Comment from Logan Spector

I have been funded as Principal Investigator by the NIH for over twenty years. My area of research is the causes of childhood cancer, which is a priority of the current administration’s (e.g. Executive Order 14355 and the Making Our Children Healthy Again Assessment). There is essentially no commercial benefit to childhood cancer research so most research in my field is supported with federal research grants. Proposed changes to the Regulation for Federal Financial Assistance threaten the entire research ecosystem for childhood cancer due to manufactured instability in federal granting. The proposed change to §200.340 is particularly destabilizing as it would give federal agencies the unilateral right to cancel grants mid-stream with no recourse. This is antithetical to the conduct of gold standard science and is inherently wasteful, because research stopped in mid-stream may not be publishable or salvageable in any way. Thus, cancelled grants waste the resources the federal government has devoted to science, which is not in the national interest. The proposed change also does not specify who at federal agencies will have the power to cancel grants at will, but elsewhere in OMB-2026-0034-001 there is a proposal to have “senior appointees” decide on whether to fund each grant application; scientifically untrained senior appointees cannot possibly properly evaluate complex scientific proposals and hence any decision they make to cancel awarded grants will be arbitrary and capricious. As a researcher in an area supported mainly by federal research grants (and which very much fits with the present administration’s priorities), I would be reluctant to apply for grants that may be cancelled at any time. One cannot easily hire and maintain a professional staff with constant uncertainty about a funding stream. This uncertainty is compounded when one considers that many federal grants are five years long, in which case a grantee could conceivably need to meet the priorities of three separate administrations. No one can predict who the president will be in the next term, much less two terms from now. The proposed change to §200.340 fails to consider its interaction with 45 CFR 46.109, which mandates that: “An IRB [institutional review board] shall review and have authority to approve, require modifications in, or disapprove all research activities covered by the policy.” In all likelihood the consenting process for federally-funded research studies will have to disclose that the grant funding it may be cancelled at any time if federal officials decide it does not advance the President’s priorities. This is likely to discourage participation in federally-funded studies. In addition, cancellation of clinical trials mid-stream for non-scientific reasons is unethical and is an injustice to participants. OMB must consider how its proposed changes affect the mandate for research to be conducted ethically which is enshrined in multiple places in federal law. Lastly, the proposed changes to §200.340 in OMB-2026-0034-0001 is justified by the authors based on similarly, “...to the existing authority at § 200.340(a)(4) to terminate awards found to be inconsistent with program goals or agency priorities.” A grant is not a contract and this comparison is simply inappropriate. My recommendation is that the proposed changes to §200.340 be struck in their entirety. The proposed changes introduce unacceptable instability into the conduct of federally-funded research and undermine the entire enterprise (and therefore undermine the President’s priorities as well). If OMB nevertheless proceeds with the changes, then it must require that personnel with the power to cancel research grants be scientifically trained and there must be meaningful recourse to recipients of cancelled grants.