Bioethics Blogs

US announces rules for potential bioterror agents

A long-awaited US government policy on biological research that could be used for terrorism or other nefarious purposes is little changed from a draft released 19 months ago, despite receiving 38 comments from institutions and researchers concerned that it goes either too far or not far enough. The centrepiece of the policy, released on 24 September, is a set of guidelines for researchers working on 15 specific pathogens or toxins. But the rules do not regulate experiments that engineer pathogens not on the list to make them more deadly – so-called gain-of-function research.  Officials from the White House and US National Institutes of Health (NIH) say the government will be addressing these concerns in coming weeks.

The White House released its first draft policy on dual-use research of concern, or DURC, in February 2013. The policy requires researchers at institutions that receive funding from the US government and are working with one of 15 specific pathogens or toxins to notify their institutions if there is potential that their work could be misused. The institutions will then assess whether or not the research qualifies as DURC. In parallel, the federal government will assess whether such research should receive funding. It will work with the institutions to plan how to manage concerns such as containment of listed pathogens and the public release of information that could allow them to be misused. Amy Patterson, director of the NIH Office of Science Policy, says that it is “incumbent upon investigators”  to report projects that have become potentially dangerous since they were funded, such as the discovery of a new pathogen, at which point the institutions and government would review the project again.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.