Comments Re Prohibition on Use of Federal Awards for Publication Costs [200.461] and Public Communications [200.421]

This is the comment I submitted in response to the OMB call for public comments on the proposed rule on federal financial assistance.

The proposed regulations make it difficult or impossible to use federal grant monies to disseminate the results of grant-funded research to both the scientific community and the wider public. And yet, dissemination of scientific results via publication and other means is exactly the point of basic research funded by the federal government. The proposed language states, “Publication costs are not inherently necessary to carry out the core programmatic objectives of most Federal awards.” This is an incorrect statement insofar as NIH and similar grants are concerned.

The proposed regulations, if enacted, will have negative consequences for both the efficiency and the ethics of science research.

I am a career biomedical scientist. I have been a professor of biomedical engineer for over 25 years. I use advanced nuclear medicine techniques (“PET imaging”) and mathematics to study alterations in brain chemistry of Parkinson’s patients and drug addicts. Knowledge of the underlying (molecular) mechanisms of these diseases brings us closer to cures.

The success of my research—and ultimately, the path to cures—depends heavily on two things: 1. A reliable and complete scientific literature of relevant experimental findings, and 2. A willingness of human volunteers to participate as experimental subjects in the research.

Re item 1, the new proposal states (under 200.421), “all advertising and public relations costs are unallowable with limited exceptions.” But no exceptions are mentioned in the proposal regarding the recruitment of patients or subjects, whereas in the current version of (200.421) there is an explicit exception to allow for recruitment, “Program outreach (for example, recruiting project participants) […] to meet the Federal award requirements.” The regulations as currently written are necessary and proper.

Re item 2. the new proposal states (under 200.461), “publication costs [are] unallowable unless such costs are expressly required by statute or approved in advance by the Federal agency on a case-by-case basis.” But (a) we cannot always anticipate the nature of our findings, so practically, that would preclude obtaining approval “in advance”. And (b), the prospect of obtaining case-by-case approval to publish and disseminate findings seems unjustifiably bureaucratic and burdensome.

If other scientists are prevented from, or even simply retarded in their efforts to publish scientific results in readily available journals, then I or other scientists may be unaware of their work. This could lead us to re-perform the very same experiments that have already been tried and proved unsuccessful. Repetition of said experiments would be needlessly wasteful of my time and the taxpayer’s money.

To find the appropriate volunteers for a given study, it is sometimes necessary to do targeted outreach to certain patient communities. Without allowable outreach (aka., “advertising” and “public relations”) it may be impossible to recruit the needed participants.

The most egregious sin, however, would be committed in violation of the trust that is established between me (as the experimenter) and my human subjects, who bravely and generously assume some measure of risk to participate in my experiments. They do so with the express hope that they will contribute to scientific and medical knowledge about their dreaded disease or condition. I know from personal experience that volunteers and others (e.g., in the Parkinson’s community) are grateful and satisfied when they read of my scientific findings in journals. The public is most likely to see scientific findings in “open access” journals. Sadly, the fees to pay for open access with federal grants is prohibited in the new proposal.

In 2024 my team published the first-ever observations of persistent changes in the brain chemistry of Parkinson’s patients following the adoption of a long-term exercise program (de Laat et al, 2024). The volunteers see these results and know that their volunteerism has resulted in the advancement of medical knowledge. Others laboring under similar difficulties are encouraged that progress is being made on their disease. I am certain that no one will volunteer if they suspect that the results will be sequestered and not published. It is a moral imperative for basic scientists to publish their results widely and in a timely manner in order to fulfill their obligations to the patients who volunteered, the scientific community who will build on the results, and the taxpayers who funded them.

References

de Laat B, Hoye J, Stanley G, Hespeler M, Ligi J, Mohan V, Wooten DW, Zhang X, Nguyen TD, Key J, Colonna G, Huang Y, Nabulsi N, Patel A, Matuskey D, Morris ED, Tinaz S. Intense exercise increases dopamine transporter and neuromelanin concentrations in the substantia nigra in Parkinson’s disease. NPJ Parkinsons Dis. 2024 Feb 9; 10(1):34.