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.
Principal Investigators (PIs) seeking the IBC’s assessment for approval are required to submit 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.
IBC Review Structure: What needs an IBC Registration?
University policies, state and federal regulations require that all research involving biological materials have the oversight by the University of Hawaii’s Institutional Biosafety Committee (IBC) and/or Biosafety Program. Oversight includes research, teaching and diagnostic activities that involve biological materials.
All research, teaching, and clinical (diagnostic) laboratories using biological materials:
- Will be inspected at least annually (sample inspection checklists can be found here)
- Must submit UH Lid Part A and Part B to UH Biosafety Program when scheduling annual inspection
- Must submit Kuali Build BSP2 Form form for transport, import, export, transfer, and/or complete destruction of biomaterials
- All personnel working with biological materials must complete, at minimum, UH General Biosafety training annually on BioRAFT. Other trainings may be required based on research activities.
In addition to the above, IBC review of research, teaching, and diagnostic activities may be required. Levels of review are described below:
IBC approval is needed prior to the initiation of research, diagnostics, or teaching activities at the University of Hawaii involving any of the following:
- Recombinant and synthetic nucleic acid work covered by III-A through III-D of the NIH Guidelines
- Generation of genetically modified animals (the purchase or transfer of transgenic rodents is exempt) or plants
- Introduction of genetically engineered microorganisms, recombinant DNA or gene transfer vectors into human subjects (including viral vectors and live vaccines if they are experimental in nature and/or not FDA approved for use in the specific study population)
- Activities involving RG2 & RG3 biohazardous agents affecting humans, animals or plants
- Materials potentially containing RG2 &/or RG3 human pathogens. Examples include but are not limited to:
- Unfixed human specimens
- Human blood, OPIM
- Sewage, stagnant water, soil
- All cell, tissue, and organ cultures of human origin, including well established cell lines, human embryonic stem cells, and pluripotent cells and their derivatives
- Toxins of biological origin and Select/Biological Agents and Toxins (CDC & USDA)
- Isolating/culturing/propagating unknown or uncharacterized microorganisms from any source
- Inoculating biological materials (i.e. virus, bacteria, cells, vectors, bioparticles, biotoxins, proteins, antibodies, genomic material, other) into animals or cells that will be used in animals
- Working with known or suspected diseased/infectious animals and plants
- Non-indigenous plant pathogens as well as those plant and animal pests regulated by the USDA-APHIS
- Projects involving endangered/threatened/protected/regulated plants and invertebrate animals
- Work that requires federal or state permits/notifications pertaining to regulated infectious materials (plant, animal, human pathogens), vectors or genetically modified organisms
Full IBC Registrations are submitted via TOPAZ for approval. To submit a Full IBC Registration within TOPAZ, navigate to Biosafety Protocols > Protocols > Create Original Protocol and choose the IBC Original Registration form.
Some activities may be considered exempt from IBC review and assessment, however; 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. IBC Exempt Registrations can be reviewed and approved by the Biosafety Office.
- IRB protocols where specimens will be processed by a core lab with full IBC review and that will NOT introduce r/sNA molecules, genetically engineered microorganisms or infectious agents into human subjects
- Those low-risk protocols from the list below that do not meet the criteria for a full IBC review, but still require an IBC approval letter for granting or regulatory agencies
- e.g. importation (interstate or international) of RG1 biological materials needing HDOA permit
Exempt Registrations are submitted via TOPAZ for approval. To submit an Exempt IBC Registration within TOPAZ, navigate to Biosafety Protocols > Protocols > Create Original Protocol and choose the IBC Exemption Request form.
In the event that a PI wishes to retain biological materials that are no longer covered by an IBC registration and have no intention for immediate use, a Storage-only Registration is required. The PI is responsible for maintaining an itemized inventory, incident response plan, and naming primary and secondary responsible persons. Should the biological materials be needed for experimentation at a later time, the PI should then submit the appropriate IBC registration prior to use. Storage-only Registrations can be reviewed and approved by the Biosafety Office.
Storage-only Registrations are submitted via TOPAZ for approval. To submit a Storage-only IBC Registration within TOPAZ, navigate to Biosafety Protocols > Protocols > Create Original Protocol and choose the IBC Storage of Biological Materials Registration form.
Some activities may only need an annual lab inspection to verify compliance with university, state, and federal regulations.
- Work with RG1 or non-risk group biological materials or procedures. Some examples include but are not limited to:
- E.coli K12, Bacillus subtilis, Saccharomyces cerevisiae. Note: These would still require a BSP2 authorization for import, export or transfer.
- Sea water
- Non-diseased plants, fruits, vegetables
- Grocery store purchased items – meat, fish, poultry, shellfish, produce, baker’s yeast
- Native non-permitted wood, seeds, plants
- Chemically preserved specimens
- Chemical, biochemical, nutrient analysis, DNA/RNA extraction
- Detection of microorganisms by staining and microscopy or PCR & sequencing only
Note: For any of the above, isolating, culturing or propagating any unknown/uncharacterized microorganisms requires a full IBC review
- Projects that only perform PCR using commercially bought synthetic nucleic acid primers and template nucleic acids for genomic analysis. Note: Sequences of concern would require a full IBC review
- Animal studies that take place in a facility, lab or field that do not involve endangered/protected/permitted/modified and/or diseased animals, or inoculation of biological materials into the animals
Annual Biosafety inspections are conducted by the Biosafety Officer and may be accompanied by members of the IBC. Researchers must submit UH Lid Part A and B to UH Biosafety Program when scheduling annual inspection at biosafe@hawaii.edu.
The above lists may change as needed based on updates to University, State, and/or Federal policies, procedures, and regulations.
Information on Risk Groups can be found in the NIH Guidelines (Appendix B) or the ABSA Risk Group Database.
Please check with the Biosafety Program (uhibc@hawaii.edu / 956-9899) if you have questions on registration requirements.
- Request a new account or reset your password in TOPAZ
- TOPAZ Elements for IBC protocol submission and management
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.
Guide on adding personnel in TOPAZ.
All persons and entities recognized on the Registration Form must comply with UH, state and federal regulations, including, but not limited to the specific training requirements of 49 C.F.R. (172.700 – 172.704). Training may consist of general biosafety, bloodborne, zoonotic, transport, and specific project training (recombinant plant, greenhouse, field trials, human trials, etc.).
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.
Guide on submitting a renewal in TOPAZ
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 first page of the 30-Day Extension Request form.
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:
- Changes to project personnel and their training as it pertains to biosafety requirements.
- Location changes
- Addition of biological materials which do not change the biosafety level, risk group or NIH classification (e.g. adding another microorganism when already approved for microorganisms)
- Change of PI
- Title change
- Significant modifications or amendments are subject to full committee review and assessment prior to commencement. Examples of major amendments:
- Changes to the overall scope of the study or additions to the experimental design or trials
- New infectious materials
- Addition of new biological material category (e.g. adding microorganisms when previously only approved for animal cell lines)
- Addition of new biological material which changes the biosafety level, risk group or NIH classification
FAQs
Generally, any recombinant and synthetic nucleic acid work covered by III-A through III-D of the NIH Guidelines or use of RG2 or RG3 biological materials. See IBC Review Structure: What needs an IBC Registration for more details.
Contact the Biosafety Program (uhibc@hawaii.edu / 956-9899) if you have questions on registration requirements.
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 (send a signed memo on department letterhead with delegation of authority to uhibc@hawaii.edu). Visiting Professors and researchers must be recognized by a UH collaborator. Graduate students and staff are not permitted to sign submit Registrations.
Submission includes the registration form and the following required information:
- New Principal Investigator Bio-sketch, curriculum vitae or resume
- Biosafety Training (Biosafety Program training courses are available on BioRAFT) of PI and all staff involved with active manipulation
- Biosafety Manual or Specific Standard Operating procedures: emergency, wastes management
- Biological Lab Incident Response Plan
- Occupational Health and Safety Plan
- Copies of permits (if applicable)
- Designation of a temporary responsible individual in the event of a leave by the PI (Temporary Responsible Individual memo)
- Tips for preparing a successful IBC protocol
- Make sure all your answers are detailed, accurate, and clear
- Follow the instructions in each section – some sections have a button with helpful information
- Update all sections that include dates (trainings, BSC and autoclave certifications, inspections)
- Submit a pre-review to the Biosafety Office for advice
Submit your protocol by the first day of the month. Submissions after this date are not guaranteed to be reviewed in that month’s meeting. Please see IBC Meeting Schedule and Deadlines
Staff members need to be added to the TOPAZ system before they can be added to your online protocol form.
Follow steps in the Adding Protocol Associates guide. If your personnel are not available to select, contact the Biosafety Program at uhibc@hawaii.edu to add the personnel to TOPAZ, or have the personnel request access to TOPAZ on Kuali.
Click on the paperclip icon in the section to add attachments or links associated with the question.
Make sure that you have clicked the submit button to send the registration to the IBC.
Then, two IBC members (along with the Biosafety Office) will review the protocol and make comments. The comments will be sent back for you to clarify and modify your protocol. After you have updated your protocol, submit back to the IBC for the IBC members to re-review.
At the monthly IBC meeting, your protocol will either be approved, returned for modification, or not approved.
Protocols are approved for 3 years of the original date. See your approval letter or TOPAZ for the expiration date. Remember to submit your renewal the 1st day of the month that it expires.
Contact the UH IBC Coordinator, Kari Seedle, at (808) 956-9899 or uhibc@hawaii.edu for instructions and questions regarding logging onto the TOPAZ system for submitting a protocol.
Yes, in compliance with federal regulations, all personnel working with biological materials must complete annual UH Biosafety training (administered through BioRAFT). Additional trainings may be required based on research activities.