Risky Research Review Act

Bill Summary: Risky Research Review Act (S. 854)

Overview

The Risky Research Review Act seeks to establish a rigorous, independent federal oversight mechanism for life sciences research that poses significant risks to public health, safety, and national security. The primary intent of the bill is to ensure that "high-risk" research—specifically gain-of-function and dual-use research—is vetted and approved by an independent board before receiving federal funding.

Key Provisions

1. Establishment of the Life Sciences Research Security Board

The bill creates the Life Sciences Research Security Board, an independent agency within the Executive Branch.
* Membership: The Board consists of 9 members appointed by the President, including an Executive Director, five nongovernmental scientists, two national security experts, and one biosafety expert.
* Independence: To prevent conflicts of interest, members cannot have been federal employees for three years prior to appointment. There are strict limits on how many members can be former employees of specific agencies (e.g., DoD, HHS, DOE).
* Authority: The Board has the binding authority to determine whether a federal agency may award funding for high-risk research.

2. Defining "High-Risk" Research

The bill provides detailed definitions to determine which projects trigger Board review:
* High-Risk Life Sciences Research: Defined as either Gain of Function research (experiments enhancing the transmissibility or virulence of high-consequence pathogens) or Dual Use Research of Concern (DURC) involving a high-consequence pathogen.
* High-Consequence Pathogens: Includes a specific list of dangerous agents (e.g., Ebola, Marburg, Mpox, various influenza types, and Sarbecoviruses) and any other agent the Board identifies via the Federal Register.

3. Oversight and Review Process

The bill implements a strict "gatekeeper" system for federal grants:
* Attestation and Certification: Entities seeking federal funding must attest under penalty of perjury whether their research is "high-risk." Federal agencies must certify the validity of these attestations.
* Mandatory Referral: Agencies are prohibited from awarding funds for high-risk research without the Board's explicit approval.
* Ongoing Monitoring: If research evolves into "high-risk" territory during the project, the researcher must pause work within 24 hours and notify the agency.
* Review Criteria: The Board evaluates risks (public health, national security, foreign location) versus benefits to determine if the research should proceed and what biosafety/biosecurity controls must be in place.

4. Enforcement and Accountability

• Penalties: Entities providing false attestations are subject to suspension and debarment from receiving federal funding.
• Employee Discipline: Federal employees who knowingly fail to follow review procedures face disciplinary action and permanent revocation of security clearances.
• Transparency: The Board must provide quarterly briefings to Congress and publish an annual report on its determinations.

Who is Affected?

• Research Institutions & Scientists: Any entity applying for federal grants for life sciences must comply with new disclosure and attestation requirements.
• Federal Funding Agencies: Agencies (such as the NIH or NSF) must implement new screening processes and cede final approval authority for high-risk projects to the Board.
• Government Officials: The President and Senate are involved in the appointment and confirmation of the Board's leadership.

Timeline and Funding

• Funding: The bill authorizes $30 million per year from fiscal years 2026 through 2035.
• Implementation:
  • The Board's review process must be published within 180 days of the initial appointments.
  • The prohibition on awarding funding without Board approval takes effect 180 days after enactment.
  • Full board duties are to begin within 270 days of enactment.