Dr. Elizabeth G. Nabel, Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members to the 217th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC). Newly appointed as the tenth Director of NHLBI, she expressed her enthusiasm for working with the Council and thanked Dr. Barbara Alving for her outstanding contribution as Acting Director of the Institute during the previous 18 months. Dr. Alving will be returning to her position as Deputy Director, NHLBI. Dr. Nabel also thanked Dr. Lawrence Friedman, who has recently been Acting Deputy Director, NHLBI, as well as Assistant Director for Ethics and Clinical Research, NHLBI. Dr. Friedman will be retiring at the end of February after 32 years of notable service to the Institute. Dr. Friedman served as a medical officer, Chief of the Clinical Trials Branch and Associate Director of the Clinical Applications and Prevention Program as well as the Director in the Division of Epidemiology and Clinical Applications Division. Dr. Friedman has received many awards including the Public Health Service’s Distinguished Service Medal in 1993.
- Ms. J. Hoxi Jones is the Director of Public Information and Volunteer Services at the Texas Department of Human Services and is an experienced administrator in health training programs.
- Dr. Jeffrey McCullough is Professor of Laboratory Medicine and Pathology and the Director of the Biomedical Engineering Institute at the University of Minnesota.
- Dr. Patricia Wahl is Dean and Professor of Biostatistics at the School of Public Health and Community Medicine at the University of Washington .
Retiring Member:
Dr. Nabel thanked Dr. Arn H. Eliasson, Chief of Pulmonary and Critical Care at the Walter Reed Army Medical Center , for his six years of service as an ex officio member representing the Department of Defense. Dr. Nabel presented him with an NHLBI crystal, a framed certificate, and a letter signed by Tommy Thompson, Secretary of Health and Human Services.
Guest Speakers:
Three guest speakers were welcomed who would later describe NIH Roadmap activities related to clinical research networks:
- Dr. Robert Harrington, Professor of Medicine in the Division of Cardiology, Department of Internal Medicine at Duke University and a member of the Duke Clinical Research Institute
- Dr. Kevin Peterson, Assistant Professor in the Department of Family Practice and Community Health, University of Minnesota
- Dr. Robert Star, Chief of the Renal Diagnostics and Therapeutics Section, Metabolic Disease Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Initiatives:
Dr. Nabel announced two Requests for Applications (RFAs) which will be released: a renewal of the NHLBI Pediatric Heart Disease Clinical Research Networks Initiative; and a trans-NIH initiative (for which NHLBI will be the lead Institute) on Small Interference RNA ( SIRNA), which are short fragments of RNA that interfere with RNA translation, leading to silencing of gene expression.
Publications:
In addition to the Council Briefing Book, the following publications were provided:
- FY 2004 Fact Book
- FYI Newsletter
- The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure
- Healthy Eight Initiative Community Action Guide
- The Heart Truth for Women: an Action Plan
- The Heart Truth for Women: When Delicious Meets Nutritious
Update on Heart Truth Campaign:
Dr. Nabel updated the Council on the latest activities of the Heart Truth Campaign, a national awareness campaign for women about heart disease, which has adopted the "red dress" as its symbol.
Policy Update:
Lastly, Dr. Nabel reviewed the new NIH policy on enhancing public access to archived publications that result from NIH-funded research. NIH-funded investigators are being asked to submit an electronic copy of their manuscripts after acceptance by a journal to the National Library of Medicine’s PubMed Central. This is a unique archive that helps ensure that the public has access to the research that their tax dollars support and it will provide a rich resource that the NIH can use to manage its research priorities. This policy will be disseminated to all NIH grantees, contractors, and intramural scientists.
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II. REVIEW OF CONFIDENTIALITY & CONFLICT OF INTEREST - Dr. Elizabeth G. Nabel
The Council was reminded that according to Public Law 92-463, the Federal Advisory Committee Act, the meeting of the NHLBAC would be open to the public except during consideration of grant applications. A notice of this meeting was published in the Federal Register indicating that it would start at 8:30 a.m. and remain open until approximately 12:00 p.m. Dr. Nabel also reminded the Council members that they are Special Government Employees and are subject to Departmental conduct regulations.
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III. REPORT OF THE DIRECTOR - Dr. Elizabeth G. Nabel
Dr. Nabel introduced Ms. Sandra Gault, Chief, Financial Management Branch, NHLBI, who gave an overview of the President's FY 2006 budget request for the NHLBI, which totals $2,951.3 million, a 0.3 percent increase over FY 2005. The budget remains about the same as in FY 2005 for all support mechanisms; any apparent changes are due to NIH Roadmap funds, which have been spread among mechanisms. Under the President's budget, funding for competing research project grants would decrease 3.8 percent from FY 2005, while funding for noncompeting research project grants would increase 1.5 percent. The current NHLBI payline is at the eighteenth percentile (20.9 percentile for new investigators).
Dr. Nabel acknowledged that the Institute is in a relatively good position, despite tight budgetary times, due to its adept planning in the recent past.
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IV. NHLBI REPORT ON INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH - Dr. Carl Roth
Dr. Carl Roth, Associate Director for Scientific Program Operation, presented the Institute's biennial report on inclusion of women and minorities as subjects in its clinical studies. He reviewed the relevant legislation and described the Institute's procedures for implementing NIH policy. Target and enrollment data for NHLBI clinical studies active in FY 2003 were presented. Dr. Roth explained that changes in reporting procedures preclude comparison of these data with previous results. In FY 2003 enrollment in NHLBI clinical studies totaled 240,574 (excluding the Women's Health Initiative), of which 65.0 percent were women and 34.7 percent were men (0.3 percent sex unknown). For each minority racial category, the Institute's target is "at or above" the percentage of the U.S. population represented by that race according to the 2000 U.S. Census.
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V. NHLBI PUBLIC INTEREST ORGANIZATION (PIO) MEETING - Dr. Carl Roth
The 6th annual NHLBI-sponsored PIO meeting was held in Bethesda , Maryland , on February 9, 2005 . PIO representatives were invited to attend the open session of the Council meeting.
Several Council members had also attended the PIO meeting and shared their impressions with the entire Council. They observed that the meeting provided a good opportunity for networking, the scientific sessions were of high quality, the roundtable discussions were creative, and the presentation about the Women's Health Initiative illustrated how clinical trials should be conducted.
In addition, PIO representatives attending the Council meeting enthusiastically expressed their appreciation to the NHLBI for holding what they characterized as a very worthwhile meeting. They emphasized the responsiveness of NHLBI staff to the needs and requests of the PIOs and noted the diversity of organizations attending.
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VI. GENERAL RECOMMENDATIONS OF THE COUNCIL - Dr. Deborah Beebe
Dr. Deborah Beebe, Director, Division of Extramural Affairs, summarized the General Recommendations of the Council (reviewed and approved annually), wherein the Council gives NHLBI staff authority to take certain actions (for example, to provide additional support up to a specified limit to cover unanticipated costs of a program). Upon review, Council approved the recommendations for another year.
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VII. NIH ROADMAP UPDATE - Dr. Lawrence Friedman
Dr. Lawrence Friedman, Assistant Director for Ethics and Clinical Research, NHLBI, presented an overview of the NIH Roadmap. The Roadmap identifies major opportunities and gaps in biomedical research that no single NIH Institute or Center can address alone and encourages cross-Institute activities.
Opportunities have been identified in three main areas:
- new pathways to discovery
- research teams of the future
- re-engineering the clinical research enterprise
The NHLBI is taking a lead role in several areas. For example, in an effort to promote new pathways to discovery, the Institute’s Division of Intramural Research is managing a project to construct an Imaging Probe Development Center to produce probes that are not readily available from a commercial supplier. Subsequent speakers described NHLBI-led activities in support of re-engineering the clinical research enterprise.
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Re-engineering the Clinical Research Enterprise : Clinical Research Networks
Dr. James Kiley, Director, Division of Lung Diseases, reported on two Roadmap initiatives related to clinical research networks (CRNs) for which the NHLBI is the lead Institute:
- Inventory and Evaluation of Clinical Research Networks – an 18-month contract to develop an inventory of CRNs, describe existing practices, and select potential “best practices”
- Feasibility of Integrating and Expanding Clinical Research Networks – 12 3-year feasibility contracts to address issues of informatics, interoperability, and opportunities for expansion of existing CRNs. Later in the meeting, two principal investigators from this program described their research plans.
The Roadmap envisions these initiatives will lead to the development of a National Electronics Clinical Trials and Research (NECTAR) Network, an informatics infrastructure that will serve as the backbone for interconnected and interoperable research networks.
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Re-engineering the Clinical Research Enterprise : Feasibility of Integrating and Expanding Clinical Research Networks
Dr. Robert Harrington, Professor of Medicine in the Division of Cardiology, Department of Internal Medicine at Duke University , and a member of the Duke Clinical Research Institute as well as the principal investigator for one of the feasibility studies supported by this initiative, summarized Duke's experiences with CRNs. He also described the aims of the Duke feasibility study supported by the initiative entitled "Creating, Implementing, and Sharing Best Practices for Clinical Trials Networks," which include: building clinical research site capability for improving recruitment, retention, and performance; creating data standards; engaging sites in identifying and developing research ideas (within their cardiovascular network); and building an information technology infrastructure.
Dr. Harrington briefly described another Duke feasibility study supported by the initiative. The study, led by Dr. Carol Dukes-Hamilton and entitled "Enhancing the U.S. Public Health System's Willingness and Capacity to Engage in Clinical Research," is investigating issues related to institutional review boards (IRBs) that are important to all multicenter clinical trials groups.
Dr. Kevin Peterson, Assistant Professor in the Department of Family Practice and Community Health, University of Minnesota , and principal investigator for another Roadmap study supported by the initiative, entitled "The Electronic Primary Care Research Network (ePCRN)," discussed the objectives of the study and the approach being taken. The main goal of the ePCRN is to build an electronic infrastructure that facilitates the performance of randomized controlled trials in primary care practices throughout the U.S. ; facilitates recruitment of subjects; and promotes rapid integration of new research findings into primary care.
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Re-engineering the Clinical Research Enterprise : Clinical Research Workforce Training
Dr. Robert Star, Chief of the Renal Diagnostics and Therapeutics Section, Metabolic Disease Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and Co-Chair of the Roadmap Trans-NIH Clinical Research Workforce Committee, described the challenges of training and retaining researchers who will comprise the multidisciplinary clinical research teams needed. He reported that the NIH recently doubled its Clinical Center research training program and described two new Roadmap clinical research career development programs:
- Predoctoral Clinical Research Training Programs (T32)
- Multidisciplinary Clinical Research Career Development Programs (K12)
The Roadmap envisions a standing corps of 50,000 to 75,000 community medical practitioners (to be known as the National Clinical Research Associates—NCRA) trained to conduct clinical research and willing to enroll and follow their patients in clinical studies. A conceptual model has been developed and is now being evaluated. Dr. Star also reported that the NIH peer review criteria have been updated to accommodate current emphasis on interdisciplinary, translational, and clinical investigations.
Council members were very enthusiastic towards the clinical research networks and noted the significant gains in population-based clinical research that have been enabled. One of the main issues is that Internal Review Boards have significant variability across institutions and are neither centralized nor standardized. Training IRB members may serve to help reduce the amount of variability. Having a web-based training tool was suggested. Dr. Star indicated that NIH would have a forum intended to familiarize IRBs with all current regulations. Another impediment is the significant amount of red tape and paperwork involved in clinical research. Dr. Amy Patterson of NIH is currently working to harmonize the various forms and procedures across Federal agencies such as the FDA, AHRP and NIH. Another issue is how to recognize individual researchers in networks who are not PIs in order to help them with academic promotions. The NIH is currently looking for ways to recognize team research to assist investigators who are building their careers. Although decrease in acute clinical care research is alarming, the overarching structure of the networks allows rapid, nationwide dissemination of new treatment standards that could not have been achieved previously.
CLOSED PORTION
This portion of the meeting was closed to the public in accordance with the determination that it concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2).
The session included a discussion of procedures and policies regarding voting and confidentiality of application materials, committee discussions and recommendations. Members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.
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VIII. REVIEW OF APPLICATIONS
The Council considered applications requesting $1,664,971,630 in total direct costs. The Council recommended applications with total direct costs of $1,623,616,245. A summary of applications by activity code may be found in Attachment B.
ADJOURNMENT
The meeting was adjourned at 3:00 p.m. on February 10, 2005 .
CERTIFICATION
I hereby certify that the foregoing minutes are accurate and complete.
___________________________________ ____________
Elizabeth G. Nabel, M.D. Date
Chairperson
National Heart, Lung, and Blood Advisory Council
___________________________________ ____________
Deborah Beebe, Ph.D. Date
Executive Secretary
National Heart, Lung, and Blood Advisory Council
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