- I. CALL TO ORDER AND OPENING REMARKS – Dr. Susan B. Shurin
- II. REVIEW OF CONFIDENTIALITY AND CONFLICT OF INTEREST – Dr. Susan B. Shurin
- III. THE MATERNAL AND PLACENTAL ORIGINS OF CHRONIC DISEASE – Dr. David Barker
- IV. NIH UPDATE – Dr. Lawrence A. Tabak
- V. REPORT OF THE ACTING DIRECTOR – Dr. Susan B. Shurin
- VI. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL STUDIES – Dr. Carl Roth
- VII. DELEGATED AUTHORITIES FROM THE NHLBAC – Dr. Stephen C. Mockrin
- VIII. REVIEW OF APPLICATIONS
Dr. Susan B. Shurin, Acting Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members to the 241st meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).
The Council was reminded that under Public Law 92-463, the Federal Advisory Committee Act, a portion of the meeting would be closed to the public, for the consideration of grant applications. Dr. Shurin also reminded the Council members that they are Special Government Employees and are subject to Departmental conduct regulations.
Dr. David Barker, Professor of Clinical Epidemiology, University of Southampton, and Professor of Cardiovascular Medicine, Oregon Health and Science University, discussed his research on the origins of chronic disease, focusing on heart disease. Dr. Barker postulates that coronary heart disease, stroke, type 2 diabetes, hypertension, and osteoporosis originate through responses to malnutrition during fetal life and infancy, and that the responses permanently change body structure, physiology, and metabolism. Dr. Barker also discussed his research on the long-term effects of childhood compensatory growth (which he defines as growth at above-normal rates after a period of retarded growth) and fetal nutrition and placental growth.
Dr. Lawrence A. Tabak, Principal Deputy Director, NIH, updated the Council on several activities of the NIH Scientific Management Review Board (SMRB), established by the NIH Reform Act of 2006 to advise the NIH Director regarding the use of certain organizational authorities.
Proposed New Center: National Center for Advancing Translational Sciences
In response to a request from Dr. Francis Collins, Director, NIH, for advice on how the NIH could improve its support of translational and therapeutic sciences, the SMRB recommended that a new translational medicine and therapeutics Center be established, and that the NIH evaluate the impact of the new Center on other relevant extant programs at the NIH, including the National Center for Research Resources (NCRR). Working groups were established to consider how to organize the new Center, which activities should be transferred to it, and how best to manage the remaining activities of the NCRR. Current recommendations include transferring the Molecular Libraries program, Therapeutics for Rare and Neglected Diseases program, Rapid Access to Interventional Development program, Cures Acceleration Network, and FDA-NIH Regulatory Science program to the new Center; transferring the Clinical and Translational Science Awards (CTSAs) and other relevant programs from the NCRR to the new Center; and transferring the remaining NCRR programs to other Institutes or Centers. The NIH welcomes feedback on the proposed reorganization (see Feedback NIH at http://feedback.nih.gov/). If approved, the reorganization will take effect October 1, 2011 (FY 2012).
Proposed New Institute on Substance Use, Abuse, and Addiction
The SMRB also recommended the creation of a new Institute focusing on research on substance use, abuse, and addiction, that would integrate relevant research portfolios from the National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), and other Institutes and Centers. The NIH welcomes feedback on the proposed new Institute (see Feedback NIH at http://feedback.nih.gov/). If approved, the new Institute will be established on October 1, 2012 (FY 2013).
Dr. Tabak also discussed how the NIH is addressing diversity/health equity issues. The NIH is working to enhance the framework by which diversity-related programs are implemented. It has broadened the eligibility criteria for its Minority Supplement Program to include individuals who are disadvantaged due to race/ethnicity, socioeconomic status, and disability, and it continues to promote consistency with these eligibility criteria in its other diversity programs. The NIH is also reviewing the evidence base in support of promoting diversity of the NIH-funded scientific workforce and reviewing program data on the diversity of its workforce, and has established a Diversity Task Force to facilitate NIH-wide strategic planning.
Dr. Shurin informed the Council that the search for a new Director, NHLBI, is continuing.
The NHLBI is working hard to maintain its funding paylines during this stringent economic period. It is the only NIH Institute with a differential payline by amendment status—that is, the Institute rank orders applications separately by percentile score within amendment status (i.e., initial application [A0], first amendment [A1], second amendment [A2]) in order to fund highly meritorious science earlier. (See the October 2010 NHLBAC meeting minutes for further discussion.) Currently, the NHLBI FY 2011 Research Project Grant (RPG) paylines are:
R01/R21 — A0: 16.0 percentile
R01/R21 — A1: 12.0 percentile
R01/R21 — A2: 10.0 percentile
Early Stage Investigator: 26.0 percentile
With a single payline policy, the NHLBI payline would be at the 13.0 percentile.
The NIH is currently operating on a Continuing Resolution for FY 2011, which allows the federal government to operate at budget levels enacted for FY 2010. The FY 2012 President's Budget for NHLBI is not significantly different from FY 2011 Continuing Resolution levels (1.7 percent increase overall).
The Institute is continuing to try to minimize the adverse effects on grantees during this lengthy period of budgetary constraint. Institute policy comprises making strategic cuts, whereby fully-funded investments thrive, rather than making across-the-board cuts that hurt all investments. The Institute continues to look carefully at budget justification, project overlap, and opportunities for alternative support, and has increased its use of mechanisms that express NHLBI interest without use of set-asides (e.g., program announcement with review [PAR] and a special funding strategy for specific program announcements [PA-star]). In addition, the Institute will limit new initiatives; defer funding of some large projects until later in the year; enhance accountability by funding few (or no) administrative supplements and by carefully considering performance measures, especially in large projects and clinical trials; and accept no applications transferred from other Institutes or Centers.
Council members expressed appreciation for the Institute's efforts during this difficult period and offered additional suggestions and comments.
Dr. Carl Roth, Acting Deputy Director of the NHLBI and Associate Director for Scientific Program Operation, presented the Institute's biennial report on its procedures for, and results of, implementing the NIH policy for inclusion of women and minorities in clinical studies. The biennial report is mandated by the NIH Revitalization Act of 1993. NHLBI procedures require Program Officials to evaluate relevant projects for appropriate representation of women and minorities; discuss concerns with senior staff; discuss concerns and possible solutions with applicants; and only release a project for Council consideration once all issues have been resolved.
Dr. Roth presented target and enrollment data, by race/ethnicity and by gender, for the Institute's clinical studies active in FY 2009 (the most recent data available). For each racial minority group, the targeted percentages exceeded the corresponding representation in the 2010 U.S. Census. Target data for Hispanic/Latino ethnic group lagged a bit behind the Census representation, but are continuing to improve. The enrollee distribution was very close to its targeted percentages for most minority groups. Enrollment numbers for Asians are expected to improve over time, since Asian target percentages exceed the corresponding Census representation. Hispanic/Latino enrollment numbers are also expected to improve as recruitment continues.
The targeted and enrolled percentages for women were 57.0 percent and 55.8 percent, respectively.
The NHLBAC found the Institute to be in compliance.
Delegated authorities allow NHLBI staff to perform specific functions without Council involvement, thereby adding flexibility and decreasing the burden on the Council. Dr. Stephen C. Mockrin, Director, Division of Extramural Research Activities, reported that in FY 2010, the Institute undertook 29 actions (totaling $3,686,828) using its delegated authorities (excluding the expedited en bloc concurrence). These actions represent 0.15 percent of the total funds awarded for grants ($2,408,309,281) in FY 2010. The Council accepted the report and agreed to continue the current policy of Delegated Authorities for another year.
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 Council considered 1,248 applications requesting $1,902,467,483 in total direct costs. The Council recommended 1,248 applications with total direct costs of $1,902,467,483. A summary of applications by activity code may be found in Attachment B.
The meeting was adjourned at 2:35 p.m. on February 15, 2011.