Life sciences research is at the forefront of scientific advancement, offering enormous benefits to society by improving public health and safety, agricultural practices, and environmental conservation. However, as with any scientific endeavor, there are potential risks associated with certain aspects of this research, particularly in biosafety and biosecurity. It is crucial to address these risks proactively to ensure that the scientific community operates responsibly and ethically. Let’s review the key points outlined in a recent request for information: Potential Changes to the Policies for Oversight of Dual Use Research of Concern (DURC) and the Potential Pandemic Pathogen Care and Oversight (P3CO) Policy Framework.
Recognizing the Importance of Oversight
Life sciences research plays a pivotal role in shaping our world, from medical advancements to sustainable agriculture. However, with great power comes great responsibility. The guidance emphasizes the importance of comprehensive oversight to manage potential risks, especially those related to biosafety and biosecurity.
Existing Regulatory Framework
The United States already boasts a robust framework of statutes, regulations, policies, and guidelines designed to address potential biosafety and biosecurity risks in research. These regulations are the foundation for ensuring the safety and security of scientific research and innovation.
Valuable Insights from Past Decades
Over the past decade, scientists, institutions, and the U.S. government have learned valuable lessons from implementing research oversight policies such as those for Dual Use Research of Concern (DURC) and the P3CO Policy Framework. These insights have informed the ongoing effort to strike the right balance between scientific advancement and risk mitigation.
The Role of NSABB
The National Science Advisory Board for Biosecurity (NSABB), a Federal advisory committee, has critically addressed biosecurity and dual-use research concerns. Their recommendations have guided policy evaluations and the development of a more comprehensive framework for research oversight.
The Policy Review and Revision Process
Following the NSABB’s recommendations, the Office of Science and Technology Policy (OSTP) has collaborated with federal departments and agencies to review, harmonize, and revise existing policies. This process aligns with the U.S. government’s goals of promoting safe and secure biological practices, as outlined in the 2022 National Biodefense Strategy and Implementation Plan.
Three Broad Goals
The policy review and revision process focuses on the three overarching goals of:
- Assessing the merger of existing Federal DURC, Institutional DURC, and P3CO policies into a harmonized policy for overseeing research involving pathogens and toxins.
- Considering the expansion of policy scope to encompass a broader range of pathogens and toxins, including biological select agents and toxins (BSAT) with the potential to impact humans.
- Exploring ways to strengthen the effective implementation of oversight throughout the research lifecycle.
Effective oversight is not just about mitigating risks; it is about maintaining public trust in life sciences research. It demonstrates that the scientific community acknowledges the implications of its work and is committed to protecting public welfare and national security.
An Invitation to Collaborate
OSTP invites input and comments from all stakeholders, including research institutions, researchers, scientific organizations, and diverse interest groups across the U.S. research ecosystem. This collaborative approach ensures that policies are well-informed and inclusive of various perspectives.
Life sciences research is a powerful force for good when conducted responsibly and securely. The ongoing efforts to review and revise research oversight policies in the United States are essential to balance innovation and risk mitigation. It is a collaborative journey that invites all stakeholders to participate in shaping the future of life sciences research for everyone’s benefit.
See the complete Request for Information for more details.