IBC Policies

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.

The above is the 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.

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.

This outlines the procedure to be followed for the Verification of the Identitiy of Attenuated Pathogens.

This is the form PIs should use to Verify the Identity of Attenuated Pathogens.

This policy implements 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.

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) regulate the transport and receipt of certain materials that could potentially harm agricultural products including livestock and plants.

Any Company (“Company”) seeking to use BU space and the BSL1, 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.

The Institutional Biosafety Committee (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.

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.

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 non-infectious and therefore they can be handled as Risk Group 1 (RG1) agent under BSL-1 conditions. This policy requires that the use of inactivated, non-infectious biological samples derived from BSL3 and BSL4 agents be reviewed and approved by both Environmental Health and Safety (EHS) and the Chair of the IBC prior to being received and used at Boston University (BU) and Boston Medical Center (BMC).

This report provides the processes established at Boston University and Boston Medical Center to evaluate and monitor Dual Use Research (DUR).

The IBC requires that all personnel listed on an IBC protocol be cleared by the Research Occupational Health Program (ROHP).

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.