IBC Training and Health Clearance Requirements Policy

I. Purpose

Boston University (BU) is committed to observing federal, state, and local regulations and the National Institute of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). The purpose of this policy is to set forth the training and medical clearance requirements for individuals listed on active IBC protocols who will be constructing and handling the following: recombinant nucleic acid (rDNA) molecules; synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules; cells, organisms and viruses containing such molecules; and biohazardous materials, hereinafter referred to collectively as “activities”.

II. Scope

This policy is applicable to all personnel who are listed on active IBC protocols and are responsible for conducting research, teaching, training and related activities at or under the auspices of Boston University (BU) and Boston Medical Center (BMC).

III. Policy

Laboratory training is assigned by the principal investigator, supervisor and/or EHS. All individuals listed on an active IBC protocol must complete laboratory safety training and/or laboratory agent-specific training and health clearance requirements before engaging in any protocol related activities.

All Principal Investigators (PIs) listed on an active IBC protocol and all individuals listed on an active IBC protocol involving recombinant or synthetic nucleic acids must complete the “IBC Policy /Recombinant DNA Training and Quiz” in Scishield before engaging in any protocol related activities.

Please see the ROHP website for specific medical clearance requirements.

IV.Procedures

Schedule and Types of Mandatory Training:

Laboratory Safety Training.

All individuals listed on an active IBC protocol must complete the Laboratory Safety Training requirement in Scishield before engaging in any protocol activities and on an annual basis thereafter. This requirement may be fulfilled by attending a “Classroom Laboratory Safety Training” or completing an online “Laboratory Safety Training.” The online training requires the completion of the “Universal Lab Safety Module” and additional modules as applicable to the laboratory work being conducted (e.g., Biosafety Training Level 1 & 2, Chemical Safety Training, Bloodborne Pathogens). After completing the initial classroom or online training, the annual refresher requirement may be fulfilled by either repeating the classroom training or completing the online “Laboratory Safety Annual Refresher Module.”

Training and knowledge of the NIH Guidelines and IBC policies.

All PIs listed on an active IBC protocol and all individuals listed on an active IBC protocol involving recombinant or synthetic nucleic acids are required to complete the online “IBC Policy / Recombinant DNA Training” and Quiz before engaging in any protocol activities and at the time of three-year renewal before continuing to engage in the protocol activities. This is a requirement for all PIs listed on an active IBC protocol regardless of whether or not they currently work with recombinant or synthetic nucleic acids.

Specialized Biohazard Safety Training.

Use of some biohazardous agents will require additional safety training that is more specialized than what is offered in the Laboratory Safety Training. These training requirements will be determined by the PI on an as needed basis and include, but are not limited to: BSL-3 Annual Training; Select Agent Training; Agent-Specific Training for Francisella Tularensis, Tuberculosis, and Y Pestis; and Shipping Biologicals Training. In addition to agent specific training, Agent Information Sheets (“AIS”) and Agent Specific Identification Cards must be made available to individuals using biological agents with the potential to cause Laboratory Acquired Infection (“LAI”).

Specialized Laboratory Safety Training.

The PI is responsible for ensuring that all individuals listed on their active IBC protocol are appropriately trained. Hands-on training and demonstrations for performing protocol specific procedures may be required to ensure that individuals listed on an active IBC protocol understand the protocol and how to safely perform their duties.

V. Responsible Parties

EHSEnvironmental Health & Safety is responsible for supporting PIs and laboratory staff through training, auditing of procedures, audit and emergency response.

The IBCInstitutional Biosafety Committee The IBC is an instituti... is responsible for overall oversight of the Biosafety Program at BU.

Principal Investigators are responsible for ensuring compliance with this policy and ensuring all personnel who work under their supervision and occupy their laboratory space are aware of this policy and understand how it applies to their areas.

ROHPResearch Occupational Health Program ROHP is part of BU R... is responsible for performing appropriate medical surveillance for all personnel performing or supporting research.

VI. Definitions

Medical Surveillance is the systematic assessment of employees exposed or potentially exposed to occupational hazards. This assessment monitors individuals for adverse health effects and determines the effectiveness of exposure prevention strategies. A medical surveillance program includes the analysis of both individual and aggregate surveillance data over time, with the goal of reducing and ultimately preventing occupational illness and injury.

Recombinant and Synthetic Nucleic Acid Molecules are defined as:

1. molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids;
2. nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or
3. molecules that result from the replication of those described in (i) or (ii) above.

VII. Related Documents

BU Biosafety Manual
Responsibility of the Principal Investigator

VIII. History

Original Date Approved: 2011
Revised: 5/17/16, 6/18/2025
Next Review Date: May 2028