Getting Started with the IBC

Prior to submitting a request to the IBC, it is important to know what should be submitted for IBC review and what happens to the submission. Approval of the Howard University IBC is required before research can begin involving any of the previously mentioned substances.

What Activities Require IBC Approval?

In accordance to the NIH Guidelines, all activities that involve work with “Biological Toxins,” “Infectious Agents,” “Select Agents”, or “Recombinant or synthetic nucleic acid molecules”, as those terms are defined below, require IBC review and approval. Approval of the Howard University IBC is required before research involving any of the previously mentioned substances can begin.

Biological Toxins
A biological toxins is a “toxic material or product of plants, animals, microorganisms (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa) or infectious substances, or a recombinant or synthesized molecule, whatever their origin and method of production, and includes any poisonous substance or biological product that may be engineered as a result of biotechnology; produced by a living organism; or any poisonous isomer or biological product, homolog, or derivative of such a substance.” See 42 CFR 73.1.

Infectious Agents
An organism, usually a microorganism, that can produce infection or infectious disease, and any organism (such as a virus, rickettsiae, bacteria, fungus or parasite) that is capable of invading and multiplying in tissues and having the capacity to cause disease or adverse health impacts on humans, plants or animals. See NIH Guidelines, Appendix B and CDC/NIH Guidelines, Section VIII.

Select Agents
All biological agents or toxins listed at 42 CFR 73, 7 CFR 331, and 9 CFR 121.

Recombinant or synthetic nucleic Acid Molecules
In the context of the NIH Guidelines, recombinant and synthetic nucleic acids are defined as: (i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids; (ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or (iii) molecules that result from the replication of those described in (i) or (ii) above.

Exemptions

The following recombinant or synthetic nucleic acid molecules are exempt from the NIH Guidelines and registration with the IBC is not required. (NIH Guidelines, Section III-F and Appendix C). However, an application should be submitted to the IBC for record keeping purposes and verification of exemption from IBC review and approval.

• Those that are not in organisms or viruses.


• Those that consist entirely of DNA segments from a single non-chromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent.


• Those that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well-established physiological means.


• Those that consist entirely of DNA from an eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species).


• Those genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any recombinant and/or synthetic DNA.


• Those that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent. A list of such exchangers will be prepared and periodically revised by the NIH Director with advice of the RAC after appropriate notice and opportunity for public comment (see NIH Guidelines, Section IV-C-1-b-(1), Major Actions).( See NIH Guidelines, Appendices A-I through A-VI, Exemptions Under Section III-F-6-Sublists of Natural Exchangers, for a list of natural exchangers that are exempt from the NIH Guidelines.)


• Those that do not present a significant risk to health or the environment (see Section IV-C-1-b-(1)-(c), Major Actions), as determined by the NIH Director, with the advice of the RAC, and following appropriate notice and opportunity for public comment. (See NIH Guidelines, Appendix C, Exemptions under Section III-F for other classes of experiments which are exempt from the NIH Guidelines.)