The OHSU IBC all reviews research involving recombinant or synthetic nucleic acid molecules, non-recombinant infectious agents and biologically derived toxins:
- Recombinant or synthetic nucleic acid molecules
In the context of the NIH Guidelines, recombinant and synthetic nucleic acids are defined as:
(i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids;
(ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or
(iii) molecules that result from the replication of those described in (i) or (ii) above.
Due to the complexity of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the OHSU IBC, like many other institutions, reviews all work with recombinant DNA or synthetic nucleic acids to determine applicable guideline requirements or if the work is exempt.
Infectious Agents are generally defined as risk group 2 agents and above (agents that can cause disease in healthy adult humans)
Biologically Derived Toxins need only be reviewed by the IBC if the toxin is a select agent, or if the toxin is lethal for vertebrates at an LD 50 of less than 100 nanograms per kilogram body weight. Please refer to the Fact Sheet on Biological Toxins for a list of more commonly used biological toxins.
virally based vectors
in vivo work with any vector or recombinantly modified cells
non-standard host-vector systems (see Appendix C of the NIH Guidelines),
experiments involving culture volumes that are >10 liters
vectors containing genes from Risk Group 3 or 4 organisms or genes for toxins lethal in vertebrates with an LD50<100ng/kg
The following types of research with rDNA would typically be exempt:
use of standard laboratory strains of bacteria or yeast, such as K-12 strains of E. coli, S. cerevisiae, S. uvarum, or any asporogenic B. subtillis or B. licheniformis
transfection of tissue culture cells with non-viral vectors (e.g. plasmids)
the purchase, maintenance, and breeding of transgenic rodents, with few exceptions as outlined in the Transgenic Animal Review Policy
Research with synthetic nucleic acid molecules, or their DNA or RNA derivatives, is covered by the NIH Guidelines if the nucleic acid molecule is being used in cells, organisms, or viruses and if it:
- has the potential to replicate in cells (e.g. a chemically synthesized virus or sequence contains an origin of replication)
- can integrate into genomic DNA (e.g. contains cis elements involved in integration)
- encodes a toxin lethal for vertebrates with an LD50 of <100 ng/kg
- or use of synthetic nucleic acid molecules >100 nucleotides in human subjects
The following types of research with synthetic nucleic acid molecules would typically be exempt:
- nucleoside analogs (e.g. BrdU) in vitro or in vivo
- siRNAs, microRNAs, or morpholinos in vitro or in vivo
- the chemical synthesis of nucleic acid molecules (including PCR)
If the research project involves one of the above examples but may also meet one of the criteria for non-exempt synthetic nucleic acid research in the top four bullets, contact the IBC for a determination.
What Biosafety Level is required for work with the different standard viral vector systems (viral vector chart)?
- Please see the Vector Table.
There is now an electronic
Institutional Biosafety Committee (eIBC) submission system which allows a
direct interface between the IBC and the researchers, electronic approval
information, real time access to forms and protocol information, and tracking
of approval status. For additional information on the eIBC, please refer to the
eIBC and the transition to eIBC
For non-exempt projects additional forms will need to be completed to provide additional detail above what is captured in eIBC.
Recombinant DNA Research Questionnaire (RDRQ):
- This form must be completed and uploaded to an eIBC protocol for protocols involving non-exempt research with synthetic nucleic acid molecules or recombinant DNA. This includes work with virally-based vectors, recombinantly modified infectious agents, or any in vivo use of recombinant DNA (with the exception of transgenic animals created by a core facility or outside your lab).
Infectious Agent /Toxin Questionnaire:
- This form is to be completed and uploaded to an eIBC protocol for projects involving non-recombinant infectious agents or biologically derived toxins.
IBC Questionnaire for Human Subjects Studies:
- Use only for human gene transfer projects.
The Principal Investigator is primarily responsible for training research staff, but there are a few institutional training and compliance modules that are also necessary.
Responsible Conduct in Research for All is required of all OHSU personnel engaged in research.
- Responsible Conduct in Research involving rDNA, synthetic nucleic acid molecules, infectious agents and biologically derived toxins is required for all personnel listed on an IBC protocol.
- An up to date Conflict of Interest in Research disclosure is required for all OHSU personnel engaged in research.
- Laboratory Safety is required of all OHSU personnel who work in a research laboratory (or supervise those that do) and covers laboratory safety concerns.
- Bloodborne Pathogen (BBP) Training for the OHSU Research Laboratory is required for any research personnel working with human blood, tissues, or cell lines;animal blood, tissue, or cell lines which may contain zoonotic pathogens (especially those from non-human primates);or performing any research involving the culturing of BBPs.
- Dangerous Goods Shipping Course is only required for individuals shipping state or federally regulated substances including biological substances (e.g. tissues, body fluids, organs, infectious substances, vectors, proteins, RNA, DNA, etc.), chemicals, animals, and refrigerants such as dry ice, liquid nitrogen, or wet ice.
When completing a PPQ for a new grant or a resubmission or competing renewal of a previously submitted grant, check yes to the biosafety question if grant involves any use of exempt or non-exempt IBC covered agents. IBC review and approval or exempt determination is not needed at time of grant submission. Approval or exemption is however needed prior to start of work involving covered agents or prior to release of grant funds, whichever comes first.
- If the scope of work in the grant involves IBC covered materials and you already have an IBC protocol covering these agents, log into eIBC and create an amendment to add the grant and the PPQ# to your IBC protocol. Please review all existing information in the protocol to make sure no other changes such as updates to biosafety cabinet certification dates or personnel need to be documented.
- If the grant involves IBC covered materials and you do not have an IBC protocol, or the new work is of a different scope from an existing IBC protocol, please create a new safety protocol in eIBC.
- If a new grant or a resubmission or competing renewal of a previously submitted grant involves exempt work with recombinant DNA or synthetic nucleic acid molecules, you must request an exempt determination for this new funding source via eIBC. The help text (blue circles with question marks) will help guide you through the exemption process.