Institutional Biosafety Committee (IBC)

Statement of Purpose

Purpose

The Institutional Biosafety Committee (IBC) has been established to advise the Boston University (BU) and Boston Medical Center (BMC) Leadership and to work with the Director of Research Safety to ensure the safe conduct of research using infectious agents, select agents and recombinant DNA technology. The IBC constitution and Biological Safety Officer roles also meet BU and BMC responsibilities as stated in the NIH rDNA guidelines.

Definitions

Biosafety Level (BSL)
A description of the degree of physical containment and work practices employed to confine organisms containing recombinant DNA molecules and biohazardous materials and to reduce the potential for exposure to laboratory workers, persons outside of the laboratory, and the environment.

Biological Safety Officer (BSO)
An individual appointed by the institution to oversee management of Biosafety risks.

Institution
In accordance with the NIH Guidelines, an institution is any public or private entity, including federal, state, and local governments.

Institutional Biosafety Committee (IBC)
An institutional committee created under the NIH Guidelines to review research involving recombinant DNA and/or biohazardous materials.

NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
A regulation issued under the Federal Register in 1976 that outlines principles for the safe conduct of research employing recombinant DNA technology. The NIH Guidelines detail practices and procedures for the containment of various forms of recombinant DNA research, for the proper conduct of research involving genetically modified plants and animals, and for the safe conduct of human gene transfer research. As a “living" document, it is periodically revised to keep pace with the changing state of science.

Office of Biotechnology Activities (OBA)
The NIH office responsible for developing, implementing, and monitoring NIH policies and procedures for the safe conduct of recombinant DNA activities, including human gene transfer.

Recombinant DNA Advisory Committee (RAC)
An NIH advisory committee whose principal role is to provide advice and recommendations to the NIH Director on:

  1. Conduct and oversight of research involving recombinant DNA, including the content and implementation of the NIH Guidelines, and;
  2. Other NIH activities pertinent to recombinant DNA technology.

A major element of this role is to examine the science, safety, and ethics of clinical trials that involve the transfer of recombinant DNA to humans.

Recombinant DNA molecules
In accordance with the NIH Guidelines, recombinant DNA are molecules constructed outside of living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or molecules that result from their replication.

Policy

The Institutional Biosafety Committee creates and recommends policies and procedures to provide adequate precautions and safeguards necessary to prevent exposure to infectious pathogens while performing research using etiologic agents (whether bacterial, viral, rickettsial, parasitic, or fungal). The Institutional Biosafety Committee, in collaboration with the Biosafety Officer, Occupational Health, and Office of Environmental Health and Safety reviews and approves all research facilities and procedures using recombinant DNA technology and/or biohazardous agents for appropriate containment of biohazardous agents as defined in the BU-BMC Biosafety Manual.

Responsibility

Associate Vice President Research Compliance (AVPRC)
  • Has overall responsibility for all research regulatory compliance matters at Boston University and Boston Medical Center
  • In consultation with the Deans appoints the membership to the Institutional Biosafety Committee, Human Gene Therapy Committee
  • Review and accept the final commissioning of the BSL4 high containment facility for operation.
  • May invoke special procedures to resolve disagreements regarding Biosafety matters.
Institutional Biosafety Committee

IBC has overall oversight responsibility for the Biosafety Program at BU and BMC. It is the responsibility of the Institutional Biosafety Committee to:

  • Review technical and safety-related aspects of the use of recombinant DNA, 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;
  • 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 AVP-RC.

Biosafety Officer

  • The Biosafety Officer provides technical support to the Institutional Biosafety Committee, including biological laboratory inspection and approval, consultation, education, and service as a liaison with regulatory bodies.
  • Overseeing periodic and unscheduled inspections to ensure that laboratory standards are rigorously maintained
  • Developing emergency plans for handling spills and personnel contamination
  • Developing design specifications and criteria for containment facilities.
  • Providing training programs as approved by the IBC.

Principal Investigators

In using etiologic agents or recombinant DNA technology, Principal Investigators must

  • Conduct their research in compliance with accepted standards of safe laboratory practice and any conditions of approval required by the Institutional Biosafety Committee and the Biosafety Officer.
  • Register research with recombinant DNA, agents that are infectious to humans, animals and plants, other potentially infectious materials, select agents and biological toxins, human materials including blood, cells, unfixed human tissues and other body fluids, xenotransplant and gene transfer clinical studies with the IBC.
  • Ensure that work with hazardous materials are performed in appropriate facilities.
  • Ensure that laboratory staff have proper training, safety equipment and personal protective equipment when working with hazardous materials.
  • Ensure that Hepatitis B and any other appropriate vaccines are offered to applicable lab staff.
Related Policies References
  • BU-BMC Biosafety Manual
  • Biosafety in Microbiological and Biomedical Laboratories, Centers for Disease Control (CDC) 5th Edition, 2007
  • Commonwealth of Massachusetts, Department of Health and Human Services, Storage and Disposal of Infectious or Physically Dangerous Medical or Biological Waste.
  • Use of Department of Health and Human Services Select Agents Program
  • NIH Guidelines For Research Involving Recombinant DNA Molecules (NIH Guidelines), April 2002
  • Boston Public Health Commission Laboratory Safety Regulation
  • BPHC Disease Surveillance and Reporting Regulations