Comment from Carmen Marsit

Federal Agency Review of Merit Proposals (§ 200.205) I am an executive associate dean for research and distinguished professor at Emory University Rollins School of Public Health. I am commenting in my personal capacity as a children’s health researcher with two decades of experience in public health research supported continuously by federal funding from the National Institutes of Health. All of the funding that the university has received to support my research has been awarded after the proposals my colleagues and I wrote underwent rigorous peer review, which informed the funding agencies on the merit of our ideas. I have also served as such a peer reviewer, including as a standing study section member for the NIH Center for Scientific Review for a four-year term, and member of over 20 ad hoc review panels. The proposed changes to §200.205 would undermine the peer review of grants, a system that has been in place since 1946, by codifying review and approval by political appointees in the issuance of grants. This would be antithetical to the broad goals of the proposed changes, which are to reduce fraud, waste, or abuse, by removing scientific peers from the decision process and allowing arbitrary decision-making by appointees without scientific knowledge. Point 1 – Application of imprecise and discretionary standards The proposal requires that federal agencies must designate a senior appointee to conduct a pre-issue review of awards to ensure awards are “consistent with applicable law, Federal agency priorities, and the national interest.” While federal law is clear, and agency priorities are often catalogued in strategic plans or other documents, “national interest” is not defined or listed, and so it is not possible for applicants to design work that can meet these criteria. The proposal also requires that recipients demonstrate a “a commitment to achieving Gold Standard Science,” another arbitrary term which is not defined and can have variable definition depending on the field or specialty. By requiring grants meet political priorities, diversity of ideas, projects, and institutions will be stifled, which will lead to less breakthroughs and impact. Point 2 – Reliance on political appointees for decision-making The proposed rule states that the political appointee required to review each award must make an independent judgment, and that peer review must remain advisory and not deferred to in making funding decisions. By codifying the advisory-only nature of peer review, this critical part of the grant-making process is weakened, as it lessens the value of serving as a voluntary peer reviewer to the scientists who serve. Removing the value of peer review will also weaken the scientific quality of awards. This will also slow the funding decisions by creating a bottleneck to awarding through one or a small number of senior appointees. Point 3 – No requirement for awards to be issued under a NOFO A notice of funding opportunity (NOFO) is a publicly available document that announces when federal grant money is available for specific projects, research, or programs. The proposed rule states that an agency is “not required to issue a discretionary award as a result of a NOFO.” This will result in a significant amount of wasted time, effort, and taxpayer funded resources, as researchers could apply for a grant, the entire peer review process could occur, and then no grants could be selected for funding. The represents over a year of time and effort for researchers as well as the federal agency workers involved in the process. Conclusion: These proposed changes will ultimately lead to reduced scientific quality by relying on arbitrary and capricious standards and not rigorous peer review. High quality, important research that could impact the public’s health will be lost. Recommendation: I recommend that OMB rescind the proposed changes to §200.250 in full. If OMB declines to withdraw these changes, then each of the ambiguous terms should be defined in full and agencies should be required to make information on what constitutes “national interest”, “Gold Standard Science”, “policy priorities”, and other broad terms be publicly available. In addition, agencies should be required to fund awards if a NOFO is issued, as to not waste time and taxpayer resources. An appeal process should also be explicitly provided in order for the decision of the appointees subject to question. Finally, if a political appointee must be involved in funding decisions, that person should have the requisite knowledge of the field and hold the credentials of a research leader in the area of the agency.