The National Institute of Health (NIH) is the primary oversight agency for biosafety in research, but other federal agencies have set forth rules and guidelines pertaining to biosafety. An institution that receives funds from the NIH to conduct research involving recombinant DNA is subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules. Other guidelines also exist for the transportation, use, and containment of biologic and biohazardous materials. Institutional Biosafety Committees (IBCs) were established under the NIH Guidelines to provide local review and oversight of research utilizing recombinant DNA. Each institution receiving federal funding for recombinant DNA research is responsible for ensuring that all recombinant DNA research conducted at, or sponsored by, the institution is conducted in compliance with the NIH Guidelines. Institutional authority and responsibility place accountability for the safe conduct of the research at the local level.


Oversight Agency and Institutional Biosafety Committees

The National Institute of Health (NIH) is the primary oversight agency for biosafety in research, but other federal agencies have set forth rules and guidelines pertaining to biosafety. An institution that receives funds from NIH to conduct research involving recombinant DNA is subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules. Various other guidelines also exist for the transportation, use, and containment of biologic and biohazardous materials.

In addition, Institutional Biosafety Committees (IBCs) were established under the NIH Guidelines for Research Involving Recombinant DNA Molecules to provide local review and oversight of nearly all forms of research utilizing recombinant DNA. Over time, institutions have chosen to assign IBCs the responsibility of reviewing a variety of experimentations involving biological materials (e.g., infectious agents) and other potentially hazardous agents (e.g., carcinogens). This additional responsibility is assigned entirely at the discretion of the institution. Each institution receiving federal funding for recombinant DNA research is responsible for ensuring that all recombinant DNA research conducted at, or sponsored by, the institution is conducted in compliance with the NIH Guidelines. Institutional authority and responsibility place accountability for the safe conduct of the research at the local level.

The NIH Office of Biotechnology monitors scientific progress in human genetics research in order to anticipate future developments, including ethical, legal, and social concerns, in basic and clinical research involving Recombinant DNA, Genetic Technologies, and Xenotransplantation.

The Recombinant DNA Advisory Council (RAC) was established on October 7, 1974, in response to public concerns regarding the safety of manipulation of genetic material through the use of recombinant DNA techniques. The RAC is advisory to the Director of NIH.

The National Science Advisory Board on Biosecurity (NSABB) has been established to provide advice to federal departments and agencies on ways to minimize the possibility that knowledge and technologies emanating from vitally important biological research will be misused to threaten public health or national security.


Guidelines

An institution that receives funds from the National Institutes of Health (NIH) to conduct research involving recombinant DNA is subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules. Various other guidelines also exist for the transportation, use, and containment of biologic/biohazardous materials.

Guidelines

NIH Guidelines for Research Involving Recombinant DNA

Guidelines for Transporting/Shipping Biologic Materials(HAZMAT/ CFR 49.)
Provides regulations and guidance for transporting biologic/biohazardous materials.

Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
CDC Summary of Recommended Biosafety Levels for Infectious Agents

CDC Primary Containment Standards for Biohazards
This site presents information on the design, selection, function and use of biological safety cabinets (BSCs), which are the primary means of containment developed for working safely with infectious microorganisms.


Other Links

Guidelines for Transporting/Shipping Biologic Materials(HAZMAT/ CFR 49.)
Provides guidance for transporting biologic/biohazardous materials.

CDC Biosafety Documents
This CDC-developed site provides various resources regarding biological/biohazardous materials.

The 1, 2, 3's of Biosafety Levels A brief overview of the CDC-defined biosafety levels.

American Biologic Safety Association
The American Biological Safety Association's (ABSA) purpose is to promote biosafety as a scientific discipline and serve the growing needs of biosafety professionals throughout the world.

OSHA Blood Borne Pathogen Standards
This site provides OSHA regulations for exposure to blood borne pathogens.