- Faculty Staff Handbook – FSH 1640.14
Principal investigators (PI) working with potentially biohazardous materials and recombinant DNA activities are required by NIH Recombinant DNA Guidelines and/or university policy to submit a biosafety form referred to subsequently as a protocol to the IBC. Approval must be obtained in writing from the IBC before proceeding with these activities. The list below is intended as a guideline for the types of activities that require IBC approval. It is not an all inclusive list. Please refer questions to email@example.com.
- Activities that include recombinant DNA molecules (rDNA)
- Any activity involving the cultivation or production of genetically modified organisms
- Any activity involving the release or cultivation of genetically modified organisms in the environment (exception for USDA deregulated items)
- Any use, possession, storage or transfer of select agents and toxins,
- Any activity involving the use, possession, storage or transfer of any biological agent (bacteria, fungi, plants, viruses, rickettsiae, chlamydiae, parasites, allergens, viroids, virions and prions) that can be harmful to humans, livestock, plants or the environment
- Research activities involving:
- Known infectious tissues/materials, [which includes established human cell lines that present human hazards and as such are classified as Risk Group 2 (RG2) agents (BSL2)],
- Substances/specimens containing infectious materials that include:
- Activities that either propagate these materials, (e.g., growth of microbiological specimens),
- Could potentially expose workers to these agents, e.g., sifting of soil samples (aerosolizing the soil) when the soil is known to contain an infectious agent or is from a region where there are infectious agents endemic in the soil (Bacillus anthracis is endemic in parts of the Southwest in the United States, for example).
All protocols (Biosafety Forms) must be submitted by the monthly submission deadline (found on our Committee Meeting page) to be included on that month’s meeting agenda. The date and location of meetings may vary, so contact the Office of Research Assurances for specific meeting details. There is some variability in meeting dates during months with holidays or to meet protocol demand. Please plan to submit a protocol at least four to six weeks in advance of the planned research start date for all BSL-1 and BSL-2 protocols. BSL-3 protocols and Select Agent protocols, please contact the Biosafety Officer of the Office of Research Assurances for assistance.
The activities listed below require oversight which is provided by Environmental Health & Safety (EH&S) but do not require submittal of a Biosafety Form to the IBC. Please contact EH&S for assistance with developing laboratory safety plans (Chemical Hygiene Plans) and complying with the OSHA Bloodborne Pathogen Standard.
- Blood draws from humans (without known infectious agents). (Does require review and approval from the Institutional Review Board [IRB].)
- Work with primary human cell lines from healthy donors. (Does require review and approval from the IRB.)
- Work with established Risk Group 1 (RG1) human cell lines from commercial sources, (e.g. ATCC. [These are considered exempt under 45 CFR 46.101 (b) Category 4 and need not be submitted to the IRB.])
- Work with Other Potentially Infectious Material (OPIM) definitions 1 and 2 as defined in the OSHA Bloodborne Pathogen Standard. Work with cells/tissue or OPIM known to contain an infectious agent requires oversight by the IBC
- Work with chemical toxins (other than Select Agents and Toxins)
The approval of a Biosafety Form is good for three years. However, changes in the scope of work that increase risk or saliently alter the scope must be submitted as an amendment to the Biosafety Form. Amendments to approved Biosafety Forms during the three-year approval period do not alter the original renewal date for the MUA. To submit an amendment or request as to whether an amendment is required, send an email listing protocol changes to firstname.lastname@example.org and you will receive a written determination as to whether an amendment is required.
Many amendments can be handled under the administrative amendment approval process which requires approval from at least two of the following individuals: Research Compliance Officer, Biosafety Officer and the IBC Chair. Some examples are provided below to help guide the types of changes that necessitate notification to the IBC. As these are illustrative only, please refer all questions to the email@example.com.
- Examples of protocol changes that must be provided to the IBC as an amendment for their approval:
- Biosafety Level 1 (BSL-1) approved protocol that proposes to add Risk Group 2 agents,
- Addition of procedures with aerosolization risks that are not planned to occur in a Class II Biosafety cabinet,
- Plans to use a fermenter or batches of organisms greater than 10 liters in volume,
- BSL-2 approved protocol that proposes to add additional agents with different risks or higher risks, (e.g. approved use of Salmonella typhimurium (RG2) and proposed addition of Salmonella typhi (RG3) or approved use of any Risk Group 2 organisms with the proposed addition of clinical isolates of the same organism with known antibiotic resistance, [increased risk]).
- Examples of protocol changes that may be administratively approved:
- Change in PI (provided equivalent expertise)
- Additional lab space (with approved facility review)
- Examples of protocol changes that do not require notification to the IBC:
- Addition of procedures to the work that do not pose a risk of aerosolization,
- Addition of lab personnel provided the protocol does not have required medical surveillance. (PI is responsible for keeping a current list of lab personnel in the Biosafety Manual and ensuring that required annual training including review of the Biosafety Manual (BSM) is documented in the BSM),
- Addition of host/vector models with lower risk.
The PI must make available to all staff a copy of the IBC approval notice, the approved facility review, the approved Biosafety Manual and the approved protocol.
The PI must comply with all NIH Guidelines in the conduct of recombinant DNA work and ensure all lab workers comply with the NIH Guidelines.
The PI is responsible to keep a current list of research staff in the Biosafety Manual and ensure that annual training to include review of the Biosafety Manual and all other specified training in the manual and other regulatory required training is maintained and documented in the back of the Biosafety Manual.
The PI is responsible to report any significant problems, violations of the NIH Guidelines, or research related accidents or illnesses, or new information bearing on the NIH Guidelines to the Biosafety Officer. Some examples of reportable incidents are:
- Spills of potentially infectious materials or recombinant DNA outside of containment.
- Improper disposal or decontamination of potentially biohazardous materials.
- Needle sticks and other personnel injuries involving potentially infectious materials.
Supervise the safety performance of lab staff to ensure appropriate practices are used.
Inform lab staff of precautionary medical practices advised or requested (e.g. vaccinations).
Investigate and report any significant problems in regards to the operations and implementation of containment practices and procedures in writing to the Biosafety Officer.
Correct work errors and conditions that may result in the release of rDNA or other potentially infectious material in order to ensure biological and physical containment of these materials.
Comply with shipping requirements for rDNA molecules per Appendix H of NIH Guidelines.
Adhere to the IBC-approved emergency plans in the protocol specific approved Biosafety Manual.
The PI is responsible to ensure that other laboratory and research safety procedures are in place, such as proper personal protective equipment, appropriate research equipment (autoclaves, Biosafety cabinets, chemical fume hoods, etc.), signage, easy access to safety information such as Material Safety Data Sheets (MSDSs), and the ability to manage different wastes (biological, hazardous chemicals, sharps, etc.).
For additional PI NIH requirements see “PI Responsibilities” section IV B. 7 of the NIH Guidelines.
See Regulations for additional guidance documents.