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Oregon State University

IBC Registration Instructions and Forms

Registration of Projects and Programs

Investigators may register individual projects involving rDNA or other biohazards, or may choose the option of registering their research program.  A project registration is generally quite defined in scope and may represent the work proposed in a single funded grant.  The program registration requires somewhat more detailed information to be submitted than a project registration, but has the advantage of covering all expected work for the duration of the registration period (i.e., multiple sponsored projects).  New project initiated with this time frame are “pre-approved” provided that they fall within the scope of the program registration submitted to and approved by the IBC.  In general, investigators who have multiple projects or areas of research emphasis will benefit from the program registration by not being required to file multiple project registrations.

Program Registrations:  Principal investigators whose research programs make use of transgenic plants or animals, rDNA or pathogen work and are conducting mutiple projects with the same containment level requirements are encouraged to complete the apprpriate Program Registration Form and send it along with supporting documentation to the campus address below.  For research involving transgenic plants, the Transgenic Plant Program Biosafety Plans are reviewed by the IBC and approved; all projects that fall within the parameters of the Plan are pre-approved during the approval period (4 years).  Likewise, investigators who work routinely with rDNA, transgenic rodents or other transgenic animals, and / or human, plant or animal pathogens are encouraged to register their programs for review rather than individual projects.  Like the Transgenic Plant Program Biosafety Plans, all work falling within the parameters of the Program Registration is approved for the duration of the approval.

Project Registrations:  A project registration can be submitted for any type of project requiring registration with the IBC using the same multi-section form by completing those sections that pertain to the project.  Registrations must include a narrative of the project.  This narrative should provide a brief overview of the goals of the project, the methods that will be applied to achieve those goals, an assessment of the hazards of the project, and the safety procedures that will be implemented to protect workers and/or the environment from potential biohazards.  Investigators may include a recommendation for the level of containment they feel is appropriate to safely conduct the proposed research. 

Note: The project narrative is distinct from a copy of a grant proposal or abstract from a grant proposal.  Grant proposals rarely include safety procedures or risk assessments.  If there is a grant proposal for the project, a copy of the research plan from the proposal may be included, along with the narrative, but is not required. 

Standard Operating Procedures:  Standard Operating Procedures (SOPs) are required for projects and programs involving RG-2 or higher human pathogens, and also for high consequence animal or plant pathogens.  Researchers should describe in detail the procedures they will use during manipulation of the pathogens and include all other information that is relevant to their projects.  For projects that require SOPs, the safety procedures in the narrative may be referenced to the SOP to eliminate redundancy.

Where to send forms:  Completed forms must be signed and should be sent to the Biological Safety Officer, Environmental Health & Safety, Oak Creek Building via campus mail.  Submission of incomplete forms or forms not signed by the principal investigator will delay the review process.  The BSO provides the initial review of the proposals and will contact the principal investigator if additional information is required. 

Once a project or program has been approved by the IBC, a memorandum of approval will be sent to the principal investigator.

Project Registration Duration:  The duration of approval for registrations, both of individual projects and programs, is three years from the date of the memorandum of approval.  If there are changes in the project / program goals, facilities, personnel, or methods then an amendment must be filed with the IBC describing the changes to the registration.  Annual updates of registrations are required.

Forms:

rDNA / Pathogen Project Registration Form

rDNA / Pathogen Program Registration Form

Transgenic Plant Program Registration Form

Amendment Form - use to amend existing approved registrations

Section D - use to supplement Amendment Form for pathogen work