The National Institutes of Health (NIH) sets requirements for research and clinical trials utilizing recombinant DNA and recombinant RNA. Listed below are the responsibilities of the Institutional Biosafety Committee (IBC), biological safety officer, Environmental Health & Safety Department, principal investigators, clinical supervisor, lab staff, and new staff members as required by NIH. These groups and individuals work together to ensure that the Hutchinson Center maintains a safe work environment when infectious agents, recombinant DNA (rDNA) materials, and blood and body fluids are handled.
The primary document used by the IBC to review recombinant DNA projects at the Center is The Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines).
Laboratory and animal biosafety practices, facilities, and controls are described in the current edition of CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL). Hutchinson Center researchers should use the BMBL and the NIH Guidelines to determine proper controls for infectious material and recombinant DNA use.
NIH grants may be suspended or terminated by the NIH if Fred Hutch does not adhere to the NIH Guidelines.
The Hutchinson Center IBC is registered with NIH to review and approve the use of infectious recombinant DNA (rDNA) and RNA. Certain experimental protocols (e.g., human gene transfer) may require review by NIH's Recombinant DNA Advisory Committee (RAC) prior to review and approval by the Center's IBC. The IBC:
- Meets quarterly to review research involving biological hazardous materials, recombinant DNA and/or infectious agents;
- Oversees the biosafety program;
- Reviews and requires approval of BSL-1 work requiring IBC approval per the NIH Guidelines, all BSL-2 or higher work via Etiologic Memoranda of Understanding and Agreement (EMUA);
- Reviews and require approves of clinical trials involving rDNA use in humans at the Center;
- Annually reviews and approves the Exposure Control Plan;
- Reviews and approve BSL-2/3 or above risk-specific manuals; and
- Initiates investigations into noncompliance.
The Center's biosafety officer:
- Reviews and approves all BSL-1 (not requiring IBC approval per NIH Guidelines) work and summarizes for IBC;
- Reviews and approves title and staff change EMUA amendments and summarizes for IBC;
- Maintains the Hutchinson Center Emergency Guide with respect to biological safety;
- Provides advice on lab security with respect to biological safety;
- Audits laboratories for biosafety;
- Provides technical advice to principal investigators, clinical supervisors, and the IBC on biological safety; and
- Reports all significant violations of the NIH Guidelines and/or WISHA Bloodborne Pathogen Standard to the IBC.
The Environmental Health and Safety Department:
- Assigns the Center's Biosafety Officer;
- Administers and maintains the biosafety program with the guidance of the IBC;
- Provides consultation and technical information to Center researchers on the handling of biological agents and blood or body fluids;
- Oversees the annual certification of biosafety cabinets;
- Oversees the testing and certification of newly installed, moved or repaired biosafety cabinets;
- Recommends purchases of biosafety cabinets and other related safety equipment;
- Coordinates decontamination service for facilities and equipment when needed;
- Provides Hepatitis B vaccinations and bloodborne pathogens training;
- Records and investigates all biosafety related incidents reported to EH&S; and
- Reports issues of noncompliance with the NIH guidelines to the Office of Biotechnology Activities.
A postdoctoral fellow or staff scientist who works under his or her own grant in a lab of an authorized principal investigator must be included on that PI's EMUA. See Section 2, Memorandum of Understanding and Agreement: Etiologic Agents and/or Recombinant DNA Experiments (EMUA) for more information.
1.4 Principal Investigator (PI) or Authorized MUA User
The principal investigator:
- Ensures research staff and support personnel are properly trained on the specific procedures and potential hazards of their labs and are listed on the EMUA where required;
- Establish policies for access to their laboratory spaces such that only persons who have been advised of the potential hazards and meet specific entry requirements (e.g., immunization) may enter;
- Ensures that research staff with potential exposure to bloodborne pathogens attend required training offered by EH&S;
- Enforces the Center's standards and policies regarding biological hazards;
- Advises the IBC and EH&S (through amendments to their EMUA) of any significant changes in protocol for the use of biological hazards, location of projects, and changes in staff;
- Reports any adverse reaction when an EMUA covers the use of human gene transfer.
- Inspects the lab periodically to ensure that safety practices are being followed;
- Reports all significant violations of the NIH Guidelines and all research-related accidents and illnesses to the BSO;
- Encourages staff to report any changes in their health status which may be related to handling infectious agents;
- Complies with packaging and training requirements for the transportation of infectious materials (EH&S provides support and information for the shipping of infectious materials); and
1.5 Laboratory Staff
Each laboratory worker must:
- Attend required safety training;
- Observe established guidelines and policies for biological safety and bloodborne pathogens as trained;
- Inform the immediate supervisor of any unsafe practices or conditions in the work area;
- Report any change in health status to the supervisor if there is a possibility it may be work-related;
- Report spills and incidents involving infectious material to the supervisor and to EH&S by completing and submitting the AIR form; and
- Contact EH&S in the event of a large spill of infectious materials (>200 mL).
Workers new to the Center are not authorized to work with infectious agents or recombinant DNA until their PIs train them in biological safety. Each worker's PI must also submit an EMUA amendment adding the worker's name to existing EMUA(s). New workers are not authorized to handle blood or body fluids until they have completed bloodborne pathogens training offered by EH&S