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Saturday, October 5, 2024

Senator Rand Paul introduces act to oversee gain-of-function research funding

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U.S. Senator Rand Paul | U.S. Senator Rand Paul official website

U.S. Senator Rand Paul | U.S. Senator Rand Paul official website

U.S. Senator Rand Paul (R-KY), Ranking Member of the Senate Homeland Security and Governmental Affairs Committee, has introduced the Risky Research Review Act. This proposal aims to establish a Life Sciences Research Security Board within the Executive Branch to oversee funding for gain-of-function research and other high-risk life sciences research that could pose threats to public health, safety, or national security.

The proposed board will be an independent entity responsible for evaluating gain-of-function research and studies involving potential pandemic pathogens. The current system lacks sufficient government oversight, allowing taxpayer dollars to be spent without appropriate checks. Dr. Paul's legislation introduces a review process for the board to assess high-risk research proposals and determine their eligibility for federal funding.

Key provisions of the Risky Research Review Act include:

- Establishing an Independent Oversight Board: A Life Sciences Research Security Board will evaluate and issue binding determinations on high-risk life sciences research proposals seeking federal funding.

- Defining High-Risk Research: Specifying high-risk life sciences research as studies with potential dual-use applications or those that could threaten public health, safety, or national security.

- Ensuring Board Independence: The board will consist of one executive director, five non-governmental scientists, and two national security experts appointed by the President and confirmed by the Senate.

- Restricting Funding Without Approval: Federal agencies will be prohibited from awarding funding for high-risk life sciences research without board approval.

- Mandating Majority Vote: A majority vote of board members will be required to approve high-risk life sciences research.

- Empowering the Board: The board will have authority to compel agencies to provide necessary information and records, including classified information.

- Demanding Full Disclosure: Grant applicants must declare if their research falls under high-risk categories or involves select agents or toxins.

- Automatic Referral: Positive attestations will be automatically referred to the board.

- Continuous Subcontract Disclosure: Agencies must submit continuous disclosures of subcontracts or subawards to the board.

- Annual Reporting: The board must submit an annual report summarizing determinations, findings, and information about entities involved in high-risk life sciences research.

Supporters of the bill have emphasized its importance in ensuring national security and preventing future pandemics. Dr. Redfield, former Director of the Centers for Disease Control and Prevention, stated that this bill could have prevented the COVID pandemic if it had been in place ten years ago. Jay Bhattacharya from Stanford University highlighted that scientists would no longer have carte blanche to regulate themselves if this bill is passed.

Dr. Alina Chan from MIT and Harvard underscored the need for external oversight due to the extreme outcomes associated with pandemic risks. Richard H. Ebright from Rutgers University pointed out gaps in current US oversight that place the country at risk of research-related pandemics.

Steven Quay from Atossa Therapeutics compared this legislation's significance to the 1946 establishment of the Atomic Energy Commission by President Truman. Bryce Nickels from Rutgers University noted that this legislation addresses major shortcomings in current guidelines for overseeing high-risk pathogen research.

Meryl Nass commended Senator Paul’s effort to improve biodefense safety through this critical legislation.

The bill also received endorsement from Neil Harrison of Columbia University in his personal capacity.

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