Improving the Safety and Security of Biological Research

5/5/2025

Executive Orders

View Original

Action Summary

Purpose: Address the risks of dangerous gain-of-function research on biological agents, which can lead to widespread mortality, public health system impairment, and national security threats.
Policy Objectives: Ensure federally funded research benefits American citizens while maintaining national security and promoting U.S. leadership in biotechnology and health research.
Immediate Actions:
- Direct the Office of Science and Technology Policy (OSTP), in coordination with the Office of Management and Budget (OMB) and the APNSA, to end Federal funding for dangerous gain-of-function research in foreign entities and other countries lacking sufficient oversight.
- Establish guidance to suspend federally funded dangerous gain-of-function research pending policy revisions.
Policy Framework Revisions:
- Within 120 days, revise or replace the existing Oversight Policy to enhance independent oversight, accountability, and transparency of dual use research.
- Within 90 days, update the Framework for Nucleic Acid Synthesis Screening to ensure comprehensive and enforceable screening practices.
Non-Federally Funded Research: Develop a strategy within 180 days to regulate and track dangerous gain-of-function research conducted without federal funding, including establishing nucleic acid synthesis screening in non-federal settings.
Accountability & Public Transparency: Mandate that institutions receiving Federal funding report dangerous gain-of-function research, with a publicly available reporting system that balances transparency with national security and intellectual property interests.
Enforcement Measures:
- Include contractual terms in every life-science research grant or contract requiring compliance with this order.
- Enforce penalties such as immediate revocation of funding and up to a 5-year ineligibility period for non-compliant recipients.
Definitions: Clarifies “dangerous gain-of-function research” as activities that enhance pathogenicity, transmissibility, or other harmful properties of agents, potentially leading to significant societal consequences.
General Provisions: Ensures that the order does not undermine existing statutory authorities, with implementation subject to applicable law and appropriations, and includes provisions regarding funding publication in the Federal Register.

Risks & Considerations

The Executive Order mandates the cessation of federal funding for dangerous gain-of-function research in foreign countries, which could impact international collaborations and research partnerships that Vanderbilt University may have with institutions in these regions.
There is a risk of increased scrutiny and regulatory compliance requirements for research programs at Vanderbilt, particularly those involving life sciences and biotechnology, as the order emphasizes enhanced oversight and accountability.
The order’s focus on public transparency and reporting mechanisms may require Vanderbilt to disclose more detailed information about its research activities, potentially affecting intellectual property and competitive advantages.
Vanderbilt may need to reassess its research funding strategies and partnerships to ensure compliance with the new federal policies and avoid potential funding suspensions or revocations.

Impacted Programs

Vanderbilt’s School of Medicine and Department of Biological Sciences may face increased regulatory requirements and oversight for research involving pathogens and biotechnology.
The Office of Research Administration will likely need to implement new compliance measures and reporting protocols to align with the federal guidelines outlined in the Executive Order.
Collaborative research initiatives with international partners may be affected, necessitating a review of existing agreements and potential adjustments to ensure compliance with U.S. oversight standards.

Financial Impact

The cessation of federal funding for certain types of research could lead to a reduction in available grants and financial resources for Vanderbilt’s research programs, particularly those involving international collaborations.
Increased compliance and reporting requirements may result in additional administrative costs and resource allocation to ensure adherence to the new federal policies.
Vanderbilt may need to explore alternative funding sources or adjust its research focus to align with the priorities and compliance requirements set forth by the Executive Order.

Relevance Score: 4 (The order presents a need for potential major changes or transformations of programs.)

Key Actions

Vanderbilt’s Office of Research should review and ensure compliance with the new federal guidelines on gain-of-function research. This includes verifying that all research activities align with the updated oversight and reporting requirements to avoid potential funding disruptions.
The Department of Biological Sciences should assess current research projects for any potential classification as dangerous gain-of-function research. Proactively adjusting research methodologies to align with the new federal policies will be crucial in maintaining funding and research continuity.
Vanderbilt’s Office of Federal Relations should engage with policymakers to understand the implications of the revised frameworks for nucleic acid synthesis screening. This engagement will help the university anticipate changes and adapt procurement processes accordingly.
Vanderbilt’s Compliance Office should establish a robust internal audit mechanism to ensure all life-science research contracts and grants adhere to the new enforcement terms outlined in the executive order. This will mitigate risks of funding revocation and maintain eligibility for future federal grants.
The Center for Health Policy should conduct research on the broader impacts of these policy changes on public health and biosecurity. Sharing these insights with the academic community and policymakers can position Vanderbilt as a leader in shaping future biosecurity policies.

Opportunities

The executive order presents an opportunity for Vanderbilt’s School of Medicine to lead in developing innovative biosecurity measures and countermeasures. By leveraging its expertise, the school can contribute to national and global efforts in biotechnology and health research.
Vanderbilt can capitalize on the increased focus on biosecurity by establishing partnerships with federal agencies and other research institutions. These collaborations could enhance the university’s research capabilities and funding opportunities in the life sciences sector.
The emphasis on public transparency and accountability offers an opportunity for Vanderbilt’s Data Science Institute to develop tools and platforms that enhance research reporting and compliance. This initiative could improve the university’s research infrastructure and reputation for transparency.
By engaging with the broader scientific community, Vanderbilt can position itself as a thought leader in the ethical and safe conduct of life-science research. Hosting conferences and workshops on the implications of gain-of-function research policies can further establish Vanderbilt as a hub for innovative scientific thought and practice.

Relevance Score: 4 (The order necessitates major process changes for Vanderbilt’s research programs due to compliance and funding impacts.)

Average Relevance Score: 3.6

Timeline for Implementation

Within 90 days: The Director of OSTP, in coordination with relevant agencies, shall revise or replace the 2024 “Framework for Nucleic Acid Synthesis Screening.”
Within 120 days: The Director of OSTP shall revise or replace the 2024 “United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.”
Within 180 days: The Director of OSTP shall develop and implement a strategy to govern and limit dangerous gain-of-function research conducted outside federally funded settings, including submission of a legislative proposal addressing any gaps in authority.

The shortest timeline specified is 90 days, which falls into the 90-179 days compliance range.

Relevance Score: 2

Impacted Government Organizations

Office of Science and Technology Policy (OSTP): Tasked with coordinating the development of new guidance and oversight frameworks, and leading revisions to key policy documents on dual-use research.
Office of Management and Budget (OMB): Involved in coordination regarding the suspension clause and revision of oversight policies, ensuring that budgetary and administrative parameters support the order.
Assistant to the President for National Security Affairs (APNSA): Works closely with OSTP and other agencies to integrate national security implications into research oversight and funding decisions.
Department of Health and Human Services (HHS): Charged with enforcing revised funding agreements and oversight policies, including embedding enforcement mechanisms into life-science research grants.
Assistant to the President for Domestic Policy: Provides leadership in developing strategies to monitor and regulate non-federally funded research, thereby mitigating risks associated with dangerous gain-of-function research.
Other Relevant Agencies that Fund Life-Science Research: Including but not limited to entities like the National Institutes of Health (NIH), these agencies must align their funding and operational practices with the updated guidelines and frameworks established by this executive order.

Relevance Score: 3 (Across 6 key agency designations and representative groups, the directive spans multiple essential government bodies.)

Responsible Officials

Director of the Office of Science and Technology Policy (OSTP) – Charged with coordinating overall policy development and guidance on stopping dangerous gain-of-function research.
Director of the Office of Management and Budget – Responsible for working alongside OSTP in formulating and implementing funding and budget-related directives.
Assistant to the President for National Security Affairs (APNSA) – Tasked with collaboration on establishing and enforcing biosecurity measures and oversight mechanisms.
Secretary of Health and Human Services – Involved in consulting and implementing guidance on suspending or modifying federal funding for risky life-science research and ensuring contractual enforcement provisions.
Heads of Relevant Executive Departments and Agencies – Required to coordinate with OSTP and other officials to ensure that both federally funded and non-federally funded research follow the updated oversight and safety frameworks.
Assistant to the President for Domestic Policy – Designated to assist in developing strategies to manage and track non-federally funded research that poses significant risks.

Relevance Score: 5 (Directs multiple high-level and Cabinet officials, ensuring the directives reach agency heads and key decision makers with national security implications).