IBC Pre-Registration Form

Institutional Biosafety Committee (IBC) Pre-Registration Form

California Pacific Medical Center Research Institute IBC#

IBC Pre-Registration/v.083111 Page 1 of 2

Table 1: Basis for the Classification of Biohazardous Agents by Risk Group (RG)

Risk Group 1 (RG1) Agents that are not associated with disease in healthy adult humans

Risk Group 2 (RG2) Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available

Risk Group 3 (RG3) Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk)

Risk Group 4 (RG4) Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk)

1) Risk Group Assessment: Classify the Project’s Risk Group, according to Table 1. RG1 RG2 RG3 RG4

Yes No

If yes, describe why (include reference to one of the exempt categories listed in the Appendix), attach a copy of your study protocol or other document that describes the research in sufficient detail, and sign the Affirmation below. If no, skip to step #3 and complete IBC Registration Form.

Principal Investigator Name: Date:

Phone: Email: Proposed Study Initiation Date:

Project Title:

Table 1: Basis for the Classification of Biohazardous Agents by Risk Group (RG)

Affirmation: I accept responsibility for the safe conduct of work with this material. I accept responsibility for ensuring that all personnel associated with this work will received the appropriate training on the hazards and the level of containment required to perform this research safely. I will report any accident or incident that results in a potentially toxic exposure to personnel or any incident releasing recombinant DNA or other potentially hazardous materials into the environment to the IBC immediately. This may be accomplished by calling the Institutional Safety Officer, Kathy Sforzo, at 600-4620 (x64620); cell: 707-291-5129.

Principal Investigator: (Print or type)

3) Please return this form to: Virginia Giblin at 475 Brannan Street, Suite 220; Fax: 600-1725; email GiblinV@cpmcri.org.

California Pacific Medical Center Research Institute IBC#

IBC Pre-Registration/v.083111 Page 2 of 2

APPENDIX

Exemption Categories

A Research Project may be exempt from IBC review when it involves recombinant DNA that is:

i. Not expressed in organisms or viruses;

ii. Entirely DNA segments from a single nonchromosomal or viral DNA source (e.g., oligonucleotides);

iii. Expressed in cell culture only, except in cases where the cells:

a) were modified using DNA from Risk Group 3 or 4 agents, or from restricted agents,

b) contain a toxin with an LD50 of less than 100 ng/kg body weight,

c) contain viral DNA in a quantity exceeding 50% of any viral genome,

d) are used in conjunction with defective viruses in the presence of helper virus,

e) are used in an experiment involving the deliberate transfer of the cell line into humans, or

f) are grown in a volume exceeding 10 liters of culture;

iv. Expressed in transgenic rodents that are purchased for experiments that require BL-1 containment;

v. Entirely from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host or when transferred to another host by well established physiological means;

vi. Entirely from a eukaryotic host including its chloroplasts, mitochondria, or plasmids when propagated only in that host or a closely related strain of the same species;

vii. Entirely segments from different species that exchange DNA by known physiological processes, though one or more may be a synthetic equivalent;

viii. Expressed using Escherichia coli K-12 host-vector systems;

ix. Expressed using Saccharomyces host-vector systems;

x. Expressed using Bacillus subtilis or Bacillus licheniformis host-vector systems;

xi. Entirely extrachromosomal elements of gram positive organisms;

xii. Part of a human clinical trial in which induction or enhancement of an immune response to a vector-encoded microbial immunogen is the major goal, such an immune response has been demonstrated in model systems, and the persistence of the vector-encoded immunogen is not expected; or

xiii. Not a significant risk to health or the environment as determined by the NIH Director, with advice from the RAC and public comment;

Unless the Project also involves:

1) The deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine or agriculture;

2) Deliberate formation of recombinant DNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram of body weight; or

3) The deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA into one or more human research subjects.

Details on certain other experiments that may be exempt, as well as exceptions, may be found in Appendix C of the NIH Guidelines.