Lax policies governing dual-use research, scientists unaware of research’s biosecurity implications
For scientists carrying out federally funded research or working at institutions that receive federal funds, federal policies and the National Science Advisory Board for Biosecurity offer guidance in developing risk mitigation plans when appropriate, the report says. But the current policy emphasis and definition of dual-use research of concern (DURC) – which focuses on 15 select agents and toxins and seven types of experiments — do not capture biosecurity concerns in all relevant areas of life sciences research, especially in emerging areas such as synthetic biology and the engineering of gene drives. Moreover, the current policies can, in some instances, constrain research that need not be subject to oversight.
In addition, there is no established process by which those not receiving federal funding — such as private-sector researchers and journal editors – can seek advice from U.S. government experts on managing manuscripts or research activities that raise potential biosecurity concerns. “A key issue we identified was how to provide researchers — and particularly journal editors — with guidance about potentially problematic research findings or manuscripts,” said Richard Meserve, co-chair of the committee that wrote the report and Senior Of Counsel at Covington & Burling LLP.
Even more likely to be effective, the report says, is intervention at an early stage – before the research is carried out, or during research when an unusual finding is encountered. Identifying such research in its early phases could produce appropriate actions — for example, a decision not to fund the research, classification, or mitigation plans — in advance of a need to make decisions about publication.
A lack of awareness about dual-use issues among many life scientists is hampering efforts to implement policies to address biosecurity risks, said the committee. Those training to become life scientists are rarely introduced to the topic in a systematic way. Education and training programs at the undergraduate, graduate, and postgraduate levels generally do not include courses or discussions about dual-use research, unless the student or trainee is involved with a select agent; even in these cases, the primary focus is on biosafety rather than security issues.
Also, policy activity at the international level has declined recently, despite ongoing concerns and discussions about specific technologies such as CRISPR-Cas9, the report says. No international organization is currently giving systematic attention to developing policy or guidance regarding dual-use research. Potential institutions exist that could fulfill this function, such as the World Health Organization or the Biological Weapons Convention, among others.
NAS says that the committee identified multiple elements as important in dealing with dual-use research of concern:
- · ongoing, interactive education and training of individuals in the broader life sciences community;
- · engagement with advisory bodies with monitoring and/or enforcement capabilities;
- · international harmonization of policies and approaches;
- · engagement with existing (e.g., World Health Organization, Biological Weapons Convention) or newly convened international entities;
- · uniform roles and responsibilities for publishers;
- · legislative, regulatory, or policy mechanisms positioned at critical stages of the dissemination process; and
- · increased engagement with the public.
Some of these options may be contentious, the committee acknowledged, and a clearer understanding of the risks, benefits, and trade-offs involved in these options is needed before policy can be successfully implemented. Implementation may also require additional resources, the establishment of best practices, refinement of policies and guidance, adoption of new laws, appropriately positioned and empowered advisory bodies, and broader stakeholder engagement. “At the same time, any new policies must be respectful of the strong First Amendment protections for speech,” said Meserve.
