Mr. Chairman, Members of the Subcommittee:
I am Ruth Kirschstein, Deputy Director of the National Institutes of Health (NIH). I
am pleased to be here this afternoon to tell you about the mission of NIH, its programs and its
use of peer review committees. My remarks today are based on a forty-two year history of
being ON the staff of NIH, of which twenty-four years have been as a senior official. In the
past twenty-five years, I have been deeply involved in all aspects of the use of advisory
committees by NIH, chairing a study team that was charged with conducting a thorough
examination of the NIH grants peer review system and the committees that reviewed grant
applications. More recently, I have participated in other NIH committees that have identified
and assessed current issues related to peer review.
Let me start by giving you some background about the National Institutes of Health.
NIH is an agency within the U.S. Department of Health and Human Services, serving as the focal
point for health research for the entire nation.
Biomedical Research and the NIH
The NIH is the world's largest organization devoted to maintaining and improving
health through medical research. It seeks to expand fundamental knowledge about the nature
and behavior of living systems and to apply that knowledge to improve the health of human
beings, extend healthy life and reduce the burden of illness and disability. The research
undertaken by the NIH assumes many forms, occurs in many places, and employs many
techniques. Some research is confined to the laboratory and attempts to understand complex
biological systems by examining individual molecules, cells, or tissues. Other research
addresses normal human biology as well as disease in the context of living subjects. Some is
based ON the study of human populations and ON clinical studies using patients who have
generously volunteered for these studies. This continuum of research provides the knowledge
base for the development of new treatment and prevention strategies.
The NIH is actually a federation of twenty-two research Institutes and Centers, each
individually mandated by Congress and charged with a unique research mission, ranging from
compelling public health problems such as drug abuse and the causes of low birth weight in
infants to particular diseases such as cancer, mental illness, or diabetes. Some Institutes
concentrate research ON a particular organ such as the heart, the kidney or the eye or ON a
stage of human development, such as childhood or aging. Each of the Institutes is prepared to
respond to new or emerging diseases such as multi-drug resistant tuberculosis, Lyme Disease
or other infectious diseases, the increase in the incidence of breast cancer or the effect of hip
fractures due to osteoporosis in elderly women.
Scope of NIH-supported Research
Not only is the research enterprise of the NIH very large but it is also complex. In
most of the Institutes, the funds appropriated by Congress (nearly $14 billion in FY 1998)
support biomedical research in two large arenas. One is the program of laboratory-based and
clinical studies carried out by scientists within the NIH itself. This is the NIH intramural
research program and accounts for about 10 percent of the NIH appropriated funds. In total,
the Institutes use more than 80 percent or $9 billion of the appropriated funds to support
research conducted at the more than 2000 academic institutions, hospitals and other research
facilities throughout the country, whose scientific faculty members do biomedical research
through the award of competitive grants and contracts. In addition, the Institutes provide
support for the training of graduate students and postdoctoral scientists who will make future
research discoveries and advances that will benefit the country in the coming years.
The NIH receives more than 40,000 grant applications a year, which include
applications submitted by an individual investigator, applications for large multisite clinical
trials, projects from small businesses, requests for fellowships from individual postdoctorals,
and applications for research training programs. The topics covered by grant applications span
a broad and complex range of science including molecular and cellular biology, behavioral
studies, community-based clinical trials, technological development, projects to map the
human genome, and the development of new drugs to treat recalcitrant cancers and drug-resistant
tuberculosis.
To accomplish its mission, the NIH seeks advice from a variety of sources including
141 chartered committees, which are described below.
The NIH Peer Review System
The bedrock of the success of NIH as the leading federal agency supporting health
research is its peer review system. The results of this system provide the primary, but not the
sole, basis upon which decisions regarding the award of federal funds are made. Funds are
awarded to academic or research institutions ON behalf of the scientist or principal
investigator whose creative project has been judged to be technically and scientifically
meritorious. As mandated by law, and to assure the proper stewardship of appropriated funds,
the review of research project applications involves two sequential levels of review, called the
dual peer review system. In this system, the technical and scientific assessment of proposed
projects is kept separate from policy decisions about the appropriate medical areas to be
supported and the level of resources to be allocated.
Initial Review Groups or Scientific and Technical Review
The first level of review, the evaluation of scientific and technical merit, is conducted
by one of the many chartered initial scientific review groups. The groups or panels of peers of
the applicants are established according to particular scientific disciplines or medical
specialties. An individual group may consist of as many as sixteen to twenty members. These
are primarily non-Federal scientists with expertise in various disciplines and areas of research,
generally drawn from academic and research institutions and organizations across the country.
Each scientific peer review group is under the direction of a full-time Federal employee
who serves as the Designated Federal Official. The primary requirement for service ON a
peer review group is competence as an independent investigator in a scientific or biomedical
discipline. Other factors such as respect among peers and quality of research accomplished
are also important. The reviewers assess each application individually before the meeting and
prepare written critiques. Those projects deemed most competitive are fully discussed and
those that are in the "upper half" in regard to technical merit are given a priority score, which
reflects the intrinsic quality and scientific merits of the project.
Special Emphasis Panels
Special Emphasis Panels (SEPs), designed to assure that research grant applications of
increasing diversity, breadth and complexity of scientific subject matter are appropriately
reviewed. The scientists who submit these applications must be confident that the system can
tap non-Federal scientific experts in areas as wide-ranging as molecular biology, structural
chemistry, behavioral and social sciences, community-based clinical trials, behavioral
interventions, the ethical, legal and social implications of the human genome effort,
bioengineering, and organ-system based physiology, to name a few. These SEPs provide the
necessary flexibility and fluidity for timely and appropriate scientific and technical review for
merit, using scientists who are designated to serve for a specific one-time review.
National Advisory Boards and Councils
In advising ON the scientific merit of applications, these initial peer review committees
convey their opinions via written summary critiques to the second level of review, performed
by National Advisory Boards or Councils of the individual Institutes. These Advisory bodies
have been mandated by law not only to provide advice to the Institute leadership but to
perform the second level in the peer review system. Two-thirds of the twelve to eighteen
Council members are, as required by legislation, chosen because of their status as
distinguished scientists in the biomedical and behavioral disciplines covered by the mission of
the particular Institute. In addition, as the law provides, one-third of the members are health
providers or lay persons who have demonstrated specific interest and activities in matters
related to health and to the specific mission of the particular Institute. This mix of Council
members provides an essential balance in the second level of review. This important second
level provides not only an affirmation (or lack of affirmation) regarding the scientific merit of
the research proposal but also addresses the relevance and importance of the proposed work in
understanding the nature and behavior of living systems and in providing new information for
the diagnosis, treatment, cure or prevention of the medical disorders that afflict our citizens.
The second level of review also considers policy issues related to scientific and health
priorities and the level of resources that should be expended ON particular programs.
This system provides the appropriate NIH decision-making officials with the best
available advice about scientific and technical merit as well as societal values and needs.
I would also like to emphasize the fact that the system by which decisions regarding the
award of research grants and training funds are made is greatly enhanced by the outstanding
work done by the full time scientifically trained professional staff of the Institutes and the NIH
unit which is responsible for the majority of the initial scientific review activities, namely the
Center for Scientific Review.
Board of Scientific Counselors to Review Intramural Research
The studies of the scientists who do research in the intramural programs of NIH also
are subject to a peer review process which differs somewhat from that described above. It is
performed by Boards of Scientific Counselors composed of non-Federal scientists who have
expertise and have made significant advances in the areas of research pertinent to each of the
institutes. The Boards assess the research in progress, proposed research, and the productivity
and performance of staff scientists. The Boards serve a dual function; they not only provide
expert scientific advice to institute Scientific Directors regarding particular projects and
employees, they also assess the overall quality of the particular institute's intramural efforts.
Program Advisory Committees
In addition, a number of the Institutes and Centers have standing Advisory Groups,
some of which are mandated to provide information and counsel in planning various programs
of research needed to allow continued or accelerated progress toward fulfilling the goals of the
Institute's mission.
Role of FACA
The initial scientific review groups, the councils or Boards, the Intramural Boards of
Scientific Counselors and the Program Advisory Groups are chartered under the requirements
of the Federal Advisory Committee Act (FACA) and the procedures followed comply with all
the requirements of this legislation. In 1997, the latest year for which data are available, NIH
had 141 chartered committees of which 21 were Advisory Councils and Boards and 28
provided program advice. The remainder were all engaged in peer review for scientific and
technical merit.
NIH is continuously monitoring its peer review system, searching for better ways to
assess scientific merit, and streamline its procedures while ensuring that we support research
of the highest quality. At the same time, we are continually increasing our ability to
communicate with members of the scientific community and the public. We have been
providing information ON the rosters of peer review groups, minutes of our national advisory
council meetings and the policies and procedures of our peer review system ON the World
Wide Web. We will continue to refine our methods for providing such information.
Conclusion
Mr. Chairman, our system of review of research has ensured that the more than 40,000
applications sent each year receive a fair, thorough, and rigorous review expected by scientists
and the public alike. We take very seriously our role as stewards of the public's money and
its trust. It is a labor-intensive system that is essential to the continuance of excellence in
basic and clinical biomedical research. The NIH has played a major role in the explosion of
new knowledge in human biology. We are proud that the scientists and clinicians whom we
have supported and trained have emerged at the forefront of research discoveries and advances
in our fundamental understanding of human biology, and of better ways to treat or prevent
disease and promote good health. Mr. Chairman, this concludes my statement. I would be
pleased to respond to any questions you may have.
