Skip to main content

Approval Process

All requests must be submitted at least two weeks prior to an IBC meeting for consideration, so be sure to get your materials in order with enough time for the IBC to review your work.

Meetings & Submission Deadlines

1Do I Need IBC Approval?

All faculty, staff and students engaging in research related to recombinant or synthetic nucleic acids or other potentially hazardous biologics, must receive IBC training and IBC committee approval of their proposed projects. Due to the nature of many projects falling under IBC review, researchers may be required to submit projects for simultaneous approval by both the Institutional Review Board (IRB) or the Institutional Animal Care and Use Committee (IACUC) and the IBC. 

Research that will most likely require IBC Review includes:


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.

Biological toxins are poisonous substances produced by certain microorganisms, animals, and plants.
Microorganisms include bacteria, protozoa, algae, and fungi. Although viruses are not considered living organisms, they are included in this classification.
Prions are abnormal, pathogenic proteins that are transmissible and are able to induce abnormal folding of specific normal cellular proteins called prion proteins that are found most abundantly in the brain.
Any research involving recombinant DNA introduced into live animals. Research involving recombinant DNA introduced into vertebrate animals will require both IBC and IACUC approval.
All cell and organ cultures and materials of animal origin, including those from humans.
Nanotechnology is the understanding and control of matter at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications.
Any research involving recombinant DNA introduced into plants. The IBC also oversees research involving soil, seed, plants, plant pathogens or other materials as regulated by state or federal policy or law.

Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

2Complete Training

This training is required of all researchers, faculty, students and principal investigators. Once you have completed the needed trainings, save all certificates as PDF files. Most CITI certifications are good for three years, except for bloodborne pathogens, which must be completed every year.

General Guidelines

  • All courses are valid for three years.
  • Required courses must be completed prior to submission of IBC proposal.
  • The trainings you take depend on your role in the project and your field of study. When you sign up for a CITI account, Questions 6 and 7 will be important for placing you in the correct training module.
  • Required Courses
    • 13314 “Biosafety Course Overview”
    • 13454 “Laboratory Acquired Infections”
    • 13455 “Biohazard Risk Assessment”
    • 13456 “Medical Surveillance”
    • 13458 “Risk Management PPE”
    • 13459 “Risk Management: Emergency and Spill Response”
    • 13898 “Risk Management: Work Practices”
    • 13899 “Work Safely with Sharp Instruments”
    • 13900 “Disinfection and Sterilization”
    • 13929 “Risk Management: Engineering controls”
    • 13945 “Centrifuge precautions”
  •  Optional courses:
    • 13484 “Risk management: Laboratory Design”
    • 13497 “Engineering Controls and Containment Devices”
    • 13946 “Safe Sharps Devices”
    • 13987 “Biosafety and Biosecurity (BSS) Introduction”
    • 16263 “Dual Research of Concern (DURC)”
  • Required Courses:
    • 13314 “Biosafety Course Overview”
    • 13454 “Laboratory Acquired Infections”13458 “Risk Management PPE”
    • 13459 “Risk Management: Emergency and Spill Response”
    • 13898 “Risk Management: Work Practices”
    • 13899 “Work Safely with Sharp Instruments”
    • 13900 “Disinfection and Sterilization”
  • Optional Courses:
    • 13455 “Biohazard Risk Assessment”
    • 13456 “Medical Surveillance”
    • 13484 “Risk management: Laboratory Design”
    • 13497 “Engineering Controls and Containment Devices”
    • 13929 “Risk Management: Engineering controls”
    • 13945 “Centrifuge precautions”
    • 13946 “Safe Sharps Devices”
    • 13987 “Biosafety and Biosecurity (BSS) Introduction”
    • 16263 “Dual Research of Concern (DURC)”
  • Required courses:
    • 13314 “Biosafety Course Overview”
    • 13454 “Laboratory Acquired Infections”
    • 13455 “Biohazard Risk Assessment”
    • 13456 “Medical Surveillance”
    • 13493 “NIH Guidelines for Research involving recombinant or synthetic nucleic acid molecules”
    • 13898 “Risk Management: Work Practices”
    • 13899 “Work Safely with Sharp Instruments”
    • 16263 “Dual Research of Concern (DURC)”
  • Optional courses:
    • 13458 “Risk Management PPE”
    • 13459 “Risk Management: Emergency and Spill Response”
    • 13484 “Risk management: Laboratory Design”
    • 13497 “Engineering Controls and Containment Devices”
    • 13900 “Disinfection and Sterilization”
    • 13929 “Risk Management: Engineering controls”
    • 13945 “Centrifuge precautions”
    • 13946 “Safe Sharps Devices”
    • 13987 “Biosafety and Biosecurity (BSS) Introduction”
  • rDNA
    • 13493 “NIH Guidelines for Research involving recombinant or synthetic nucleic acid molecules”
  • Bloodborne Pathogens
    • 13902 “OSHA Bloodborne Pathogens Standard”
    • 13903 “Hepatitis B virus (HBV Vaccination”
    • 13904 “Labels and Engineering controls”
    • 13913 “Universal Precautions and Work Practices”
    • 13914 “Emergency Response Procedures”
  • Animals
    • 13654 “Animal Biosafety”
    • Nanotechnology
    • 14044 “Understanding Nanotechnology and Its Implications”

3Prepare a Protocol

The principal investigator (PI) or instructor completes the applicable sections of the proposal form for the proposed research. Please note, the principal investigator must be a faculty or instructor; students cannot be the PI.

Complete Protocol Application

If the proposed research requires additional permits or permission from internal or external sources (for example, research involving recombinant DNA introduced into live animals will also require IACUC approval), appropriate documentation needs to be included in the submission. Examples of additional documentation:

4Submission & Review Process

Combine the Protocol Application Form, CITI certificates and any additional documentation into a single PDF which together constitutes a Complete Protocol. Submit the PDF to ibc@uwgb.edu. You must submit your complete protocol to the IBC at least two weeks prior to an IBC meeting to ensure your protocol will be reviewed.

Initial Review

The initial review takes approximately two weeks. The chair of the IBC or a designated member will evaluate the protocol. You may receive a revise and resubmit letter that describes the corrections needed for your protocol. All changes requested must be addressed in your resubmission, with the changes annotated in the resubmission email. If no corrections are necessary, you will be notified of your committee review date and time.

Committee Review

After the initial review, your complete protocol will go through a full committee review. These must be submitted at least two weeks in advance of the next IBC meeting. The committee will then review your protocol, make note of any concerns or questions, and submit these items back to the Principal Investigator to be addressed. PIs are welcome and encouraged to attend meetings. If no concerns are raised, then committee will vote to approve the protocol. Approvals are valid for 3 years.

5Post Approval

While IBC protocols are approved for 3 years, you must submit an Annual Review to the IBC each year of the project. At the end of the 3 year period, the PI must indicate in the Annual Review form if the project is continuing or terminating. If the project is complete, only the Annual Review Form is needed. If the project is continuing, the PI must also submit a new Protocol Application.

Complete Annual Review Form

Georgette Heyrman

Ask Our Experts

If you have a question or concern about IBC approval, reach out to our committee members.

Contact Us