Biological and biomedical research offers vast opportunities for improving our understanding of biological processes and for targeting new and more effective therapies for medical conditions. However, this research involving recombinant DNA, infectious agents, and other potentially hazardous biological, chemical, and radioactive materials carries inherent safety risks. Working at an appropriate biosafety containment level and with the appropriate safety precautions is crucial for mitigating those risks.
Institutional Biosafety Committee
As mandated by the NIH Guidelines, WMed’s Institutional Biosafety Committee is responsible for assessing the biosafety containment level for research involving recombinant DNA and synthetic nucleic acid molecules. The WMed Institutional Biosafety Committee (IBC) also oversees research with other potentially hazardous substances. The WMed IBC currently oversees:
- Recombinant or synthetic DNA/RNA materials, including human gene therapy
- Microbes and disease-causing agents including bacteria, viruses, fungi, prions, protozoa, and parasites
- Human cells and cell culture, organs or tissues, or biological samples that are infectious, potentially infectious, or recombinant
- Genetically manipulated vertebrate animals; and/or vertebrate animals used in association with pathogens and/or recombinant materials
- Biological toxins
- Radiation and radioactive materials
Scope of IBC Authority
The IBC has jurisdiction over research conducted by WMed personnel at the W.E. Upjohn, Oakland Drive, and Innovation Center campuses, and it may give approval to non-faculty members (i.e., non-WMed entities performing work on campus) on a case-by-case basis. The IBC reports to the Founding Dean, who has authority over this compliance area at WMed, including appointment authority to the committee.
Researcher Roles & Responsibilities
Principal investigators or project directors at WMed are responsible for:
- Understanding the requirements governing research involving potentially hazardous biologics, including recombinant and synthetic nucleic acids, infectious agents, and biological toxins.
- Submitting an IBC registration to secure required approval for all research involving recombinant or synthetic DNA/RNA, radiation, or biohazardous materials before beginning the project.
- Amending the approved IBC registration prior to implementing changes to the research.
- Ensuring that all laboratory personnel have received the necessary training for the work they will perform. Principal Investigators are responsible for making sure personnel can safely use recombinant or synthetic DNA/RNA, radiation, biohazardous materials, and laboratory chemicals.
- Adhering to and promoting applicable biosafety procedures, including:
- Ensuring the use of proper microbiological practices and laboratory techniques at the approved biosafety level
- If working at BSL2, making sure there is a Biosafety Manual available for use by lab personnel
- If working at BSL2, scheduling and completing an annual BSL2 laboratory inspection with the WMed IBC
- Fulfilling any additional PI/PD responsibilities as detailed in Section IV-B-7 of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
References & Resources
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
- Biosafety in Microbiological and Biomedical Laboratories, CDC/NIH. Current Edition
- CITI Program
For more information about the IBC or to submit a registration, call 269.337.4276 or email firstname.lastname@example.org.