US government officials have passed two more checkpoints on the long, winding road towards a policy for dealing with risky research. That journey was forced into overdrive at the end of 2011, when a government body recommended against publishing two studies showing how a deadly form of avian influenza H5N1 could be made to pass between mammals.
Today, the US National Institutes of Health (NIH) announced a final framework for vetting specific types of experiments before funding them. The US Office of Science and Technology Policy (OSTP) also published a long-awaited draft policy for how scientists and institutions should monitor and report on a wide range of research that malevolent forces could manipulate to do harm. This type of research, called dual-use research of concern (DURC), is fundable if the potential benefits are deemed significant and the risks deemed manageable.
The new NIH framework was discussed at a workshop this past December attended by researchers and interested parties from around the world. Its finalization was seen as one of the last steps before allowing NIH-funded research on mammalian-transmissible H5N1 to resume (a moratorium on the research had been in place for over a year but was lifted recently). Amy Patterson and her colleagues at the NIH summarized the framework in a commentary in Science today.
The framework adds two levels of review, in addition to established reviews for scientific merit and DURC, but only to studies designed to give highly pathogenic avian influenza H5N1 the ability to transmit between mammals by respiratory droplets. It applies criteria aimed at assessing whether scientists and research institutions can minimize the risks of accidental or intentional release. It also demands that such research should lead to public-health benefits, something that the authors of the commentary note is debated.
Marc Lipsitch, an epidemiologist and microbiologist at the Harvard School of Public Health in Boston, Massachusetts, argues that it is unclear how imperative such work is. “People suggest that scientific advances are good things — which they are — and then they slide into the less-justifiable idea that this particular advance is necessary or sufficient for vaccine development or surveillance,” he says. “I’d argue that it’s not.”
In broader efforts to oversee DURC outside the realm of these particular H5N1 experiments, the OSTP released a draft policy for institutions and researchers to review and monitor experiments of concern from their inception through to publication. These are now open for public comment.
This is the second half of a policy released in March 2012 just as the government was deciding to allow the final publication of the two H5N1 papers. The policy covers research for 15 pathogens and toxins. Ron Fouchier of Erasmus Medical College in the Netherlands, one of the virologists whose H5N1 work had been under scrutiny, says that the list is “odd”. “If I were to do harm, I would use bugs that are not on this list,” he says in an e-mail. He would prefer a more generic “code of conduct” approach with regards to DURC. “Laws and regulations will slow down people with good intentions, but will do nothing against people with bad intentions,” he says.
Fouchier and Yoshihiro Kawaoka of the University of Wisconsin–Madison, who had open grants with the NIH to develop H5N1 mammalian-transmissible strains, will have to submit a package of information to be evaluated through the new NIH framework before they can resume their work.
These new developments pertain only to US-funded research, but an international consultation on DURC will convene next week at the World Health Organization in Geneva, Switzerland, to further discuss these issues.
See all our coverage of the mutant H5N1 studies.