Instructions and Certifications (Failure to follow may result in a delay in processing) ORC Use Only. Date Received: IBC Determination:

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1 ORC Use Only Date Received: IBC Determination: Exempt Experiment Determination for Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines); Registration for Experiments that Require Institutional Biosafety Committee Approval Before Initiation; and Registration for Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation Instructions and Certifications (Failure to follow may result in a delay in processing) Complete this form to request a determination whether the recombinant or synthetic nucleic acid molecules used in the research, testing, or teaching may be exempt from the National Institutes of Health (NIH) NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). However, other federal, state, and institutional standards of biosafety may still apply. This form is also used as a Registration for Experiments that Require Institutional Biosafety Committee Approval Before Initiation and as a Registration for Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation. If the research, testing, or teaching involves the use of the following, complete the form entitled Biohazardous Use Protocol for Research, Testing, or Teaching (Parts I-IV), instead of or in addition to this form: Biological agents that cause disease in humans, animals, or plants; Non-exempt recombinant or synthetic nucleic acid molecules as defined in the NIH Guidelines; Human and non-human primate blood, tissue, cells, and cell lines; Toxins of biological origin as defined in Biosafety in Microbiological and Biomedical Laboratories (BMBL); or Any material requiring a Centers for Disease Control and Prevention (CDC) or U.S. Department of Agriculture (USDA) permit. By submitting this form, all Principal Investigators (PIs), co-pis, and personnel (collectively, Researchers ) or Instructor(s), as applicable, certify the following: 1. Have read and understood the laboratory s standard operating procedures and/or biosafety manual; will implement and maintain required records of activities; 2. Have read and reviewed this form; 3. Have submitted this form a minimum of thirty (30) days in advance of the anticipated start date of the research, testing, or teaching; and

2 4. Will abide by other federal, state, and institutional standards of biosafety, as applicable. After completing the foregoing, submit the form via to: I. Applicability of Exempt Sections Those synthetic nucleic acids that: (1) can neither replicate nor generate nucleic acids that can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or contain elements known to interact with either DNA or RNA polymerase), and (2) are not designed to integrate into DNA, and (3) do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight. If a synthetic nucleic acid is deliberately transferred into one or more human research participants and meets the criteria of Section III-C, it is not exempt under this Section. (Section III-F-1) Those that are not in organisms, cells, or viruses and that have not been modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular membranes. (Section III-F-2) Those that consist solely of the exact recombinant or synthetic nucleic acid sequence from a single source that exists contemporaneously in nature. (Section III-F-3) Those that consist entirely of nucleic acids from a prokaryotic host, including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well-established physiological means. (Section III-F-4) Those that consist entirely of nucleic acids from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species). (Section III-F-5) Those that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent. (Section III-F-6) Those genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any recombinant and/or synthetic DNA. (Section III-F-7) Those that do not present a significant risk to health or the environment (see Section IV-C-1-b-(1)-(c), Major Actions), as determined by the NIH Director, with the advice of the RAC, and following appropriate notice and opportunity for public comment. See Appendix C, Exemptions under Section III-F-8 for other classes of experiments which are exempt from the NIH Guidelines. (Section III-F-8)

3 If the selection in this section was None, continue to II. If any other selection was made, also continue to II. II. Exceptions 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. (Section III-A) Deliberate formation of recombinant or synthetic nucleic acid molecules containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight (e.g., microbial toxins such as the botulinum toxins, tetanus toxin, diphtheria toxin, and Shigella dysenteriae neurotoxin). (Section III-B) The deliberate transfer into human research participants of either: Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria: o Contain more than 100 nucleotides; or o Possess biological properties that enable integration into the genome (e.g., cis elements involved in integration); or o Have the potential to replicate in a cell; or o Can be translated or transcribed. (Section III-C) DNA from Risk Group 3, 4, or restricted organisms or cells known to be infected with these agents. (Appendix C-1-A through C-V1-A) Whole plants regenerated from plant cells and tissues cultures that do not remain axenic cultures. (Appendix C- 1-A through C-V1-A) Large scale experiments (more than 10 liters of volume in a single culture vessel). (Appendix C-1-A through C- V1-A) Deliberate introduction of genes coding for the biosynthesis of molecules that are toxic for vertebrates with an LD50 greater than 100 nanograms/kg but less than or equal to 100 micrograms/kg. (Appendix F) If the selection in this section was None, then continue to III. If any other selection was made, stop and do not continue completing this form. Instead, complete the form entitled Biohazardous Use Protocol for Research, Testing, or Teaching (Parts I-IV). Consult with the Office of Research

4 Compliance (ORC) or the Institutional Biosafety Committee (IBC). III. Experiments that Require Institutional Biosafety Committee Approval Before Initiation Experiments using Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents as host-vector systems. (Section III-D-1) Experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems. (Section III-D-2) Experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems. (Section III-D-3) Experiments involving whole animals. (Section III-D-4) Experiments involving whole plants. (Section III-D-5) Experiments involving more than 10 Liters of Culture. (Section III-D-6) Experiments involving influenza viruses. (Section III-D-7) If the selection in this section was None, then continue to IV. If any other selection was made in this section, do not complete IV, and follow these instructions: If a selection was made in I and in III, continue to V and complete the non-highlighted sections the research, teaching, or testing is exempt from NIH Guidelines. If a selection was made only in III, continue to V and complete the non-highlighted sections, in addition to the section entitled Registration for Experiments that Require Institutional Biosafety Committee Approval Before Initiation. IV. Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation

5 Experiments involving the formation of recombinant or synthetic nucleic acid molecules containing no more than twothirds of the genome of any eukaryotic virus. (Section III-E-1) Experiments involving whole plants. (Section III-E-2) Experiments involving transgenic rodents. (Section III-E-3) If the selection in this section was None, then stop and do not continue completing this form. Consult with the Office of Research Compliance (ORC) or the Institutional Biosafety Committee (IBC). If any other selection was made in this section, follow these instructions: If a selection was made in I and in IV, continue to V and complete the non-highlighted sections the research, teaching, or testing is exempt from NIH Guidelines. If a selection was made only in IV, continue to V and complete the non-highlighted sections, in addition to the section entitled Registration for Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation. V. Experiment Information Principal Investigator or Instructor Name: Office (Building and Room): Laboratory Location (Building and Room): Emergency Contact: Emergency Phone: Co-Principal Investigator or Instructor Name: Office (Building and Room): Laboratory Location (Building and Room): Emergency Contact: Emergency Phone: Co-Principal Investigator or Instructor Name: Office (Building and Room):

6 Laboratory Location (Building and Room): Emergency Contact: Emergency Phone: Maestro # (if funded) Title of Experiment Description of Experiment Registration for Experiments that Require Institutional Biosafety Committee Approval Before Initiation Sources of DNA: Nature of the inserted DNA sequences: Host(s) and vector(s) to be used: Whether an attempt will be made to obtain expression of a foreign gene: Yes No If yes, indicate the protein that will be produced: Containment conditions that will be implemented (NIH Guidelines): PI Signature: Date: Registration for Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation Describe the procedures of the experiment: Containment conditions that will be implemented (NIH Guidelines): PI Signature: Date: Comments IBC USE ONLY Determination

7 Exempt determination confirmed Approval of Registration for Experiments that Require Institutional Biosafety Committee Approval Before Initiation Revisions required for Registration for Experiments that Require Institutional Biosafety Committee Approval Before Initiation (specify in Comments) Recommendation for full committee review of Registration for Experiments that Require Institutional Biosafety Committee Approval Before Initiation (specify in Comments) Approval of Registration for Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation Revisions required for Registration for Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation (specify in Comments) Recommendation for full committee review of Registration for Experiments that Require Institutional Biosafety Committee Approval Before Initiation (specify in Comments) Non-exempt determination made (specify in Comments) BUP required (specify in Comments) Recommendation for full committee review (specify in Comments) Other (specify below)