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Saturday, October 5, 2024

Senator Rand Paul introduces act for gain-of-function research oversight

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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, introduced the Risky Research Review Act on July 10, 2024. The legislation proposes establishing a Life Sciences Research Security Board within the Executive Branch to oversee gain-of-function research funding 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 body tasked with evaluating studies involving potential pandemic pathogens. Dr. Paul emphasized that current oversight of life sciences research is insufficient, leading to taxpayer dollars being spent without adequate checks. His legislation aims to create a stringent review process for assessing high-risk research proposals before approving federal funding.

Key components of the Risky Research Review Act include:

- Establishing an Independent Oversight Board: The 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: This includes studies with dual-use applications or those posing significant public health, safety, or national security threats.

- Ensuring Board Independence: The board will operate as an independent agency within the Executive Branch and 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 would be prohibited from awarding funds for high-risk life sciences research without board approval.

- Mandating Majority Vote: A majority vote of board members would be required to approve such research.

- Empowering the Board: The board would have authority to compel agencies to provide necessary information and records.

- 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 would automatically be referred to the board.

- Continuous Subcontract Disclosure: Ongoing disclosure of subcontracts or subawards would be enforced.

- Annual Reporting: The board must submit an annual report summarizing its determinations and findings.

Dr. Robert Redfield, former CDC Director (2018–2021), stated, "This is a very important bill which when implemented will ensure national security is prioritized when making US life science funding decisions."

Jay Bhattacharya from Stanford University noted that if passed, "scientists will no longer have carte blanche to regulate themselves" in conducting potentially dangerous experiments.

Dr. Alina Chan from MIT's Broad Institute emphasized that "research with pandemic risks must be subject to external and independent oversight."

Richard H. Ebright from Rutgers University highlighted that addressing gaps in current oversight is essential for preventing research-related pandemics.

Steven Quay of Atossa Therapeutics compared this initiative to President Truman’s establishment of the Atomic Energy Commission in 1946.

Bryce Nickels from Rutgers University asserted that this legislation addresses major shortcomings in existing guidelines for pathogen research oversight.

Meryl Nass also praised Senator Paul's effort as crucial for improving biodefense safety in the U.S., while Neil Harrison from Columbia University endorsed it in his personal capacity.

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