Institutional Biosafety Committee

IBC Charter Pdf

Approved May 17, 2022

Scope of Committee Oversight

The Institutional Biosafety Committee’s (IBC) scope extends to BU and Boston Medical Center (BMC) and to all laboratories affiliated with, served by, owned, or controlled by BU.

Committee Responsibilities

The IBC is an institutional committee created under the National Institutes of Health (NIH) Guidelines to review research involving recombinant and synthetic nucleic acid molecules (rDNA). The IBC also reviews all research involving biohazardous materials and has overall oversight and responsibility for the Biosafety program at BU and BMC. The IBC carries out these functions pursuant to requirements set forth by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA), the City of Boston Public Health Commission (BPHC), the Massachusetts Department of Public Health (DPH), and Boston University.

It is the responsibility of the IBC to:

• Review technical and safety-related aspects of the use of recombinant or synthetic nucleic acid molecules, infectious agents and any other biohazardous agents;
• Develop and maintain a safety and operations manual for use of etiologic and other potentially biohazardous agents;
• Certify that facilities, procedures, and practices have been reviewed and approved;
• Promulgate a Biosafety program in conjunction with the Director of Research Safety that satisfies federal, state, and local laws and regulations;
• Limit, suspend or revoke an investigator’s authority to use Biohazardous materials if such use presents a hazard to individuals or violates health and safety codes;
• Review the potential of research protocols for any possible Dual Use Research of Concern (DURC) and facilitate remedial actions;
• Implement the provisions of the use of Department of Health and Human Services Select Agents and Toxins;
• Perform other duties to fulfill its charge, as may be required by the Associate Vice Provost of Research Compliance (AVPRC).

The IBC will advise and collaborate with other standing committees, including but not limited to: the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUCInstitutional Animal Care and Use Committee IACUC oversee...), the Dual Use Research of Concern Review Committee (DURRC), the Laboratory Safety Committee (LSCLaboratory Safety Committee), and any additional relevant BU Committees and subcommittees.

Composition of the Committee

Members are appointed by the AVPRC in consultation with leadership from BU and BMC. All members are appointed for three-year renewable terms, as determined by the AVPRC. The committee’s composition is intended to be representative of the laboratories within its scope of oversight and includes members representing both BU and BMC.

BU IBC adheres to the recommendation of the NIH Guidelines Section IV-B-2-a-(1) on the structure of the committee and is composed of:

• No fewer than five (5) members with collective experience and expertise in recombinant and synthetic nucleic acid molecule technology, the capability to assess research safety, and to identity any potential risk to public health or the environment;
• At least two (2) community members that are not otherwise affiliated with BU;
• Animal containment expert;
• Plant Research expert (when plant research is ongoing);
• Biosafety Officer;
• If needed, appropriate scientific expertise from BU or an outside organization may be added to the committee on an adhoc basis at the Chair’s discretion.

In addition to the committee members required by the NIH guidelines, the BU IBC ordinarily also includes senior or key members from the following offices that significantly contribute to the health, safety and welfare of University workforce members:

• BU Research Occupational Health
• BU Environmental Health and Safety
• BU Facilities and Management

IBC Member Responsibilities

IBC Members are expected to attend all scheduled meetings, which may be held in person, or via video conferencing, as necessary. Members who are assigned to review and present protocols are expected to review all information provided and send a written report to the IBC office ordinarily within five (5) days before the next scheduled meeting. Designated committee members who are unable to attend a meeting may send their comments to the IBC office which may be read by a secondary reviewer or the Chair at the meeting.

Members of the IBC, including the Chair, may not be involved in reviewing any protocol in which they have a conflict of interest (i.e. financial or otherwise, serving as PIPrincipal Investigator View Boston University's policy on... or research personnel), and may not be present for the vote on protocols in which they have such conflicts. IBC members must maintain confidentiality of information they receive in their role on the committee and may not disclose or use the information for any purpose other than to serve on the IBC.

IBC Meetings

The convened IBC ordinarily meets on a monthly basis,  at such times and frequency it determines to be necessary or appropriate, or at the discretion of the Chair. A quorum shall be a majority of voting members (fifty percent plus one).

Agenda, Minutes and Reports

The Chair, with assistance from Research Compliance staff, shall be responsible for establishing the agenda for convened meetings. The agenda, drafted minutes, and relevant materials will be sent to IBC members at least five (5) business days in advance of the meeting. Meeting minutes shall be drafted by Research Compliance staff and approved by committee members at the following meeting. Members should report biosafety issues and initiatives within their domain to the IBC and in return, should communicate IBC activities to other members of their departments.

IBC Charter Approval

The IBC Charter and any subsequent amendments to the Charter are reviewed by the members in a regularly convened meeting and will vote on its approval.

• Recombinant or synthetic nucleic acid molecules
• Hazardous biological agents (virus, bacteria, fungi, parasite, prion, rickettsia etc.)
• Other potentially infectious materials (human or non-human primate blood, serum, plasma, body fluids, unfixed tissue, organ and cells)
• Biological toxins including select agent toxins
• Inactivated Biological Samples derived from BSL-3 or BSL-4 agents
• Attenuated pathogens derived from BSL-3 or BSL-4 agents
• Human gene transfer
• Transgenic animals or plants
• Sheep and any tissues derived from them (these tissues can transmit Coxiella burnetii, the causative agent of Q-fever)
• Field studies with wild animals and their tissues inherently infected or would be experimentally infected with BSL-2 or higher agents

Note:

Complete all IBC applications online in the Research Information Management System (RIMS).

Principal Investigators (PIs) must complete a RIMS PI Account Registration in order to access the IBC application. The PI can designate others to assist in completing the application, however, only the PI can submit the application. IBC requires that all PIs be members of the BU/BMC faculty. Projects from postdoctoral scholars or other non-faculty members will require a faculty PI sponsor.

PIs seeking IBC approval for the first time also need to submit a NIH biosketch with their application. Please see this example biosketch for reference.

All personnel must complete the Lab Safety Training(s) and ROHP Clearance requirements. Additionally, PI must complete “Recombinant DNA / IBC Policies Training.” Other training will be required based on the nature of project. Personnel will need to have a RIMS Training Profile in order to complete these requirements.

All applications must be received by the deadline to allow time for review by the committee members and a Biological Use Authorization Site Assessment by EHS. Upcoming deadlines can be found under Meeting Dates & Deadlines. Each application will be assigned to a primary reviewer and a secondary reviewer. Reviewer comments will be discussed at a convened IBC meeting.

IBC approval of recombinant or synthetic nucleic acid molecules and biohazardous research projects is effective for three years. However, PIs must complete an IBC Annual Renewal each year for up to three years after the initial approval to continue work. After three years, the application must be resubmitted and reviewed by the committee.

• Recombinant or synthetic nucleic acid molecule research for conformity with the NIH Guidlines
• Potential risk to the environment and public health
• Containment levels per NIH Guidlines
• Adequacy of facilities, procedures, practices, and training and expertise of personnel
• Adverse event report

Note:

Research involving the following may require additional review

• Select Agent
• Biological agents with potential to cause Laboratory Infection (LAI)

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 health 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”).

III. Policy

All individuals listed on an active IBC protocol must complete the following training and health clearance requirements before engaging in any protocol related activities:

• Laboratory Safety Training;
• Health Questionnaire; and
• Laboratory Specific Training.

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 following training before engaging in any protocol related activities:

• IBC Policy /Recombinant DNA Training and Quiz.

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 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."

Health Questionnaire

All individuals listed on an active IBC protocol must complete an Initial Health Questionnaire and be cleared by the Research Occupational Health Program (“ROHP”) before engaging in any protocol activities. If the individual’s work environment changes to working with a new agent or hazard and they are listed on an active IBC protocol, they must complete and submit an updated Health Questionnaire to ROHP and be cleared by before engaging in the protocol activities. On an annual basis, individuals listed on active IBC protocols must complete the Annual Health Status Questionnaire and be cleared by ROHPResearch Occupational Health Program ROHP is part of BU R... before continuing to engage in the protocol activities. In some cases, a physical exam, a TB test, vaccinations, or respirator fit testing may be required for clearance.

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 IBC 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.

ROHP is responsible for establishing and 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
Next Review Date: May 2019

Training is a critical component of any integrated biological safety program. Training is intended to provide the understanding, technical knowledge, and tools that the trainee can use to improve his or her daily laboratory safety practices.

The PI is responsible for ensuring that his or her employees receive proper training in the biohazards and controls specific to his or her laboratory and the safe conduct of the experimental procedures to be used. The Biosafety Program provides different types of training associated with the BU and BMC biological, chemical, and radiological safety programs. Each of these has its own driver and emphasis.

Mandated general biosafety training is required for all laboratory workers (faculty, staff, students, and visiting scientists) at BU and BMC. The exact training required for a particular person will depend on the hazards to which he or she is exposed. “Laboratory Safety Training” is a training program offered by Environmental Health & Safety (EHS) that is designed for those working in laboratories.

The BU Laboratory Safety Training is now available in two formats, both accessible from the BioRAFT platform.

BU Laboratory Safety Training

Laboratory safety training satisfies the basic competency regulatory requirements for those working in labs. It does not satisfy the need for department-specific training, shipment of infectious agents, select agents, Biosafety Level 3 or 4 work, or other specialized training.

In addition to Annual Laboratory Safety Training, all personnel listed on an IBC protocol must register with the Research Occupation Health Program. (Please contact them directly at rohp@bu.edu or 617-358-7647.)

Accessing and Completing Office of Research Compliance Laboratory Safety Training

The IBC may require additional trainings be completed as deemed appropriate.

Contact Info

For questions related to:

• RIMSResearch Information Management System Learn more and acc...: Sajal Ghosh
• BioRAFT: Sony Heir, EHS