IBC Risk Assessment, Recommendations, and Approvals

IBC Scenario

Each pair of students will assume the role of an Institutional Biosafety Committee advisory subcommittee that has been tasked with reviewing a research protocol. Your team will be randomly given a proposed research protocol submitted by a JMU faculty member for review by the IBC. The proposal will describe a hypothetical scenario for research involving recombinant DNA manipulations and experiments that may involve infectious agents and recombinant DNA. Information will be provided on organisms, biological agents, cell lines, vectors, hosts, or DNA sequences to be used in the proposed research. A protocol of proposed experiments will be provided. As an IBC advisory subcommittee, you will review the proposed research, perform a comprehensive risk assessment, make detailed recommendations for containment, and identify all approvals required for the research.

Risk Assessment

Review the proposed research and perform a comprehensive risk assessment as described in the NIH Guidelines. Address factors such as virulence, pathogenicity, infectious dose, route of spread and communicability for any biological agents used as well as toxicity and physiological activity for any gene products. Evaluate how the agent itself will be manipulated and address factors such as heterologous gene expression and host-vector systems. Identify and address all health and safety issues. All sections and sub-headings of the NIH Guidelines used in your risk assessment as well as any supporting literature will be referenced but note quoted. Identify any additional potential issues or concerns that may be associated with the proposed research.

Recommendations

Following thorough consideration of the agent itself and how it will be manipulated, make recommendations for the appropriate containment conditions. Multiple sets of containment conditions may be needed for various aspects of the proposed research. In addition to a Biosafety Level (BL) recommendation, provide detailed descriptions of standard practices and physical barriers to be used in your containment recommendations. Special practices or specialized equipment needed for this research will be identified and described.

Approvals

Describe the type and levels of approvals recommended with reference to the NIH Guidelines. Recommendations can be made to the research proposal that may reduce the risk and the containment needed as well as the approval required. Explain the reasoning or justification for these recommendations.

Deliverables and Timelines

A professional typewritten report that addresses the three areas of Risk Assessment, Recommendations, and Approvals is required. The report should contain a cover page with a title for the report, your names, date, place, and an executive summary of your review. The report should contain three sections for risk assessment, recommendations, and approvals. References can be added at the end.

The format can be of your own design, but must be 12-point font and double-spaced. You should clearly reference the section and sub-headings of the Guidelines where appropriate, but do not quote text from the Guidelines. There is no limit on length, but excessive and irrelevant wordage will be downgraded. The entire class will act as an IBC and you will present the research proposal as well as your report to the full committee and answer any questions. February 12, 2015 will be the IBC meeting at which time you will make a presentation and submit your report. You are not defending the protocol but rather leading a discussion of a critical review. PowerPoint presentations are not permitted. All the research proposals will be distributed in class and posted on Canvas prior to the meeting and everyone is expected to read the proposals and participate in the meeting. This exercise has a value of 30 points.