National Advisory Board on Medical Rehabilitation Research (NABMRR)National Center for Medical Rehabilitation Research (NCMRR)Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)December 3-4, 2012
Dr. Pamela Duncan, Board Chair, called the 45th meeting of the NABMRR to order at 8:45 am. Minutes from the previous meeting were approved.
Michael Dean Pamela DuncanCarol Espy-Wilson Edgar Garcia-RillDavid GoodCarmen Green
Marilyn HamiltonGeorge KraftTodd KuikenNicholas LaRoccaS.B. LeeRich Shields
Gary SmithRoger O. SmithMarilyn Price Spivack Denise TateJonathan Wolpaw
Lyndon Joseph, NIALana Shekim, NIDCDLois Tully, NINR
Martin Gould, NCDCate Miller, NIDRRRoger Miller, NIDCD
Beth Ansel, NICHDJohn Chae, Case Western ReserveRebecca Craik, Arcadia Univ.Theresa Cruz, NICHDDiane Damiano, CC Tinera Fobbs, NICHD Marc Goldstein, APTA Ramona Hicks, NINDSTammara Jenkins, NICHD
Rusti Johnson, NICHD Lisa Kaeser, NICHDNaomi Kleitman, CHNFAnne Krey, NICHD Michael Marge, NICHD Carol Nicholson, NICHDRalph Nitkin, NICHDJo Pelham, CSR
Matt Portnoy, ODLou Quatrano, NICHD Mary Rogers, NIBIBMona Rowe, NICHDNancy Shinowara, NICHDCathy Spong, NICHDPeter Thomas, DRRC Biao Tian, CSR
Dr. Ralph Nitkin reviewed the agenda for the meeting followed by introductions from the Advisory Board Members (including four new members) and visitors. The minutes from the previous meeting were approved.
The majority of the morning session was spent discussing the NIH BRP on Rehabilitation Research final report, which was made public just prior to the Board meeting. At the May 2012 meeting, Dr. John Chae provided the Board with some background on the BRP discussions and his presentation to the National Advisory Child Health and Human Development (NACHHD) Council. Dr. Pamela Duncan began by referring back to the NABMRR charter, which states that “the Board advises the Director, NIH, the Director, NICHD, and the Director, National Center for Medical Rehabilitation Research, on matters and policies relating to the Center’s medical rehabilitation research and training programs. The Board shall review and assess Federal research priorities, activities, and findings regarding medical rehabilitation research and shall continue to advise on the provisions of the statute-required comprehensive research plan for the conduct and support of medical rehabilitation.”
To get the discussion going, Dr. Duncan invited each Board member to present his or her initial thoughts on the BRP recommendations, which included the following comments. Rehabilitation research is supported by several NIH Institutes in addition to the NICHD, and basic research relevant to rehabilitation may extend this support more broadly across the NIH. The focus of the recommendations should not be on the amount of funds per se, because many NIH constituencies feel that they are underfunded. In an era of level funding, the focus should be on how to use the given funds more productively. About 15% of the population has disabilities, so it is discouraging that rehabilitation research across the NIH is not more coordinated and has so little identity. Staffing and research opportunities come down to funding; rehabilitation should have a separate and meaningful budget, appropriate peer-review expertise, and a revised strategic plan. The extraordinary recent accomplishments in rehabilitation research need more recognition and the NCMRR should lead this effort. Structural changes for the NCMRR should be considered a more long-term goal; the immediate focus should be on increasing the quality and scope of research through support of collaborations, workshops, and partnerships with industry, not-for-profit organizations, and other federal agencies -- beyond the usual sources. Rehabilitation research draws on such diverse expertise that it is not clear how it fits into the more categorical model of the NIH; support for rehabilitation research may require a hybrid model or some other unique administrative structure.
The Board asserted that rehabilitation only recently developed the necessary base of basic and translational research; it is now time to reassess how successfully the field is meeting the needs of its constituencies. Although there is some evidence from translational research, it is mostly at the T1 and T2 levels, with little support for T3 and T4 research that shapes clinical practice and changes real-world outcomes. There is a need for more strategic planning and involvement of the target audiences. It is not clear how well the NCMRR is known beyond the NICHD; meetings are needed to highlight the impact of rehabilitation research and new opportunities. The Board reiterated that the BRP discovered that 80% of rehabilitation research is supported outside of the NCMRR, but this involves overlapping missions and a lack of overall coordination. Rehabilitation research is too focused on neurological disease; it should cover other areas such as musculoskeletal disorders. Moreover, there is a need to go beyond pathophysiological- and impairment-based research.
The Board suggested that large clinical departments see NIH funding as difficult to get. Current NCMRR research is largely portfolio-driven, but this means that the agenda is set by a small number of peer reviewers rather than by a broader strategic plan. Rehabilitation research could be stimulated through strategic program announcements, cross-agency collaborations, and review in special-emphasis review panels. The Board felt that the release of the BRP report provides a special opportunity to highlight the NCMRR and rehabilitation research at the NIH. Although an independent Center would be great, it is unlikely in the current climate; the focus should be on low-cost coordination, minimal additional bureaucracy, and cofunding opportunities to enhance coordination with other NIH Institutes. Rehabilitation has arrived and now competes well with other clinical research departments. There is a need to publicize research opportunities and improve dissemination to the public, while also enhancing communication from the public back to researchers.
Several members of the Board supported the BRP recommendations, but some felt that the focus should be expanded to include other relevant federal agencies. The NIH does not adequately address certain key issues in rehabilitation such as pain, health disparities, chronic disease management, women’s health, and caregiving. The 2007 Institute of Medicine report on The Future of Disabilities in America would be a good starting point for renewed strategic planning with public listening sessions, and this effort should go beyond the NIH to the level of the U.S. Department of Health and Human Services. There are also significant policy issues related to rehabilitation that require the involvement of the Center for Medicare and Medicaid Services (CMS). Disability is the beginning of a disease process, length-of-stay continues to be decreased even for very serious conditions, and in the absence of access to necessary resources and support, function will continue to decline.
Dr. Duncan summarized the Board discussion as follows: There is a need for strategic vision and/or planning with respect to both larger administrative issues as well as specific research details. Some level of coordination and partnering is needed. Medical rehabilitation requires a broad perspective that includes health services and policy, and not just research. There is some uncertainty about the implications for various proposed changes to the administrative structure of the NCMRR. The current NCMRR budget is portfolio-driven, but creation of an independent Center may fix the budget at a certain level. An updated research plan and funding announcements would stimulate rehabilitation research. The NIH is focused on science and research, not health policy. There was a call for increased communication with consumers and caregivers as well as improving the profile of rehabilitation research. Within rehabilitation, there is a special need to continue to support clinical researchers and train the next generation. The NIH should consider creating a special office that coordinates rehabilitation activities and reports to the NIH Director. Research support at the NIH still comes down to money and budget. Although the Board was unanimous in their support for increased coordination of activities, they were not able to reach consensus on a recommendation for the NCMRR to have a fixed budget for rehabilitation research (initial vote: 9 yes; 4 no).
Dr. Matthew Portnoy, NIH Coordinator for the Small Businesses Innovative Research (SBIR) and Small Business Technology Transfer (STTR) Programs, gave a presentation to the Board outlining the NIH’s SBIR and STTR grant programs, with specific emphasis on fiscal year (FY) 2012 reauthorization legislation. The goal of the SBIR/STTR program is to move technology into the marketplace. The set aside amounts for both programs have increased and will continue to increase through FY17. The NICHD spends about $31 million a year in SBIR/STTR grants and contracts. Even with the funding increases, Dr. Portnoy indicated that the funds may not be adequate to support all the good proposals submitted.
Dr. Louis Quatrano presented some specifics on the use of SBIR/STTR mechanisms within the NCMRR. He explained that, although largely applicant-driven, NCMRR SBIR/STTR funding peaked in FY09. Likewise, the number of funded applications dropped due to the increased cost of specific grants and the lack of any significant budgetary increases across the NIH during those years. Compared to other parts of the NICHD, the NCMRR funds more than its share of SBIR grants but has a lesser proportion of STTR grants; it is unclear why this disparity between NCMRR SBIR and STTR funding trajectories exists.
Dr. Quatrano presented some background on successful projects supported through the SBIR line. An NCMRR grant to Simbex, LLC provided for the development of the Head Impact Telemetry SystemTM, which aims to understand the biomechanical factors associated with brain injury. Over the subsequent 13 years, this project has led to numerous other federal grants, patents, and even policy changes enabled by the SBIR research findings. The NCMRR also funded Kinetic Muscles, Inc. to produce the Hand MentorTM and Foot MentorTM, which are currently in clinical effectiveness trials funded by the National Institute of Neurological Disorders and Stroke and the Veterans Administration. Dr. Quatrano recommended that small business research should support translation to other rehabilitation domains, such as home therapy, and drug and device development. Professional societies could also help to identify gap areas that small business might address. In addition, Dr. Quatrano also described an infrastructure network that was funded through the R24 mechanism to specifically help rehabilitation researchers go beyond prototype development to explore the commercial potential and to bring their product to the market. The Board commented that one of the difficulties of the SBIR program was that it was designed as a linear process, but in reality science and technology develop in a reiterative manner.
Because of its broad expertise, the Board is sometimes called on to provide the NCMRR with a first level of review for potential research initiatives. Board members received brief background material in the weeks prior to the meeting for two specific proposals described below. Dr. Anne Krey, from the NICHD Scientific Review Branch, presided over the concept clearance process. Dr. Weinrich indicated that for the upcoming fiscal year, the NICHD was seeking research initiatives based on seven topics in the NICHD Vision process.
The first concept, Orthotics for Healthy Development, was developed to stimulate research in the area of pediatric orthotic device development, utilizing advances in materials science, computer-aided design techniques, computer modeling, and biological plasticity to promote motor development in children with physical and developmental disabilities. The Board was enthusiastic about this proposal. They encouraged staff to consider dynamic orthotics with modular design and to actively seek applications from new investigators in the field.
The second concept was a broad proposal to explore the epidemiology, diagnosis and treatment of mild traumatic brain injury (TBI), a topic that is especially timely given the recent interest in federal investment in this area. TBI remains problematic because of under-reporting, biased case ascertainment, and a lack of both consistently applied diagnostic criteria and specific diagnostic tests. For patients with persistent complaints following mild TBI, the most prominent issue for both patients and their families is loss of cognitive processing abilities. Yet TBI treatments are generally symptom-based and TBI patients are largely treated on an empiric basis. The NCMRR proposed a three-pronged initiative to accelerate research on epidemiology, diagnosis, and treatment of mild TBI. The Board encouraged the NCMRR to work with other agencies to minimize overlap and maximize focus on this specific rehabilitation-related niche. Board discussion included a range of issues, including treatment of executive function deficits, epidemiology, biomarkers, axon/glial communication, single-subject trial design, improved animal models, head injuries in people with disabilities, secondary head injury and prevention, acceptable lower limits of head injury, and sports injury in the pediatric population. The Board accepted the concept with the suggestion that the NCMRR collaborate with the newly formed NICHD Pediatric Trauma and Critical Illness Branch.
Dr. Michael Weinrich gave the NCMRR Director’s report. Administrative updates included the recent retirement of Janice Wahlmann and Dr. Nancy Shinowara although the latter would be returning as a part-time contractor; the hiring of Rusti Johnson as administrative assistant; and promotion of Dr. Theresa Cruz to from research analyst to program officer. As discussed at previous Board meetings, the NCMRR would be renaming the research programs but the action was been put on hold until the larger reorganization of the NICHD is finalized. Because of the legislative mandate for its existence, the NCMRR would be the sole Center remaining in the NICHD. It would function, along with all the other NICHD Branches, under the newly organized Division of Extramural Research, but would retain a direct organizational link to the Institute Director. Pediatric Critical Care was moved from the NCMRR into a newly formed Pediatric Trauma and Critical Illness Branch, but pediatric rehabilitation would remain a priority within the NCMRR.
The NICHD budget continues to be a challenge. NCMRR funding has remained stagnant over the last few years at a level that is ~20% below the peak level of FY2007. Part of this decrease resulted from the closing of the TBI Clinical Trials Network, which was deemed duplicative of activities supported by other federal agencies and, at times, even resulted in competition for enrolling TBI patients into overlapping clinical protocols. The decrease in NCMRR funding for investigator-initiated proposals also resulted from the drop in the NICHD payline, which plummeted from the 24th percentile in FY2000 to around the 10th percentile FY2012.
Results from a major NCMRR-funded TBI clinical trial recently appeared in the Journal of the American Medical Association. NICHD leadership gave the NCMRR clearance to pursue two new rehabilitation research initiatives (as discussed in the concept clearance session above). And the NIH BRP on Medical Rehabilitation Research submitted their final report to the Director of the NICHD.
The precipitous drop in the funds available for travel raised some issues about how the NCMRR should prioritize resources. Dr. Weinrich indicated that about one-half of the allotted NCMRR travel funds went to the two biannual Advisory Board meetings, while the remainder of the funds allowed NCMRR staff to travel to professional meetings and to initiate occasional research conferences and workshops. Thus, the NCMRR was faced with the following choices: further restrict staff travel and NCMRR conferences or decrease the cost of Advisory Board meetings, perhaps by staging the May meeting in a virtual format (which would probably limit the agenda to a three-hour session). The Board felt that the virtual format would be inadequate to promote the necessary interactions and discussions, but understood that it may become necessary (and if so, it would require more email exchange leading up to meeting and an increased dependence on written feedback after the meeting). As a possible compromise, the Board suggested cutting the May meeting back to a one-day session.
In follow up discussions, the Board asked if there was any consideration at the NIH of allowing applicants to have an additional chance at revising a given application (returning to the “A2” policy), especially with the reduced paylines across all the Institutes. Dr. Weinrich indicated that the NIH position was that the current policy provided for a more efficient and timely funding of meritorious applications and was considering any further revisions in this policy. (More background on this issue is available in the discussion from the NIH Office of Extramural Research: http://nexus.od.nih.gov/all/2013/01/02/fy2012-by-the-numbers-success-rates-applications-investigators-and-awards/ ). The Board also expressed some concerns about reorganization of the NICHD administrative structure, which placed the NCMRR in the dual role of reporting directly to the NICHD Director, but functioning under the Division of Extramural Research.
The Co-chairs of the NIH BRP on Medical Rehabilitation Research, Dr. Chae and Dr. Rebecca Craik, came to provide additional background to the Board about the Panel’s discussion. Overall, Drs. Chae and Craik praised the BRP process: Panel members were generous with their time and NIH staff was responsive. They indicated that the general consensus of the BRP was that the NCMRR should be given more autonomy with respect to both budget and structure, but the BRP chose not to dictate specific details.
The BRP found the NCMRR to be functioning but not thriving. The NCMRR provided only about 20% of rehabilitation research funding across the NIH. However, there was a disconnect between the priority of disability funding at the NIH and the amount of disability in the U.S. population. The BRP focused primarily on rehabilitation research coordination across the NIH, but also considered the larger perspective of other federal agencies. The BRP recommended that specific funds be set aside to support coordination activities, and that these activities should involve specific representatives from all the appropriate NIH institutes. The activities could also include educating program officers across the NIH on broader rehabilitation issues, the constructs of disability, and workforce development. The BPR also recommended providing a pool of funds to partially support or augment grants in other NIH Institutes that had a rehabilitation connection but that might not otherwise get funded.
The BRP considered various models for coordination of research activities across the NIH (including the Office of AIDS Research and the trans-NIH Pain Consortium) that the NCMRR might emulate as the Center moves forward. The BRP expressed some concern that defining a set-aside budget for rehabilitation research would, in effect, place a cap on any further funding growth. Moreover, members considered that other NIH Institutes and Centers may be reluctant to continue funding rehabilitation research in their programs, ceding the responsibility to the NCMRR. The BRP charged the NCMRR with the task of updating its strategic plan and taking a broader view of rehabilitation.
At the Board meeting, Dr. Tricia Dorn from the Veterans Administration endorsed the need to build partnerships and reduce redundancy in federal funding of rehabilitation research. She indicated that Defense Advanced Research Projects Agency provided $150 million for the research and development of two high-end prosthetic arms, and that the VA was funding clinical trials to explore their effectiveness. It was also suggested that the NCMRR continue to work with Interagency Committee on Disability Research (ICDR) and the National Institute on Disability and Rehabilitation Research (NIDRR), in the Department of Education.
With the understanding that implementation of many of the broader BRP recommendations would require Congressional action, the Board focused on more short-term issues. The Board voted to endorse the overall BRP report. The Board went on to recommend that the NCMRR increase coordination through the establishment of a coordination office budgeted for one full-time equivalent and about $3 million for specific coordination activities. Members recommended that the NCMRR write a new vision and mission statement as well as an updated strategic plan with input from the other NIH Institutes. Longer-term goals were also discussed, such as moving the NCMRR to the NIH Office of the Director or promoting the NCMRR to the status of a separate Institute but no consensus was developed on the specifics of either proposal.
Board members were asked to provide additional comments for the long-term vision to Dr. Duncan in the days following the Board meeting; Dr. Duncan would then provide the Board with a draft letter for a more formal response to the NCMRR and NICHD Directors. A motion was made that the NCMRR be given an annual budget of $125 million, of which $25 million would be used for coordination; the remainder would fund grants. The Board spent a long time discussing the merits and disadvantages of setting a budget for the NCMRR, but decided (with one member dissenting) to table this issue for discussion at the next meeting.
Dr. Alan Guttmacher gave the NICHD Director’s Report to the Board. In news from the NIH, the National Football League gave $30 million for TBI research to the Foundation for NIH. The NIH hoped to bring other funders into this endeavor and to advertise TBI issues to the general public. Dr. Christopher Austin was named the new Director of the National Center for Advancing Translational Sciences (NCATS). NCATS also launched the Discovering New Therapeutic Uses for Existing Molecules program to give researchers access to compounds that have been abandoned by pharmaceutical companies (usually for financial reasons) to identify potential therapeutic drugs. Dr. Janine Clayton was been named Associate Director for Research of the Office of Research on Women’s Health (ORWH). Dr. David Murray was been named Associate Director for Disease Prevention and Director of the Office of Disease Prevention; and Dr. Richard Nakamura has been named Director of CSR.
Dr. Guttmacher indicated that the NIH has recently published a program announcement entitled Opportunities for Collaborative Research at NIH Clinical Center to enable extramural researchers to collaborate with the special resources of the NIH Clinical Center. He noted that the NIH hosted a Celebration of Science event in September to highlight for the general public medical advances made possible by NIH grants. A new interagency working group on neuroscience was formed to focus on brain injury, cognition, and other neurological conditions. Recent Capitol Hill briefings, focused on TBI, chronic pain, and robotics research. The NIH would be operating under a continuing resolution until March 27, 2013. Sequestration scheduled for January 2, 2013, would cut discretionary funding by 8.2%. There were plans to develop trans-NIH policies to address sequestration, but that would also allow some flexibility for Institutes and Centers. Although the NIH traditionally had good bipartisan support in Congress, it was difficult to know what the ultimate NICHD budget will be.
Dr. Guttmacher went on to provide some news from the NICHD. The Institute’s 50th anniversary celebration would culminate in scientific colloquium on December 5, 2012; video archive of the day’s event is available at www.nichd.nih.gov/news/resources/spotlight/Pages/120412-scientific-colloquium.aspx. The NCMRR would be represented by Dr. Michael Selzer, who would focus on neural repair and rehabilitation. The reorganization of the NICHD was complete. The extramural Centers were eliminated, except for the NCMRR and the Division of Extramural Research was created (with Dr. Cathy Spong as Director) to decrease silos and increase transdisciplinary work. In addition, two new NICHD Branches were also created: Gynecologic Health and Disease Branch, and Pediatric Trauma and Critical Illness Branch. The term “trauma” was chosen rather than “injury” to be more inclusive (i.e., physical and psychological incidents); research on poisoning, drowning, and other non-impact accidents would also be included in this Branch. NICHD’s Scientific Vision document was been published and posted at www.nichd.nih.gov/vision/Pages/index.aspx. Dr. Guttmacher emphasized that this is not a strategic plan; Institute activities would be informed but not dictated by it.
The Board asked about talent management and knowledge retention, especially given the retirement of senior staff and the sometimes low incentive to work for the government. Dr. Guttmacher responded that NICHD staff was wonderful and hardworking and that the Institute aimed high in recruiting, including recruitment of people with disabilities. By working at the NICHD, he explained that people could have a real impact on health and the nation. The Board asked several questions about the new Pediatric Trauma and Critical Illness Branch, including issues about surveillance, epidemiology, and the impact of severe injury/trauma on families. Dr. Guttmacher responded that although surveillance and prevention were primarily the domain of the Center for Disease Control and Prevention, the NICHD was also active in these areas. The NICHD had a long history of looking at the effects of illness and trauma on families. The Institute was also home to an intramural program in epidemiology (Division of Epidemiology, Statistics and Prevention Research) and the National Children’s Study, which will be THE epidemiology study of our lifetime. Moreover, the new Branch and program would still collaborate with the NCMRR on pediatric rehabilitation issues. Dr. Guttmacher added that the two new NICHD Branches will not receive new staff or budget, but that the Institute would shift portfolios and staff from current NICHD programs.
Dr. Nitkin and Dr. Cruz provided some brief background on the development of research and career-development initiatives and responses from the research community. Dr. Cruz showed the Board how investigator-initiated applications written in response to a program announcement may be reviewed in a special emphasis panel, and the impact that this type of review may have on success rates and overall funding compared to applications that are reviewed in standing peer-review panels. The outcome may justify the added staff effort required to craft funding announcements that get reviewed by special emphasis panels even when no set-aside dollars are available. Dr. Nitkin presented updates on the NCMRR career development networks that provide special mentor and support (including salary). These networks, currently targeted for physiatrists, allied health professionals, and rehabilitation engineers, respectively, have produced an impressive cadre of rehabilitation researchers.
Several topics were suggested for further meetings: increasing the number of high-quality research applications to the NCMRR; reviews of the diversity supplements and loan repayment programs; NIH efforts to reach and recruit younger students; methods to improve the quality of rehabilitation applications; dialogue with Dr. Charlie Larkin from the National Institute on Disability and Rehabilitation Research (NIDRR), particularly on the Interagency Coordinating Committee for Disability Research; and dialogue with the NIH Office of Research on Women’s Health to discuss coordination models.
The meeting was adjourned at 12:00 noon on December 5, 2012.