Summary Minutes - December 12, 2011

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 12, 2011

Dr. John Chae, Board Chair, called the 43th meeting of the NABMRR to order at 8:45 am. Minutes from the previous meeting were approved.

Future Board meetings will be: May 3-4, 2012, December 3-4, 2012, May 2-3, 2013

Introduction of New Members

The four new Advisory Board Members were welcomed and gave brief introductions. Dr. Carmen Green is from the University of Michigan, School of Public Health. She is a professor of health management and policy, anesthesiology, and obstetrics and gynecology. Her clinical practice focuses on pain management, while her research focus is health disparities and the intersection of policy and health. Dr. Todd Kuiken is the director of the Center for Bionic Medicine at the Rehabilitation Institute of Chicago and a professor of physical medicine and rehabilitation at the Feinberg School of Medicine, Northwestern University. His research interests are in advanced prosthetics control, particularly the use of targeted muscle reinnervation. Dr. Nicholas LaRocca is the director of Health Care Delivery and Policy Research at the National Multiple Sclerosis (MS) Society. He is a clinical psychologist and his research interests are the neuropsychology effects of MS, symptom management, and quality of life. Dr. Jonathan Wolpaw is a research physician at the Wadsworth Center, New York State Department of Health and Professor in the School of Public Health, University at Albany, State University of New York. His research interests are in spinal cord plasticity, neurophysiology, and brain/computer interface. Current board members also gave introductions.

Update on NIH Blue Ribbon Panel (BRP) on Rehabilitation

Dr. Chae gave an update on the NIH BRP, a working group convened as a result of discussions among the medical rehabilitation research community, NIH Director Francis Collins, and NICHD Director, Alan E. Guttmacher. The panel is co-chaired by a member of the National Advisory Child Health and Human Development Council and by a member of the NABMRR
(Drs. John Chae and Rebecca Craik, respectively) and will report its results to the NICHD Director. A listing of the panel members is available at http:// www.nichd.nih.gov/news/releases/Pages/083111-blue-ribbon-panel.aspx.  

The BPR has a broad charge that includes evaluating the progress of the NCMRR, the scope of rehabilitation within the NICHD, and the coordination of rehabilitation research activities across the NIH. The panel was informed of the limitations of NIH legislation and funding, but given free reign to meet with Institute liaisons and discuss opportunities and barriers. The panel hopes to have a written report prepared by May/June 2012 for submission to the NABMRR and the NACHHD as well as to Drs. Guttmacher and Collins.

The BPR began with an attempt to define “medical rehabilitation” and the extent of research support across the NIH. Dr. Chae presented the BRP operational definition of medical/physical rehabilitation as:  

The study of mechanisms, modalities, and devices that improve, restore or replace lost, underdeveloped or deteriorating function where function is defined at the level of impairment, activity, and participation according to the International Classification of Function, Disability, and Health.

Unlike the NIH-wide definition of “rehabilitation,” the proposed definition of medical/physical rehabilitation would exclude research that focuses primarily on dementia, substance abuse, alcohol/drinking, drugs, nicotine, psychiatry, mental disorders and schizophrenia. The Board gave Dr. Chae feedback regarding the proposed definition, which he will bring back to the BRP. The Board suggested a dynamic definition that incorporates ideas regarding prevention, pediatrics, and disability across the lifespan. Members also suggested deletion of the phrase “lost, underdeveloped, or deteriorating” and replacing “modalities” with “interventions.”  

Dr. Chae briefly reviewed first BRP meeting, held October 11, 2011. The group reviewed the legislature establishing the NCMRR, the history of the NCMRR, the current landscape of rehabilitation research across the NIH, and the Institute of Medicine perspective on rehabilitation research. The next meeting of the BRP is scheduled for January 12-13, 2012 and would feature other NIH institute reports on rehabilitation. He added that all are welcome to attend BRP open sessions, which take place on the first day.

Report of the NCMRR Director

Dr. Michael Weinrich gave the following NCMRR director’s report. He noted neither personnel nor organization changes. As of December 11, the NIH was operating under a Continuing Resolution without an official budget. An Executive Order was been issued for cutbacks on travel and new restrictions on conferences.

Dr. Weinrich pointed out that overall funding for the NCMRR has decreased in recent years and attributed it to many factors. He explained that the NCMRR published few new initiatives while the Institute was undergoing the Vision Process. Moreover, funding from the American Recovery and Reinvestment Act ended. The NIH had a slight budget decrease last year, resulting in tight paylines especially within the NICHD. During this time, the NCMRR transferred meritorious applications to other Institutes that had better paylines. Finally, the Traumatic Brain Injury (TBI) Clinical Trials Network has closed.

National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDE) For Clinical Trials

Dr. Naomi Kleitman from the NINDS gave the Board a presentation about the NINDS-sponsored CDE program. This endeavor seeks to establish data standards for clinical research with common collection instruments to increase the efficiency of the research enterprise, improve data quality, and facilitate meta-analyses and data sharing. She explained that the CDE project is not a database, but rather a source for forms and standards for data collection. The CDE project began in 2006 and, today, there are six disease categories and a “general” category available to the public; five more disease categories in progress. A CDE is a logical unit of data, pertaining to information of one kind. For example, patient-specific factors, treatment-specific factors, and outcomes are all domains relevant to CDE for TBI. The CDE will align with other databases and projects at NIH, such as Patient Reported Outcomes Measurement Information System (PROMIS). For more information and to access the CDE, see http://www.commondataelements.ninds.nih.gov/  

Representation of Disability in the National Children's Study

Dr. Steven Hirschfeld, associate director of clinical research at NICHD and acting director of the National Children’s Study, gave an update to the Board. The National Children’s Study is a congressionally mandated study to examine the relationships between environmental exposures and genetics on growth, development, and health. The environment is broadly defined to include factors such as air, water, soil, dust, noise, diet, social and cultural setting, access to health care, socio-economic status, and learning. The guiding principles are that the Study will be data driven, evidence based, and community and participant informed. The goal is to follow 100,000 children from the prenatal period to age 21.

The Vanguard study portion of the National Children’s Study is designed to evaluate the feasibility, acceptability, and cost of the recruitment, logistics and operations, and study visits and assessments. Currently, the Vanguard Study has recruited 2,000 babies and is now shifting to retention. The Vanguard Study revealed racial/ethnic differences in recruitment of mothers based on the type of recruitment strategy (healthcare provider based, enhanced household, or direct outreach). This information will help inform recruitment of the Main Study, which is scheduled to begin in 2012. For more information regarding the National Children’s Study, visit https://www.nichd.nih.gov/research/NCS/Pages/default.aspx.

The Board emphasized that efforts should be made to measure the positive and negative effects of the environment, especially as they pertain to children with disabilities. Furthermore, the Board encouraged the inclusion of appropriate disability measures.

NICHD Support for Training Activities

Dr. Ralph Nitkin gave a presentation on training activities supported by NCMRR. He explained that there are many mechanisms to support the training and career development of predoctoral fellows (F31, T32), postdoctoral fellows (F32, T32, K99), and junior faculty (K01, K08, K23, K25, K12); in addition, early researchers are supported directly on research grants. Despite the importance of training a new cadre of investigators, especially in the area of medical rehabilitation, funding for training and career development across the NIH has not increased in recent years. He added that the appeal of a career in biomedical and behavioral research is diminishing as NIH paylines and the number of academic faculty positions decrease. Despite these obstacles, he noted that the NCMRR continues to work for training support, competitively accessing 13 percent of NICHD funds (about two times greater than its proportion of NICHD research support).

One of the primary means of departmental predoctoral and postdoctoral training support is the T32 Institutional Training Award. These awards provide stipend, tuition, and associated costs for a small number of trainees in meritorious academic departments. Training awards also serve to attract top-caliber students, develop new areas of science, and foster communication and collaboration across labs. Dr. Nitkin reported that the NCMRR currently supports T32 grants in a wide variety of topic areas including basic, applied, and clinical research; pediatric critical care and pediatric emergency medicine; biomechanics and movement science; rehabilitation engineering; neurological injury; pathophysiology and neuroplasticity; clinical trials; psychosocial research; outcomes and health services research; neuroimaging; and prosthetics and orthotics.

The NICHD initiated a new pilot to standardize the review of training grants across the institute. Previously, applications for departmental T32 grants were reviewed by domain-specific peer-review panels. However, there was a need to standardize review and scoring across these diverse domains, especially with the increasingly competitive NICHD paylines. This year, the NICHD Division of Scientific Review developed a pilot program to pool applications and review them all in a single large, diverse study section. Peer reviewers were selected who had experience with training programs and proportionally represented the diverse scientific disciplines in the NICHD applicant pool.

He noted that NCMRR training grant applications seem to have been adequately served in the initial round of reviews. The review panel included about a six reviewers with some connection to medical rehabilitation. All NCMRR T32 applications were “discussed” and the median score for NCMRR applications was the same that of the entire NICHD pool, although the actual number of NCMRR T32s that will be funded has not been determined.

The Board asked about the success of trainees from diverse backgrounds and those with disabilities. Dr. Nitkin explained that all T32 applications are required to include a recruitment plan for minorities, and competitive renewal applications are specifically rated on the success of past recruitment efforts. However, he noted that the NIH does not currently highlight recruitment of people with disabilities on departmental training grants. He described the diversity supplement program to support the addition of qualified people with disabilities to existing research grants, but very few applications are submitted. Participants agreed that recruitment and support of people with disabilities is a topic that should be followed up in a future Board meeting.

Report of the NICHD Director

NICHD Director Dr. Alan Guttmacher gave the following report to the Board. He explained that he began a three-year term on the NIH Steering Committee to advise NIH Director Dr. Collins on policies, programs, and organizational issues at NIH. The NICHD was recruiting for the position of associate director of extramural research; suggestions for qualified applicants were encouraged. NICHD leadership was contemplating changes in the organizational structure of the extramural program, including flattening the structure and re-configuring the Branches to encourage more transparency and collaboration. Public input would be sought prior to any changes. The NICHD Vision paper is slated to be published early next year with the aim of inspiring the research community to achieve critical scientific goals and meet pressing health needs, and to inform, not dictate, NICHD’s future plans. Eight theme areas would be included in the final product, including “Plasticity and Rehabilitation.”

Dr. Guttmacher reviewed the current budget situation. He explained that the NCMRR has seen a decrease in funding since 2009. The most recent drop in funding, from fiscal year 2010 to fiscal year 2011 was mostly attributed to the planned closing of the TBI Clinical Trials Network, carryover funds from a large K12 grant (which would be reinstated in fiscal year 2012), and the transition from large Phase II Small Business Innovative Research/Small Business Technology Transfer projects that have recently concluded to an emerging cohort of starting Phase I grants. The NICHD budget for fiscal year 2012 was unknown, but was not expected to increase.

Dr. Guttmacher added that the NIH has longstanding programs to support diversity in biomedical and behavioral research. Despite these efforts, a recent NIH commissioned paper revealed that African Americans/black applicants are still 10 percentage points less likely to receive a Type 1 NIH R01 compared to white applicants, when controlling for NIH training, research experience, and institution. The number of citations and previous review committee experience reduced the disparities for African American/black applicants. The NIH was taking this report very seriously and was taking steps to determine the causes of differential success rates and to implement effective interventions. These action items could include:

• Early-career reviewers program 
• Grants to strengthen the pipeline of diverse applicants
• Formation of two high-level working groups to recommend actions
• Experiments on the review process
• Encouraging pre-application mentoring

There were also several recent revisions to research regulations. The Federal Policy for the Protection of Human Subjects (45 CFR 46, “The Common Rule”) was under proposed revisions to enhance human subjects’ protections and eliminate redundancies and inefficiencies. The public was encouraged to submit comments. In addition, a Final Rule was established to update the Financial Conflict of Interest regulations. Major changes included a new definition of “significant financial interest,” new institution reporting requirements, public availability of disclosures, and investigator training.

New Issues and Future Agenda Items

Potential topics for the May 2012 meeting were discussed, including diversity, disparities in success rates for disabled researchers, pain, aging with disability, plasticity and function, the environment in the Vision process, rural services, and the R24 infrastructure network.

The meeting adjourned at 5 pm.