Dual-Use Research Policies Issued

The United States government has issued a draft policy calling on institutions to exercise new oversight of so-called life sciences dual-use research of concern (DURC). Such experiments involve work that, while scientifically justifiable, could be used for malevolent purposes. The policy requires places such as universities to develop an additional layer of review for this kind of research. It focuses on experiments that involve 15 agents and toxins and seven categories of experiments. The draft is available for public comment for 60 days. Simultaneously, the Department of Health & Human Services announced late last month its final framework for funding or rejecting dual-use research on generating highly pathogenic avian influenza H5N1 viruses that are transmissible among mammals by respiratory droplets. Two such research efforts on H5N1 viruses in 2011 set off a debate on whether such work should be published. The arguments led to a moratorium on further studies that has recently been lifted. The dual-use policy says that principal investigators need to identify DURC to their institutions and they should assess the risks and benefits, develop a risk mitigation plan, and oversee its implementation. The framework for evaluating H5N1 research establishes seven criteria that must be met for proposals to be acceptable for HHS funding. These include requirements that the resultant virus could have been produced through an evolutionary process and that biosafety and biosecurity risks can be managed. Richard H. Ebright, a professor of chemistry and chemical biology at Rutgers University, says that the new policy on DURC is a “step in the right direction,” albeit a significantly circumscribed one because of its limits. By contrast, Ebright labels the framework on H5N1 research “a shell of a policy.” A draft of this framework released in December 2012, Ebright says, required actual evidence that the research would produce a virus that could arise through a natural evolutionary process in the foreseeable future. Those provisions are not in the final framework. “The deletion of the requirement for evidence and the qualifier in the foreseeable future,” Ebright says, “renders the provision essentially meaningless.”