Dr. Paul’s Bipartisan Risky Research Review Act to Oversee Gain-of-Function Research Advances in Committee
WASHINGTON, D.C. – Today, U.S. Senator Rand Paul (R-KY), Ranking Member of the Senate Homeland Security and Governmental Affairs Committee, announced that his bipartisan Risky Research Review Act, a first-of-its-kind proposal to establish a Life Sciences Research Security Board within the Executive Branch, was advanced by the Committee during today’s business meeting. This independent board will oversee gain-of-function research and other high-risk life sciences research that potentially poses a threat to public health, safety, or national security.
The Life Sciences Research Security Board will serve as an independent body responsible for thoroughly evaluating gain-of-function research and other potentially harmful studies involving high-consequence pathogens. Currently, the funding and study of life sciences research lack sufficient government oversight, allowing American taxpayer dollars to be spent without proper safeguards. NIH funneled federal dollars through EcoHealth Alliance to support gain-of-function research at the Wuhan Institute of Virology and multiple federal agencies sent taxpayer funds to China’s Academy of Military Medical Sciences supporting the People’s Liberation Army (PLA) research. Dr. Paul’s legislation establishes a much-needed stringent review process for the board to assess high-risk research and decide whether tax dollars should support specific research proposals, ensuring accountability and strengthening transparency.
The Risky Research Review Act will:
- Establish an Independent Oversight Board: Form a Life Sciences Research Security Board dedicated to protecting public health, safety, and national security by evaluating and issuing binding determinations on high-risk life sciences research proposals seeking federal funding.
- Define High-Risk Research: Specify high-risk life sciences research as studies with potential dangerous uses, or dual use research of concern involving a high-consequence pathogen, or gain-of-function research.
- Ensure Board Independence: Position the board as an independent agency within the Executive Branch, consisting of one executive director, five non-governmental scientists, two national security experts, and one non-governmental biosafety expert, each serving up to two four-year terms.
- Restrict Funding Without Approval: Prohibit federal agencies from awarding funding for high-risk life sciences research without board approval.
- Mandate Majority Vote: Require a majority vote of board members to approve high-risk life sciences research.
- Empower the Board: Authorize the board to compel agencies to turn over necessary information and records, including classified information.
- Demand Full Disclosure: Require life sciences research grant applicants to declare if their research falls under high-risk life sciences categories or involves select agents or toxins.
- Automatic Referral: Mandate that all positive attestations are automatically referred to the board.
- Continuous Subcontract Disclosure: Require grant recipients to continuously disclose subcontracts or subawards to agencies, with agencies required to submit these disclosures to the board.
- Annual Reporting: The board will submit an annual report to the appropriate congressional committees and publish it online, summarizing determinations, findings, and information about entities and sub-awardees involved in high-risk life sciences research.
You can read S.4667, the Risky Research Review Act HERE and watch Dr. Paul’s remarks from the business meeting on the Risky Research Review Act HERE
See below for statements of support for the Risky Research Review Act:
“This is a very important bill which when implemented will ensure national security is prioritized when making US life science funding decisions. If we had this bill in place ten years ago we could have prevented the Covid pandemic.”– Dr. Redfield, M.D., Former Director (2018-2021), Centers for Disease Control and Prevention, U.S. Department of Health and Human Services
“The Risky Research Review Act is a great step forward toward the goal of protecting the American people from scientists conducting the kinds of dangerous experiments that likely led to the covid pandemic. If the bill is passed, scientists will no longer have carte blanche to regulate themselves to sign off on such experiments. It is far past time for the people who pay for the scientists’ work to have a voice in the risks they take on the peoples’ behalf.” – Jay Bhattacharya, M.D., PH.D., Professor of Health Policy, Stanford University
“Research with pandemic risks can result in millions of deaths and trillions in economic damage. Research with such extreme outcomes must be subject to external and independent oversight. A responsible government would put in place measures and systems to ensure high visibility into such research and accountability when lab-based outbreaks ensue.” – Dr. Alina Chan is a molecular biologist at the Broad Institute of M.I.T. and Harvard, and a co-author of “Viral: The Search for the Origin of Covid-19”
“I have closely reviewed the legislative proposal, and I strongly support the legislative proposal. The gaps in current US oversight of research on potential pandemic pathogens place the US at risk of research-related pandemics, with medical, economic, and national-security impacts as disruptive and damaging as, or even more disruptive and damaging than, those of the COVID-19 pandemic. Addressing the gaps in oversight is essential and urgent. The legislative proposal sets forth an approach to close the gaps in oversight and, appropriately, addresses only the small subset of biomedical research that poses highest risk (with definitions tailored to cover less than 0.1% of biomedical research) and balances the need for strengthened oversight with the need not to constrain biomedical research that could provide positive medical, industrial, or national-security value. The proposal sets forth an approach that will close the gaps with minimal costs and minimal adverse impacts. Thank you in advance for your leadership in considering and approving this legislation.” – Richard H. Ebright, Board of Governors Professor of Chemistry and Chemical Biology, Rutgers University, Laboratory Director, Waksman Institute of Microbiology at Rutgers University
“The Risky Research Review Act is historic. For the first time, the risk of a laboratory accident starting a pandemic worse than COVID-19, which killed over one million Americans, is being taken out of the hands of the scientists doing the work and placed in an independent agency. Senator Paul should be commended for his leadership in putting forward this legislation. Historians will compare this to the 1946 establishment of the Atomic Energy Commission by President Truman, which had the same goal: make sure advanced technology, in that case atomic energy, are only used for the benefit of the American citizens. COVID was a bipartisan killer; this bill should be strongly supported by both parties.” – Steven Quay, M.D., PH.D., Chief Executive Officer Atossa Therapeutics, Inc. and Former Faculty, Stanford University School of Medicine
“Senator Paul’s legislation to establish the Risky Research Review Board is both necessary and urgent. It addresses major shortcomings in both the current guidelines for oversight of high-risk pathogen research and the new guidelines scheduled to take effect in 2025. Critically, the legislation would replace decades of self-regulation with an independent oversight mechanism for federally funded high-risk pathogen research, the first of its kind. This is much-needed, common-sense legislation that, unlike the existing guidelines and those scheduled to take effect in 2025, will safeguard the public from the threat of lab-generated pandemics.”– Bryce Nickels, Co- Founder, Biosafety Now and Professor of Genetics, Rutgers University
“Senator Rand Paul has introduced an important new bill for the oversight of potentially dangerous gain-of-function research. I highly commend the Senator for this critical effort to improve the safety of the US’ biodefense enterprise.” – Meryl Nass, M.D.
“Modern genetics holds phenomenal investigational power. Used responsibly it bodes well. The 21st century has seen the generation of novel human pathogens anticipated to spark a pandemic, or the resurrection of extinct viruses like Spanish flu. The benefits of this work have been grossly overrated while the risks have been simultaneously underrated. Self-governance has failed. This US generated work can be used irresponsibly by a swath of groups as it is freely available on the web. Populations, health care infrastructures and national security are challenged by what is low-cost science. Accordingly, an oversight committee independent of the NIH and backed up by law is necessary to review such work and ascertain what can and cannot be done. The Risky Research Review Act provides the elements to achieve these goals. Life scientists would do well to work with Senator Paul to forge a code of conduct which protects freedom of enquiry while showing responsibility to society that finances research.” – Simon Wain-Hobson, Emeritus Professor, Institute Pasteur, Paris
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