Updates from NIH Theresa Hayes Cruz Ph D

Updates from NIH Theresa Hayes Cruz, Ph. D Program Officer National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development American Society of Neurorehabilitation November 7, 2013

NIH 101 National Institutes of Health – NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. – ~80% of $29 Billion budget is awarded to extramural scientists – that’s you! – 27 separate Institutes and Centers, plus the Office of the Director, each with mission, goals, and budget.

National Center for Medical Rehabilitation Research (NCMRR) • Established 1990 by Public Law 101 -613 • To foster development of scientific knowledge needed to enhance the health, productivity, independence, and quality of life of persons with disabilities • Located within the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) So if you are looking for NCMRR – you have to look under NICHD

Other NIH Institutes support Medical Rehabilitation Research National Institute of Neurological Disorders and Stroke • SCI, TBI, stroke, CP, PD; interventions, mechanisms, plasticity National Institute of Biomedical Imaging & Bioengineering • BCI, neural prosthetics, FES National Institute on Aging • geriatric populations, frailty, falls, osteoporosis

Other NIH Institutes support Medical Rehabilitation Research National Institute on Nursing Research • pain, caretakers, symptom management National Institute on Arthritis and Musculoskeletal and skin Diseases • arthritis, muscle physiology, bone & skin National Institute of Deafness and Other Communication Disorders • cochlear implants, aphasia, balance

Applying to the NIH • Majority of funds go to investigator-initiated proposals; rather than applications developed in response to program initiatives • Funding decisions are driven by peer review scores • Electronic submissions!!! • Support provided to institutions in name of investigator • From submission to funding: at least 9 months • Only two chances for a given proposal

FOA: Funding Opportunity Announcement • Parent Announcements for Each Grant Mechanism – (e. g. R 01, R 21, R 03, R 15, R 13, SBIRs, STTRs, Ks, F 32…) • Special Research Initiatives: – Program Announcements (PA) • • Highlights Institute(s) interest in specific area Three-years running Reviewed in regular study sections No special funds set-aside – Request for Applications (RFA) • One-time set aside for applications in specific area • Special ad hoc review group • Unsuccessful RFA applications can be used elsewhere – Request for Proposals (RFP) • Contract mechanism: One time set aside for specific product

Research Project Award: R 01 • Investigator-initiated applications (majority of basic and clinical NIH funding) • Focus on specific set of aims • Budget: Typically $150 -250, 000/year; permission required for > $500, 000 Direct Cost/year • May request up to 5 years; Renewable

Small Grants Mechanisms: R 03 & R 21 • R 03 – Pilot studies; feasibility; stepping stone to a larger grant (R 01) – $50, 000/yr (direct costs) – 2 yrs • R 21 – innovative research; high-risk; pushing the envelope; new methodology or technology – $275, 000 (direct costs spread over 2 yrs) • Not renewable; may not to be used to supplement already-funded projects

Academic Research Enhancement Award (AREA): R 15 • Schools that have not been major recipients of NIH funding (e. g. , undergraduate institutions) • Especially projects that engage undergraduate students • Up to 3 years, aggregate budgets up to $300, 000 direct costs, renewable 10

Small Business Tech Transfer (STTR, R 41/42) Small Business Innovation Research (SBIR, R 43/R 44) Innovative research, potential for commercialization • Small Business Tech Transfer (STTR, R 41/42) – Phase I: $150, 000 (up to 1 year) – Phase II: $1, 000 (up to 2 years) • Small Business Innovation Research (SBIR, R 43/R 44) – Phase I: $150, 000 (up to 6 months) – Phase II: $1, 000 (up to 2 years) 11

Career Development Grants - K Awards • Provide support and “protected time” for a supervised career-development experience in the biomedical, behavioral, or clinical sciences leading to research independence (K 01, K 08, K 23, K 24, K 25, etc. ) • K 99/R 00 - postdoctoral scientists receive both mentored and independent research support from the same award. – 1 -2 years of mentored support for highly promising, postdoctoral research scientists followed by up to 3 years of independent support contingent on securing an independent research position 12

“There is no grantsmanship that will turn a bad idea into a good one, but… There are many ways to disguise a good one. ” - Dr. William Raub, Former Deputy Director, NIH

Winning over Reviewers • Develop a focused application with explicit goals • Provide a mechanistic basis for your approaches (if possible) May not be biological! • Raise interesting and important question (clinical/basic) and propose a direct solution • Discuss your proposal in the context of previous studies, current clinical practice • Write to your likely peer-review audience in a style that is logical, interesting and readable • Revisions – Be persistent! Respond to previous critiques

Considerations for Rehabilitation Research • Focus on individual rather than cell/tissue/organ • Addresses longer time frame • Considers functional outcomes, participation, and quality-of-life • Must consider the interaction of subject with their environment • Ecological validity: dealing with treatments in “realworld” settings (e. g. home, community) • Is there a “significant” difference? Statistically significant vs clinically significant 15

Considerations for Rehabilitation Research • What is the “active ingredient” in your therapy and how do you operationalize it? • What are appropriate “control” groups • Importance of blinded assessors and appropriate outcome measures • Recruitment and support strategies • Human subjects issues: safety, confidentiality, heterogeneity among subjects & in response, inclusion/exclusion criteria • “Power calculation” to determine adequate numbers of subjects needed based on likely effect size and inherent variability 16

NIH Resources Medical Rehabilitation Research Infrastructure (MRRIN) Sponsored by NICHD/NCMRR, NINDS, NIBIB www. ncmrr. org Centralized research infrastructure in specific domains, especially appropriate for young rehab researchers Seven centers across the country provide: State-of-the-art research facilities Courses and workshops Mentorship and consultations Pilot grants and other collaborative opportunities

Current MRRIN Centers • Eric Hoffman, Children’s National Med Washington, DC: molecular genetics and proteomics • Rick Lieber, UCSD: muscle physiology and function • Scott Delp, Stanford Univ: modeling and simulation • Zev Rymer, Rehab Inst Chicago: bioengineering and robotics • Alan Jette, Boston Univ: outcomes measurement • Ken Ottenbacher, UTMB: analysis of large datasets • Rick Greenwald, Simbex & Dartmouth Univ, NH: technology assessment & product development

You are Encouraged to Contact NIH staff • Look through websites of NIH Institutes to identify appropriate Program Officials • As introduction, email your abstract and specific aims • You can discuss potential grant mechanisms, funding initiatives, and Institute and Study Section assignments • After the review, program official can help interpret your summary statement and likelihood of funding • But funding decisions are largely driven by you getting the best possible score from the study section

Shutdown Updates • Thank you for your patience • Thank you for working with us on rescheduling review meetings • Over 200 review meetings are being rescheduled for 11, 000 applications • Receipt Dates have been shifted

Changes to NCMRR

Leadership • Mike Weinrich, Director of NCMRR, has moved to a new role as Senior Advisor to the NICHD Director for Device Development, Biotechnology, and Bioengineering. • A national search for a new Center Director will begin soon. • Ralph Nitkin is serving as Acting NCMRR Director.

NIH Blue Ribbon Panel • Empanelled in 2011 by the NICHD director and the NIH director, but reporting to the NICHD director alone • A response to concerns from the rehabilitation research community • A working group of NICHD’s Council and NABMRR

Blue Ribbon Panel Roster • • • John Chae (Co-chair; PM&R, CWRU) Rebecca Craik (Co-chair; PT, Arcadia Univ) Tom Buchanan (Mech Engineering, U Delaware) Steve Cramer (Neurology, UC Irvine) Tony Delitto (PT, Univ. of Pittsburgh) Walter Frontera (PM&R, Vanderbilt) Lynn Gerber (PM&R, George Mason) Rick Greenwald (Biomed Engineering, Simbex LLC, Dartmouth) Alan Jette (PT, Public Health, BU) Michael Johnston (Neurology, Pediatrics, Hopkins) Randy Nudo (Molecular & Integrative Physiology, Kansas) Ken Ottenbacher (OT, Univ. of Texas Medical Branch)

Charge to the Blue Ribbon Panel • While focusing on NCMRR, assess the state of rehabilitation research across the NIH; what are the scientific opportunities for rehabilitation medicine across the NIH and how are they best realized? • What could NCMRR and NIH do to better catalyze and support rehabilitation research? – Functionally – Structurally

The Panel’s Work • Reviewed authorizing legislation for NCMRR • Analyzed funding levels and trends at NICHD • Learned about rehabilitation portfolios at other institutes and centers (ICs) • Gathered input from NICHD, staff from many other ICs, and the trans-NIH rehabilitation research coordinating committee • Interviewed leadership of selected NIH coordinating bodies (ORWH, OAR, etc. ) • Released final report in December 2012

“Critical Need” To substantially increase all aspects of rehabilitation research across the continuum of translational research in order to meet the growing rehabilitation needs of Americans

BRP Report: Our Main Take-Aways • Need for better coordination across NIH to identify and pursue opportunities and to reduce duplication • Desire of the BRP for NCMRR to have more independence and a dedicated budget • Opportunity for NCMRR and its advisors to play a greater role, both in coordination and visionary guidance

Response: A New Funding Model • NCMRR would support: – Primarily through co-funding with ICs: • Research project grants – most RPGs would be supported jointly with other ICs, with limited funds for direct NCMRR support – Both through co-funding with ICs and directly: • • Research infrastructure Training and career development Conferences SBIR/STTR applications

Response: Funding Model, cont. • NCMRR would have dedicated funding: 7. 0% of NICHD’s extramural funds (a modest increase over last five years’ average) • Note that NICHD would fund some rehabilitation research (pediatric, obstetric, gynecologic, etc. ) through its other extramural programs, and - like any NIH institute or center potentially with NCMRR co-funding

Response: What Does Not Change • NCMRR remains placed within NICHD • Current grants will spend out their remaining time at NICHD, but renewals may need to find new homes at NIH

Response: Important Additional Aspects • NCMRR staff will focus more on coordination, catalyzing, etc. and less on grants administration than previously • NABMRR, reflecting stakeholder communities, would help provide strategic thinking • We need to ensure that all rehabilitation researchers have appropriate “homes” at some specific IC(s)

Roll Out • No timeline yet, but an NIH Guide notice will inform the research community

Summary • Much stays the same, but much changes • Designed to increase NCMRR’s ability to be a leader in the field • NIH is committed to funding rehabilitation research

Thank you! Questions? Theresa Hayes Cruz cruzth@mail. nih. gov