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• IBC Research Protocols

IBC Research Protocols

Types of Submissions

• Initial Submission: The initial "registration" of the research or teaching protocol in the SPARCS system.
• Continuing Review: A "check-in" that is submitted annually for each approved registration. If you will be making changes to your protocol, a modification/amendment must also be submitted.
• De Novo Review: Protocols must be renewed or expired every three years. Changes can be made to the protocol at the this time.
• Modification/amendment: Any changes in procedures or type of recombinant DNA molecules/etiologic agents must be submitted to the IBC. This includes changes in key personnel, laboratories, or other modifications to the protocols.

Investigator's Responsibilities

The Principal Investigator (PI) is responsible for reviewing this policy and complying with its requirements. Specifically, the PI will: 

1. File the appropriate Registration Document (i.e. protocol submission) and an Annual Renewal form for each project and meet all the requirements of the NIH Guidelines for Research Involving Recombinant DNA Molecules, the CDC Biosafety in Microbiological and Biomedical Laboratories, and the university's Bloodborne Pathogens Exposure Control Plan.
2. Make available to laboratory staff and students copies of the registration documents and other protocols that describe potential biohazards and the specific precautions to be taken;
3. Provide appropriate instruction and training in practices and techniques necessary to ensure laboratory safety, as well as maintain training records for all personnel associated with protocol;
4. Supervise the laboratory staff to ensure that appropriate safety techniques and procedures are employed;
5. Report in writing to the IBC any significant problems pertaining to the operation and implementation of containment practices and procedures;
6. Take prompt corrective actions on all issues during periodic inspections and/or incident reports

Required Components for IBC Protocols

You may use the protocol template to record your information before logging it into the SPARCS system. It is recommended practice to always save a copy of your protocol before entering in SPARCS. A PDF copy can be downloaded from SPARCS during and after board approval.

A protocol should include the names of ALL persons (including students and staff) who are to be approved to work with all aspects of infectious/biohazardous material.

Protocol Template for IBC SubmissioN

Covered Activities

Each investigator/instructor using recombinant DNA molecules or biological agents as defined previous is required to submit the appropriate procedure as described below. To submit your protocol, please use the Hazard Safety Module in SPARCS.

• Research/Teaching Involving Recombinant DNA

  Investigators/instructors employing recombinant DNA molecules and technology, including the construction and use of transgenic animals, and transfection of mammalian cell lines.
  • Section III-D: Protocol approval for these experiments can only be granted during convened meetings in which a quorum of the IBC is present.
  • Section III-E: Can be given "conditional approval" with formal approval given at the convened meeting.
  • Section III-F and Appendix C: Exempt from approval at IBC meetings, but still need to be "approved" in SPARCS prior to work on the project beginning.

    If your research invovles use of recombinant DNA, you are subject to the NIH Guidelines (April 2024). Please review the guidelines to make sure your research is alignment with the requirements. Below, is a list of the "Sections" from the NIH guidelines and what level of review is required prior to approval.

    

• Research/Teaching Involving Etiologic Agents

  Investigators/instructors employing biological agents in their research and teaching, but not involving recombinant DNA technology

• Research/Teaching Involving Human Tissue or Body Fluids

  Investigators/instructors employing human tissue or body fluids, including saliva, urine, blood, or primary human cell cultures

• Research/Teaching Involving Wild-Caught or Random Source Animals or Animal Tissues

  Investigators/instructors employing animals that may carry zoonotic disease, or for those investigators/instructors employing biologically-derived chemicals.