Comment from Jeffrey Segall

200.205 I am Professor of Pathology at the Albert Einstein College of Medicine, with a PhD in Biology and Physics from the California Institute of Technology. I have done scientific research for 47 years, trained over 20 graduate students and postdoctoral fellows, and received millions of dollars in research grants. My work has focused on cancer metastasis for the past 20 years. Section 200.205 has a number of provisions that will undercut science. I describe each section, its effect and the harm it will do to scientific research in the United States. In summary, the proposed changes to Section 200.205 should be deleted because they will do significant harm to US science and consequently US progress. “(1) Discretionary awards must, where applicable, demonstrably advance the President's policy priorities. “ Critique: The President’s policy priorities are not based on scientific significance but rather on political advantages. Thus funding of grants will be based on political correctness, rather than scientific merit. This will lead to a loss of leadership in science in the US and a resulting loss of health and economic advances. “(3) All else being equal, preference for discretionary awards should be given to institutions with lower indirect cost rates. “ Critique: The phrase “all else being equal” gives license for deciding how grants are equivalent based on policy rather than scientific merit. Section d below indicates that peer review scoring will be advisory only – this raises the possibility that indirect cost rates may become as important as scientific merit. This will waste US tax dollars. “(4) Discretionary awards should be given to a broad range of recipients. Research grants should be awarded to a mix of recipients likely to produce immediately demonstrable results and recipients with the potential for potentially longer-term, breakthrough results, in a manner consistent with the notice of funding opportunity.” Critique: Especially when it comes to the potential for longer term breakthrough results, scientific evaluation is critical. This change combined with downgrading peer review importance will waste US tax dollars and fund bad science. “(7) To the extent institutional affiliation is considered in making discretionary awards, agencies should prioritize an institution's commitment to rigorous, reproducible scholarship over its historical reputation or perceived prestige. For science grants, agencies should prioritize institutions that have demonstrated success in implementing Gold Standard Science.” Critique: Gold Standard Science has been poorly defined and left to the discretion of political appointees to implement. This change will simply provide a way for political appointees to fund politically important constituencies and take away funding from good science. It provides a threat to institutions that show independence from political correctness. “(c) Procedure for pre-issuance review. When conducting a pre-issuance review, senior appointees (or their designee) must not ministerially ratify or routinely defer to the recommendations of others, but must instead use their independent judgment when evaluating Federal award proposals.” Critique: This is an explicit statement that political appointees should ignore the merit review process performed by experts in the field. This will severely distort the direction of science towards pet projects by political appointees and damage our health research progress. “(d) Use of peer review. Nothing in this part must be construed to discourage or prevent the use of peer review methods to evaluate proposals for discretionary awards or otherwise inform agency decision making, provided that peer review recommendations remain advisory and are not ministerially ratified, routinely deferred to, or otherwise treated as de facto binding by senior appointees or their designees. Further, nothing in this part must be construed to create any rights to any particular level of review or consideration for any funding applicant except as consistent with applicable law.” Critique: This will create a huge backlog and delay in funding as political appointees ignore scientific peer review and decide on funding based on their personal feelings. This will create huge damage to US science that could last a decade or more. This is similar to what happened to genetic research under Stalin, where Lysenkoism rejected evidence based science in favor of pet theories, setting back Soviet agriculture and generating food shortages and starvation. Overall summary. The proposed changes have multiple negative effects that will significantly damage US science, US leadership, and progress. Taxpayer dollars will be wasted, and the improvement in health treatments that we have seen in past decades will be significantly slowed. The changes proposed to section 200.205 need to be retracted.