University of Hawai‘i
The Principal Investigator must make the determination whether the proposed research or activity is exempt or non-exempt under the classification of the NIH Recombinant and Synthetic Nucleic Acids Guidelines. When a completed Registration Form is received, it is date-stamped and assigned a new or updated registration identification number that will be referenced on all subsequent IBC correspondence to the specific study or activity. This number is provided to the Principal Investigator in an electronic memorandum confirming IBC receipt of the registration. The full IBC will review all completed submitted applications. The Registration Form provides links for information about the types of research activities that require full committee review. Additional steps are necessary for studies involving live whole animal studies or human clinical trials. IACUC approval is required for proposed vertebrate animal use only. Do not submit invertebrate animal use proposed activities to the IACUC for review.
For live whole animal studies in which the animal’s genome is to be altered by stable introduction of recombinant DNA, or DNA derived from, then incorporated into the germ-line (transgenic animals) and experiments involving introduction of recombinant DNA or viable recombinant DNA-modified microorganisms tested on whole animals, simultaneous IBC and Institutional Animal Care and Use Committee (IACUC) approval must be obtained (or an IACUC approval number should be provided). Knock-Ins, Knock-Outs and other modified animal species lines must also be registered.
There are no exempt protocols in this category of experimentation or testing, and all such procedures require IBC approval before initiation. The purchase or transfer of most transgenic rodents is exempt under NIH Guidelines but, needs to be registered with the IBC unless these animals are being exposed to rDNA constructs or viable recombinant DNA-modified microorganisms. All IBC registrations that involve whole animals (vertebrate and invertebrate) must include detailed descriptions of constructs to be administered to the animals, appropriate biocontainment, any potential risks to researchers, animal handlers, or other research animals and waste management (bedding and carcass).
Human Clinical Trials
Experiments involving the deliberate transfer of recombinant or synthetic nucleic acid molecules or DNA, or RNA derived from recombinant or synthetic DNA, into one or more human research participants require IBC, Institutional Review Board (IRB) approval, and Recombinant DNA Advisory Committee (RAC) review before research participant enrollment.
In addition to the completed IBC Registration Form, Principal Investigators must submit a) the Clinical Protocol, b) the Investigator’s Brochure and c) informed consent forms to the IBC.
Gene Transfer study applications must also be accompanied by a completed Appendix M, Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA Molecules into the Genome of One or More Human Subjects from the NIH Guidelines. The IBC must assured that all aspects of Appendix M have been appropriately addressed by the Principal Investigator before submission to the RAC. Final IBC approval is granted only after the RAC review process has been completed (see Appendix M-I-B, RAC Review Requirements).