IBC Policies & Procedures

The Institutional Biosafety Committee (IBC) is an institutional committee created under the NIH Guidelines to review research involving recombinant DNA and synthetic nucleic acid research. The IBC also reviews all research involving biohazardous materials and has overall oversight and responsibility for the Biosafety program at BU and BMC.

Please note that if you are performing this type of work without IBC approval, you (and as a result, the institution) are out of compliance with current NIH and local regulations.

IBC Policies

BU Biosafety Manual

The purpose of this manual is to define the biological safety policies and procedures pertaining to research operations at Boston University and Boston Medical Center. These policies and procedures are designed to safeguard personnel and the environment from biologically hazardous materials and to comply with federal, state, and local regulatory requirements. All BU and BMC principal investigators and laboratory workers must adhere to the biological safety policies and procedures in the conduct of their research and the management of their laboratories.

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Responsibility of the Principal Investigator

Responsibility of the principal investigator for personnel with potential exposure to bloodborne pathogens and other potentially infectious material and other research-related occupational health issues.

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Verification of the Identity of Attenuated Pathogens

This policy covers attenuated pathogens which meet the following criteria: 1. the attenuated pathogen is derived from a known, virulent pathogen that requires BSL3 or BSL4 biosafety containment; 2. attenuation results in decreased virulence of the organism; 3. attenuation results in a reduction in the level of biosafety containment in which the attenuated pathogen can be handled, compared with the biosafety level required for the safe handling of the non-attenuated counterpart.

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Strain Verification Procedure

This outlines the procedure to be followed for the verification of the identity of attenuated pathogens.

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Disease Surveillance Reporting Policy

This policy implements the Boston Public Health Commission’s (BPHC) “Guidelines for Implementation and Enforcement of Boston Public Health Commission’s Disease Surveillance and Reporting Regulation.” The BPHC guidelines require laboratory registration and a medical surveillance program for research laboratories working with high-risk agents. The guidelines are designed to ensure that BPHC receives timely access to information regarding incidence of disease syndromes, any outbreak or cluster of a disease, and potential exposures to reportable diseases deemed harmful to the public health.

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USDA/APHIS Permit Application Procedure

The purpose of this procedure is to outline the application process for a principal investigator (PI) to obtain a USDA/APHIS permit with assistance from the IBC office. The United States Department of Agriculture/Animal and Plant Health Inspection Service (USDA/APHIS) regulates the transport and receipt of certain materials that could potentially harm agricultural products including livestock and plants.

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Tenant or Licensee Companies Procedure

Any company seeking to use BU space and the BSL‐1, 2, and 3 level laboratory facilities through a lease agreement, premises license agreement, or other agreement must demonstrate to BU’s satisfaction that it is in compliance with all regulatory requirements and safety standards as a condition to conducting any biological research activity in such space.

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Training Policy for IBC

The IBC seeks to ensure the qualifications of all individuals who handle biologicals to enable them to carry out their responsibilities in compliance with applicable guidelines and regulations. The IBC must consider the qualifications of personnel involved in conducting research as part of its protocol review and approval.

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Inoculation of Viral Vectors in Laboratory Rodents

The Inoculation of Viral Vectors in Laboratory Rodents serves as a guide for PIs and indicates the acceptable containment for handling and injection of vectors in the lab and the acceptable animal containment or housing conditions.

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Inactivated Biological Sample Use Policy

The purpose of the Inactivated Biological Samples Use Policy is to develop a process whereby samples generated as BSL-3 and BSL-4 can be used safely at lower biosafety levels. Inactivation of biological samples renders them noninfectious and therefore they can be handled as Risk Group 1 (RG1) agents under BSL-1 conditions. This policy requires that the use of inactivated, noninfectious biological samples derived from BSL-3 and BSL-4 agents be reviewed and approved by both Environmental Health & Safety (EHS) and the Chair of the IBC prior to being received and used at Boston University (BU) and Boston Medical Center (BMC).

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Dual Use Research of Concern Policy (DURC)

This report provides the processes established at Boston University and Boston Medical Center to evaluate and monitor dual use research (DURC).

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BU Human Embryonic Stem Cell Research Guidelines

Research involving human embryonic stem cells is governed by federal and state regulations, NIH Guidelines on Human Stem Cell Research, and Boston University and Boston Medical Center policies. All research that involves the use of human stem cells, human embryos, or their derivatives, must be reviewed and approved by the appropriate oversight committee (e.g. IRB, IBC, and/or IACUC) and the Embryonic Stem Cell Research Oversight Committee (ESCRO) as appropriate, prior to the commencement of the activity.

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Biological Agents with an Increased Potential to Cause Laboratory Acquired Infection (LAI)

Biological agents deemed to have an increased potential to cause LAI are reviewed by the full IBC and added to the “Biological Agents with Potential to Cause Laboratory Acquired Infection (LAI)” list. The subcommittee also reviews agents proposed on IBC applications that are new to the University prior to approval of the associated IBC protocol. The Research Occupational Health Program (ROHP) provides all individuals listed on projects involving an LAI agent(s) with a special “High Hazard Agent” identification card. This card should be kept on the person and provided to medical care professionals to assist in evaluating for a potential LAI.

List of biological agents with potential to cause LAI 

Regulations

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

The NIH guidelines provide the IBC with the standards that guide containment and safe reserach practices for recombinant DNA research. The Recombinant DNA Program promotes scientific advancement and safety in the conduct of basic and clinical recombinant DNA research.

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Office of Biotechnology Activities (OBA)

The NIH Office of Biotechnolocy Activities (OBA) promotes science, safety, and ethics in biotechnology through advancement of knowledge, enhancement of public understanding, and development of sound public policies. OBA accomplishes its mission through analysis, deliberation, and communication of scientific, medical, ethical, legal, and social issues.

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Dual Use Research (NSABB)

The Dual Use Research Program is a focal point for the development of policies addressing life sciences research that yield information or technologies with the potential to be misused to threaten public health or national security.

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Boston Public Health Commission—Biological Laboratory Regulations

The Boston Public Health Commission Biological Laboratory Regulations govern labs using biological agents and recombinant DNA in the city of Boston.

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National Select Agent Registry (CDC)

The Federal Select Agent Program is jointly comprised of the Centers for Disease Control and Prevention/Division of Select Agents and Toxins and the Animal and Plant Health Inspection Services/Agricultural Select Agent Program. The Federal Select Agent Program oversees the possession, use, and transfer of biological select agents and toxins which have the potential to pose a severe threat to public, animal, or plant health, or to animal or plant products.

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Agricultural Select Agent Program (USDA)

APHIS issues permits for the import, transit, and release of regulated animals, animal products, veterinary biologics, plants, plant products, pests, organisms, soil, and genetically engineered organisms.

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Final Rule on Possession, Use, and Transfer of Select Agents and Toxins

Provides more specific information from the CDC and USDA on select agent regulations.

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Centers for Disease Control and Prevention

Provides more resources on biosafety guidelines.

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