Dual-use research and research using enhanced pathogens in high-income countries: whose business?

Area of Science:

• Biosecurity and Biosafety
• Infectious Disease Research
• Public Health Policy

Background:

• U.S. regulations governing dual-use research of concern (DURC) and research with enhanced pathogens of pandemic potential (ePPP) are subject to potential changes.
• Extensive discussion has focused on the optimal regulatory frameworks for such research.
• However, the procedural aspect—specifically, who should be involved in shaping these regulations—remains less explored.

Purpose of the Study:

• To address the procedural question of appropriate stakeholder involvement in the development of U.S. regulations for DURC and ePPP.
• To propose a framework for inclusive deliberation and decision-making processes concerning biosecurity and biosafety research policies.

Main Methods:

• This commentary analyzes the procedural aspects of regulatory development.
• It advocates for a broad and inclusive approach to policy formation.
• The analysis is based on principles of scientific governance and public deliberation.

Main Results:

• The commentary posits that current regulatory discussions may be too narrowly focused on a limited group of experts.
• It highlights the need to incorporate a wider range of perspectives to ensure robust and effective regulation.
• The findings suggest that a more inclusive process will better serve the interests of the scientific community and public safety.

Conclusions:

• It is proposed that U.S. virologists and the broader scientific community would benefit from including diverse voices in regulatory shaping.
• Involving external experts and international stakeholders is crucial for developing comprehensive and globally relevant policies.
• An inclusive approach to regulation development is essential for responsible oversight of high-consequence biological research.