Do I Need IBC Review?

Experiments or teaching activities involving the following must be registered with the IBC:

• Pathogens affecting humans, animals, or plants;
• Materials potentially containing human pathogens (e.g. unfixed human specimens, human blood);
• Recombinant DNA molecules including viral vectors;
• All cell and organ cultures of human origin, including well established cell lines, human embryonic stem cells, and pluripotent cells and their derivatives;
• De novo generation of transgenic animals (using recombinant DNA technology to add foreign DNA or subtract a portion of the animal's genome);
  • Generation of de novo transgenic animals: Defined as the addition of foreign DNA or subtraction of a portion of the animal genome using recombinant DNA technology. Examples of recombinant DNA technology include (1) Direct microinjection of a chosen gene construct from another member of the same species or a different species into the pronucleus of a fertilized ovum; (2) Insertion of the desired DNA sequence by homologous recombination into an in vitro culture of embryonic stems and cells; (3) Use of a plasmid or virus to transfer the genetic material into germ cells. Breeding animals to generate transgenics need not be registered with the IBC. Those transgenics that already exist or which have been purchased are not subject to IBC registration.
• De novo generation of transgenic plants;
• Introduction of recombinant DNA (plasmids) or gene transfer vectors (including viral vectors) into human subjects; and
• Introduction of genetically engineered micro-organisms or infectious agents into human subjects (including live vaccines if they are experimental in nature and/or not FDA approved for use in the specific study population).

Yes. IBC registration and approval of research involving these biohazards is required. Biohazards includes the following: 

• Naturally occurring or engineered micro-organisms or viruses capable of causing disease in humans and/or animals are Risk Group (RG) 2, 3 or 4 pathogens as defined by NIH (Note: This list is not all inclusive). Those agents not listed in RG 2, 3, and 4 are not automatically or implicitly classified as non-pathogens or in RG.
• A risk assessment must be conducted based on the known and potential properties of the agents and their relationship to agents that are listed. Consult the following web sites for guidance.
  • NIH list - https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy/
  • CDC list - https://www.cdc.gov/safelabs/resources-tools.html
• Human or mammalian cell lines (including embryonic & established), human tissue or blood.
• Toxins derived from plants, animals or micro-organisms that will have adverse effects in humans or animals.
• Plant pathogens or pests (arthropods, nematodes, weeds) that are regulated by state or federal policy or law. Consult the following web sites for up to date lists of regulated organisms.
  • USDA/APHIS - http://www.aphis.usda.gov/ppq/regpestlist
• Select biological agents that may adversely affect public health, animal or plant health, or animal or plant products (Note: All possession and use of select biological agents requires special registration through the Biological Safety Officer).
  • CDC program - http://www.cdc.gov/od/sap/index.htm

No – Each principal investigator is responsible for full compliance with the NIH Guidelines in the conduct of recombinant DNA research and with the biosafety requirements.

Investigators may not “piggy-back” on the existing IBC protocols of other investigators. Therefore, a separate IBC form must be completed for each grant, project, or set of experiments.

You must notify the IBC about your proposed work. If your research is being “conducted entirely outside of TAMU-CC and/or the U.S.”, and no work will be done on TAMU-CC campus, review by TAMU-CC’s IBC may not be needed. However, institutional approval must be obtained from the collaborating institution.

Contact the Office of Research Compliance at ibc@tamucc.edu to discuss.