January 8, 1999
RESPONSE OF THE NATIONAL HEART, LUNG,
AND BLOOD INSTITUTE TO ITS NATIONAL ADVISORY COUNCIL'S WORKING GROUP ON
In its October 22, 1998, report to the National Heart,
Lung, and Blood Advisory Council, the Working Group on Epidemiology identified
four general goals and seven programmatic and procedural strategies for
enhancing the Institute's epidemiology program. The following represents the
response of the Institute.
Goal A. Explore Novel and Unique
Areas in Cardiovascular Epidemiology
- Use data from longitudinal cohort studies as a
resource for (1) new investigator-initiated proposals through R01 or other
mechanisms, (2) inter-Institute NlH-wide initiatives, and (3)
- Identify genetic risk factors that influence the
response to traditional and nontraditional cardiopulmonary risk factors and to
implementation of these risk factors.
- Identify subclinical disease for early
- Enhance training opportunities.
- The Institute enthusiastically supports this goal
and it will send a strong message to the scientific community encouraging
studies that are responsive to it.
- The Institute will continue to sponsor Task Forces
or other study groups that will make recommendations for further studies. The
Institute will analyze carefully these recommendations and issue Program
Announcements to stimulate submission of applications.
- The Institute will continue to support resources
that can be made available to the scientific community on a competitive basis.
(The Mammalian Genotyping Service, which provides genome-wide scanning to
population studies, is one such example.)
- The Director, Division of Epidemiology and Clinical
Applications (DECA), will work with the epidemiology research community to
emphasize the training opportunities in this field and to develop a plan for
Goal B. Provide More
Leadership in the Development and Fostering of Prevention Science in the Area
of Cardiovascular Disease
- Identify behavioral and social factors that
- Assure effective, meaningful translation.
- Include both individual and population-wide
strategies for research.
- Address primordial prevention.
- Promote investigator-initiated clinical trials.
- The Institute wholly supports this goal and will
intensify its work with other organizations (American Heart Association,
American College of Cardiology, and National Committee for Quality Assurance)
to foster activities in this area and to ensure meaningful translation.
- The Director, Office of Prevention. Education, and
Control (OPEC), will examine carefully all OPEC programs to ensure the
inclusion of individual as well as population-based approaches wherever
- The extent to which recommendations of various Task
Forces and other working groups have been implemented will be assessed and, as
appropriate, research on preventive strategies will be stimulated with Program
Announcements. The Director, DECA, will take the lead in this assessment in
conjunction with the other Division directors.
Goal C. Foster Maximum
Application of Epidemiologic and Biostatistical Methods as Enabling Strategies
to the Spectrum of Basic and Translational Research in Heart. Lung. and Blood
- The Institute shares the Working Group's
appreciation of epidemiology as a key enabling science that has the capability
of building bridges between other research approaches. The Institute will
increase its efforts to fully exploit the potential of epidemiology in the
prevention and control of cardiovascular, lung, and blood diseases.
- The epidemiology group will provide technical
support for the design and conduct of research in its area.
- The Institute will ensure that it has the
capability to meet emerging needs in epidemiologic and statistical methods. To
this end, the Institute is recruiting staff with expertise in genetic
biostatistics and will be considering further staff recruitments in this area.
Goal D. Establish a
Scientific Advisory Subcommittee of the NHLBI Council to Work with Staff on
Recommending Priorities and Initiatives
- The Institute supports the concept of a scientific
advisory structure and regrets that it was forced to disband the structure that
had been in place for many years.
- The Institute is developing a new Council
"subcommittee"-type entity that will be structured to provide scientific and
programmatic advice on all of the extramural programs of the Institute. It will
be called the Board of Extramural Advisors and will make its recommendations to
- The Institute will work to strengthen the role of
the National Advisory Council in establishing priorities. We intend to convene
a working group of Council and staff members to examine how this can best be
Program I. Importance of
Epidemiology/Prevention and Resource Value of Cohort Studies
- Importance of
- Areas in Which Such Research is Particularly
- Resource Value of Cohort Studies.
- The Institute agrees that longitudinal
population-based cohort studies remain an essential component of its overall
research program. They constitute a unique resource that has important
potential for uncovering new disease risk factors, as well as health
- The Institute is keenly interested in fostering
such studies and in continuing them as long as they satisfy programmatic needs
and proposals for continuation meet scientific requirements.
- The Institute, in consultation with the Council,
will develop processes to conduct independent programmatic reviews of ongoing
studies and will ensure rigorous scientific merit review before deciding on
extending funding beyond the initial commitment.
- The Institute will encourage investigators to
"branch out" from the original goals of a population-based study and to seek
support by way of an investigator-initiated grant proposal.
- Using all mechanisms available (e.g., Internet,
publications, conferences) and following the NlH-wide guidelines and
regulations, the Institute will work with the investigators it supports to
ensure wide availability of the data derived from longitudinal cohort
- The Institute will work with the Council to ensure
that all the programs and disciplines receive fair consideration for funding.
Program II. The
Need for More Clearly Defined Opportunities in Translational
- Better translation of research to the
- The Institute is fully committed to fostering
translation of research data to clinical and community settings. To this end,
the Institute will establish a formal process to ensure full knowledge of
research outcomes by OPEC and community health leaders.
- OPEC will be required to work more effectively to
align its programs with the research activities and outcomes of the Institute.
To this end, the interactions within OPEC and DECA and among OPEC, DECA, and
other Institute Divisions will be strengthened.
- While encouraging investigator-initiated clinical
trials, the Institute will strengthen its advisory process (through the
aforementioned establishment of a Board of Extramural Advisors) to determine
the appropriateness and timeliness of Institute-initiated studies.
- The Institute will continue to foster its
collaboration with other government agencies. This goal is already being
pursued by the forthcoming conduct of several major conferences. To the extent
possible, the Institute will continue to work with voluntary organizations on
issues of mutual interest.
Program III. Investigator-lnitiated vs.
Institute-Initiated Research (Support-Review- Funding)
- Mechanisms of review and support.
- The Institute fully agrees with the concept that
"the future of (any) field and the vision for research comes from the
scientific community." In line with this is full acceptance of the principle
that "RFAs and RFPs should be initiated in priority areas when
investigator-initiated mechanisms fail to stimulate scientific initiatives." We
anticipate that the new Board of Extramural Advisors will closely examine the
need for new RFAs and RFPs, with the burden of justification resting with NHLBI
- The Institute unambiguously supports the view that
staff cannot initiate studies without the community's involvement. The
Institute will require that appropriate documentation be developed to
demonstrate the community's review of any proposed new study. The Council has
the statutory responsibility to "clear" or not "clear" the concept of such
- The Institute, however, must continue to use
cooperative agreements, which have been proven to be most effective in ensuring
the completion of studies in a timely manner and within the allocated
- The Institute recognizes the sensitivity about the
NlH-wide policy that investigators seek its approval to submit applications
exceeding $500,000 in any one year of the project. This policy has, however,
greatly enhanced our ability to manage our extramural funds. The Institute
looks forward to exploring with the Council approaches that can be used to
achieve the goals of the policy while minimizing its deterrent effect on
- The Institute will continue to support the current
NIH policy of granting support for no more than five years unless there is a
truly exceptional case. It would not be prudent to grant a policy exemption to
all population-based studies, because they are so numerous that waiving the
rule would distort the profile of grant duration throughout the entire
- Whenever possible, the Institute will continue its
practice of providing some modest "close out" support of the end of
population-based studies. The investigators will be encouraged to request such
support in their applications so that decisions about providing such funds can
be guided by peer review.
Training of New Investigators
- The need for review of the NHLBI training
- Use of NHLBI-initiated studies as a training
- The Institute shares the views of the Working Group
that further and expanded training opportunities must be developed, especially
in view of the importance of new relevant disciplines such as molecular
- The Institute is committed to the support of the
new K23 and K24 mechanisms, which can be used for the development of
observational and interventional population-based scientists. In addition, the
Institute will continue to support tailored-made programs, such as the course
on Genetic Approaches to Complex Diseases that is given once a year at the
- Investigators pursuing population-based studies are
strongly encouraged to involve the participation of individuals who are in the
developmental phase of their careers, and we will intensify our efforts to
ensure that this message reaches them.
- The Institute is creating a new internal structure
to oversee its training programs and their responsiveness to current needs.
Process I. Scientific Advisory
Subcommittee of the Council
- Background: Concerns regarding review and long
range planning process.
- Rationale for creation of this Subcommittee of
- The Institute is currently in the process of
developing the abovementioned Board of External Advisors and hopes to implement
it in the current fiscal year. This Board will provide much of the
accountability and sustained outside input into Institute programs that has
been diminished in the last several years. The goal of the process is to serve
the entire Institute, and not just one program.
- The Institute has the responsibility to ensure that
such a process involves appropriate expertise, but also appropriate
independence so that all the areas and disciplines within the purview of the
Institute receive equal consideration.
- The Institute will strive to work more effectively
to ensure that the Council exercises more fully its oversight and advisory
- The Institute will work with the scientific
community to encourage it to come forth with research proposals.
Structure of DECA
- The Institute recognizes that the excellent
capability and competence of DECA staff may not be as fully utilized for all of
its programs as it should. However, there is actually much more interaction
going on than the Working Group appears to perceive.
- The Institute is presently overseeing the issue
very carefully, and more continuous interactions between staff are now
explicitly required. For example, the Institute has created an award program
that aims at recognizing inter-Division performance. Similarly, Institute-wide
retreats are designed to foster cooperation.
- The Institute is well aware of the possible
conflicts that may result from the dual role of its staff (i.e., as manager of
science vs. as collaborating scientist).
- Regarding the participation of the staff in
decision-making about programs supported by cooperative agreements and
contracts (and even by grants in some instances), provisions exist to exclude
responsible project officers from this process. The Institute will ensure that
this requirement is adhered to by the Divisions.
- Regarding participation in publications, the
Institute has reviewed and updated its policy to make it more rigorous and
ensure oversight by responsible officials. This policy will be shared with
investigators as needed.