IBC Forms, Policies and Guidelines

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.

Forms

IBC Protocol Closure Form

If research under an approved IBC protocol is no longer required, PI must complete this IBC protocol closure form clarifying appropriate disposal of all biohazardous materials or their transfer to another approved IBC protocol and appropriate decontamination of the laboratory space as per EHS’s recommendation. The completed form must be sent to IBC office for verification.

Policies and Guidelines

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.

Comprehensive Risk-Based Laboratory Inspection Program

The purpose of the laboratory safety inspection program is to ensure that appropriate service is being provided to assist laboratories in complying with Federal, State, Municipal and Institutional requirements. Each laboratory area will receive, at a minimum, one laboratory safety inspection per year from the Office of Environmental Health and Safety (OEHS), which will support this goal. All inspections are conducted with either the Principal Investigator or his or her assigned Laboratory Safety Coordinator present. Following the inspection, EHS will issue a report containing the findings, identifying the responsible party, proposing a corrective action, and giving a target date for the corrective action to be completed.

Disease Surveillance Reporting

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.

Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP)

Although biological research produce useful knowledge for health, and in creating beneficial products and technologies, some research may present biosafety and biosecurity risks or provide knowledge, information, products, or technologies that could be misapplied to do harm with no, or only minor, modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. Any research that may fall into the categories stated above are defined as Dual Use Research of Concern (DURC) or pathogens with pandemic potential (also known as PPP or ePPP), especially those that have been modified in the laboratory for better understanding of their pathogenesis and for the study of therapeutic intervention strategies, may also have serious biosafety and biosecurity concerns that may require additional review by the BU IBC.

Exposure Control Plan (ECP)

The Occupational Safety and Health Administration (OSHA) enacted the Bloodborne Pathogens Standard in 1991. Its purpose is to promote safe work practices and to ensure that all workers are protected from exposure to the Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and other disease-causing pathogens in human blood, body fluids, and tissues. Environmental Health and Safety has prepared this plan to be used as a guide in developing department-specific procedures for reducing exposures to bloodborne pathogens in the workplace.

It is the policy of Boston University (BU) to maintain a safe and healthy workplace for all employees, including those who work with human and other potentially infectious materials (OPIM). The provisions of the OSHA Bloodborne Pathogen Standard and Biosafety Manual are the basis for the Boston University compliance program and all employees, contractors and visitors are required to follow the requirements described in this Exposure Control Plan. Boston Medical Center (BMC) has a separate Exposure Control Plan for Hospital employees and operations.

Guidelines for the Use of Human Embryonic Stem Cells

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.

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).

Incident Reporting Requirements for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

The purpose of this policy is to set forth the incident reporting requirements for research involving recombinant or synthetic nucleic acid molecules.

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.

Obtaining US Dept. of Agriculture and Centers for Disease Control and Prevention Permits for Importing and Transferring Animal Pathogens and Related Biological Materials

This document provides guidance to the BU researchers about the requirements and resources for bringing animal pathogens whose research are regulated by the USDA and CDC.

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.

Training Policy for IBC

The Institutional Biosafety Committee seeks to ensure the qualifications of all IBC personnel who handle rDNA and biohazardous materials to enable them to carry out their responsibilities in compliance with applicable guidelines and regulations. IBC must consider the training and experience of personnel involved in conducting research as part of its protocol review and approval.

Transgenic Rodent Guidelines

The purpose of this guideline is to identify the types of experiments that involve transgenic rodents that require approval by the Institutional Biosafety Committee (“IBC”) and to describe the Animal Biosafety Level (“ABSL”) containment level to be used, as stipulated in the NIH Guidelines for Research Involving Recombinant DNA Molecules (“NIH Guidelines”).

Verification of Attenuated Biosafety Level 3 (BSL-3) Pathogens Policy

The purpose of this policy is to set forth the procedures for verification of attenuated BSL-3 pathogens before they may be safely handled at the lower biosafety level (“BSL”) designated for the attenuated pathogen.