STANFORD UNIVERSITY
CHARGE TO
THE ADMINISTRATIVE
PANEL ON
BIOSAFETY
(October
2003)
GENERAL
CHARGE
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 faculty, staff, students and/or
visiting
scientists which involve biosafety
activities whether
the activities are carried out on campus or off campus (usually under
other
Institutional Biosafety Committees). 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 Cooperation
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 up to 5 biosafety
protocols per year from VAPAHCS
researchers not
otherwise affiliated with Stanford
University.
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 their responsibilities.
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.
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 attached 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.
In such cases, the Panel will
immediately notify the affected investigator(s), the relevant school
dean, the
Vice Provost and Dean of Research and Graduate Policy, 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 and Graduate
Policy.
DEFINITIONS
Biohazardous
Agents:
A. Infectious/pathogenic agents classified in the
following categories: Class 2, 3, 4 and 5 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.
Gene Therapy:
Delivery
of exogenous genetic material
(DNA or RNA) to somatic cells for the purpose of
modifying those cells.
GUIDELINES
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 Panel Proceedings.
The
following guidelines are established to aid
the Panel in the exercise of its
responsibilities:
Biohazardous Agents
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 or the duration of their funding.
Protocols
involving Class 1 agents that do not involve recombinant DNA,
are not
reviewed by the Panel.
Research
using Class 4 and Class 5 agents is not currently
being
carried out at Stanford.
Toxins
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, Additional
Requirements for Facilities Transferring or Receiving Select
Agents.
Recombinant
DNA
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
which involves pathogenic agents, human subjects, live animals,
plants,
and/or planned release of recombinant DNA organisms into the
environment.
Gene
Transfer/Therapy
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. Final approval is contingent upon protocol
submission to ORDA/RAC.
Experiments
classified as "Exempt" in the NIH
Guidelines do not require Panel review.
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.
APPEALS
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 and Graduate Policy for
mediation.
MEMBERSHIP
The
Panel is
appointed by the Vice Provost and Dean of Research and Graduate
Policy
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 Graduate Policy 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.
REPORTING
OBLIGATIONS
The
Panel reports to the Vice Provost
and Dean of Research and Graduate Policy.
The Biosafety Officer is the institutional official
responsible for the
day-to-day operation of the biosafety
program and
reports to the Associate Vice-President, Department of Environmental Health and Safety.
PANEL
MEETINGS
The
Panel shall meet as necessary to
conduct its business but no less than bi-monthly. The
Chair shall submit an annual report of
Panel activities and deliberations to the President by October 1st of the following year.
STAFF
SUPPORT
EH&S and the
Office of the Vice Provost and Dean of Research and Graduate Policy
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. |