February 2002

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).

Fiscal Year 2002 Appropriations

I am pleased to announce that Congress provided the NHLBI with a fiscal year (FY) 2002 budget of approximately $2.6 billion, which is $278 million more than our FY 2001 allocation. As a result of this generous increase, we anticipate being able to fund grants at approximately the same level as in FY 2001.

Personnel Changes

Since I last wrote to you in April 2001, several senior staff members in our extramural research programs have taken new positions within the Institute. Dr. Barbara Alving, former Director of the Division of Blood Diseases and Resources (DBDR), is now the Institute's Deputy Director. Dr. Charles Peterson is serving as Acting Director, DBDR, while a permanent director is sought. Dr. Peter Savage, Acting Director of the Division of Epidemiology and Clinical Applications, has been appointed to his position on a permanent basis. Dr. Deborah Beebe, whom many of you knew as our Review Branch chief, is now Director of the Division of Extramural Affairs.

New Requirement for Clinical Studies

As of January 10, 2002, applications and proposals for clinical studies must comply with the revised federal requirements for collecting and reporting ethnic/racial data (1997 OMB Directive 15). Investigators must indicate the total number of subjects proposed for the study and provide their distribution according to race, ethnicity, and sex using the new PHS 398 (Rev.05/01) Target/Planned Enrollment Table and the revised ethnic/racial categories explained in the NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research.

The requirement applies to all new applications and proposals. Annual progress reports, competing continuation applications, and competing supplement applications for research grants and contracts also must comply unless data collection is ongoing or complete. I urge all clinical investigators to become familiar with the policy document, which explains the new categories and contains answers to "frequently asked questions." The NHLBI has a legislated obligation to support and enforce this policy; any application or proposal that does not comply will not be funded.

Refocused Specialized Centers of Research

After extensive discussions with extramural reviewers, program officers, and the National Heart, Lung, and Blood Advisory Council, the NHLBI has reconfigured its Specialized Centers of Research mechanism to strengthen its clinical orientation. Future programs supported by this mechanism—be they brand-new programs or programs that are being recompeted—must consist of three or more projects related directly to the program topic. More important, the number of clinical projects under a program must equal or exceed the number of basic science projects, both at the time of award and throughout the noncompeting grant period. To reflect the clinical emphasis, the new programs will be called Specialized Centers of Clinically Oriented Research (SCCOR).

I have described the revitalization of the program in an editorial in the January 29 issue of Circulation, a copy of which is posted on our Web site. More details are available in the Report from the Committee to Redefine the Specialized Centers of Research Programs. Guidelines will be published in the NIH Guide for Grants and Contracts as requests for applications are released for specific programs.

Skills-Development Cores

Beginning in FY 2003, new and competing renewal applications for large clinical research programs (SCCOR, clinical networks, and multicenter clinical studies) may include proposals for skills-development cores. Applicants may request up to $100,000 per year in direct costs to support activities to develop capabilities of new investigators through a broad interdisciplinary team approach. The cores will not function as training grants that provide salary support for additional trainees; they should be designed to enhance the research experience of researchers who already are slated to work on the parent program.

Skills-development cores are not requirements of the applicable grant programs, and their absence will not disadvantage applicants. However, we believe that they represent ideal opportunities to develop clinical research expertise in the context of vibrant environments. A commentary on this new option may be found and application guidelines are available through our Web site.

Loan Repayment Programs

The NIH is accepting applications for several educational loan repayment programs available to scientists engaging in various types of research activities. The programs provide for repayment of up to $35,000 of the educational loans of awardees per year. Because eligibility requirements and definitions of eligible research vary by program, I encourage you to visit the NIH loan repayment programs' Web site for additional details.

Expanded Minority Supplements Programs

For over a decade, the NHLBI has participated in the NIH Research Supplements for Underrepresented Minorities Program, which allows the Institute to add money to certain ongoing research grants so that the principal investigator can provide a research experience for underrepresented minority individuals at the high school, undergraduate, graduate, postdoctoral, or investigator level. The program has been expanded to include post-baccalaureate and post-master's degree students who have graduated recently and wish to pursue graduate-level training. Moreover, principal investigators on NHLBI contracts now can apply for research supplements for underrepresented minorities to support researchers at all education levels.

The Institute encourages all investigators with eligible grants and contracts to participate in the program. More information is available through our Web site and in the NIH-wide program announcement in the NIH Guide for Grants and Contracts.

Limits on Direct Cost Requests

The Institute has increased the limit on the direct costs that may be requested for program projects for fiscal years 2003 and beyond. Applications for new (type 1) grants submitted for the February 1, 2002, application receipt date and thereafter may request up to $1,420,000 for FY 2003, up to $1,450,000 for FY 2004, and up to $1,480,000 for FY 2005. Annual increases in noncompeting years are limited to 3 percent per year. Applicants for competing renewal (type 2) grants are limited to the dollar amounts given above, or a 10 percent increase over the last noncompeting year, whichever is greater.

Let me take this opportunity to remind you of the longstanding NHLBI policy regarding allowable direct costs in competing renewal applications for research project grants: Such awards are limited to the Council-recommended level or 10 percent more than the amount awarded for the last year of the preceding project period, whichever is less. Applicants who contemplate expanding the overall scope of a research project would be well advised to consider developing and submitting the expanded project as a separate application.

Career Development Awards

The Institute is committed to increasing the number of scientists conducting high-quality clinical research and welcomes applications for Mentored Patient-Oriented Research Career Development Awards (K23) and Midcareer Investigator Awards in Patient-Oriented Research (K24). We have created online "hints" to help potential K23 and K24 candidates prepare their applications. Prospective applicants are also encouraged to review the funding and operating guidelines for these mechanisms.

Human Embryonic Stem (ES) Cell Research

The NHLBI has created an on-line list of resources that may be useful when proposing research using human ES cells. The Web page includes links to the NIH human ES cell registry recent NIH Guide notices regarding policies on human ES cell research, and "frequently asked questions." NHLBI contact information is also provided for anyone needing additional information.

Public Input

In response to recommendations from the Institute of Medicine (IOM) report Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the National Institutes of Health the NHLBI has been holding annual meetings with representatives of various public interest organizations as a way to increase public participation in planning and decision-making. Many of these groups are interested not only in raising awareness about their specific subject areas, but also in funding research and in involving their constituents in clinical protocols. A list of the groups and links to their Web sites are available.

Act in Time to Heart Attack Signs

Last fall, the NHLBI and the American Heart Association launched an education campaign urging physicians to educate their patients about heart attack warning signs and the importance of calling 9-1-1 as soon as symptoms begin. Act in Time to Heart Attack Signs provides educational materials for health care providers, heart attack patients, and the public, including a booklet, an educational video, and a patient action plan "prescription pad." All are available through the campaign's Web site. To help raise public awareness, the American Red Cross and the National Council on the Aging will be offering Act in Time classes through their national networks.

Act in Time is based on the results of our REACT (Rapid Early Action for Coronary Treatment) study, the first large-scale study to evaluate the effects of education on the time it takes people to recognize the warning signs of a heart attack and seek appropriate help. REACT showed that relatively few patients call emergency medical services when experiencing chest pain and that few people are aware of the benefits of early treatment, in part because they have little communication with their physicians about heart attack symptoms and survival.

Act in Time is just one of our efforts to help achieve the objectives of Healthy People 2010, the federal government's blueprint for building a healthier nation. Its objectives include raising awareness of heart attack symptoms, increasing the number of patients treated in the first hour after symptoms begin, and improving access to emergency care.

Task Force Report on Research in Prevention of Cardiovascular Disease

In January 2001, we convened a Task Force on Research in Prevention of Cardiovascular Disease to develop a research agenda and provide guidance for allocating NHLBI resources for Institute- and investigator-initiated research on the prevention of CVD. Its report identifies specific research priorities in the context of the research the NHLBI currently supports and the gaps that exist in its portfolio. We hope the community will pay close attention to the recommendations.

I invite you to visit the NHLBI Web site for additional information on these and other subjects. As always, I would be pleased to hear your reaction to this information and your comments on other topics of interest or concern. I can be reached via e-mail at NHLBI.listens@nih.gov.

Sincerely yours,

Claude Lenfant, M.D.
Director