The American Society for Microbiology appreciates the opportunity to submit written comments to the IOM/NAS Committee to study the NIH Research Priority Setting Process. The ASM would like to make observations concerning the NIH research priority and planning process and offer several recommendations for the Committee to review as it considers improvements.
The single most important force that has made the National Institutes of Health (NIH) the leader of the nation's biomedical research enterprise is the strong government investment in excellent, untargeted, peer reviewed basic research. In general, the role of Congress has been one of appropriation and oversight, not political management of disease research. The NIH and the nation's research enterprise have benefited from this climate of flexibility without inappropriate political control over scientific decision making. The NIH has been able to respond to changes and opportunities in research and this has led to enormous scientific progress against disease and disability. It is essential that this approach be continued in the future to maximize the nation's investment in health-related research.
The significant number of new discoveries resulting from NIH supported research attest to the effective way in which the NIH carries out its mission. By balancing unsolicited meritorious research grants with special initiatives, NIH has tried to respond to urgent public health needs, emerging scientific opportunities, and gaps in scientific knowledge. The NIH Institutes have developed decision making processes for planning and priority-setting that incorporate input from a variety of sources, including the Congress, the Administration, other federal R&D agencies, scientific societies, the scientific community, patient groups, community advisory boards, public interest groups, and the pharmaceutical industry. Patient advocacy groups who are concerned about funding for specific diseases play an important role in voicing their concerns to the NIH and the Congress. The process of listening and responding to their concerns is in the interest of biomedical research. The Institutes' National Advisory Councils and other standing and ad hoc advisory bodies include scientific as well as lay advisors who play a key role in shaping priorities and directions for research. These mechanisms and methods have a proven record of contributing to the success of the NIH. They should be further strengthened and the elements of the decision making process should be clearly explained to the public and Congress.
It is critical that scientific directions and research priorities be identified at the Institute level to ensure the best and most appropriate scientific expertise is brought to bear on decisions concerning strategies to exploit research opportunities, to assess the implications of new molecular analytic tools, and to evaluate major changes in science and public health needs in relationship to resource allocations. In this regard, the NIH extramural scientific community could play an even greater role in working with the NIH scientific staff.
The ASM is most familiar with the National Institute of Allergy and Infectious Diseases (NIAID), which has developed a well defined framework to facilitate consultations and interactions with scientific and lay advisors on scientific program decision making. This process helps guide the Institute in identifying research opportunities, public health needs and the priorities of constituent groups and Congress. The Institute Director and program managers hold policy discussions and information exchange meetings with scientific societies and voluntary health organizations throughout the year and actively seek the advice of grantees concerning research opportunities and neglected areas that may need special attention. The Institute reviews recommendations in relationship to ongoing research supported by the Institute as well as other Institutes. Program officers closely monitor scientific developments and public health trends from the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO). Blue-ribbon panels are convened when needed to advise on research plans and priorities in specific areas. This iterative process appears to work well at the NIAID and has contributed to scientific progress with significant public health benefits. Although structured, the NIAID approach has the necessary flexibility and discretion that are needed to pursue under-explored opportunities in different fields of research and to move rapidly on urgent public health issues.
The NIH is a creation of the public will and the representatives of the public in Congress. The ASM is concerned, however, about statutory directives because targeted areas compete for limited resources with other meritorious programs which may have to be reduced when additional new funding is not provided. The process for allocating NIH funds must be careful to accommodate highly meritorious basic research that is not easily classified in a disease category but may lead to new cures and treatments for disease. It is historically the case that research aimed in one direction provides knowledge and benefits in an entirely unexpected direction. However, it is important for members of Congress to continue to express their priorities in report language that accompanies appropriations bills.
The ASM would like to offer the following specific issues and suggestions for the Committee to consider:
- NIH should examine best practices with regard to research priority setting. Each Institute has developed a series of mechanisms for identifying new research opportunities, for reaching out to constituents and for setting priorities. It is unclear whether all the useful approaches being used are even known by other Institutes, let alone shared. The NIH Director could establish a task force to examine and evaluate best practices and share the information and conclusions with the Institute Directors and Advisory Councils. Focus groups could also be convened with constituent groups to gather external advice in this process. The NIH should seek advice from a broad cross section of scientists in all areas.
- The Committee should review the need for NIH to have more direct access to the Administration and Congress to submit an annual budget that presents real priorities and resource requirements for scientific research that are based on professional judgement and advice from the scientific community and the informed lay public. Additional mechanisms may be needed to ensure that the NIH Director has the authority and funds to convene advisory panels of experts for the purpose of planning priorities and resource requirements for biomedical research that provide input into this process.
- The Committee should review whether the NIH Director needs access to greater budget authority and discretion to take action when unexpected opportunities or health emergencies arise when the appropriations process would be too slow a mechanism to respond.
- The need for a Center for Communications at NIH should be considered. The NIH should make recommendations about how to improve its capabilities to share with the broader public the successes as well as the limitations of discoveries in research, treatment and prevention. Since NIH is the source of support for most biomedical research in the nation, a more comprehensive and focused public communications office with the latest technology for web site development, a TV studio and perhaps even a daily newspaper could be a significant source of information.
- It is essential for NIH to foster opportunities for cross-disciplinary research. NIH should organize, either directly or through the NRC, periodic cross-disciplinary meetings between biomedical researchers and mathematicians, physicists, chemists, economists among others. to explore both general opportunities based on sharing of overlapping research and to specifically exploit clearly identified breakthroughs that have immediate relevance.