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. As part of our responsibility to assess and manage these risks, WMed maintains a biosafety program that includes a Biosafety Office and an Institutional Biosafety Committee (IBC). WMed’s Biosafety Office and the IBC collaborate with Principal Investigators, faculty, staff, and students to ensure that laboratory research is conducted in compliance with safety standards, and regulatory requirements.
- Biosafety Office
The WMed Biosafety Office operates in the Office of Research Compliance. The Biosafety Office supports research and laboratory projects by:
- Overseeing the proper use and handling of biological materials and other hazardous substances.
- Educating laboratory Supervisors and Principal Investigators on best practices for minimizing risks associate with laboratory work.
- Overseeing the orientation and training of all WMed laboratories on Personal Protective Equipment (PPE), safety protocols, and emergency procedures.
- Working with WMed’s Occupational Health and Infection Control staff to assist with (or conduct) risk assessment and hazard identification for physical, chemical, and radiological hazards.
- Providing guidance during experiments, such as assisting with IBC approval for experiments using recombinant or synthetic nucleic acid molecules, risk group 2 biological agents, human samples, stem cells, and radioisotopes.
- Conducting lab inspections that includes ensuring proper lab setup, availability of PPE, proper signage, and all workers have received appropriate training.
- Reviewing incident reports, conducting investigations, and developing preventative measures.
- Ensuring compliance with national and international regulations with those set by the Occupational Safety and Health Administration (OSHA), Centers for Disease Control and Prevention (CDC), and Environmental Protection Agency (EPA). This includes working with laboratories to provide training on safety data sheets (SDS), arranging chemical disposal, and adhering to WMed’s guidelines and policies.
- Institutional Biosafety Committee
The IBC has jurisdiction over research conducted by WMed personnel at the W.E. Upjohn, Oakland Drive, and Innovation Center campuses. The IBC reports to the Senior Associate Dean for Research who works collaboratively with the Biosafety Officer and Senior Director, Research Compliance. 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
All IBC approved meeting minutes will be posted at the bottom of this webpage.
- Researcher Roles and 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 (PI) 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.
- Fulfilling any additional PI responsibilities as detailed in Section IV-B-7 of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
- Lab Safety Coordinators
The Biosafety Office leads a program with designated Lab Safety Coordinators in every lab or department. This PI appointed Lab Safety Coordinator is responsible for the following:
- Assist the PI and oversee that safety practices are implemented in the lab’s daily operations.
- Assist the PI with ensuring all lab personnel receive the appropriate training and documentation prior to beginning work in the lab.
- Authorized to represent the PI in matters related to the implementation of laboratory and worker safety.
- Serve as the contact, alongside the PI, for issues related to safety.
- Maintain a lab roster of all lab members, including students and ensure all appropriate training documentation is maintained.
- Participate in lab inspections and ensure all deficiencies are addressed.
- Alert the PI and/or Biosafety officer if any safety procedures, policies, or SOPs are being violated.
The biosafety program is committed to fostering a culture of safety and ensuring that all research and laboratory activities are carried out responsibly. If you have any questions or concerns, please contact biosafety@medwmich.onmicrosoft.com. For more information about the IBC or to submit a registration email ibc@wmed.edu.
IBC Approved Meeting Minutes
In compliance with NIH Notice NOT-OD-25-082, all approved meeting minutes must be posted publicly on the institution’s website. These documents serve as the official record of IBC meetings, capturing key discussions, decisions, and actions related to research involving potentially hazardous biological agents.
Below, you’ll find links to the approved meeting minutes, organized by year and month: