(revised September 2013)
General Charge
The Administrative Panel on Biosafety reviews all University research and teaching activities involving the use of biohazardous agents and recombinant DNA molecules and synthetic nucleic acid (sNA) 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 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 Biosafety Level 2 or 3 agents AND/OR non-exempt recombinant DNA AND/OR synthetic nucleic acid 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 subject protocols involving gene transfer, 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 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.
Definitions
Biohazardous Agents:
A. Infectious/pathogenic agents classified in the following categories: Biosafety level 2, 3, and 4
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.
Synthetic Nucleic Acid Molecules:
A. Can replicate or generate nucleic acids that can replicate in a living cell and/or
B. Are designed to integrate into DNA and/or
C. Produce a toxin with a LD50<100ng/kg body weight.
Synthetic nucleic acids that are deliberately transferred into one or more human subjects and:
A. Are >100 nucleotides and/or
B. Can integrate into the genome and/or
C. Can replicate in a cell and/or
D. Can be transcribed or translated.
Gene Transfer:
Delivery of exogenous genetic material (DNA or RNA) to somatic cells for the purpose of modifying those cells.
