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NCRR and the 2009 Recovery Act
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Advisory Council Meeting Minutes - February 12, 2009SEE ALSO:
The National Advisory Research Resources Council convened its 141st meeting at 8:00 a.m. on Thursday, February 12, 2009, in Conference Room 10, Building 31, on the National Institutes of Health (NIH) main campus. Dr. Barbara M. Alving, director, National Center for Research Resources (NCRR), NIH, presided as chair. The meeting was open to the public until 12:30 p.m., at which time it was closed to the public for the review, discussion and evaluation of grant applications as provided in Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 10(d) of Public Law 92-463. VIEW THE VIDEOCAST ContentsEach link scrolls this page to the corresponding section. I. Call to Order Council Members PresentDr. William F. Bria, II Council Members AbsentDr. James P. Collins, Liaison Member, National Science Foundation Special Invited Guests for Open SessionDr. Brian D. Athey, University of Michigan Staff of Other NIH ComponentsMs. M. Virginia Wills, National Institute of Allergy and Infectious Diseases Others PresentDr. Andrea Baruchin, Foundation for NIH
Open SessionI. Call to Order: Dr. Barbara M. Alving, director, NCRRDr. Alving officially called the meeting to order and welcomed members and guests to the 141st meeting of the National Advisory Research Resources Council. II. Consideration of Minutes: Dr. Barbara M. AlvingThe minutes of the Council meeting held on September 16, 2008, were approved as written. III. Rollout of the NCRR Strategic Plan 2009–2013: Ms. Lori Mulligan, Director, Office of Science Policy, NCRRA. Introduction of New Council Member and Council Member UpdateDr. Alving introduced Dr. Joel Kupersmith, the chief research and development officer of the Department of Veterans Affairs (VA), who is representing the VA on the Council. He oversees the four main areas of VA research: biomedical labs, clinical science, health services and rehabilitation. Dr. Kupersmith is a Navy veteran and received his medical degree from New York Medical College and trained there in internal medicine. Subsequently, he completed cardiology training at Harvard's Beth Israel Deaconess Medical Center. At Texas Tech University, he was the dean of the School of Medicine and Graduate School of Biomedical Sciences, vice president for clinical affairs and CEO of the faculty practice. Dr. Kupersmith has been a Scholar-in-Residence at the Institute of Medicine and the Association of American Medical Colleges, and he has completed numerous projects and publications on health policy and research issues. Dr. Alving congratulated Council member Dr. Nancy Brown on her recent appointment to the position of chief of the Division of Clinical Pharmacology at the Vanderbilt School of Medicine. B. NIH's 2009 Darwin Evolution Revolution (EvoRevo)Dr. Alving noted that today's meeting is on the 200th anniversary of the births of both Abraham Lincoln and Charles Darwin. She pointed out that Darwin is the name associated more with science, but in fact both men made important contributions to the field. In 1863, in the midst of the Civil War, Lincoln signed legislation establishing the National Academy of Sciences, which serves to investigate and report on any subject of science or art as charged by the government. Dr. Alving reported that in celebration of Darwin's work and the 150th anniversary of the publication of On the Origin of Species, the NIH has created a year-long series of events and educational programs called the Darwin Evolution Revolution (EvoRevo). In support of EvoRevo, NCRR's Science and Education Partnership Award program has awarded six administrative supplements to the following individuals:
C. NIH LeadershipDr. Alving noted that Dr. Raynard S. Kington was named acting director of NIH on October 31, 2008, following the departure of Dr. Elias A. Zerhouni. Dr. Zerhouni has joined the Bill & Linda Gates Foundation as a senior fellow and serves on the board of the Lasker Foundation. D. Budget UpdateDr. Alving reported that about $500 million of NCRR's total FY 2009 budget of $1.149 billion has been made available to NCRR under a continuing budget resolution in effect through March 2009. NCRR's FY 2010 budget request is $1.16 billion, an increase of approximately $11 million. These additional funds include support of the planned expansion of the Clinical and Translational Science Awards (CTSA) consortium. The president's 2010 budget will be released in April rather than the customary first Monday in February. E. Clinical and Translational Science AwardsDr. Alving explained that CTSA has had two application cycles this year, but in the future will have only a single annual application round. Today, the Council will review the first round of applications. It is expected that up to five new CTSAs will be funded by the end of 2009. Dr. Alving reported that a new application called "federated access" will allow users to access multiple NIH-related Web sites with a single user name and password. The launch of federated access for the CTSA program will take place February 18 and will benefit about 1,500 users at 38 CTSA institutions, as well as 75 academic medical centers across the country. F. Workshops and MeetingsDr. Alving described a number of workshops and meetings that have just occurred or will be taking place in the next few months. She noted that although some of the workshops are designed primarily for the CTSA network, they are open to anyone. Decision Making in T1 Translational Research CTSA Workshop: SNA to Evaluate Translational Collaboration Pediatric Medical Product Development: Setting Specifications and Expectations Technology Cores Workshop: Designs for Efficient Management and Utilization After describing the workshops, Dr. Alving outlined the following upcoming meetings.
National Technology Centers for Networks and Pathways — All Hands Meeting
RCMI Program Directors Meeting
Detection, Impact, and Control of Specific Pathogens in Animal Resource Facilities Workshop
8th Annual Mutant Mouse Regional Resource Center Program Meeting
Improving Health WITH Communities: The Role of Community Engagement in Clinical and Translational Research
NIH-NCRR SEPA Annual Program Director's Meeting 2009
Frontiers in Telemedicine: Improving Access to Evidence-Based Care
Technology Cores: Designs for Efficient Management and Utilization G. Personnel UpdateOffice of the Director
Division of Biomedical Technology
Division of Research Infrastructure
Office of Administrative Operations
Office of Communications
Office of Grants Management
Office of Information Technologies
Office of Review
Office of Science Policy
H. NCRR "Spotlight" RetreatDr. Alving announced that NCRR has created a brief retreat forum called a "Spotlight," in which staff across all of NCRR will focus on a specific issue of interest to the organization. The first NCRR Spotlight will be held February 20, 2009 on communications, outreach and networking with NCRR's target audiences. The participants will identify the best networking tools to facilitate information management and meeting collaboration. The staff also will discuss way to reach out across NCRR, NIH, research and professional communities, media, and Congress to increase awareness of NCRR programs and its impact. I. Women in Biomedical ResearchDr. Alving announced the publication of Women in Biomedical Research: Best Practices for Sustaining Career Success, the proceedings of a March 2008 workshop cosponsored by NCRR, the Office of Research on Women's Health, and the NIH Working Group on Women in Biomedical Careers. The proceedings, which Dr. Alving co-chaired, include best practices for retaining and supporting women in diverse settings, including business, the military and academic medical centers. Dr. Alving reported that data have shown a high dropout rate for women after they complete work funded by their first R01 grant. Noting that 50 percent of the trainees in the CTSA program are women, Dr. Alving stressed the importance of retaining that talent pool. IV. Enhancing Peer Review — Highlights of Changes Effective for September 2009 Council: Dr. Sheryl K. Brining, director, Office of Review, NCRR
Dr. Brining explained that significant changes in scoring of grant applications are taking place across all of NIH. She highlighted changes that the Council will find in the grant applications to be reviewed at its September 2009 meeting. The range of reviewer scores will be 1–9 instead of 1–5, and scores will be given only in whole numbers. The average of all reviewers' scores on each application will be multiplied by 10, resulting in score of 10–90. In light of this, it is more likely than in the past that application scores will be tied. A new term to be used for scoring is "impact/priority," and reviewers will be encouraged to consider the impact of proposed projects. Dr. Brining said that the NIH database used to create the application summary statements is designed on the R01 model, which captures only five criterion scores. As a result, reviewers will have the option of scoring a maximum of five specific criteria, such as significance, investigator, innovation, approach and environment, using numerical scores of 1–9. NCRR is assessing all of its grant programs to determine how to adapt NCRR mechanisms to the new systems. In the new peer review process, reviewers will be instructed to focus on strengths and weaknesses and to refrain from giving advice. Each reviewer's critique may start with a table of criterion scores.
Dr. Brining presented a list of members of the NIH Peer Review Oversight Committee and provided the Web site (http://enhancing-peer-review.nih.gov V. Biological and Environmental Research: Dr. Anna Palmisano, associate director of the Office of Science for Biological and Environmental Research, U.S. Department of Energy
Dr. Palmisano presented an overview of the Office of Biological and Environmental Research (BER), one of six program offices in the Department of Energy (DOE) Office of Science. Dr. Palmisano focused her presentation on one of BER's four priorities — developing new tools to explore the interface between biological and physical sciences. She reported that the Office of Science has oversight of 10 of the 17 DOE National Laboratories. As examples of biomedical research programs supported by BER, Dr. Palmisano described approaches used at the three bioenergy research centers to develop methods to convert plant cellulose to ethanol and other biofuels, and she described the activities related to "Genomics: GTL Program" (formerly Genomes to Life), which explores microbes and plants at the molecular, cellular and community levels. She also discussed the BER National User Facility called the Joint Genome Institute (JGI) in Walnut Creek, Calif. JGI partners with five other institutions to provide high-throughput genomic sequencing and analysis for the scientific community and also hosts workshops and conferences that advance the science and encourage interaction among investigators. BER's low-dose radiation research program uses advances in genomics and molecular biology to study radiation risk, providing evidence needed to develop policy for clean-up of nuclear waste. In addition, BER is developing new radiochemistries to synthesize and radiolabel new molecular probes, as well as new imaging and instrumentation tools for real-time high-resolution imaging. Dr. Palmisano described a number of DOE-supported resources that are available to researchers. Synchrotron light sources are in place at four national laboratories, and three high-flux neutron beam sources are available at two national laboratories. Among the more than 60 capabilities available to the scientific community at the Environmental Molecular Sciences Laboratory are advanced mass spectrometers for proteomics and several very high field nuclear magnetic resonance spectrometers. In addition, the national laboratories provide computing resources for scientific research that are among the most advanced in the world. BER partners with DOE's Office of Advanced Scientific Computing Research to provide grants for research projects through SciDAC (Scientific Discovery through Advanced Computing) and INCITE (Innovative and Novel Computational Impact on Theory and Experiment). Dr. Palmisano concluded by emphasizing that the partnership with NCRR is highly valued by the DOE, and her goal is to build on this collaboration. VI. DOE &apm; NCRR — Interagency Collaboration for Development of Biomedical Technology: Dr. Douglas M. Sheeley, health scientist administrator, and Dr. Amy L. Swain, health scientist administrator, Division of Biomedical Technology, NCRR
Dr. Sheeley reported on how NCRR leverages DOE resources for biomedical research. Most of the interactions between NCRR and DOE take place through the NCRR's Biomedical Technology Research Centers (BTRC) program, which has the goal of converting discoveries made in the physical sciences into useful tools that help advance biomedical research and ultimately may impact healthcare. Nine of the 52 BTRCs supported by NCRR are located at DOE national laboratories. Dr. Sheeley said that the interdisciplinary teamwork and the infrastructure of the National Laboratories contribute greatly to the success of the BTRCs. BTRCs are classified into five broad technology areas: imaging technology, informatics resources, optics and laser technology, technology for structural biology and technology for systems biology. Dr. Sheeley focused his presentation on some of the specific resources and research advances at three BTRCs that provide technology for systems biology: the National Flow Cytometry Resource at the Los Alamos National Laboratory in New Mexico, the National Resource for Biomedical Accelerator Mass Spectrometry at the Lawrence Livermore National Laboratory in California, and the Proteomics Research Resource Center for Integrative Biology at the Pacific Northwest National Laboratory in Washington. Dr. Swain focused her presentation on synchrotron X-ray technology, which produces extremely intense beams of radiation that can reveal structural details at the level of atoms and molecules. NCRR supports seven BTRCs at synchrotrons, six of which are located at DOE National Laboratories. Through a Cooperative Stewardship model, DOE funds the construction and operation of the synchrotron particle storage ring facilities, while partners such as NIH pay for building and operating the X-ray beamlines and experimental stations. Three synchrotron BTRCs are jointly sponsored with the DOE's BER, allowing them to provide beamline access to a larger and broader community, resulting in greater impact. Dr. Swain described some of the advanced synchrotron technologies and outlined the scientific mechanisms and some translational applications of macromolecular crystallography, X-ray absorption spectroscopy, X-ray scattering, X-ray microscopy and fiber diffraction. Dr. Swain pointed out that synchrotron biomedical research has significant impact in numerous areas of translational research, citing as examples the exploration of DNA transcription, contributions to the NIH Protein Structure Initiative, and the design of new medicines. She concluded her presentation by noting that although NCRR and BER have different missions, they enhance the impact of their programs through collaboration.
VII. Update on CTSA Activities — Strategic Plan: Dr. Gordon R. Bernard, principal investigator (and co-chair of the CTSA Consortium Steering Committee), Vanderbilt University; and Dr. Steven E. Reis, principal investigator, University of Pittsburgh
Dr. Reis explained that the CTSA consortium has traditionally used subcommittees of content experts to address challenges and work on projects. However, as the CTSA program matured, the consortium recognized that a strategic plan was needed to identify national priorities and develop a unified approach to address them. The strategic planning process began in April 2008 with the identification of 12 initial goals. Broad input about these goals was then sought, and in October 2008 a mission statement and four strategic goals were finalized. The mission statement reads: "The goal of the Clinical and Translational Science Award program is to improve human health by transforming the research and training environment, thereby enhancing the quality and efficiency of clinical and translational research." Dr. Bernard presented the four strategic goals finalized in October and outlined the near-term plans to address them. Goal 1 is to enhance the national capability for clinical and translational research. One of the first tasks undertaken by the committee assigned to Goal 1 is designed to reduce the time needed to initiate a protocol by developing metrics to be applied in contracting and in Institutional Review Board reviews. Goal 2 is to enhance the training and career development of clinical and translational scientists. A Web portal for open access to sharable training resources is being created to achieve this. Goal 3, to enhance consortium-wide collaborations, will be accomplished by creating a national resource inventory, establishing a data-sharing network, and initiating social networking to link scientists with each other. Noting that informatics tools are needed to foster collaboration, Dr. Bernard described several cross-institutional informatics projects already in place. He emphasized that although such resources are initially used within the CTSA consortium, they will ultimately be available to all researchers. Goal 4, to enhance the health of our communities and the nation, is being addressed by developing model methodology for comparative effectiveness research, for health policy and health services research, and for linking a community-based research network.
VIII. CTSA Informatics Key Function Committee Update: Dr. Brian D. Athey, professor of biomedical informatics, University of Michigan; Dr. Paul Harris, associate professor, Vanderbilt University; and Dr. Elaine S. Collier, assistant director, Division for Clinical Research Resources, NCRRA. Key Function Committee Overview
Dr. Athey described the process the CTSA Informatics Key Function Committee (IKFC) used to identify areas and projects of highest priority to CTSA informatics directors. A completed project template for each informatics project facilitates online tracking and communication using the CTSA Informatics Wiki. The IKFC has been proactive and engaging the CTSA principal investigators (PIs) through their very active CTSA PI liaisons to ensure their priorities are aligned with CTSA Strategic Goal priorities. Dr. Athey reported that several IKFC projects overlap with overall CTSA priorities: exchanging data sharing frameworks and models, providing a portal for sharing information about informatics resources at CTSAs, developing a national recruitment registry, defining informatics competencies for training of clinical and translational scientists and developing an informatics infrastructure for research networking. B. Subject Participant Recruitment Portal
Dr. Harris reported on the national volunteer research Web portal being developed at Vanderbilt University. The public side of the Web site will guide users to enter demographic and health information, thereby creating a database that researchers can search to help in identifying study participants. Dr. Harris described Vanderbilt's six-year-old registry that has served as a prototype for developing the national portal. He noted that even though the Vanderbilt University site has not been promoted, it includes information for about 5,000 individuals. For the national recruitment portal, each participating CTSA is appointing a liaison with responsibility for local Institutional Review Board awareness and for promoting the registry among the pubic and researchers. The liaisons will begin having monthly meetings in March 2009, and the project launch is expected in midsummer. C. Informatics Pilot Projects
Dr. Collier reported on three informatics pilot projects recently funded by the National Center for Research Resources. These projects, which total $4 million over two years, are focused on providing tools for scientists conducting small to medium-sized clinical studies. The NIH Roadmap Program for Reengineering Clinical Research is a partner in support of these projects. University of Washington — in collaboration with three other CTSA institutions — is extending Harvard's i2b2 software to support multi-institutional querying of clinical data repositories. Vanderbilt University — with Mayo Clinic and Oregon Health and Sciences University — is extending REDCap, a widely adopted and freely available tool for managing clinical studies, to support standards, sharing of case report forms, and additional types of studies. Case Western Reserve University — with four other institutions — is developing Physio-MIMI to help investigators manage many complex and diverse types of data across institutions and various studies. IX. Report from the IDeA Eligibility Working Group: Dr. Fred Taylor, health scientist administrator, Division of Research Infrastructure, NCRR; and Dr. Valerie Copié, associate professor of biochemistry, Department of Chemistry and Biochemistry, Montana State University
Dr. Taylor summarized the history and activities of the IDeA program, which is intended to enhance the geographic distribution of NIH funding. He presented a map showing the 24 states and territories currently eligible to participate in the program and described the two main activities that IDeA supports: Centers of Biomedical Research Excellence (COBRE) and IDeA Networks of Biomedical Research Excellence (INBRE). A working group was recently convened to consider options for eligibility criteria and activities in the IDeA program. Dr. Copié, who represented the Council together with Dr. Richard A. Rudick and Dr. Kevin B. Johnson, reported the group's findings and recommendations. Under the current eligibility criteria, states are eligible if their success rate in obtaining NIH research awards was less than 20 percent during 2001–2005, or if they had an average of less than $120 million in NIH funding during 2001–2005 (excluding IDeA awards and research and development [R&D] contracts). The working group found that grant success rates are no longer valid indicators of the needs of states and that continuing to use these criteria would not be consistent with the goals of the IDeA program. In light of this, the working group recommends the following:
X. Centers of Biomedical Research Excellence (COBRE) Phase III — Transitional Centers: Dr. Fred Taylor, Division of Research Infrastructure, NCRR
Dr. Taylor summarized the history and goals of the COBRE program, which is intended to expand biomedical faculty research capability and enhance the research infrastructure in institutions within IDeA-eligible states. COBRE currently provides support for two sequential five-year periods. Phase I supports the development of and research conducted by junior investigators, and Phase II continues to support and mentor junior investigators, allows research support for more established investigators, and provides mechanisms to reward mentorship and to encourage long-term commitments of more established investigators to the mentoring mission of COBRE. Dr. Taylor presented a concept proposal to add a third phase to the COBRE program. The proposed Phase III would not support research but would help maintain core resources such as supplies, service contracts, management and equipment upgrades. The funding proposed for Phase III is $500,000 per year for five years, including management and administration. The Council approved going forward with further development of a Phase III in the COBRE program and recommended increasing the award amount to $750,000 (total costs per year) and providing support for pilot projects. XI. NCRR FY 2007 and FY 2008 Biennial Report on Population Tracking: Dr. Shelia A. McClure, health scientist administrator, Division of Research Infrastructure, NCRR
Dr. McClure presented NCRR's report on population tracking for FY 2007 and FY 2008. She reviewed NIH policy on the inclusion of women and minorities in clinical research, explaining that NCRR is required to track data and report every two years on compliance with the policy. In FY 2007, NCRR reported 226 protocols (182 with enrollment) of which 72 percent of the participants enrolled were women; 34 percent were members of minority groups; and 44 percent were Hispanic/Latino. In FY 2008, NCRR reported 197 protocols (176 with enrollment) of which 77 percent of the participants were women; 29 percent were members of minority groups; and 25 percent were Hispanic/Latino. The Council approved submitting the NCRR population tracking report for inclusion in the NIH Director's Report to document compliance with the policy. XII. Recognition of Retiring Council Members: Dr. Barbara M. Alving, director, and Dr. Louise E. Ramm, deputy director, NCRRDr. Alving and Dr. Ramm recognized Drs. Bettie Sue Masters, Arthur W. Toga, and Tilahun D. Yilma for their service to the Council and presented them with plaques. Closed SessionThis portion of the Council 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). Council members discussed 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. XIII. Application ReviewThe Council reviewed 310 applications (with total direct costs of $216,673,354). The Council concurred with the review of all applications. AdjournmentThe Council adjourned at 2:23 p.m. on February 12, 2009. CertificationWe hereby certify that, to the best of our knowledge, the foregoing minutes and supplements are accurate and complete. /s/ /s/ These minutes will be formally considered by the Council at its next meeting; corrections or notations will be incorporated into the minutes of that meeting.
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