Guidelines and Regulations

Dual Use Research of Concern

According to NIH, Dual Use Research of Concern is any research that can be reasonably anticipated to provide knowledge, products or technologies that could be misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel or national security.

If your research falls under this category, please contact the Biological Safety Team for assistance. 
NIH Guidelines for Dual Use Research of Concern can be found on their website.

NIH Guidelines for working with Recombinant DNA

In the early 1970s, newly developed recombinant DNA (rDNA) technology raised concerns within the scientific community and among the public regarding the safety and ethics of research utilizing this technology. These concerns, voiced at the 1973 Gordon Conference, initiated a dialogue among scientific leaders to assess the potential hazards and benefits of this research and establish specific actions or guidelines for future work. Shortly thereafter, the scientific community called for a voluntary self-imposed moratorium on rDNA experiments that could result in the introduction of antibiotic resistance or toxin formation, or experiments where DNA from oncogenic viruses was put into plasmids or viral vectors. In addition, it was recommended that other rDNA experiments only be undertaken after very careful consideration and when more was known about their safety. In 1975, an international conference was held in Asilomar, California, to discuss these issues. It was concluded at this meeting that rDNA technology was too important to restrict altogether and experiments should continue, but under well-defined guidelines in which the institution manages oversight of the work at the local level and in collaboration with the NIH for certain categories of experiments. This led to the formulation of the first draft of what we now know as the NIH Guidelines. These guidelines were formally published in 1976 by the NIH’s Office of Biotechnology Activities (OBA). Multiple revisions have been issued since, with the most recent revisions issued in October 2012 including regulations on research with synthetic nucleic acid as well as recombinant nucleic acid.

The purpose of the NIH Guidelines is to specify practices for constructing and handling:

  • Recombinant nucleic acid molecules;
  • Synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules; and
  • Cells, organisms, and viruses containing such molecules.

The NIH Guidelines apply to all research at institutions that receive any NIH funding for rDNA research. Therefore, all recombinant or synthetic nucleic acid work at the University of Chicago is subject to the NIH Guidelines, even if the lab in question does not receive NIH funding. The full text of the NIH Guidelines can be found here.

One of the mandates of the NIH Guidelines is that each institution has an Institutional Biosafety Committee (IBC) to oversee rDNA research. At the University of Chicago this committee reviews all protocols involving recombinant or synthetic nucleic acids, human pathogens classified as Risk Group 2 or higher, and/or certain animal and plant pathogens. For more information please visit the University of Chicago’s Institutional Biosafety Committee website.

For commonly asked questions, please visit the NIH FAQs page.

OSHA Bloodborne Pathogen Standards

Bloodborne Pathogens are defined as pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV) and human immunodeficiency virus (HIV). For definitions relating to and standards set forth by the Occupational Safety & Health Administration in reference to working with bloodborne pathogens, please refer to their website.

Guidelines for Safe Transport of Infectious Substances and Diagnostic Specimens

Due to the collaborate nature of research science, you may often find it necessary to send or receive shipments of infectious substances or diagnostic specimens. In 1997, the World Health Organization published the Guidelines for Safe Transport of Infectious Substances and Diagnostic Specimens. Should you need assistance in preparing your shipment or are unclear how to receive your shipment, please contact our Biological Safety Team.