associate Vice-Provost for Environmental
Health and Safety.
The Panel shall meet as necessary to conduct its business but no less than bimonthly.
The Chair shall submit an annual report of Panel activities and
deliberations to the President by October 1st of the following year.
EH&S and the Office of the Vice Provost and Dean of Research shall provide the
necessary staffing and administrative assistance. EH&S shall provide technical
expertise and advice as necessary for the Panel to fulfill its duties.