University of Hawai‘i
Principal Investigators (PIs) seeking the IBC’s assessment for approval are required to send a completed IBC Registration Form at least three weeks prior to the IBC meeting date. Committee meetings are generally held on the last Wednesday of each month at 2:00 p.m.
When a registration application is approved, a formal letter of approval is sent to the PI. An approved IBC Registration Form may be required by granting agencies, or by a State, Federal Agency to secure a permit or extramural support for a study.
If you are planning to submit an IBC Registration Form application and you have questions or require information, please contact the IBC Coordinator who will assist you with this process at email@example.com or 956-8009. It is highly suggested that a draft registration be submitted for review.
An IBC Registration Form captures information about the specific research, instructional or clinical activities. These forms are subject to revision without notice. Please download a new form from this website prior to writing each new submission.
Biological material* that requires UH IBC registration:
- Biological derived toxins (poison, venom)
- Biological Engineered nanomaterial
- Cell lines/Tissues (animal only)
- Diagnostic/clinical samples
- Dual Use Research of Concern (DURC) materials
- Environmental Samples (soil, sediment, water, archeological samples, indoor air sampling)
- Genomic materials (DNA, RNA, siDNA)
- Human origin materials (including embryonic STEM cells: nESC)
- Infectious materials/pathogenic /disease causing
- Large Scale (>10Liter) (bioreactors)
- Microorganisms (bacteria, virus, parasites, protozoan, etc.)
- Plant, plant parts, algae including cell/tissue cultures
- Prions (CJD, Transmissible spongiform encephalopathy, and related biomolecules
- Recombinant Activity/synthetic nucleic acid (r/sNA)
- Select agents/toxins
- Vertebrate animals (not human)
*Biological Materials include but are not limited to plants, animals, arthropods, invertebrates, insects, bacteria, viruses, parasites, fungi, oomycetes, mycoplasmas, RNA, recombinant DNA, prions, proteins, GMOs, cell lines [specify if transformed, immortalized], tissues (e.g., blood, lung), human specimens (sputum, urine, feces, tissue, swabs), non-human animal specimens, fetal calf serum, algae, protoclones and nematodes, weeds, biological control agents (including those not presently discovered or known to exist in Hawai‘i) and “new” microorganisms identified as those “combining genetic material from organisms in different genera.”
Submission includes the registration form and the following required information:
- New Principal Investigator Bio-sketch, curriculum vitae or resume
- Biosafety Training of PI and all staff with active manipulation
- Biosafety Manual or Specific Standard Operating procedures: emergency, wastes management,
- Lab sketch. The sketch should include the location of exits/entrances, sinks, biosafety cabinets, BSL2/BSL3 equipment (centrifuges, incubators, etc.), benches, etc.
Only the Principal Investigator (PI) is permitted to sign the Registration Form to validate its submission to the IBC. Post-doctoral students with funding may sign with the PI co-signing. Visiting Professors and researchers must be recognized by a UH collaborator. Graduate students and staff are not permitted to sign and submit Registration Forms.
Submitted IBC Registration Forms must be filled out completely, signed, and dated. Incomplete registration forms will not be reviewed and returned to the applicant. Only typewritten computer-generated print Registration Forms are accepted.
This renewal verifies whether work will be conducted in accordance with the previously approved registration. The Biosafety Program office will contact you prior to the anniversary date with instructions on how to proceed with the continuous renewal.
Amendments to Registration
Changes or modifications to approved registrations are required to be reported to the IBC. Complete the Registration Form as an Amendment to an ongoing study or activity.
- Minor modifications or amendments may be only subject to committee Chair/designee review and approval. Examples of minor amendments are changes to project personnel and their training as it pertains to biosafety requirements. The training criterion are mentioned in the following paragraph.Proper training is required under federal, state and UH regulations to handle biological materials. All persons and entities recognized on the Registration Form must comply with federal regulations, including, but not limited to the specific training requirements of 49 C.F.R. (172.700 – 172.704). Training may consists of general biosafety, bloodborne, zoonotic, transport, and specific project training (recombinant plant, greenhouse, field trials, human trials, etc.).
- Significant modifications or amendments are subject to full committee review and assessment prior to commencement. Changes to the overall scope of the study or additions to the experimental design or trials are examples of significant amendments or modifications that require full committee review and assessment.
Some activities may be considered exempt from IBC review and assessment. However, these must be registered and on file through the Biosafety Program Office. Please call IBC Coordinator for information.