ABSTRACT
This Viewpoint discusses specific areas of improvement in the National Institutes of Health's funding of and research criteria for clinical trials to be inclusive, transparent, and broad reaching.
Subject(s)
Biological Specimen Banks/ethics , Biomedical Research/ethics , Human Experimentation/ethics , Informed Consent/ethics , National Institutes of Health (U.S.)/ethics , Organizational Policy , Betacoronavirus , Biological Specimen Banks/history , Biomedical Research/history , COVID-19 , Codes of Ethics , Coronavirus Infections , HeLa Cells , History, 20th Century , History, 21st Century , Humans , Informed Consent/history , Pandemics , Personal Autonomy , Pneumonia, Viral , Racism/history , SARS-CoV-2 , United StatesABSTRACT
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.
ABSTRACT
After a decade of intensive policy discussions on the topic of dual-use research of concern (DURC) in the life sciences, there has been a lack of consensus on how to practically define DURC; whether it is feasible to identify and regulate DURC experiments; how to address the risks associated with DURC; and how to balance this risk with the necessity of fostering life sciences research for public health and biodefense. The publication of two avian influenza studies has brought the DURC issue back into sharp focus and has resulted in a new set of federal guidelines. However, the new DURC policy raises questions regarding whether this is the best policy solution to a complicated biosecurity concern.