Comment from David Hessl

I am a Professor at a major U.S. university writing to express my dismay and concerns about the proposed Federal Regulations regarding scientific review of grant applications. I have been the Principal Investigator on numerous NIH funded projects focusing on neurodevelopmental disorders and neurodegenerative diseases, especially fragile-X associated disorders, Down syndrome, and autism. I have also served as a reviewer for NIH many times. I am writing to express my own personal opinions and I do not speak on behalf of my University. The most troubling aspect of the Regulations, in my view, is the insistence that grants may be awarded or discontinued according to whether they align with the "president's priorities." It is not (and should not) be within the purview of the executive branch to have unilateral decision making on scientific matters, and it is wrong and dangerous to have a politically appointed person make decisions about science. Why would it be advisable to have a single person's policies guide the nation's scientific mission? Also, would the supporters of the current administration want such political appointees or the president to have such authority if and when the administration is led by "Democrats" or more liberally minded folks? This would lead to a whiplash effect across administrations that would be very damaging to scientific progress, and would likely also be financially wasteful as the whole enterprise changes course so often. The Regulations mention "Gold Standard Science." There is no acceptable definition of this term as it applies to different fields of science. Because this is not defined, the administration would retain broad, unguided discretion in favor or against various institutions by simply saying "it's not Gold Standard"; it would be anyone's opinion, and this could easily be used in harmful, punitive ways. The rule that active grants, in mid-award, could be terminated at any time, for any reason or without cause, threatens the entire scientific enterprise in the U.S. We build research teams and recruit participants/patients that take years to develop, and some degree of stability and trust in the system is essential. The provision that applicants can be denied awards based on organizational affiliations with "anti-American" activity is very problematic because there is no accepted definition of what American or anti-American mean. This of course could be abused and used as political weaponization of particular institutions. “The costs for attending conferences are allowable only if participation in the conference is expressly approved by the Federal agency and included in the terms and conditions of the Federal award.” This is unrealistic and overly restrictive. This means every conference a researcher wishes to attend using grant funds must be pre-approved by the agency and written into the award at the time it is made. Conferences not anticipated when the award was issued cannot easily be added later, and the agency has full discretion to deny approval or simply decline to include any conferences in the terms at all. Conferences are where scientists present results, receive peer critique, discover new approaches, and build the collaborations that advance their fields. Giving political appointees gatekeeper authority over conference attendance is a direct tool for isolating researchers from their professional communities. “Publication costs (including page charges, article processing charges (APCs), or similar fees such as open access fees for professional journal publications and other peer-reviewed publications) are unallowable under Federal awards.” If the scientific project is federally funded, this costs must be allowable. Indeed the federal government expects scientists to publish in peer reviewed journals. Publishing scientific work is the bedrock of dissemination to the public. There are numerous other concerns I have. But in summary, these Regulations are moving control of U.S. federal funding decisions into one branch of government, the White House, and responsive to political concepts, when it should be ultimately regulated by representatives of the U.S. in congress based on science.