January 8, 1999

RESPONSE OF THE NATIONAL HEART, LUNG, AND BLOOD INSTITUTE TO ITS NATIONAL ADVISORY COUNCIL'S WORKING GROUP ON EPIDEMIOLOGY

Contents
GOALS
	Goal A. Explore Novel and Unique Areas in Cardiovascular Epidemiology
	Goal B. Provide More Leadership in the Development and Fostering of Prevention Science in the Area of Cardiovascular Disease
	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 Disease
	Goal D. Establish a Scientific Advisory Subcommittee of the NHLBI Council to Work with Staff on Recommending Priorities and Initiatives
PROGRAMMATIC STRATEGIES
	Program 1. Importance of Epidemiology/Prevention and Resource Value of Cohort Studies
	Program II. The Need for More Clearly Defined Opportunities in Translational Research
	Program III. Investigator-Initiated vs. Institute-Initiated Research (Support-Review-Funding)
	Program IV. Training of New Investigators
PROCEDURAL STRATEGIES
	Process 1. Scientific Advisory Subcommittee of the Council
	Process II. Structure of DECA
	Process III. Staff Role

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) cross-institutional collaborations.
  
  
• 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 intervention.
  
  
• Enhance training opportunities.

Response:

• 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 enhancing them.

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 negate prevention.
  
  
• Assure effective, meaningful translation.
  
  
• Include both individual and population-wide strategies for research.
  
  
• Address primordial prevention.
  
  
• Promote investigator-initiated clinical trials.

Response:

• 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 appropriate.
  
  
• 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 Disease

Response:

• 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

Response:

• 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 Council.
  
  
• 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 achieved.

Program I. Importance of Epidemiology/Prevention and Resource Value of Cohort Studies

• Importance of Epidemiology/Prevention.
  
  
• Areas in Which Such Research is Particularly Needed.
  
  
• Resource Value of Cohort Studies.
  
  

Response:

• 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 determinants.
  
  
• 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 studies.
  
  
• 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 Research

• Better translation of research to the community.

Response:

• 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.

Response:

• 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 staff.
  
  
• 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 studies.
  
  
• 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 resources.
  
  
• 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 investigator-initiated applications.
  
  
• 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 Institute.
  
  
• 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.

Program IV. Training of New Investigators

• The need for review of the NHLBI training portfolio.
  
  
• Use of NHLBI-initiated studies as a training opportunity.

Response:

• 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 genetics.
  
  
• 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 Jackson Laboratory.
  
  
• 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 Council.

Response:

• 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 statutory responsibilities.
  
  
• The Institute will work with the scientific community to encourage it to come forth with research proposals.

Process II. Structure of DECA

Response:

• 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.

Process III. Staff Role

Response:

• 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.