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Policy

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 Committees (IBCs) are charged with enforcing a mandatory biosafety training policy to ensure that all personnel working with biohazardous materials are provided with the training necessary to understand the associated risks, conduct research safely, and gain knowledge of the pertinent regulations.

The IBCs recognize that relevant training occurs within each laboratory and that many individuals have experience that qualifies them in certain aspects in using biohazardous agents. However, standardized training on institutional process and understanding regulatory oversight of research are essential.

Principal Investigators must be aware that it is ultimately their responsibility to manage who is listed on their IBC registration and to ensure appropriate training of all personnel involved in a project. The IBC Office will document completion of any required training as described below.

Types of Mandatory Training

Prior to beginning work with registered biohazardous materials, all personnel must complete the relevant training and be added as project personnel on the IBC Registration. The required training will depend on the type of work covered by the IBC Registration.

Training on NIH Guidelines for Principal Investigators

New Principal Investigators (PIs) of an IBC registration must take this training at least once, regardless of whether or not they currently work with recombinant DNA and/or synthetic nucleic acids. This training includes important information about IBC oversight, procedures, and compliance responsibility

Basic Biosafety Training

All personnel must complete the NIH Guidelines Module and either the Biosafety Level 1 Module OR the Biosafety Level 2 Module. This will depend on the Biosafety Level that is approved in the IBC Registration. These modules must be completed before personnel can be added to an IBC Registration and must be renewed every three years. Please note that PIs must complete these modules, even if they are not working with the agents.

  • 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.

This requirement can also be satisfied by attending an in-person Basic Biosafety session, which covers all of the information in the above modules. These sessions are offered intermittently on all three campuses.

Specialized Biosafety Training

Use of some biohazardous agents 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 staff 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:

  • Agent-specific Training
  • Biosafety Level 3 Training
  • Select Agents and Toxins Training

Alternate Training and Exemptions

There may be situations that require a training exemption or an alternate method of training than the ones listed above. The IBC Chair or Biosafety Manager may authorize an exemption 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 mandatory training requirement is not completed or renewed on time, the individual will not be allowed to work with the agents listed in the IBC registration. If work continues, it will become an issue of non-compliance that will be followed up by the IBC Office.