May 1999

Dear Colleague:

I am writing to provide information about policies and activities that may be of interest to you as a recipient of support from the National Heart, Lung, and Blood Institute (NHLBI).  Further details on these and other topics are available on our home page.  I invite you to browse through it and offer us feedback on its usefulness to the community that we serve.

Congressional Hearings

National Institutes of Health (NIH) Appropriations

The Senate and House appropriations hearings took place in late winter, amid a general atmosphere of enthusiasm about NHLBI accomplishments and support for its programs.  Members of the House subcommittee took careful note of recent data from the Framingham Heart Study that indicate a remarkably high lifetime risk of developing heart disease for men and women in the United States.  I believe the message that many research challenges and opportunities will face us in the years ahead was well understood and appreciated.

Chelation Therapy

On the heels of the appropriations hearings came a hearing of the House Committee on Government Reform titled "Cardiovascular Disease:  Is the Government Doing More Harm Than Good?  EDTA Chelation Therapy."  Among other issues raised at the hearing was the lack of federally supported research on the effectiveness of chelation therapy in treating cardiovascular diseases.  The answer to that is simple:  during the past several decades, we have not received a single grant application on this topic that was judged meritorious by peer review.  I assured the committee of our willingness to accept applications in this area and to assist investigators in every way possible.

Setting Our Research Agenda

The SPARK Working Group

As I mentioned in my letter of August 1998, one year ago the NHLBI convened a working group of the National Heart, Lung, and Blood Advisory Council (NHLBAC) consisting of selected NHLBAC members and other accomplished scientists.  Through much of 1998, this SPARK working group (so named because it is expected to kindle a new generation of research ideas for the Institute) assisted the Institute in identifying extraordinary research opportunities that warrant funding in the event of a significant increase in financial resources.  During its initial meeting in May and a subsequent meeting in June, the group developed a research schema and identified several possible themes for research opportunities.  It then solicited the expertise of three major professional societies—the American Heart Association, the American Thoracic Society, and the American Society of Hematology—at a conference titled From Genes to Health and Health to Genes.  The objective was to focus on broad research themes and identify approaches necessary to engender new research in specific areas.  Four areas of opportunity were identified:  tissue genesis and organogenesis, immunobiology, gene–environment and gene–gene interactions, and functional genomics.  Recommendations in these areas are being developed for implementation as budget resources permit. For more information, see the SPARK Conference Summary.

Board of External Advisors

The Institute has long recognized the importance of having a scientific advisory structure and regretted that it was forced, several years ago, to disband the structure that had been in place for many years.  We have developed a new NHLBAC "subcommittee"-type entity to provide scientific and programmatic advice on all of the extramural programs of the Institute.  This Board of Extramural Advisors will make its recommendations to the NHLBAC.  In addition to providing detailed advice on Institute priorities, the Board is expected to address specifically the appropriateness and timeliness of NHLBI-initiated studies.

Public Liaison

In accordance with the Institute of Medicine (IOM) report, Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the National Institutes of Health, the NIH has established an NIH Director's Council of Public Representatives (COPR) to provide public input into the NIH planning and decision-making process.  Selection of members has been completed and the COPR met for the first time on April 21 to hear presentations by several NIH components, including the NHLBI, regarding current and planned public liaison activities.  The NHLBI strongly supports the move to increase participation of the public, including patients and patient advocacy groups, in NIH activities and is currently considering how best to increase such participation in its own planning and decision-making processes.  The entire IOM report can be found on the Internet.  The NIH also now has a public liaison home page.

Strategic Plan

The IOM report also included a recommendation that each NIH component develop a strategic plan.  The Director, NIH, has made that recommendation a requirement, with a draft plan for a 2-5 year planning horizon due to him by December 31, 1999.  The Institute has already initiated several activities, including the SPARK meetings mentioned above, that relate directly to the process of developing a strategic plan.  We intend to present a proposed plan to the NHLBAC at its September 1999 meeting, and then make it available for comment by the scientific community and the general public before submitting the final version.

Training

In recognition of the dynamic nature of trends in modern biomedical research, the NHLBI is engaged in a comprehensive evaluation and restructuring of its training, fellowship, and career development programs to ensure the availability of investigators who are fully equipped to address the challenges and opportunities of the post-genomic era.  It is clear that the scientific directions of these programs must now come to embrace the increasingly transdisciplinary nature of biomedical research.  Already, the standards and concepts of biology are being modified by new insights from mathematics, physics, and engineering, in order to cope with the burgeoning mass of information that has its origins in molecular genetics and the Human Genome Project.  Our approach is first, to evaluate carefully the scientific content of existing programs and to examine the scientific attitudes and standards adopted by reviewers of training grant applications.  We will then work closely with the scientific community to assess the likely general directions to be taken in research in the post-genomic era and identify the fundamental knowledge, skills, and aptitudes that investigators may be expected to require to be fully effective in their research.  A comparison of these reviews will indicate the long-term changes in scientific directions that may be necessary.

Short-term innovations are also in order.  Over the years we have witnessed a proliferation of training mechanisms that make it difficult for potential investigators to find the most appropriate way into the system.  We are making a detailed evaluation of these mechanisms with a view to immediate simplification.  In addition, we are considering entirely new ways to support trainees most effectively and to provide encouragement to minority candidates.

None of these changes will be worthwhile without the engagement and commitment of the scientific community that we serve.  All of the issues I have outlined here will be the subject of detailed discussion at a meeting we will convene this fall, at which research scientists, training directors, and trainees will be invited to present their own perspectives on the problems we are determined to solve.

Research Supplements for Underrepresented Minorities

For nearly a decade the NHLBI has participated in the NIH Research Supplements for Underrepresented Minorities Program.  It allows the Institute to add money to certain new and ongoing research grants so that the principal investigator can recruit a minority individual at the high school, undergraduate, graduate, postdoctoral, or investigator level to become involved in the research.  Assessments of the program show that it is an effective mechanism for minority career growth as well as a means of providing investigator support.

The Institute is pleased with the results of the program and encourages all investigators with eligible grants to consider participating in it.  Effectively immediately, an information bulletin will be enclosed in the pay letter of each grant eligible for the supplements program to inform the principal investigator about the program and about where to go for additional information.  If you have not participated in the program, I encourage you to identify and recruit minority candidates for your eligible research efforts.

Further information on this program is available on the following NHLBI Web pages. Please select the appropriate academic level.
High School
Undergraduate School
Graduate School
Postdoctorate
New Investigator

Epidemiology Programs

In January 1998 I requested that members of the NHLBAC form a working group with national experts in epidemiology to examine the funding balance between studies using long-term, observational methods and studies using newer technologies and approaches to epidemiology.  It was believed that the group could contribute valuable insights and analyses that would help the Institute achieve an appropriate balance in its epidemiology portfolio.  The working group report was delivered at the NHLBAC meeting on October 22, 1998.  It identified the following four major goals, and recommended strategies to achieve them:

• Explore novel and unique areas in cardiovascular epidemiology;

•  Provide more leadership in the development and fostering of prevention science in the area of cardiovascular disease;

• 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;

• Establish a scientific advisory subcommittee of the NHLBAC to work with staff on recommending priorities and initiatives.

Program Projects and Specialized Centers of Research (SCORs)

The Institute has increased the limit on the direct costs that may be requested for fiscal years 2001 and beyond (i.e., for the February 1, 2000, application receipt date and thereafter).  New program project grant applications may request up to $1,280,000 for fiscal year 2001 and $1,350,000 for fiscal year 2002.  As in the past, competing renewal applications may request 10 percent more than the last noncompetitive award or an amount equal to the cap on new applications, whichever is greater.  The same dollar limits apply to SCOR applications.

Acceptance Policy for Grants Requesting Direct Costs of $500,000 or more

This policy—which involves applications submitted to any NIH component, not just the NHLBI—was discussed in my letter of August 1998.  While recognizing that sensitivity about this policy exists within the scientific community, we also must emphasize that it has greatly enhanced our ability to manage our extramural funds.  We are currently exploring approaches that can be used to reap the benefits of the policy while minimizing its perceived deterrent effect on investigator-initiated applications.  We will post the outcome of this effort on our web page as soon as it is available.

Feedback

As always, I would be pleased to hear your reaction to this information and your comments on other topics of interest or concern.  Please feel free to contact me directly by conventional means, or to use the e-mail address NHLBI.listens@nih.gov to share your thoughts.

Sincerely yours,

Claude Lenfant, M.D.
Director