The NIH Office of Biotechnology Activities Site Visit Program: Observations About Institutional Oversight of Recombinant and Synthetic Nucleic Acid Molecule Research.

Institutions that receive National Institutes of Health (NIH) funding for research involving recombinant or synthetic nucleic acid molecules are required, as a term and condition of their funding, to comply with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) (NIH, 2013). Under the NIH Guidelines, institutions must establish and register an Institutional Biosafety Committee (IBC) with the NIH. The IBC is then responsible for reviewing and approving research projects subject to the NIH Guidelines. The IBC review of projects involving recombinant or synthetic nucleic acid molecules is critical to ensuring that such research is conducted in a safe and responsible manner. In 2006, staff from NIH began conducting educational site visits to institutions that had an IBC registered with NIH. The purpose of these site visits is to assist IBCs with their institutional programs of oversight for recombinant or synthetic nucleic molecules. Based on our findings, the site visit program has been beneficial to institutional biosafety programs. The information gathered during the site visits has allowed NIH to tailor its educational materials to help institutions address their oversight challenges. Additionally, since NIH's visits are primarily educational in nature, we have been able to foster a positive environment in which IBC members and staff feel comfortable reaching out to NIH for advice and assistance.

Biocontainment laboratory risk assessment: perspectives and considerations.

The ability to respond to public health emergencies involving infectious diseases as well as our ability to adequately prepare for as yet unknown or unrecognized emerging infectious diseases requires suitable facilities within which scientific investigations can take place. To ensure the safe conduct of such investigations so that laboratory workers and the general public are protected from potential consequences of accidental or intentional release of high consequence pathogens, special containment facilities have been designed and constructed. Evaluation of the adequacy of containment for these types of investigations requires a risk assessment (RA) as part of the overall construction project for these types of laboratories. A discussion of the RA process along with considerations that impact the design of such studies and the overall results is presented.