Glossary of IBC Terms
- Biohazardous Material
Biohazardous materials and organisms include all infectious agents or biologically derived infectious materials that present either a risk or a potential risk to the health of humans or animals, either directly through infection or indirectly through damage to the environment.
Human, Animal, and Plant Pathogens:
- viruses, including oncogenic and defective viruses (includes viral vectors)
- bacteria, including those with drug resistance plasmids*
- undefined or other infectious agents, such as prions
- toxins (bacterial, fungal, plant)
- All human blood, blood components and products, tissues and body fluids
- Cultured cells (all human and non-human primates) and potentially infectious agents these cells may contain
- Animals or animal tissues that may transmit zoonotic or human pathogens designated at BL-2 or higher
- Non-human primates and any tissues derived therefrom
- Sheep and any tissues derived therefrom
* Lab K-12 strains of E-coli are not included
- Biological Safety Officer (BSO)
An individual appointed by the institution to oversee management of Biosafety risks.
- Biological Use Authorization (IBC Application)
- 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.
- Boston Public Health Commission (BPHC)
- Biological Safety 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.
- DURC (Dual Use Research of Concern)
The National Science Advisory Board for Biosecurity (NSABB) has defined Dual Use Research of Concern (DURC) as: “research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment or materiel”.
An excellent short video discussing DURC is posted on the NIH Office of Biotechnology Activities (OBA) website. All investigators are strongly recommended to view the video for a better understanding the issues (http://oba.od.nih.gov/biosecurity/biosecurity.html).
- Environmental Health and Safety (EHS)
Environmental Health and Safety’s mission is to provide a safe environment for students, employees, faculty, and staff as well as patients and others visiting our facilities and to help ensure compliance with federal, state, and local codes and regulations, in accordance with the Boston University Statement of Commitment to Environmental Health and Safety.
Environmental Health and Safety (EHS) is comprised of Campus & Clinical Safety, Emergency Response Planning, Environmental & Waste Management, Medical Physics & Radiation Safety, and Research Safety. These five divisions provide a full range of environmental, health, and safety services to the Boston University and Boston Medical Center communities.
- Human Embryonic Stem Cells
Boston University and Boston Medical Center Guidelines for the Use of Human Embryonic Stemm Cells (hESC) can be found here
- Human Gene Therapy
In accordance with the NIH Guidelines, an institution is any public or private entity, including federal, state, and local governments.
- Institutional Animal Care and Use Committee (IACUC)
The mission of the Institutional Animal Care and Use Committee (IACUC) is to consider the care and use of animals in research and teaching from an ethical perspective and to ensure institutional compliance with federal requirements through oversight of the laboratory animal care program.
- Institutional Biosafety Committee (IBC)
An institutional committee created under the NIH Guidelines to review research involving recombinant DNA and/or biohazardous materials.
- Institutional Review Board (IRB)
- Laboratory Safety Training (LST)
- NEIDL (National Emerging Infectious Disease Laboratories)
The National Emerging Infectious Diseases Laboratories (NEIDL) is part of a national network of secure facilities studying infectious diseases that are—or have the potential to become—major public health concerns. The laboratories are dedicated to the development of diagnostics, vaccines, and treatments to combat emerging and re-emerging infectious diseases. In addition to BSL-2 and BSL-3 laboratories, the NEIDL houses a BSL-4 laboratory. The NEIDL adds to the growing life sciences industry in the region, throughout the Commonwealth of Massachusetts, and across the country. For more information www.bu.edu/neidl.
- 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.
- NIH – OBA (NIH Office of Biotechnology Activities)
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.
- NIH – RAC (NIH Recombinant DNA Advisory Committee)
An NIH advisory committee whose principal role is to provide advice and recommendations to the NIH Director on:
- Conduct and oversight of research involving recombinant DNA, including the content and implementation of the NIH Guidelines, and;
- 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.
- Research Occupational Health Program (ROHP)
The Boston University Research Occupational Health Program provides prevention, diagnosis, and treatment for work-related injuries and illnesses for the employees of Boston University in compliance with OSHA, CDC, and other regulatory requirements.
The Institutional Biosafety Committee requires that all investigators and their research personnel register with the Research Occupational Health Program (ROHP), by completing the Initial Health Questionnaire.
- Risk Groups
- Select Agents
- Tenant and Licensee Companies