What principal investigators and laboratory directors must do when working with potentially biohazardous material
Because Washington State University receives National Institutes of Health (NIH) support, any research conducted at or sponsored by WSU that involves recombinant or synthetic nucleic acid molecules must comply with the NIH guidelines. Highlights of NIH requirements for work with recombinant DNA (rDNA) molecules are listed below.
“On behalf of the institution, the Principal Investigator is responsible for full compliance with the NIH guidelines in the conduct of recombinant or synthetic nucleic acid molecule research.”
—NIH Guidelines, Section IV-B-7, April 2016
Before work begins
Understand biosafety practices and principles
Practices are designed to protect workers, lab support personnel, products, and the environment. Labs working with potentially biohazardous material are required to have the following:
- Supervisor who is adequately trained in microbiological techniques and standard practices, and who is knowledgeable of biosafety practices
- Personnel who are aware of potential hazards and proficient in biosafety practices
- Lab-specific biosafety manual
Facilities must be outfitted with safety equipment.
Review the biosafety training presentation (pdf).
Become thoroughly familiar with the WSU IBC Manual
The manual (pdf) describes and explains various aspects of the review process and regulatory requirements. You should carefully review sections of the manual that address your specific research activities as they relate to your IBC protocol.
Obtain Institutional Biosafety Committee (IBC) approval
Investigators must register with the IBC using a biosafety approval form prior to conducting any research involving the following:
- Recombinant or synthetic nucleic acid molecules (even if your activities are classified as exempt based on current NIH guidelines)
- Human fluids or tissues
- Infectious agents/biohazardous materials, including human, animal, or plant pathogens
Registration is required regardless of the investigator’s funding source.
Steps for registering r/sNA molecules with the IBC
The principal investigator must do the following:
- Determine required levels of containment, physical and biological, in accordance with NIH Guidelines.
- Select microbiological practices and laboratory techniques to be used for the research.
- Submit the initial research protocol and any subsequent changes (e.g. changes in the source of DNA or host-vector system) to the IBC for review.
- Remain in communication with the IBC throughout the conduct of the project.
If you are unsure if your proposed work requires IBC approval
- Refer to the definition of potentially biohazardous materials.
- Contact the WSU biosafety officer.
Obtain permits and permissions
You may need agency permits—for example, from entities such as the following:
- U.S. Department of Agriculture Animal and Plant Health Inspection Service (USDA-APHIS)
- Centers for Disease Control and Prevention (CDC)
- U.S. Food and Drug Administration (FDA)
- Environmental Protection Agency (EPA)
- Other agencies
Get permits before you begin work. Submit copies with your biosafety approval form.
Develop or adopt a Biosafety Manual
The principal investigator for each proposal is responsible for developing/adopting a Biosafety Manual (BSM) based on risk assessment. The BSM includes current appropriate biosafety practices and standards as well as protocol-specific information. It serves as a training tool for project staff. Biosafety Manuals are required for all research activities involving recombinant or synthetic nucleic acid molecules.
The IBC provides templates to help you develop a BSM.
Train staff and students in biosafety practices
The principal investigator must ensure that personnel receive training on potential hazards and precautionary measures applicable to work with potentially biohazardous materials. This includes instruction in specific practices and techniques required for safely handling the agents (including standard microbiological practices) and procedures for dealing with accidents.
When graduate students apply for graduation, the Graduate School will ask whether they were authorized to work with potentially biohazardous materials. This section of the BAF provides the necessary documentation.
Provide precautionary information to laboratory personnel
- Make available to all laboratory staff the protocols that describe potential biohazards and precautions to be taken.
- Inform laboratory staff of the reasons and provision for any precautionary medical practices advised or requested, (e.g., vaccinations or serum collection).
While work is in progress
Supervise the safety performance of laboratory staff
Ensure that the required safety practices and techniques are employed. Correct work errors and conditions that may result in the release of hazards or r/sNA molecules.
Maintain inventories of all biohazardous materials
Current, accurate inventories must be kept of potentially hazardous materials stored in freezers, refrigerators, or other equipment.
- Dispose of biological materials no longer needed. Use an approved collection container or destroy biological materials following appropriate methods. Biological materials that cannot be documented should be destroyed.
- Report unregistered select agents or toxins. Contact the WSU biosafety officer immediately if an unregistered select agent or toxin is discovered.
Ensure the integrity of containment mechanisms
This includes both physical containment (e.g., biological safety cabinets) and biological containment (e.g., purity and genotypic and phenotypic characteristics).
- Certification of biological safety cabinets in Biosafety Level 2 (BSL-2) or Biosafety Level 3 (BSL-3) laboratories is required annually. Please contact the biosafety officer for current contact information to schedule service.
- Facility reviews are required annually for BSL-3 work and every 3 years for all other IBC-covered work activities. Refer to the inspection checklists for specific information about the nature of reviews.
To get a head start on scheduling a BSL-2 or BSL- 3 facility review—before you submit a BAF—contact the biosafety officer.
Report accidents, adverse or unplanned events, and new information
Within 30 days, report to the IBC, NIH Office of Biotechnology Activities, and other appropriate authorities any of the following:
- Any significant problems pertaining to the operation and implementation of containment practices and procedures
- Violations of NIH Guidelines
- Any significant research-related accidents and illnesses
- Any new information pertinent to NIH Guidelines
Even natural events must be reported to the IBC.
The biosafety officer will assist in all reporting. He will help you mitigate further problems.
Follow emergency plans
Adhere to IBC-approved emergency plans in your Biosafety Manual (BSM) for handling accidental spills and personnel contamination.
Comply with shipping requirements
Specific rules apply when shipping pathogens or r/sNA molecules. See Appendix H in the NIH Guidelines and WSU shipping policies and procedures.