The Ad Hoc Group for
Medical Research Funding

Other sections of the Ad Hoc Group's proposal:

Executive Summary

Why Double?

What Progress From Past Investments?

What Investments are Needed?

How Do We Ensure That Progress Continues?

NIH manages an annual investment in medical research of over $20 billion, the principal goal of which is to serve the nation's health by developing new ways to fight diseases. Most NIH-funded research is conducted through research grants to medical schools, teaching hospitals, universities and independent research institutions, with the balance being carried out by federal scientists in NIH-operated laboratories. NIH has a careful system for deciding which topics - and which researchers - to fund, as well as careful systems for monitoring the research conducted by grantees and NIH to ensure it is carried out ethically, responsibly, and consistent with the funding award.

Priority-setting and researcher selection -- NIH sets priorities through a complex series of evaluations and judgments among its more than two-dozen Institutes and Centers, and no simple formula can be relied on to determine how research dollars should be invested among them. Each of the separate NIH Institutes and Centers has a different research focus, and the first level of priority setting for each revolves around the annual budget request that is submitted by the President and then transformed by Congress into appropriations legislation and eventually signed into law. This process recognizes the range and scope of the separate disease-related research activities of the Institutes and Centers, setting the overall spending level for each.

Each of these Institutes and Centers, in turn, relies heavily on evaluations by expert peer review panels; on advice submitted by patient organizations, voluntary health associations, and other members of the public; and on advice and guidance from NIH councils and other experts within NIH, elsewhere in the Executive Branch, and from the Congress. This process is necessarily iterative, particularly as public health needs arise and are brought to the attention of NIH.

In practical terms, the first line of evaluation for much of biomedical research comes at the level of scientific merit review of individual research proposals. NIH convenes groups of experts, drawn from throughout the research community, that scrutinize each research proposal submitted to NIH. These experts evaluate proposals for their scientific merit, doing so within the context of other proposals submitted within a specific scientific field. Before grants involving human subjects are allowed to enter this process, they have to be approved by independent bodies charged with ensuring that the proposed research is grounded in sound science, and that potential research subjects will be treated ethically.

Beyond the reviews that evaluate individual research proposals, each Institute and Center convenes national advisory councils to review its priority setting policies and provide a second level of review for the grant applications. These councils, whose members include various stakeholders from the community of medical interests being served by each Institute and Center, provide a broad perspective on the research being undertaken.

Across different medical needs, scientific disciplines, and the separate Institutes and Centers, NIH works to maintain a balance among the many, shifting priorities with which it is presented. Often advances in combating a specific disease arise from research that was intended to serve an altogether separate health need. Thus it is essential that NIH have sufficient resources so that it can sustain ongoing funding commitments while adapting rapidly to new and unforeseen health research challenges. The bedrock of the system has remained this two-tiered merit-review process, which helps ensure that whatever funding can be invested in NIH in a given year is allocated to those applications determined to be of the highest quality and greatest scientific and health-related import. While the merit review and priority-setting systems are less than perfect, they are the best means that have yet been found to make sure that the federal funds involved are used in the wisest possible way.

Accountability at grantee institutions and NIH laboratories - Research performers, whether universities, medical schools, teaching hospitals, independent research institutions, or federal laboratories, take seriously their responsibilities to ensure that Federal research funds are used carefully to advance science. Investigators and institutions work together to assure that all research is conducted in conformity with the highest ethical standards. The recent strengthening of the oversight system involving protection of human subjects in research has caused investigators and the institutions in which they work to re-focus their attention to ensuring that human beings who are the subject of research are treated ethically and responsibly. Institutions and investigators also adhere to federal laws and regulations regarding conflict of interest, scientific misconduct, care and treatment of animals used in research, use and disposal of hazardous materials, cost accounting standards, and have been increasing their compliance efforts in recent years. To ensure that the next generation of investigators is well-versed in these matters, all federally-funded research institutions and programs are required to provide courses on the responsible conduct of research. In combination, this system of training, compliance, and oversight mechanisms ensure that American research institutions and scientists consistently perform responsibly and accountably.

In the last analysis, the very best measure of whether the nation's medical research system is setting the right priorities, and funding the best scientists to work on the most important scientific problems in a cost effective manner, is to compare the frequency of medical breakthroughs generated by NIH-supported scientists to those generated by scientists supported by all other nations. By this measure, NIH is the world's leader in medical research, and America has the world's most highly acclaimed and emulated medical research system.