Submit: Topaz

IBC Registration Forms are now available in electronic format in the Topaz Protocol Management System (Topaz Elements).  Please login to Topaz, information below, to submit a New, Renewal or Amended IBC registration.   Old Paper forms will not be accepted.

Principal Investigators (PIs) seeking the IBC’s assessment for approval are required to send a completed IBC Registration Form by the 1st of the month prior to the IBC meeting date. (refer to posted meeting and deadline schedule)  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.

Pre-Review (Highly Recommended)

A  pre-review with the Biosafety Office will help to ensure your application is complete and increase your likelihood of approval upon your first submission. Please contact the IBC Coordinator who will assist you with this process at uhibc@hawaii.edu or 956-8009. It is highly suggested that a draft registration be submitted for pre-review.

Submit or Manage a Protocol

Accessing Topaz Elements

Adding personnel to the protocol

Staff members need to be added to the Topaz Elements system before they can be added to your online protocol form. Contact Biosafety to make arrangements at uhibc@hawaii.edu.

Adding supportive documents and links to your protocol

Where a paperclip icon is present in the question’s title bar, add attachments and links associated to clarify on your response to the question.

FAQs

Contact Steve Case at (808) 956-8009 or stevec@hawaii.edu for instructions and questions regarding logging onto the TOPAZ system for submitting a protocol to use biological materials.

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
  • Invertebrates
  • 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 involved 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 submit the Registration in Topaz. Post-doctoral students with funding may submit with the PI delegation of authority. Visiting Professors and researchers must be recognized by a UH collaborator. Graduate students and staff are not permitted to sign submit Registrations.

Submitted IBC Registrations must be filled out completely and electronically signed in Topaz. Incomplete registrations will not be reviewed and returned to the applicant.

 

Continuing Renewal

Registrations that have been previously approved and are continuing for more than three years are required to be assessed by IBC at the three-year anniversary regardless of whether changes will be incurred.

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.

If you need to request a 30 day Extension, please submit your request via Topaz.

Within Topaz, navigate to Biosafety Protocols > Protocols > Create Interim Review Protocol. Find and choose the protocol you wish to request an extension for. Select and complete the 30 Day Extension Request form.

Amendments to Registration

Changes or modifications to approved registrations are required to be reported to the IBC. Complete the Amendment Form in Topaz 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.

 

Exempted Activities

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 contact the IBC Coordinator at uhibc@hawaii.edu or 956-8009 to help determine if your project is exempt. Exempt Registrations are submitted via Topaz for approval.

Within Topaz, navigate to Biosafety Protocols > Protocols > Create a Original Protocol and choose the IBC Exemption Request form.