Informal consultation on Dual Use Research of Concern
In 2011 research on the genetic basis of the transmissibility of H5N1 conducted by two groups (one in the Netherlands1 and the other a joint Japan/USA group2) resulted in the creation of laboratory-modified H5N1 viruses capable of respiratory transmission between ferrets; these findings raised a number of issues. On 16–17 February 2012, WHO convened a technical consultation to address the most urgent concerns, including the scientific and public health benefit of the studies, management of the laboratory-modified viruses and public dissemination of any findings3. These experiments were considered to be examples of dual use research of concern (DURC), i.e. life sciences research intended for benefit, but which might easily be misapplied to do harm.
During that meeting, several issues relating to the ethical, societal, scientific, security and safety implications of DURC were noted but not explored in detail. There was general agreement that WHO should facilitate a broader discussion.
In response, WHO convened an informal consultation on 26-28 February 2013. The purpose was to identify key issues and concerns related to DURC; to identify existing management approaches and gaps to address such concerns; and to explore possible actions and mechanisms to address the gaps.
Participants were individuals with a wide range of professional backgrounds who came from countries in all WHO Regions. Plenary sessions provided an overview of life sciences research and its associated benefits and challenges. A series of panel presentations introduced a range of perspectives on different aspects of DURC. The major work of the consultation was accomplished in eight breakout groups: research and public health; ethics; security; outreach and education; international issues; publishing and communications; biotechnology and the private sector; and societal impact.
Participants raised a number of important issues, including the following:
- DURC is an issue for all countries. Scientific research is conducted in virtually all countries and is critical to strengthening global response to all health threats and hazards, including those posed by naturally occurring and by accidentally or intentionally released biological agents.
- The management of DURC-related risks should take into account all stages of the research cycle, from initial conceptualization and development of a proposal, to provision of funding, to conduct of the research, analysis of results, storage and potential use of material results. including modified biological agents, and dissemination of findings.
- Some countries and institutions have developed oversight mechanisms to manage DURC-related risks. Many, however, have not done so, owing to competing demands on resources and capacity, limited awareness of the issue, or a perception that it is not relevant to their particular context or priorities. Nonetheless, oversight mechanisms which take into account both the benefits of undertaking such research as well as the risks are important.
- The development of guiding principles, toolkits, best practices and other forms of technical assistance would help countries formulate their own policies and procedures for managing DURC. Although establishment of a legally binding global agreement or regulation is theoretically possible, such an approach would be expensive, slow, likely impractical and would not necessarily yield the desired benefits..
- Communication and continuing dialogue across a broad range of sectors and stakeholders are essential to create a culture of responsibility, cooperation and trust. In particular, improving mutual understanding of the various approaches to risk identification and assessment among stakeholders will be critical to establishing that dialogue.
- Awareness-raising, education and training on biosafety, biosecurity and DURC are essential not only for researchers but also for all sectors and stakeholders.
1 Herfst S, Schrauwen EJA, Linster M et al. Airborne transmission of influenza A/H5N1 virus between ferrets. Science 2012; 336: 1534-41.
2 Imai M, Watanabe T, Hatta M, et al. Experimental adaptation of an influenza H5 HA confers respiratory droplet transmission to a reassortant H5 HA/H1N1 virus in ferrets. Nature 2012; 486:420–28.
3 World Health Organization. Report on technical consultation on H5N1 research issues, Geneva, 16–17 February 2012. Available at: http://www.who.int/influenza/human_animal_interface/mtg_report_h5n1.pdf.