Understanding biosafety practitioner perspectives

Area of Science:

• Biosafety and Biosecurity
• Public Health Policy
• Risk Management

Background:

• The U.S. government briefly implemented a policy in 2024 to regulate Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP).
• This policy aimed to strengthen oversight of sensitive biological research but faced immediate implementation hurdles.

Purpose of the Study:

• To explore biosafety practitioners' interpretations and assessments of the DURC/PEPP policy.
• To identify challenges encountered in implementing the policy from the perspective of those directly involved.

Main Methods:

• Utilized an inductive, grounded theory approach.
• Conducted a 2-day deliberative workshop with 45 biosafety officers, compliance professionals, and researchers.
• Analyzed qualitative data using NVivo software.

Main Results:

• Participants identified ambiguous policy language, insufficient federal guidance, limited legal scope, and unfunded administrative burdens as key barriers.
• Practitioners found the policy's definitions imprecise and lacked practical examples for implementation.
• Concerns were raised regarding the administrative and financial feasibility of compliance.

Conclusions:

• Effective biosafety and biosecurity policies require clear definitions, actionable guidance, and practical implementation strategies.
• Early and substantial engagement with operational practitioners is crucial for developing durable and effective oversight.
• Future policy development should incorporate feedback from biosafety professionals to ensure feasibility and compliance.