OHSU

FAQ

Instructions for revised rDNA/Infectious agent questions on the PPQ:

For rDNA or infectious agent work that is already approved and has an IBC registration #:

  • If you are submitting a grant renewal or a new project where the rDNA or infectious agent work is IDENTICAL to a previously approved IBC project, fill in the IBC # on the form. Depending on the date of your last approval, you may need to complete the annual renewal form for this project
(see http://www.ohsu.edu/research/rda/ibc/ibcpolicies.shtml). The IBC coordinator will contact you if this is the case. You must have an approval by the IBC within the past 12 months in order to have grant funds set-up into your account.
  • If the rDNA or infectious agent work is nearly identical but some modifications are needed (e.g., new gene inserts), you may still include your approved IBC #. Check the revision policy (http://www.ohsu.edu/research/rda/ibc/ibcpolicies.shtml) to see if your modification needs advanced approval, or contact the IBC if you are unsure

For rDNA work that was previously determined to be exempt:

  • If you are submitting a non-competing renewal and are not adding any new rDNA work that may not be exempt (e.g., in vivo work or using a viral vector), you may check the box that indicates the project is exempt
  • If you are submitting a new or competing grant, you must also submit the Initial rDNA Research Classification form to get a new exempt determination by the IBC

For new rDNA or Infectious agent work:

  • Submit either the Initial rDNA Research Classification form and/or Infectious Agent Questionnaire as appropriate
  • If you are unsure whether this work can be included under a previous IBC # or not, contact the IBC
 

 

Guide to Forms and Usage:

  


Initial rDNA Research Classification form (IRDRC): 


  • This form must be submitted with the PPQ for all new grant/contract submissions when recombinant DNA work included in project, unless the work can be included under a previously approved IBC project. See above FAQ

Recombinant DNA Research Questionnaire (RDRQ): 
 

  • This form must be included for new non-exempt recombinant DNA research. 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)
  • The Initial rDNA Research Classification form should precede this form. The IBC will inform you if an RDRQ is needed.

Infectious Agent /Toxin Questionnaire:
 

  • This form must be submitted with the PPQ for all new grant/contract submissions, if you do not have previous approval by the IBC for the same infectious agent or toxin

Investigational Human Gene Transfer Agent Supplemental Questionnaire: 
 

  • Use only for human gene transfer projects.
  • Annual Renewal/Project Modification form:
  • This form is now dual-purpose. It should be used for annual project reviews when required, or, it should also be used to make changes to previously approved recombinant DNA or infectious agent projects when advanced approval is required (see revision policy and annual review policy.

What types of non-recombinant infectious agents and toxins must be reviewed by the IBC?

Infectious Agents are generally defined as risk group 2 agents and above (agents that can cause disease in healthy adult humans)

Use of 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 50of less than 100 nanograms per kilogram body weight.

 

What is Recombinant DNA?

The NIH Guidelines for Research Involving Recombinant DNA Molecules defines rDNA as either:
  1.  molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or
  2. molecules that result from the replication of those described in (i) above.

That means research projects involving the use of all recombinant plasmids/vectors/viruses, even though many are exempt, should be submitted to the IBC for review (exempt determination should be made by IBC).

 

How do I submit an rDNA or infectious agent/biologically-derived toxin project for review?

For a new project, submit the Initial rDNA Research Classification form or Infectious Agent/Toxin Questionnaire (see Guide to Forms and Usage).

Investigators should also make sure they have completed the rDNA portion of the required responsible conduct of research (check your record by logging onto Big Brain, and the infectious agent shipping module if applicable*.

*Training is required for all individuals who package, handle, or prepare paperwork for the shipment of hazardous materials, including infectious substances.

Individuals at the Marquam Hill campus should complete the on line training at http://ozone.ohsu.edu/ehrs/mh/pages/gen/train.shtml before taking the package to the designated shipping location.

Live training is offered at the West Campus and should be completed before any hazardous materials are offered for transport. A schedule of training sessions is available by contacting EH&RS at 748-1501.

For Recombinant DNA Research:

For exempt projects where exempt determination can be made from the initial form, an exempt letter will be sent to the investigator. If more information is required, the investigator will be asked to complete the rDNA Research Questionnaire (RDRQ).

The RDRQ should be completed in full, with a description of the vectors, packaging systems, etc used in order to be reviewed and approved by the IBC. Please be sure to include a reference or product information specifically describing the details of the vector system (see examples of appropriately completed RDRQs here).

What Biosafety Level is required for work with the different standard viral vector systems (viral vector chart)?

Please see the Vector Table