Jon R. Lorsch, PhD Director, National Institute of General Medical Sciences National Institutes of Health 45 Center Drive Bethesda, MD 20814

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1 Jon R. Lorsch, PhD Director, National Institute of General Medical Sciences National Institutes of Health 45 Center Drive Bethesda, MD Submitted electronically via: May 19, 2015 Dear Dr. Lorsch: The Federation of American Societies for Experimental Biology (FASEB) is concerned about stability of the biomedical research enterprise and thanks the National Institutes of Health (NIH) for working to address this critical problem. Over the past two years, FASEB has carefully assessed this issue and developed Sustaining Discovery in Biological and Medical Sciences: A Framework for Discussion. This data-driven effort involved extensive consultation with its 27 constituent societies, subject matter experts, and other stakeholders. This response to NIH s Request of Information (Notice Number NOT-OD ) reflects the key findings of this document and highlights select recommendations. It has also been submitted electronically to the RFI website. Investment in biological and medical research has paid enormous dividends, and it has made the United States the world leader in this critical area of science. Unfortunately, the research enterprise that has yielded so much in the past and that offers so much promise for the future is now under tremendous strain. Research budgets have not kept pace with expanding opportunities and rising costs. Consequently, the fraction of submitted proposals that are ultimately funded is at an all-time low. There are more highly meritorious requests for research funding than the system can accommodate. Insufficient funding and rising costs are delaying progress in biological and medical research. From FY , NIH has lost 22 percent of its capacity to fund research due to a combination of budget cuts and inflationary losses. Growing regulatory burdens drain scarce resources and delayed federal budgets reduce the impact of available funds. While potential cost savings exist, they are insufficient to fully replace budgetary losses. Stable and predictable increases in federal funding for biological and medical sciences are necessary to maintain the preeminence of the U.S. in bioscience research.

2 Concurrent with funding shortfalls, scientific opportunities and the demand for research grants have risen. The NIH-associated research workforce has grown, with more investigators seeking NIH funding, more students completing graduate training, and more individuals working in postdoctoral positions. Continued workforce growth compounds the consequences of constrained funding, producing even greater workforce instability. As a result, many talented investigators are forced to seek other careers and many promising research projects are prematurely terminated; this wastes prior investments and delays future discovery. To stabilize the enterprise, FASEB offered a series of recommendations in Sustaining Discovery aimed to maximize research funding, improve workforce utilization and training, and optimize funding mechanisms. While we recognize that some recommendations are beyond the scope of NIH to address, there remain many areas where NIH can take action. As NIH seeks to strengthen the enterprise through optimization of funding policies and strategies, we hope that NIH s efforts will be guided by the following recommendations. We also appreciate that NIH has already initiated some changes to improve funding rates and training conditions. Increase portfolio evaluation Successful optimization of NIH s funding policies and strategies will require a solid understanding of NIH institute and center (I/C) research portfolios and funding mechanisms. Therefore, we call NIH s attention to our recommendations for increased portfolio evaluation (Recommendation 2.5 and 2.6). FASEB commends NIH I/Cs that are already engaged in such evaluation activities (e.g., NIGMS and NINDS) and encourages other I/Cs to follow suit. Regular review of funding allocation is essential to ensuring an I/C s research portfolio is balanced and consistent with its mission. NINDS, for example, found that the number of R01 grants had declined and that the number of basic research proposals had plummeted. The Institute is conducting additional analyses to better understand these changes and is taking steps to restore basic research funding. FASEB recommends that all NIH I/Cs regularly evaluate portfolio allocation and share these finding with the broader community. Making results publicly available can alert other funders (both within and outside of NIH) of problematic trends that may also affect their own portfolios. In addition, a public dialog can help communicate I/C priorities to researchers, such as NINDS s affirmation of the value of basic research. Similarly, FASEB recommends regular evaluation of individual funding mechanisms and programs. Research needs and opportunities continuously change as discoveries are made and new areas emerge. Periodic evaluation can identify funding mechanisms in need of restructuring or

3 downsizing. This can enhance the effectiveness of the mechanism and potentially make funds available for other priority areas. For example, NIGMS initiated major, external analyses of two larger programs in This ultimately resulted in programmatic revisions and reassignment of some funds to other mechanisms. Prioritize investigator-initiated research FASEB encourages NIH to prioritize investigator-initiated research, including basic research, within its portfolios. The path-breaking ideas that have advanced biological and medical science have been made, for the most part, by individuals and teams of scientists working on hypothesisdriven research. While large-scale projects and initiatives have aided science in many ways, they should be carefully scrutinized before funding and rigorously evaluated throughout their lifespan. In addition, the proportion of targeted awards (through Funding Opportunity Announcements) has expanded within some NIH I/C portfolios. While some I/Cs have already taken steps to reverse this trend, we encourage NIH to review their utilization, especially in regard to their impacts on the composition of research portfolios and types of grant applications received. Explore new funding mechanisms In addition to optimizing current funding mechanisms, FASEB recommends that NIH continue to develop and test new funding mechanisms. While a mechanism or funding strategy may have been highly successful in the past, it may no longer be optimal in the present and new mechanisms may be required. It is crucial that robust evaluation plans for assessing the outcomes of pilot programs be released for public comment, ideally before a large-scale funding announcement is issued. In Sustaining Discovery, FASEB proposed several types of mechanisms to consider, including funding of scientists or research programs instead of specific projects (Recommendation 2.7), monitoring and limiting funding to an individual or research group to ensure a broader distribution of funding (Recommendation 2.8), and awarding partial funding based on an application s priority score (Recommendation 2.9). The Federation applauds NIH for its many efforts to-date in exploring and piloting novel mechanisms and encourages NIH to continue scientifically testing ways to better support research. Promote more efficient workforce utilization To maximize the efficacy and impact of research funding, NIH must also take steps to stabilize the research workforce. Progress in biological and medical research is dependent on the availability of bright, well-educated, and highly motivated researchers. Concerns have been raised, however, about using trainees as the primary source of research labor, including the quality of training provided, laboratory inefficiencies due to frequent student turn-over, and declining career prospects for

4 trainees. An alternative structure to consider is one in which a greater proportion research is conducted by staff scientists and technicians. This approach would enhance continuity and retention of expertise for laboratories, reduce the number of trainees required, and increase the proportion of stable research positions within the workforce. However, many barriers exist to adopting this change in workforce composition, including the higher salary and benefit costs associated with staff scientist positions. FASEB commends NCI for piloting a grant program that would provide funds for research specialists and encourages NIH to continue exploring ways to promote use of staff scientist positions (Recommendation 3.7). Limit expansion of external salary support on research grant The growing reliance on external grants to fund faculty salary and benefits is another source of workforce instability. This places investigators and members of their laboratory at a greater risk of job loss when grant success rates fall, producing inefficiencies as careers are prematurely cut short and promising projects are abandoned. Therefore, FASEB recommends NIH explore ways to gradually increase the percentage of principal investigator salary provided by research institutions. At a minimum, we must limit the growth in the percent of principal investigator salaries charged to external funding sources (Recommendation 3.1). Principal investigators cannot be expected to compete for new awards if all of their time is charged to sponsored research, nor can they carry out any institutional responsibilities. NIH should set reasonable limits on salary support that recognize differences in institutional missions. A gradual approach would minimize shock to the system, allowing time for investigators and institutions to adapt. Continue efforts to mitigate regulatory burden In the past two decades, the number and range of federal regulations, policies, and guidance has greatly expanded, making it increasingly difficult and costly to maintain compliance. To adapt, research institutions have hired more administrative staff and reduced administrative services provided to faculty. Risk-averse administrators also have created a culture of over-compliance. All of these factors raise research costs and reduce investigator time dedicated to active research, thus delaying discovery. FASEB commends NIH for its efforts to promote more efficient regulatory practices, such as the use of a single Institutional Review Board of record for multi-site clinical studies and recommends additional actions to increase regulatory efficiency (Recommendations ). NIH should continue to work towards harmonizing rules, policies, guidance, and training requirements, both within the agency and across the federal government. FASEB also recommends that NIH regularly assess existing policies and guidance, including cost-benefit analyses and evaluation of

5 implementation practices. This information can empower NIH to strategically fix sources of unnecessary burden. Finally, while the research time lost to administrative tasks is of great concern, NIH should also examine the detrimental effect of regulatory burden on morale. Ameliorating key areas of frustration may bring significant relief to researchers even if the total amount of time required cannot be significantly reduced. Support the development of new metrics Metrics and ratings of the biomedical research enterprise use absolute measurements of research volume that reward growth. Few use variables that address quality or sustainability. This focus on size encourages expansion of research operations even when funding is scarce and contributes to instability. NIH can help counteract metric-based incentives for growth by supporting the creation of metrics to assess the quality and sustainability of the research enterprise (Recommendation 1.14). NIH should encourage the National Science Foundation and the National Academies to include such measurements in their surveys and assessments. These might include: faculty turn-over rates, number and percentage of endowed faculty positions, percentage of faculty salary for research activities supported by the institution, and more extensive career outcome data for trainees. Identify ways to better support shared resources Shared resources can extend the value of research investments. There are many opportunities for increased efficiency ranging from greater use of shared equipment at the local level to shared core facilities at the regional level and stock centers and databases at the national level. Unfortunately, mechanisms for support are limited in scope and flexibility and are unable to meet the wide range of needs. FASEB recommends that NIH work with the research community to identify better ways to encourage use of and support for shared resources (Recommendations 1.11 and 1.12). In conclusion, FASEB thanks NIH for this opportunity to share our perspective on these critical issues. We offer our assistance as NIH continues to explore these challenges and develop policies and strategies to increase the sustainability of the NIH-supported research enterprise. Please do not hesitate to contact me should you require additional clarification about any of our comments or if there is an opportunity for us to work together on these shared goals. Sincerely, Joseph R. Haywood, PhD FASEB President