Research Protections

The Institutional Biosafety Committees (IBCs) were established under the NIH Guidelines to provide local review and approval of research protocols involving the use of biohazardous agents including, but not limited to:

• Recombinant or synthetic nucleic acid molecules in organisms including their use in animals (including arthropods) and plants,
• Human and other non-human substances (blood, body fluids, cell lines or tissues),
• Organisms and viruses infectious to humans, animals or plants (e.g. parasites, viruses, bacteria, fungi, prions, rickettsia),
• Biologically active agents (i.e. toxins, allergens, venoms) that may cause disease in other living organisms or cause significant impact to the environment or community

1. Compliance promotes the safe conduct of research involving recombinant or synthetic nucleic acid molecules. The guidelines focus on risk and containment
2. We receive NIH funding. We risk losing the ability to gain future funding if we are shown to be non-compliant.
3. Institutions that fail to comply with the NIH Guidelines risk:  
   1. Suspension, limitation, or termination of financial assistance for:
   • Non-compliant NIH projects;
   • NIH funding for other research involving recombinant or synthetic nucleic acid molecules at the institution;
4. Having to obtain prior NIH approval for any research involving recombinant or synthetic nucleic acid molecules.

Each institution is responsible for ensuring that all research involving recombinant or synthetic nucleic acid molecules conducted at or sponsored by that institution is conducted in compliance with the NIH Guidelines. This is regardless of funding.

If you are storing materials, organisms, or conducting procedures that fall under IBC oversight, failing to report it puts Appalachian State University out of compliance. Noncompliance has to be reported to the NIH; we don’t want that.

Section III-F of the NIH Guidelines describes experiments that are exempt from the requirements. Details on certain other experiments that may be exempt, as well as exceptions to the exemptions, may be found in Appendix C of the NIH Guidelines.

Yes, the creation of all transgenic animals is covered under Section III-D-4 of the NIH Guidelines.

If animals are transgenic -> YES.

If you will be making transgenic animals -> YES.

If you are still unsure, please contact either IACUC@appstate.edu or IBC@appstate.edu

Visit http://researchprotections.appstate.edu/biosafety/biosafety-form

1. Determine whether your activities fall under an exempt or general review application and download the corresponding form.
2. Determine the risk group and the biosafety level.
3. Take required training.
4. Make sure your students are also trained.
5. Submit your application to IBC@appstate.edu

When an occurrence of non-compliance with the NIH Guidelines is identified, a complete report of the incident must be forwarded within 30 days, to the National Institutes of Health, Office of Biotechnology Activities, along with any recommended actions to NIH OBA. OBA staff will respond with comments on the incident and on the institutional response. In general, OBA will evaluate the adequacy of that response and make recommendations on any additional measures that should be taken.

• Possible measures include a site inspection.
• Possible consequences include the inability to obtain NIH funding, or rescinding of current funding.