Letter to Senator Cassidy on NIH Modernization

As a non-profit society publisher of 16 scientific journals, APS plays a key role in the dissemination of scientific findings in the field of physiology, including research that was funded by the NIH. APS journals are edited by working scientists who together with a professional staff bring articles from submission to final publication in a timely manner. APS currently makes all final published articles available to the public, regardless of funding source, 12 months after publication. For authors who elect to pay an Open Access fee, articles are available without embargo. As a society publisher, APS adds value by providing standards and integrity checks for rigor and reproducibility, peer review administration, copy editing and composition, digital and print publication, and ethical management of articles. APS also maintains content so that the integrity of the scientific record is preserved over time and provides resources that make the content accessible to the public, including blogs and podcasts that share research results in context.

As NIH and other federal agencies finalize and implement policies to increase public access to scientific literature, APS is working to implement financially sustainable mechanisms to allow the Society to meet the needs of federally funded authors. APS encourages Congress to ensure that publishers of scholarly journals are able to continue to work in partnership with NIH and members of the academic research community to quickly disseminate high-quality research findings and contribute to the advancement of science.

Earlier this year, NIH implemented a requirement for grant applicants to include a plan for data management and sharing with their applications for funding. The policy became effective on January 25, 2023 and applies to all grants that generate data. Because the policy only applies to newly submitted grants, the first projects that received funding with the new requirement to manage and share data are just now getting underway. Each grant lasts an average of 4 years, which means that it will be multiple years before data is available on how well the policy is working.

A key consideration for investigators in making data available is sufficient funding for data management and sharing, as well as access to appropriate repositories for data deposition, which can vary by field. Making funds available for these purposes will set investigators up to succeed in meeting the goals of the policy.

The discoveries that emerge from NIH-supported basic and translational research provide the foundation for new drugs and therapies and prepare our nation to confront challenging public health threats such as obesity and an aging population. While the private sector brings the majority of new treatments to the market, it relies on the breakthroughs from federally funded research to identify new targets and strategies to treat diseases. This symbiosis between industry and academic research has been key for decades of success of the American biomedical industry. A study published in the Proceedings of the National Academy of Sciences found that every single one of the 210 new pharmaceuticals approved by the FDA between 2010 and 2016 depended on research funded by the NIH. While improving outcomes for translational and clinical projects is an important goal, the fundamental research that NIH supports must continue to be a priority.

R01 grants represent the main funding mechanism used by most academic investigators to fund their labs. Most investigators rely on a single grant to support their research programs, but many have found that in recent years it is harder to sustain their work without additional funds. Inflation has led to increased costs for research materials, and a need to raise salaries for skilled workers who perform the research. Providing adequate funds for investigators to pursue their ideas is key to supporting transformational science.

In 1998, NIH introduced the modular budget in an effort to streamline the grant application process for investigators requesting less than $250,000. Modular budget grant applications do not require a detailed budget, thus reducing the administrative burden associated with preparing an application. However, in the 25 years since the introduction of the modular budget, the limit of $250,000 has remained unchanged. This erosion of purchasing power has led to a decrease in the utilization of the modular budget over time.

Time spent writing grants and applying for funding is time not spent working in the lab and mentoring trainees. A 2018 survey by the Federal Demonstration Partnership (FDP) showed that faculty researchers spend an average of 44.3% of their time associated with federally-funded projects fulfilling administrative and other requirements. This was an increase from data collected in 2005 and 2012 when researchers spent 42.3% of their time on administrative requirements, indicating that administrative burden continues to increase over time. Exploring ways to reduce the administrative burden associated with federal funding would support transformational science by allowing investigators to spend more of their time focused on research, and less on administrative requirements.

The salaries of academic researchers are typically supported by a combination of institutional funds and extramural grants, including research project grants and training and career development awards. Because the salaries of early-career researchers may depend on continued funding through research project grants, gaps in project funding can leave them financially insecure. Training awards such as institutional T32 grants can help cover the salary of graduate students and postdoctoral researchers. However, there are many institutions and programs that don’t receive enough training funds to provide a livable salary to trainee researchers.

NIH provides a range of funding mechanisms targeted at early-career researchers, including career transition K99/R00 awards aimed at postdoctoral researchers seeking their first position as independent researchers. However, most postdocs will not end up in tenure-track academic research positions. There is a lack of funding mechanisms designed specifically to support hiring, training, and retaining of research technicians and staff scientists. As a result, academic labs often rely on the labor of postdocs, who can spend years in their positions without significant career advancement. NIH should provide additional support for researchers who seek career pathways as staff scientists.

On October 19, 2023, the NIH announced a simplified grant review process following analysis of comments received from the community in response to a December 2022 request for information (RFI). APS responded to NIH’s request for stakeholder input and supports the implementation of a simplified review process.

To reduce reviewer burden and minimize bias, reviewers will be asked to evaluate three factors in their review: the importance of the research; rigor and feasibility; and expertise and resources. The first two factors will be scored individually, and the third factor will not be scored individually but will contribute to the reviewer’s determination of the overall score. With more than a year before the implementation of the simplified review framework in January 2025, NIH has laid out plans to help both applicants and reviewers understand the new process.

By simplifying the review process, reducing the burden associated with serving as a reviewer, and providing adequate training, the hope is that investigators will find it less burdensome to participate. Over the years, NIH has made several other changes that have improved the experience and efficiency of grant review, including instituting flexible deadlines, holding some review meetings virtually or in geographic locations outside of the DC area, and inviting scientific societies to nominate members for consideration on review panels. The Early Career Reviewer program at the Center for Scientific Review has also served to bring new voices into the grant review process while providing a beneficial experience for participants.

As NIH fully implements the announced changes to peer review, it will be important to evaluate multiple outcomes, including how the changes impact both reviewers and applicants, as well as review outcomes and success of the funded research. As with the new data management and sharing policy, it will take time for the new review framework to be implemented and for evaluation of the impacts to be measured and analyzed.

An issue related to peer review that has not been addressed is the level of communication between staff at NIH who coordinate program (research) priorities, and those who oversee the peer review process. Better coordination between those who are establishing priority areas for funding and those who oversee the grant review could increase the likelihood of funding grants that target areas of scientific interest and opportunity.

While researchers may exit the academic workforce at all career stages, the period of postdoctoral training incurs particularly high rates of attrition: 75% of postdocs are unable to find a tenure-track position within five years. The typical postdoc salary is very low compared to similar high-skill jobs in other sectors, but a number of other factors also contribute to dropout. While a postdoctoral position is intended to train individuals to become independent researchers, there is no well-defined timeline for this training, and their mentors may be unprepared or unwilling to spend the effort to develop the knowledge and skills of the postdoc. The lack of available tenure-track positions means that many postdocs end up taking multiple postdoctoral positions before finding more stable employment.

Many people enter their postdoctoral fellowship period while they are in the early stages of starting families, which significantly contributes to the financial strain and the pressures of geographic relocation. Because postdocs are often classified as trainees and not employees, benefits packages available to them may be more limited, making it difficult to support healthcare for family members, parental leave, and access to childcare. Postdoctoral research can also be mentally and emotionally stressful due to competition over funding and resources, pressure to publish research, and typically long working hours. "Postdoc burnout" is a common challenge and frequently causes reduced productivity and drives many to seek careers outside of research.

Postdoctoral training should represent the final stage of training for the highly skilled independent researchers that drive biomedical innovation, and there should be an assurance that postdocs will be adequately prepared for their chosen career path after 2 – 3 years. NIH can support this goal by building upon existing programs and by developing clearer training guidelines. NIH can bolster the availability of career development opportunities for postdocs through the creation of instructional materials, mentoring rubrics, workshops, and other mechanisms, which can be developed in partnership with third parties such as scientific societies. NIH should also develop clear standards and guidelines for postdoctoral training to support career transition to the breadth and variety of careers that postdocs pursue, including careers in academia, industry, and government. Existing NIH programs that facilitate career transition that should receive increased support include K99, K01, and K08 awards, which support researchers and clinicians through a guided pathway toward career transition. Implementing these changes would help postdocs enter their careers more swiftly and with better preparation and reduce the likelihood of taking multiple postdoctoral positions.

For more information, see physiology.org/NIHPostdocTraining

As noted in a previous response, the 2018 survey from the FDP showed that administrative burden associated with federally funded research continued to increase over the period studied. In addition to being asked about the level of administrative burden, faculty members were asked to identify administrative requirements that they considered to be a high priority area in need of change. Administrative requirements associated with animal care and use were ranked as a high priority area in need of change at both the pre- and post-award stages.

Passed in 2016, the 21st Century Cures Act required NIH to work with the USDA and FDA to review policies and procedures and identify steps to reduce administrative burden on investigators using animals in research while maintaining the integrity and credibility of research findings and the protection of research animals (Section 2034(d)). In response to this legislation, the NIH, USDA, and FDA convened a working group of federal subject matter experts to carry out a review of applicable regulations in policies and to identify approaches to reduce administrative burden on researchers. This report can be found on the NIH Office of Animal Welfare (OLAW) website.

In addition to the federal report, interested stakeholders from the Federation of American Societies for Experimental Biology (of which APS is a member), the Association of American Medical Colleges, the Council on Government Relations, and the National Association for Biomedical Research convened a workshop and published a report entitled “Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden.” This report outlines several policy changes that could reduce administrative burden on institutions and investigators using animals in research.

Despite these efforts, the community has seen little effective change since the passage of 21st Century Cures. OLAW has continued to provide comment periods for policy guidance via Requests for Information (RFIs). However, few of the RFIs propose meaningful changes and it is unclear how OLAW incorporates community feedback received in response to the calls for stakeholder input.

Further efforts are needed to meaningfully decrease administrative burden on investigators using animal models. NIH should continue to seek opportunities to work with other agencies to produce meaningful change in this area.

While we highlight here the impact of administrative burden associated with animal care and use, there are many other aspects of federal projects that contribute to the amount of time and effort spent on meeting requirements. The 2018 FDP survey identifies other major contributors, including data management, budgeting, and progress reporting.

As referenced above, additional efforts to address levels of administrative burden associated with animal care and use could be undertaken through further interagency cooperation between the NIH, USDA and FDA, as well as other agencies that fund research.

The biomedical research community continues to face challenges in developing a workforce that reflects the diversity of the American population. Without an adequately diverse research workforce, scientific progress will continue to fall short in effectively addressing the needs of all people within the United States and around the world.

NIH is engaged in ongoing efforts to address disparities in funding for researchers from underrepresented groups. Since 2014, the NIH Chief Officer of Scientific Workforce Diversity has led coordinated efforts across the agency to increase and sustain diversity in the scientific workforce. This office is charged with using evidence-based approaches to enable “NIH and NIH-funded institutions to benefit from a full range of talent, fostering creativity and innovation in science.” The efforts of the Chief Officer of Scientific Workforce Diversity complement work going on at every level and within each institute and center at the NIH to comprehensively address this challenge and make progress toward a fully inclusive scientific workforce. These efforts will succeed only with sustained support over time.

A frequent topic of concern in biomedical research is the ethics of experiments that involve animals and humans. Federal laws and regulations establish protections for both human and animal subjects in research and those protections are essential to conducting good science. Physiologists frequently make use of animal models in their research as they seek to understand how biological processes work in the context of a living organism. APS expects members and authors to adhere to the Society’s Guiding Principles for the Care and Use of Animals in Research and Teaching. Such research is highly regulated, and the selection of an appropriate experimental model is subject to scrutiny at the level of grant review at NIH, and by the local Institutional Animal Care and Use Committee. NIH should continue to empower researchers to use the most appropriate model for their research question in order to produce the best results.

As NIH continues to increase transparency on a variety of fronts, care should be taken to ensure that these efforts do not compromise researcher safety. One such example is that of researchers working with animal models. Opponents of animal use in research have subjected researchers working with animal models, including trainees, to threats and harassment. Increased transparency may inadvertently make identifiable information more accessible. The agency should continue to increase efforts to support and protect the safety of researchers receiving NIH funds. This should be considered in current efforts, such as data management and sharing practices, as well as future efforts to increase transparency.