Guidelines and Regulations

Our biological safety team can help you with any questions about following national and international guidelines and policies for the following research activities:

Working with recombinant or synthetic DNA

In the early 1970s, newly developed recombinant DNA (rDNA) technology raised ethical and safety-related concerns within the scientific community and among the public. Several years of international dialogue led to the formulation of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, first published in 1976 and subsequently revised multiple times by the NIH’s Office of Science Policy. The most recent revision was published in April 2019.

The NIH Guidelines specify practices for constructing and handling the following:

  1. Recombinant nucleic acid molecules
  2. Synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules
  3. Cells, organisms, and viruses containing the types of molecules described in (1) or (2)

The guidelines apply to all research at institutions that receive any NIH funding for rDNA research. Therefore, all UChicago labs are subject to the NIH Guidelines, even if the lab in question does not receive NIH funding. 

One of the mandates of the NIH Guidelines is that each institution has an institutional biosafety committee to oversee rDNA research. The Institutional Biosafety Committee at the University of Chicago reviews all protocols involving recombinant or synthetic nucleic acids; microbial agents that impact human, animal, or plant health; certain biological toxins, and some other biohazardous agents. 

Working with bloodborne pathogens

Bloodborne pathogens are pathogenic microorganisms present in human blood that can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus, hepatitis C virus, and HIV.  The U.S. Occupational Safety and Health Administration sets standards for workers who could be exposed to bloodborne human pathogens.

Doing research that falls under dual use research of concern policies

According to the National Institutes of Health (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, material, or national security.

If your research includes elements that can be reasonably expected to fall under dual use research of concern policies, please contact the biological safety team for help complying with NIH policies for dual use research of concern.

Transporting infectious substances and diagnostic specimens

Due to the collaborative nature of research science, you may often find it necessary to send or receive shipments of infectious substances or diagnostic biological specimens.

All researchers involved with categorizing, identifying, preparing, packing, labeling, or offering potentially hazardous material for shipment must complete the hands-on dangerous goods regulation training offered by the Office of Research Safety. You can register for this training through the EHSA training portal. Should you need additional assistance in preparing or receiving a shipment, please contact our biological safety team.

UChicagoSocial: Office of Research Safety