When researchers in biology and life science think of work with recombinant nucleic acids, commonly known as rDNA work, phrases like non-viral transfection, viral transduction and even CRISPR come to mind. rDNA work is also associated with the National Institutes of Health, or NIH, because they developed the NIH Guidelines in the 1970s that provide the framework for oversight. rDNA work in an academic setting has to be approved by their internal Institutional Biosafety Committee, or IBC. In many institutions, this approval is required regardless of whether or not the work is funded by the NIH or a federal agency.
Reviewing rDNA work at an IBC meeting has many advantages. It’s a formal, documented process to verify that the scope of work aligns with proposed or established biosafety practices, and can act as a safeguard to help ensure compliance. The Committee consists of scientific experts who can provide context about the project, and non-scientists and individuals not associated with the institution that confirm that the work is safe based on the information communicated to them. It can be a forum to discuss biological or regulated medical waste procedures, and to ensure that waste is disposed of in compliance with regulations.
rDNA work in a company that is not federally funded is not required to follow the NIH Guidelines unless there are state or local regulations that adopt it, although they should follow the Guidelines as best practice. In New York, the Recombinant DNA Research and Activity Regulation (10 NYCRR 61-1) states that entities that conduct rDNA work must comply with NIH Guidelines, and outlines the requirements for an IBC. The regulation also includes measures to keep proprietary information confidential while complying with the regulations. While the Department of Health has not implemented a formal enforcement process for this regulation, they still recommend that entities conducting rDNA work hold IBC meetings.
IBC meetings serve as a gateway to rDNA safety and oversight. Whether in academic or corporate settings, adherence to the NIH guidelines and establishment of an IBC allows researchers to prioritize biosafety and regulatory compliance, enabling a responsible contribution to science while decreasing potential risk.
For additional information on rDNA work, biosafety and IBCs at your facility, please contact us!
This blog was written by Rae Moore, Safety Partners’ Senior Quality, Research, and Training Specialist.
