WHO report: Global guidance on dual-use research needed

May 1, 2013 (CIDRAP News) – Participants in a World Health Organization (WHO) meeting held in February agreed that a binding global agreement to govern potentially dangerous life-sciences research is unlikely, but global guidance on the thorny issue could help nations figure out their own policies, according to a WHO report of the meeting.

The conference, held Feb 26 to 28, focused on "dual-use research of concern" (DURC)—studies whose results could be used for good or harm. The term gained currency in the wake of the controversy that erupted late in 2011 over experiments in which two teams of scientists developed lab-modified H5N1 viruses capable of airborne transmission in ferrets.

The detailed reports of those two studies were published in 2012, but debate and concern have continued over how to govern research that renders pathogens more dangerous or poses similar kinds of risks.

The sense of the WHO consultation was that governments need help in developing ways to manage DURC, but that a global agreement or set of rules is unlikely to be the answer, according to the WHO report on the meeting, which was posted recently.

"The inventory, sharing, and, where needed, 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," the report says.

"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 results," it adds.

"The lack of global guidance or a framework for management of DURC that bridges the many stakeholder communities was repeatedly noted as a critical gap," the report states. Such guidance might include general principles, types of experiments of potential concern, and strategies for weighing risks and benefits and for reducing risks.

Meeting participants felt that it would take a forum of key stakeholders, governments, and international organizations to develop such a framework, and that the WHO could take the lead in convening such a meeting, the report relates.

Regarding next steps, the report says the WHO will work with "member states and others to assess how best to encourage effective approaches."

So far the agency has had little chance to do further work on the issue, WHO spokesman Gregory Hartl told CIDRAP News today. "We have been so involved in nCoV [novel coronavirus] and then H7N9 that I don't know if there has been time for a lot of anything else," he said.

The meeting, called an informal consultation, stemmed from a "technical consultation" the WHO had convened in February 2012 to address the most urgent issues raised by the two H5N1 transmissibility studies. At that session there was a consensus that the WHO should facilitate a broader discussion of the ethical, societal, scientific, security, and safety implications of DURC, the report explains.

Participants at the recent meeting, who were not named in the report, had a wide range of professional backgrounds and came from countries in all WHO regions. They heard a series of panel presentations offering a range of perspectives on DURC; later they broke into eight groups to discuss various issues, such as research and public health, ethics, security, and publishing and communications.

The report cites the following among additional points that emerged at the meeting:

  • DURC is an issue for all countries.
  • "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 mechanisms to manage DURC-related risks, but many have not, because of competing demands on resources, limited awareness of the issue, or a perception that it is not relevant to their particular context or priorities.
  • "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."

The US government announced a pair of policy moves on DURC in February of this year, shortly after the WHO consultation.

The National Institutes of Health (NIH) released a framework to guide its funding decisions for projects expected to generate respiratory-transmissible H5N1 viruses in mammals. In addition, the White House Office of Science and Technology Policy published a draft policy outlining the roles and responsibilities of institutions and researchers who conduct certain types of work on pathogens.

See also:

Summary of WHO report on DURC meeting

Full report on DURC meeting

Feb 21 CIDRAP News story "Feds unveil new policies for 'dual-use' H5N1 research"

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