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Reading Room Production — page 160

of 496 pages

← p.159 p.161 → · this page in the original PDF · package

o According to the next section at the bottom of the page, it looks like maybe only experiments that meet DURC/GOF criteria with these agents would need centralized board review, and if it were possible to obtain clarification that nonDURC/GOF experiments are not subject to the Act provisions that might mitigate some of the potential concerns, but there is the possibility that uncertainty about interpretation could still have major impact on willingness to conduct or review research in some of the relevant areas of importance for public health. • The text of the proposed legislation reads as if the Life Sciences Research Security Board could review all life sciences research. Throughout the text of the proposed legislation, the terms used seem to vary between "high-risk life sciences research," which is defined very specifically, and broader terms like "life sciences research." The scope of review seems far beyond what a single Board could reasonably be able to review especially given the broad definition of life sciences research, even if limited to high-risk life sciences research and even with the Board trying to develop expert committees. Creating such a broad scope of review for the Board risk delays of important research, which does not rise to the level of high-risk life sciences research, that could be adequately addressed at a more local or Agency review level and is already subject to laws, regulations, guidances, and policies. Expertise/Board Processes and Makeup • While biosafety expertise is now included, the makeup and processes of the board could introduce a number of issues. For example, the limitations on prior federal service and designation of participation in high-risk research as a "conflict of interest" could limit the board from accessing relevant national security and life sciences expertise. The exclusion of those involved in high-risk research, based on the definition in the draft legislation, could exclude anyone with a current BSL3 or BSL4 program, excluding individuals with key expertise on how to conduct work safely. These limitations may also exclude individuals who work in government with relevant knowledge of intelligence, threat assessments, and biosecurity. Risk assessment is best when diverse voices are heard, the lack and actually clear refusal to ensure persons with experience in high and maximum containment principles are included would not provide a comprehensive and scientifically robust review of this work. • We also recommend relaxing the limitations on membership of the board and note that a number of the timelines are untenable (e.g., Congressional notification requirements within 3 days of identifying a potential conflict of interest; publishing procedures in the Federal Register within 90 days of the appointment of initial members; etc.). We note that several provisions relating to the membership of the Board or its support staff are vague, including the requirement that Board members be "impartial" and that support staff be prohibited from "directly or indirectly influenc[ing]" the Board. The proposed legislation would also politicize independent peer review by making the constituent members presidential appointees. • As drafted, the Board will have significant control over funding decisions, which may interfere with existing statute on NIH funding activities. • We have concerns about the Board reaching out directly to applicants/recipients, which is outside traditional NIH reporting procedures.

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