Contents
Cal Poly Pomona

Institutional Biosafety Committee (IBC)

Purpose

The Institutional Biosafety Committee (IBC) provides guidance to University researchers who use Biologics, Infectious Agents and Recombinant DNA within the scope of their work.

Such work must be approved by the IBC before work may begin and any funding made available. The IBC was designed to facilitate researchers and their goals by streamlining the process of submiting proposals for approval in a way that reduced the redundnaices within various regulatory requirements.

 

IBC Schedule

 

Committee Functions

The following are functions performed by the IBC to adequately regulate research in the area of Biologics, Infectious Agents and Recombinant DNA. These functions are focused on reducing the regulatory burden imposed on researchers, while maintaining safe work environments for all employees who work with those materials.

  • Recognize and assess dangers associated with respective research in Biologics, Infectious Agents and Recombinant DNA;
  • Assure Federal, State and Local agencies of compliance in regards to IBC related research;
  • Assisting faculty researchers in upholding safe laboratory and research practices in the areas of Biologics, Infectious Agents and Recombinant DNA;
  • Review research proposals to effectively assess the safety of proposed work;
  • Publish templates for Standard Operating Procedures, written programs, plans and policies for reseachers to reduce the regulatory burden.
  • Collaborate with the Office of Research and Sponsored Programs to ensure that funding is released to the Principle Investigator (PI) when IBC approval is reached.
  • Promote open collaboration between on-campus committees to facilitate the transfer or sharing of information pertinent to proposed research projects and to reduce the amount of information required for submittal when already required for another committee's approval. Such overlap can occur between the Animal Care and Use Committee (ACUC) and Radiation Safety Committee.

All committee functions and procedures are detailed in the Institutional Biosafety Committee Memorandum.

 

What Needs Approval?

In order to maintain a safe work environment and research, certain experiements are regulated by the IBC and must be approved prior to starting work. In some cases when grant funding is applicable, IBC approval is required before funding can be released. The following table outlines regulated experiments and provides access to the applicable submission forms which must be submitted to the IBC for approval.

 

Tip: Hover your cursor over the form links to display the form titles.

An image displaying a mouse cursor hovering over the link "Form 1" to display the title "Registration of Research Involving the Use of Biological Materials".

 

*Note: Forms are currently under development and will be available shortly. Please contact EH&S with any questions.

BIOLOGICAL MATERIALS

FORM(s) TO COMPLETE

ADDITIONAL SECTION PAGES

(if additional sections are needed)

Recombinant DNA experiments listed as "covered" by the NIH Guidelines

Form 1

Form1.SectionV.Personnel

Form1.SectionVII.Location

Form1.SectionIX.rDNA_insertedDNA

Form1.SectionIX.rDNA_vector-host

Form1.SectionX.InfectiousMaterials

Infectious Organisms (bacteria, fungi, parasites, prions, rickettsias, viruses, etc) that may cause disease in healthy humans, or cause significant environmental or agricultural impact

Form 1

Human gene therapy

Form 1

Select agents

Form 1

Work with human, nonhuman primate, other mammalian tissues, fluids, excretions, secretions, cells or cell culture

Form 2

Form 1 - if use of the materials involves recombinant DNA and/or culture of infectious organisms (no need to complete Form 2)

Form2.SectionVII.Personnel

Work with animals or animal specimens known to be potential reservoirs or vectors of zoonotic disease (EXEMPT: Rodents from approved vendors)

Form 2

Form 1- if use of these materials involves recombinant DNA and/or culture of infectious organisms (no need to complete Form 2)

Form2.SectionVII.Personnel

Transgenic Plants (Recombinant DNA-modified Whole Plants)

Form 3

Form 1 – if use of transgenic plants involves infectious organism(s) known to cause significant environmental or agricultural impact (no need to complete Form 3)

 

Transgenic Insects or Animals

Form 4

Form 1 - if use of animals involves infectious organism(s) that may cause disease in healthy humans, or cause significant environmental or agricultural impact (you must complete form 4)

Form4.SectionIII.TransgenicAnimals

 

Biological toxins

Form 5 

If other hazards are involved in the research, other forms referenced above may beed to be completed

Form 5

Submission Guidelines

  • Forms are available in Microsoft Word Format only.
  • Forms must be typewritten. Handwritten forms will be returned.
  • An original signature must be submitted for new or renewal applications.
    • Signed signature pages may be mailed to EH&S Building 98, B1-102
  • Blank fields that do not apply should indicate "N/A" and not left blank.

 

Registration Updates and Renewals

Registrations are good for a period of 3 years before a renewal is required. Updates may be filed at any time and will be reviewed by the committee.

 

IBC FAQ's

View Frequently Asked Questions about IBC's (Flash)

View Frequently Asked Questions about IBC's (Text)

 

National Institute of Health (NIH) Guidelines

View the NIH Guidelines which are referenced by the IBC when reviewing research protocols.

Please note that in certain situations, the Cal Poly IBC reserves the right to impose stricter requirements than what is required under the NIH Guidelines. Such changes require a majority consensus within the committee.

 

NIH Exempt Experiments

Certain experiments have been exempted from IBC approval as recommended by NIH.

As stated in Section III-F of the NIH Guidelines, experiments are exempt when they involve recombinant DNA that is:

  • Not in organisms and viruses;
  • Entirely DNA segments from a single nonchromosomal or viral DNA source;
  • 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;
  • 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,
  • Entierly segments from different species that exchange DNA by known physiological processes, through one or more may be a synthetic; see Appendix A of the NIH Guidelines; or
  • Not a significant risk to health or the environment as determined by the NIH Director, with advice from the RAC and public comment; See Appendix C of the NIH Guidelines for a detailed listing;

Unless these experiments also involve:

  • 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 DNA containing genes for the biosynthesis of toxin molecules lethal for vertabrates at an LD50 of less than 100 nanograms per kilogram of body weight [Section III-B]; or
  • The deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA into one or more human research subjects [Section III-C].

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

Additional resources are available through the Office of Biotechnology Activities (OBA), a division under NIH. http://oba.od.nih.gov/index.html