The ability to conduct research at Tufts University and/or Tufts Medical Center depends on institutional compliance with federal, state, and local regulations governing this research. To this end, the Institutional Biosafety Committee (IBC) is charged with enforcing a mandatory biosafety training policy to ensure that all personnel working with biological materials covered under the IBC scope are provided with the training necessary to understand the associated risks, conduct work safely, and gain knowledge of the pertinent regulations.
The IBC recognizes that relevant training occurs within each laboratory and that many individuals have experience that qualifies them in using biological materials. However, standardized training on institutional processes and the understanding of regulatory oversight of research are both essential. This standardized training is separate from any lab and agent-specific training provided by the Principal Investigator (PI). PIs must be aware that it is their responsibility to manage who is listed on their IBC registration and to ensure that they are appropriately trained. The IBC Office will document completion of any required training as described below.
Types of Mandatory Training
All personnel that will work with any IBC-registered biological materials must complete the relevant training and be added as project personnel on the IBC registration prior to initiation of work. The required training will depend on the type of work covered by the IBC Registration.
Training on NIH Guidelines for Principal Investigators
New PIs of an IBC registration must take this training module at least once, regardless of whether or not they currently work with recombinant or synthetic nucleic acids. This training includes important information about IBC oversight, procedures, and PI responsibilities. This must be completed PRIOR to IBC approval being granted, so it is in the PI’s best interest to complete this before or upon submitting a new registration for review.
Basic Biosafety Training
All personnel must complete the NIH Guidelines Module and either the Biosafety Level 1 OR Biosafety Level 2 Module. This will depend on the Biosafety Level that is approved in the IBC Registration. These modules must be completed before being added as approved personnel to an IBC Registration and must be renewed every three years. PIs must also complete this Basic Biosafety Training to be approved as a PI on the registration, even if they will not be working with the biological materials.
NIH Guidelines Awareness Module
All personnel must complete this training to understand regulatory oversight and incident reporting requirements.Note:Since this material is covered in “Training on NIH Guidelines for Principal Investigators” described above, new PIs do not need to take this awareness module as part of their initial training, however it must be completed as a refresher every 3 years.
Biosafety Level 1 Module
This module must be completed by any personnel that work only at Biosafety Level 1. Note: If a registration that was approved at BSL-1 is amended to include BSL-2 work, then all personnel must complete the Biosafety Level 2 Module.
Biosafety Level 2 Module
This module must be completed by any personnel that work at Biosafety Level 2. Note: This module includes all information covered in the Biosafety Level 1 Module so it is not necessary to take both.
Specialized Biosafety Training
Use of some biological materials will require additional training that is more specialized than what is offered in the Basic Biosafety training. Most of this training will be agent-specific and will be required by the IBC upon registration review, thus these training sessions will be scheduled on an as needed basis. The personnel listed on these registrations will be required to attend the “Specialized Biosafety” training in addition to the Basic Biosafety training. Examples of specialized training include but are not limited to:
Biosafety Level 3 Training
Select Agents and Toxins Training
Training Exemptions, Extensions, or Alternatives
There may be situations that require a training exemption, extension, or an alternate method of training than those listed above. The IBC Chair or Biosafety Manager may authorize an exemption, extension, or alternate training method on a case by case basis if there is appropriate justification. Please contact the IBC Office for determination on the appropriate process for the specific situation.
Failure to Complete or Renew Mandatory Training
If any individual fails to complete or renew any mandatory training requirement as advised, it may become an issue of non-compliance for the Principal Investigator that will be followed up by the IBC Office.