Reading Room Production — page 180

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. • Regarding support from agencies to board personnel, it is unclear how an agency representative can be expected to both provide technical assistance but not indirectly influence the board. Technical assistance should factor into the decision. • Regarding 7904 (b)(3), if such disclosure is required drafters should be specific as to what laws on protection of commercial confidential information and trade secrets are being waived. Review Process and Criteria • While a path for expedited review has been added, there could still be major issues with continuity of science due to delays of reviews or membership being confirmed. Among other concerns, in particular, this will significantly impede the USG's ability to prepare for and detect emerging infectious diseases/epidemics/pandemics and will also significantly impede the USG's research response to an epidemic/pandemic. We recommend establishing a default rule that research may proceed if a decision is not made within a fixed timeframe to ensure that any lapse in function by the Board (e.g., delays in confirmation) do not result in life sciences research grinding to a halt. We also recommend a formal appeals process and an exemption to public reporting requirements if the information could pose national security risks. • criteria: The bill does not articulate a principle or threshold that guides whether the board should or should not approve a study for funding - for example, should the Board approve research where it determines that the potential public health benefits of the research outweigh the potential risks to U.S. national security? Or should some other standard govern the Board's review? Any statute mandating this style of review should clarify the applicable standard. • It is unclear if it is the drafters' intent to prohibit funding for an entire award prior to Board approval or only work related to potential "high-risk" research. Similarly, there is a later provision that would require a pause in research due to a change in circumstance, but it is unclear if such a pause would apply to an entire award or only work related to potential "high-risk research. Classified review and intelligence concerns • We recommend striking provisions that mandate the provision of security clearances to Board members, Board staff, and members of Congress, or that require these individuals: The legislation continues to authorize the board to access and review all classified research funded by any agency, including non-life sciences research. Those provisions extend beyond the scope of oversight that is reasonable for this board to take on and they may impinge on the constitutional authority of the Executive to control classified national security information. We also recommend that clauses be included to enable the intelligence