Institutional Biosafety Committee (IBC)
Announcement: NIH Guidelines revised to include Synthetic Nucleic Acid Molecules
Starting March 5th, 2013, the NIH Guidelines will cover work with synthetic nucleic acid molecules, although many uses of synthetic nucleic acid molecules (e.g. siRNA) will be exempt from IBC review.
In order to be in compliance with the revised NIH Guidelines, the IBC is issuing revised forms and policies. Revised documents on the forms and policy page will be highlighted as either NEW or UPDATED.
Forms and policies that have undergone more significant revisions to incorporate research with synthetic nucleic acid molecules are listed below.
·Initial Classification Form – Updated version required for submissions after March 5th, 2013.
·Annual Renewal/Project Modification Form – Updated version required for submissions after March 5th, 2013.
·New ePPQ question asking if a grant/project involves research with synthetic nucleic acid molecules in cells, organisms, or viruses.
The NIH Guidelines Involving Recombinant or Synthetic Nucleic Acid Molecules, defines these nucleic acid molecules as:
(i) molecules that (a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids;
(ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e. synthetic nucleic acids, or
(iii) molecules that result from the replication of those described in (i) or (ii) above.
Infectious Agents are generally defined as risk group 2 agents and above (agents that can cause disease in healthy adult humans).
Use of Biologically Derived Toxins need only be reviewed by the IBC if the toxin is a select agent, or if the toxin is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight