What should the institutional biosafety committee (ibc) consider when reviewing proposed research?

The NIH Guidelines for Research Involving Recombinant DNA or Synthetic Nucleic Acid Molecules outlines the requirements for an Institutional Biosafety Committee that must be in place at any institution that receives any NIH Funding for research that fall under these guidelines.

The Institutional Biosafety Committee at UWM Will Consist of no less than the following voting members:

• Animal Expert
• Plant Expert
• Microbiological Expert
• rDNA Expert (Which may be embedded in one of the positions above)
• Chair of the IBC (Which may be any of the above experts)
• 1 Laboratory Personnel Staff
• Two Community Members not affiliated with UWM

In addition to the faculty/ staff members appointed to three year terms, the following are ex-officio members are appointed to the IBC to provide input based on their areas of expertise and roles within the University.

• Biological Safety Officer
• Campus Research Animal Veterinarian
• Campus Health Officer
• Associate Director for Research Compliance
• Research Safety Program Manager

Responsibilities’ of IBC Members

As a member of the IBC, it is the member’s responsibility to do the following:

• Commit to attending monthly meetings to review research involving recombinant DNA, synthetic nucleic acid molecule, infectious biological agents or toxins, potentially infectious materials, and/ or select agents at UWM.
• Provide constructive review details to the Biological Safety Officer to record and send as feedback to PIs that submit protocols.
• Approve, table, or deny research protocols submitted to the IBC (except for ex-officio members, who do not vote).
• Determine the appropriate biosafety level (BSL) of containment for the PI’s submitted research and determine if the protocol fits the BSL.
• Review reports of lab inspections given by the biological safety officer and provide feedback regarding research occurring in the lab facilities and necessity for a registered and approved IBC protocol.
• Participate in annual review of the IBC and provide feedback and suggestions to the chair and BSO for strategies and techniques to implement in the next fiscal year.
• Discuss and report any significant problems or violations of the NIH Guidelines with PIs/ lab managers and any significant research related accidents or illnesses to the Department of University Safety and Assurances and the NIH Office of Science Policy within 30 days of the incident.

Meetings of the Institutional Biosafety Committee

The Institutional Biosafety Committee will meet monthly, typically on the last Friday of the month, to review protocols and to conduct other official IBC business. The biological safety officer is responsible for coordinating and scheduling all IBC meetings, and the IBC chair is responsible for leading the sessions. The BSO will assist with leading meetings and will maintain documentation of meeting minutes. The general public may request copies of the minutes through the Biological Safety Program.

The NIH Guidelines for Research Involving Recombinant DNA or Synthetic Nucleic Acid Molecules outlines the requirements for an Institutional Biosafety Committee that must be in place at any institution that receives any NIH Funding for research that fall under these guidelines.

The Institutional Biosafety Committee at UWM Will Consist of no less than the following voting members:

• Animal Expert
• Plant Expert
• Microbiological Expert
• rDNA Expert (Which may be embedded in one of the positions above)
• Chair of the IBC (Which may be any of the above experts)
• 1 Laboratory Personnel Staff
• Two Community Members not affiliated with UWM

In addition to the faculty/ staff members appointed to three year terms, the following are ex-officio members are appointed to the IBC to provide input based on their areas of expertise and roles within the University.

• Biological Safety Officer
• Campus Research Animal Veterinarian
• Campus Health Officer
• Associate Director for Research Compliance
• Research Safety Program Manager

Authority of the IBC

The IBC makes decisions to approve or reject biological research protocols based on the following policies, procedures, guidelines, regulations, and laws:

• The NIH Guidelines for Research Involving Recombinant DNA or Synthetic Nucleic Acid Molecules, amended April 2016, is the most current set of guidelines that the IBC, researchers, and the University as a whole are required to follow. These guidelines outline research involving recombinant DNA, synthetic nucleic acid molecules, human cells, tissues, and blood; human gene transfer; biological agents, biological toxins, viruses, and large-scale culture propagation.
• CDC/ NIH Biosafety in Microbiological and Biomedical Research Laboratories (BMBL), 5th Edition, outlines current standard microbiological practices, laboratory design, laboratory biosafety and biosecurity, risk groups, and biocontainment levels.
• University of Wisconsin-Milwaukee Biosafety Manual, Version 2 (July 2017). This outlines university guidelines and procedures for biological research.
• University of Wisconsin-Milwaukee Chemical Hygiene Plan, which outlines institutional policies regarding the safe use of chemicals in the laboratory.
• OSHA Bloodborne Pathogens Standard 29 CFR 1910.1030, which regulates exposure to any cells, cell lines, tissues, body fluids, and blood originating from humans or non-human primates.

Criteria for IBC Approval of Registration Form

The IBC Evaluation Form is used to approve/ review all submitted protocols. In order to approve any protocols using rDNA, synthetic nucleic acid molecules, pathogens, select agents, or biological toxins the following will be considered by the IBC:

Section 1: General Information

IBC members evaluate laboratory personnel credentials, standard operating procedures of the facility, and training requirements for research in the lab facility, including the training of the PI.

Section 2: Research Description

The PIs research description must be complete and include all procedures used, safety measures in place to prevent accidental exposure or release, and if using a viral vector, a map and explanation of the vector.

Section 3: Experiments Covered by the NIH Guidelines for Research

This is the most important section in terms of IBC approval. Research that falls under sections III-A, III-B, III-C, or III-D require IBC approval before commencing the research (Sections III-A, III-B, and III-C require additional approvals outside of the institution, see the NIH Guidelines for details). Section III-E research requires IBC notification concurrent with the commencement of the research. Section III-F research is exempt from IBC approval but does require registration.

Section 4: Biohazards

The IBC will evaluate all of the biohazards the researcher presents in their registration. Identification of risk group(s), mode(s) of transmission, risks to human health and the environment, etc. must be clearly identified and discussed in this section.

Section 5: Biosafety Level (Containment)

The IBC will be reviewing the biocontainment proposed by the PI and ensuring that the appropriate BSL has been selected for the research. Evaluation of PPE, biosecurity measures in place in the lab facility, decontamination and waste disposal procedures, and summary of the contents of the laboratory biosafety manual will also be screened.

Section 6: Occupational Health

IBC members are tasked with evaluation of the occupational health measures in place in the lab facility. These should include health monitoring, any required vaccinations, and adverse event monitoring.

Section 7: Reporting

The PI must agree and sign the reporting section.

Appendices

All appropriate appendices must be completed and the IBC must evaluate the appendices submitted to ensure that they are complete and contain all of the necessary information for IBC registration.