Comment from Anon Anon

I am an Assistant Professor at a public university who has received NIH funding for the past 6 years. I am concerned about the proposed changes as below: §200.205 — Political appointee review of grants: The grant review process is incredibly rigorous and supported by physicians and PhD-level scientists who have expertise in the research being reviewed. As an early stage investigator who needs a R01-level grant in order to continue my career, I am disheartened that funding success rate for early stage investigators has dropped from ~30% to 19%. The overall success rate for a NIH R01 grant has already decreased to 13% from 19%-22% in previous years. A change which will make the peer review process advisory in nature greatly threatens the quality of research in the United States and the success of early stage investigators who need these grants to succeed. Further, the additional review by public appointees, most of whom have no scientific training and many who have only rudimentary knowledge of detailed research procedures, will not only slow the award progress (and thus stymie the overall quality and trajectory of US research) but create the opportunity for political interference in research rather than letting the quality of research dictate funding. §200.340 — Grant termination: As someone who spends a great deal of time planning a study, following proper regulatory procedures, and investing in the creation of infrastructure that supports quality research for every project I conduct, having a grant terminated if "in the interest of the Federal agency" would be devastating to research progress. Further, research participants who are heavily invested in a study can experience adverse effects when an investigational drug they are receiving is discontinued. Even participants in my observational study would be incredibly disappointed if they were not longer able to participate in a project that they view as important. Not only would this be disruptive to research as a whole, but it will place the US behind other countries who do not experience this degree of federal interference in research activities. • §200.432 — Conference attendance pre-approval: Research results often dictate which conferences are most appropriate to attend. Further, the timing of results is not always entirely predictable, and it would be more conducive to public dissemination of results to continue to allow flexibility for timing of presentation and conference location. This proposed change will hinder the dissemination of research to other scientists and the general public. • §200.461 — Publication costs (now unallowable): Not allowing for publication costs also hinders dissemination of the research, which is a critical part of the research process itself, especially when there is a federal requirement to publish using an "open access" designation, which is incredibly more expensive than a standard designation. Publication fees can range from $3,000-$6000+ for one journal article, and not allowing researchers to use federal funds to meet a federal requirement to publish research is shortsighted and will also prevent timely publication of important research. §200.220 — Foreign collaboration prohibition: Foreign collaborations give US researchers access to resources that are not always available in the US. Staying in collaboration with researchers from other countries allows us to continue to refine our methodology so we advance to the highest level of research; these collaborations only strengthen our US-based research programs. No longer collaborating will limit our access to cutting edge technology and hinder research progress, as the rest of the world works together to make ground breaking discoveries. As an early stage investigator, I am deeply concerned that these proposed changes will impede research progress as a whole in the US and that they will also hinder my own potential to be successful as an independent investigator. My ability to secure funding and conduct research of the highest quality is directly affected by these proposed revisions, and I urge OMB to withdraw the provisions as above and not finalize these rules.