Part 1: A Conversation with Funding Agencies · 2018-12-27 · Naomi Kleitman, PhD Sr. Vice President Craig H. Neilsen Foundation chnfoundation.org Why bother with foundations? Diversify

Research Funding Symposium 1/24/2019

This information is the property of the speakers and should not be copied or otherwise used without express written consent of the authors. 1

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d. Research Funding Symposium

Part 1: A Conversation with Funding Agencies

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SpeakersGeorge Washington University/Moderator: David Scalzitti, PT, PhD

Neilsen Foundation: Naomi Kleitman, PhD

Foundation for Physical Therapy: Stuart Binder-MacLeod, PT, PhD, FAPTA

APTA: Robyn Watson Ellerbe, PhD

NIDILRR: Leslie Caplan, PhD

VA: Karen Siegel, PT, MA

NIH: Theresa Cruz, PhDAmanda Boyce, PhDLyndon Joseph, PhD

Ralph Nitkin, PhD

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Disclosure

No relevant financial relationships exist

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Session Description

This session is the first of 2 sessions on research funding for novice and experienced researchers. This session will focus on a discussion of

various opportunities for research funding. The speakers, including representatives from various foundations, the National Institutes of

Health (NIH), and other Federal agencieswill present the latest information on extramural research programs, current research

initiatives, and opportunities for training and career development. A panel discussion and opportunities for one-to-one conversations will

follow the individual presentations.

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Learning Objectives

• Identify research areas supported by these foundations, agencies, institutes, and centers.

• Recognize current funding initiatives relevant to exercise, physical function, aging, rehabilitation, and technology.

• Discuss opportunities for research training and career development.

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d. www.pollev.com/drscal



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Research Agenda forPhysical Therapy

Phys Ther. 2011:91:165-174

Foundations and Philanthropy

Naomi Kleitman, PhDSr. Vice President

Craig H. Neilsen Foundation

chnfoundation.org

Why bother with foundations?Diversify your portfolio, add flexibility• Funding to generate pilot data, small studies and pilot trials

• May favor postdoctoral or predoc opportunities, including non-US citizens

• Foundation cultures offer insight and experience with the people your research is meant to help

– They advocate for research; may help recruit for trials; opportunities to meet people with disorder(s) of interest

• Other non-federal opportunities:– State or local agencies (e.g., state traffic‐ticket funds for trauma research); may be

limited to in‐state

About foundations & public charitiesNot-for-profit; purpose is aid to serve public good Aka “non-governmental organizations” (NGOs), “voluntaries”May be tax-exempt; Section 501(c)(3) of IRS Code

Private Foundation vs. Public Charity• Both serve public interests: charitable, educational, religious, etc.

‒ Private grant‐making fdns mostly fund other NGOs/nonprofits; have stricter IRS restrictions and disclosure rules

‒ Public charities make grants to individuals, other organizations and/or may provide direct services

• Source of Assets/Income‒ Private foundations receive the majority of their money from only one individual,

family or corporation‒ Public charities have a broad‐base of support from the general public as well as

variety of other funding sources.

Where to find foundation opportunities• Ask advice from your mentors and colleagues

• Look at acknowledgments research papers & talks

• Consult with your Grants & Contracts Office:

– May offer introductions to philanthropy reps

• Look for Foundation staff at national meetings, booths

• Subscribe to newsletters/listservs about funding opportunities (e.g., Community of Science)

• Google “Brain Research Funders”

– www.insidephilanthropy.com/grants‐brain‐science‐disease/– Muscular Dystrophy Association, ALS Association, Brain Research Fdn…

Foundations you might considerMay be disease specific or fundamental neurosci

• American Heart Association (stroke)

• Muscular Dystrophy Association

• National Multiple Sclerosis Society

• Craig H. Neilsen Foundation (SCI)

• Wings for Life or Spinal Research (SCI, Europe)

• Cerebral Palsy International

• Robert Wood Johnson Foundation (health)

• James S. McDonnell Foundation (cognition)

• Dana Foundation (brain research)etc., etc.



What to look for – Is it a good fit???Their mission, goals, interests• Types of funding, eligibility

– Geographic, career stage, citizenship, institution type

– Who reviews for them? Funding strategy, history?

• Follow their instructions, timeline, procedure

– Pre-application process (Letter of Intent)

– Read their website, then contact staff with questions

Don’t waste their time, or yours• If it isn’t a good fit, look elsewhere• Don’t overwhelm them in details• Don’t waste space on what they already know• If it is a good fit, build the relationship

– If asked, help out with advice or as a reviewer

Find out how they do businessUnderstand their timeline, receipt dates, and especially their application procedures

• Go to their website, Talk to a foundation representative: What types of applications are they seeking?

• Ask about pre-application procedures: Letter-of-intent or other formalized invitation?

• Are there geographical constraints?

• Is their funding research vs. patient services & support?

• Do they fund equipment, supplies, or salaries?

Caveat: most fdns limit indirect rates, if any– Check to be sure your institution will accept

How do foundations review?Reviews vary. Family fdns/donors may prioritize personal interactions but larger fdns have a peer-review processes

Unlike NIH, but like VA & NSF, foundation staff may serve in both Programmatic and Review roles

• Reviewers are people with broad expertise; may be consumers – May be more focused and/or less technical at a disorder-based fdn

• Mission relevance– Is your work relevant to their mission? If new to their field, do you need a collaborator to

succeed in the foundation’s area of interest? – Training goal is to cultivate their field – Fellowships should augment your training, your

expertise, host lab’s expertise. Is your mentor strong, funded, experienced? Consider a Co-mentor

• Preliminary data: is it a question of feasibility or risk?– Foundations may help you get preliminary data to de-risk a project, so long as it’s a feasible

test of the hypothesis

How to increase your chances

Help Reviewers do their job Make it reader-friendly

– Emphasize understandable significance & rationale

– Foundations need to address their impact in lay terms• Write abstracts (especially lay abstracts) in terms that inspire an educated and

insightful non-expert

• State things explicitly – don’t assume readers will “know what you mean” – review may include advocates

• But don’t waste much space on boilerplate about the foundation’s primary disorder – they know the prevalence, etc.

– Address all major review criteria

– Don’t be sloppy; follow the directions

– Give an explicit, realistic timeline

Advice on working with foundations*Understand their mission, culture, and goals• Try to discuss your interests with a foundation rep

– If appropriate, include a cover letter reviewing any previous contacts and your invitation to apply

• Follow their instructions and timelines

• How would their funds be leveraged by your other resources?

Don’t drown them in technical details

Foundations’ review processes vary widely: – Find out who’s on the panel: researchers or advocates/trustees?

– What topics have they funded in the past?

– May not be transparent; may not even get feedback

– If invited to revise/reapply, your application may go to a different review group than the first time

*C t f D R l h Nitki

About the Neilsen Foundation

• Mission – Funding is dedicated to supporting both programs and scientific

research to improve the quality of life for those affected by and living with spinal cord injury

• Our funding focus is SCI

– Research: cells to psychosocial; dishes to animals to people

– Programs (sports, health, education, jobs…)

– Scholarships, SCI Medicine Fellowships

– Special Projects

• Our portfolios currently fund ~$22M/yr

– Fully endowed private fdn, don’t fundraise



Neilsen Foundation portfolios

http://chnfoundation.orgLists staff and review boards; Searchable grants database

• SCI Research on the Translational Spectrum (SCIRTS)

• Psychosocial Research

• Creating Opportunity & Independence – Program resources and options for people with SCI

• SCI Medicine Fellowships

• Neilsen Scholarship Program – For students w/ SCI

We prioritize SCI relevance

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Funding Opportunities 2019 The Foundation for

Physical Therapy Research

Presenter:

Stuart Binder‐Macleod, PT, PhD, FAPTA Foundation Trustee

Introduction

Mission:The Foundation for Physical Therapy Research funds research and develops researchers to optimize movement and health.

Vision:Shaping the future of healthcare through physical therapy research.

History:Celebrating 40 years of funding physical therapy research and researcher.Awarded over $17M to more than 530 researchers Awardees have acquired over $804M in add-on funding

BUILDING THE FOUNDATIONOur ModelWe identify the best qualified applicants for grants, scholarships and fellowships.These innovative researchers advance care across medical disciplines and patient populations.

Our Mechanisms:

Promotion of Doctoral

Scholarships (I & II)

New Investigators Fellowship

Training Initiative (NIFTI)

Research Grants

Eligible Applicants:

Pre-Candidacy PhD Students

PhD Candidates Postdoctoral

FellowsEmerging Investigators through

Experienced Investigators

< than 5 years since PhD awarded



Predoctoral Scholarships

Promotion of Doctoral Studies (PODS) I:

● $7,500 for 1 year

● Can be awarded 2 times to same applicant in different years

Promotion of Doctoral Studies (PODS) II:

● $15,000 for 1 year

● Can be awarded 2 times to same applicant in different years

Learn more at Foundation4pt.org/funding-opportunities/scholarships/

Postdoctoral Fellowships

New Investigator Fellowship Training Initiative (NIFTI):

$100,000 for 2 years

Can only be awarded once per applicant

Can focus on any topic in PT, including health services

research

Learn more at Foundation4pt.org/funding-opportunities/fellowships/

Research GrantsFall 2019 Research Grant Funding Opportunities:

● Foundation Research Grant: $40k to emerging investigator to research any area

related to physical therapy

● Health Services Research Pipeline Grant: $50k for 1 year to anyone wishing to study

HSR and health poilcy related to PT

● Magistro Family Foundation Research Grant: $100k to anyone looking to

evaluate the cost- effectiveness of interventions delivered by PTs

● Pediatrics Research Grant: $40k to emerging investigator seeking to conduct

research consistent with APPT's research agenda

● Women's Health Research Grant: $40k to emerging investigator seeking to

advance research in abdominal and pelvic health PT● Goergeny Research Grant: $240-360k over 2-3 years to anyone researching manual

therapy and the musculoskelatal system

Learn more at Foundation4pt.org/funding-opportunities/research-grants/

*NEW in Fall 2019

Research Grants Continued

Other Research Grant Funding Opportunities:● Geriatric Research Grant: $40k to emerging investigator for research focused on the

development of feasible, effective, and sustainable interventions to be implemented

in older adults

● Orthopaedic Research Grant: $40k to emerging investigator exploring clinical

outcomes of physical therapy practice for patients with musculoskeletal conditions

● Paris Patla Musculoskeletal Grant: $240-360k over 2-3 years to anyone researching

manual therapy and the musculoskelatal system

● Moffat Geriatric Research Grant: $40k to emerging investigator evaluating

effectiveness of physical therapist examinations and/or interventions in geriatric

populations

● Snyder Research Grant: $40k to support relevant clinical research projects

Learn more at Foundation4pt.org/funding-opportunities/research-grants/

Health Policy & Services Research

Learn more at www.bu.edu/cohstar/

Health Services Research Pipeline Grant:

● (2018): Beth McManus at the Colorado School of Public

Health

● Funding provided by APTA

Center on Health Services Training & Research (CoHSTAR):

● Brown University (PI: Linda Resnik)

● Boston University● University of Pittsburgh

Offers Pilot Studies, Visiting

Scientists & Postdoctoral &

Faculty Fellowships

Our Funding Research

Total Awards Distributed868

$17 Millionawarded in grants, fellowships, andscholarships

$804 Millionin follow-on funding awarded to foundation researchers

530+ Researchersfrom 41 states and D.C.



Best Practices for Funding Applications?

Thank You!

@foundation4pt/foundation4pt www.foundation4pt.org

ATTEND TO FIND OUT!

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APTA Research Funding Opportunities

Robyn Watson Ellerbe, PhDAPTA Vice President, [email protected]

APTA Combined Sections MeetingWashington DCJanuary 24, 2019

APTA & Research DepartmentAPTA: The mission is to build a community that advances the profession of physical therapy to improve the health of society.

Research Department: The mission is to deliver research services, guidance and material assistance to the Association; support research efforts within the Profession; and provide operational oversight to the Physical Therapy Journal.

Health Services Research Pipeline Grant• In collaboration with the Foundation for Physical Therapy

• $50,000 one year grant

• Designed to support fundamental, exploratory, and explanatory studies that investigate the impact social factors, financing systems, health policy, organizational structures and processes, health technologies, and personal behaviors have on access, clinical outcomes, utilization, and/or distribution

• https://foundation4pt.org/funding‐opportunities/research‐grants/all‐research‐grant‐information/

Purpose: Promote academic excellence and advance research that improves physical therapist education and practice, payment strategies, and policy advocacy, by funding a research fellowship.

• 2 Fellowship Opportunities; Emerging Investigator or Postdoctoral; One or more awarded per year

• 2015‐2016: Megan Warren, PT, MPH, PhD; Associate Professor; Northern Arizona University

• 2018‐2019: Mary Jane Rapport, PT, DPT, PhD, FAPTA; Professor; University of Colorado

• 2018‐2019: Heidi Kosakowski PT, DPT; Professor; Peruvian University of Applied Sciences, San Pedro University

http://www.apta.org/APTAJobs/Fellowship/

APTA Visiting Scholar Fellowships



Grantsmanship and Mentorship in Education Research (GAMER)

A 4 day grant‐writing workshop for education researchers that emulates the successful model used by The Intensive Grant Writing Workshop (TIGGR) which results in many junior investigators receiving NIH and other funding.

Collaborative Research Studies

APTA/United Healthcare/OptumLabs: A study on the potential impact of early physical therapy and other nonopioid strategies to address low back pain. Thanks in part to that study, United Healthcare is exploring possible policy changes that would make it easier—and less expensive—for patients to see PTs

Physical Therapy Outcomes Registry

Payment

Quality

Research

Practice

• Inform payment contract

negotiations• Guide payment

policy

• Fulfill quality reporting requirements

• Support quality improvement

initiatives

• Track performance of care delivery and documentation patterns

• Assess adherence to CPGs

• Drive health services research initiatives

• Demonstrate value of physical therapist services

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National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR)

Administration for Community LivingU.S. Department of Health and Human Services

Leslie Caplan

American Physical Therapy Association, 2019



Overview

• NIDILRR Mission

• NIDILRR’s Approach to Disability, Independent Living, and Rehabilitation Research

• What NIDILRR Funds

• NIDILRR Funding Mechanisms

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NIDILRR Mission

To generate new knowledge and to promote its effective use to:

• improve the abilities of individuals with disabilities to perform activities of their choice in the community;

• and to expand society’s capacity to provide full opportunities and accommodations for its citizens with disabilities.

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NIDILRR’s Approach to Disability, Independent Living, and Rehabilitation Research

• Reflected in the mission statement

• The goal: to simultaneously optimize the rigor of research and the relevance of that research to the lives of people with disabilities

• Important concepts:

• “Nothing About Us Without Us”

• Social Model of Disability• Importance of Community Living Outcomes

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What Kind of Research Does NIDILRR fund?

• NIDILRR funds applied research and development from many disciplines, in three targeted outcome domains that are important in the lives of people with disabilities:

– Health and function

– Employment

– Community living and participation

• Many grants are cross‐domain, cross‐disciplinary

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NIDILRR Grant Mechanisms

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Switzer Fellowship Program– Awards to the individual rather than to the institution– One‐year awards – Topic, methods, etc., proposed by applicant– “Merit”

• Most grantees are early‐career PhDs• Up to $70,000

– “Distinguished”• Must have terminal degree• Must have seven years experience in disability/rehabilitation research• Up to $80,000

– Competition every year

Example (Distinguished): Family‐Clinician Collaboration to Improve Neglect and Rehabilitation Outcome After Stroke48



Advanced Rehabilitation Research Projects– Provide advanced rehabilitation research training at post‐doctoral level– ARRTs in all three outcome domains– Awards made to institutions of higher education institutions only– Must provide interdisciplinary training– Up to $150,000 per year– Five‐year awards– Competition every year

Example: Advanced Rehabilitation Research Training in Neuromuscular and Neurodevelopmental Disorders

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Field‐Initiated Projects– Topic, methods, outcome domain, target population, etc.

proposed by applicant– May be for research or development projects– Up to $200,000 per year– Three‐year awards

Examples: ‐Efficacy of an Interactive Web‐Based Home Therapy Program in the Recovery of Arm and Hand Following Stroke: A Randomized Trial ‐Environmental Barriers and Facilitators to Assisted Toilet Transfers by People Aging with Disability and their Spousal Caregivers

50

Disability and Rehabilitation Research Projects (DRRPs)

– Projects emphasize research, development, dissemination, technical assistance

– May be for research or development– Some agency‐initiated, some field initiated– NIDILRR may specify the general area– $300,000–$1,246,000 (specified by NIDILRR)– Up to five years– Announcements as needed– Example: Dose‐Response Effects of Transformative Exercise in Improving

Health and Function in Adults with Stroke and Multiple Sclerosis51

Rehabilitation Research and Training Centers (RRTCs)

– Advanced programs of research– Multiple projects

– Some agency‐initiated, some field initiated in broad areas– Focus on new knowledge– Research training, dissemination, and technical assistance required– Affiliation with institutions of higher education– $650,000−$950,000 per year (typically around $850,000)– Five‐year awards – Announcements as needed– Example: Rehabilitation Research and Training Center (RRTC) on Promoting

Healthy Aging for People with Long‐Term Physical Disabilities

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Rehabilitation Engineering Research Centers (RERCs)

– Advanced research & development of an engineering or technical nature– Multiple projects– Some agency initiated, some field initiated in broad areas of rehabilitation engineering– Emphasis on technology transfer– Affiliation with institutions of higher education– $900,000−$950,000 per year (specified by NIDILRR)– Five‐year awards– Announcements, as needed

Examples:

RERC on Exercise and Recreational Technologies for People with Disabilities

Improving Health and Function Through Use of Performance Standards in Wheelchair Selection

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Model Systems:– Traumatic Brain Injury (16 centers + follow‐up centers)

– Spinal Cord Injury (14 centers + follow‐up centers)

– Burn Injury (4 centers)

– Longitudinal data collection within each network: centers submit participant data to central database. Data collected on pre‐injury, acute care, rehabilitation, and outcomes at regular subsequent intervals (1, 2, 5, 10 years post‐injury, every 5 years thereafter)

– Each center conducts site‐specific research, as well as collaborative research with other members of the network

– Five‐year awards (centers and data centers)

– Center and non‐center investigators publish research based on data in the database

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Small Business Innovation Research (SBIR)– Products that improve the lives of persons with disabilities– Phase I

• Develop prototypes, models, proofs‐of‐concept• Up to $100,000 for six months• Competitions every year

– Phase II• Substantial R&D toward bringing products to commercialization• $200,000−$300,000 per year• Awards for two years

Example (Phase II): Development of a Wearable Robot for Motor Rehabilitation in Acute Stroke

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For Further Information• ACL’s website: https://www.acl.gov/

• For more information about current and past NIDILRR grants

– http://naric.com/

• To learn more about NIDILRR grant mechanisms:

– https://www.acl.gov/programs/research‐and‐development/

• To find information about announcements:

– Subscribe to NIDILRR grants announcement emails: https://www.naric.com/?q=node/33

– Check grants.gov, entering “NIDILRR” in the search box

• To learn about applying for grants: (note that NIDILRR grants are ‘competitive grants’):

– https://www.acl.gov/grants/applying‐grants

• Contact me: Leslie Caplan

– [email protected]

– 202‐795‐7321

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VA Office of Research and DevelopmentProgram Overview

Karen Lohmann Siegel, PT, MADeputy DirectorRehabilitation Research and Development Service

Combined Sections Meeting | Washington, DC | January 24, 2019

VETERANS HEALTH ADMINISTRATION

Veterans Health Administration

• Largest integrated health care system in the nation

• 170 medical centers, > 90 with research

• More than 1,200 sites of care nationwide

• More than 53,000 independent licensed health care practitioners

• About 9 million Veterans receive care per year;over 90 million outpatient visits

• Largest single provider of graduate medical education

• Supports unique intramural research program focused on Veterans' needs ($779M in FY 2019)

2017 Most Prevalent Service-Connected Disabilities of

All Compensation Recipients (n=4.5 M)

1. Tinnitus 2. Hearing loss 3. Post-traumatic stress disorder 4. Scars, general 5. Lumbosacral or cervical strain 6. Limitation of flexion, knee 7. Paralysis of the sciatic nerve8. Limitation of motion of the ankle 9. Migraine10.Degenerative arthritis of the spine

Source: VBA Annual Benefits Report Fiscal Year 2017https://www.benefits.va.gov/REPORTS/abr/docs/FY17-Compensation.pdf


Office of Research and Development (ORD)

Under Secretaryfor Health

Deputy Under

Secretary for Discovery, Education and Affiliate Networks

Chief Research and

Development Officer

Biomedical Laboratory R&D

Clinical Science R&D

Cooperative Studies Program

Health Services R&D

Rehabilitation R&D

BLRD: basic biological or physiological principles in animals or humans not involving intact human beings

ORD Mission: To discover knowledge and create innovations that advance the health and care of Veterans and the nation

CSRD: clinical, epidemiological, interventional and effectiveness studies

HSRD: health care organization and delivery health care quality, access, outcomes and value

RRD: develop and test novel approaches to maximize function and independence of Veterans




VA PrioritiesAgency Level

• Customer Service

• MISSION Act Implementation (Community Care/Caregivers)

• Business Transformation

• VA/DoD Collaboration (EHR, Suicide)

Health System Level

• Restore Trust

• Create a Learning Organization

• Modernize Systems


ORD Priorities


RR&D Special Emphasis Areas

• Prosthetic needs of Women Veterans with amputations

• Exoskeleton Research, including externally powered motorized orthoses for Veterans with stroke, traumatic brain injury or other non-SCI/D diagnoses

• Non-pharmacological activity-based interventions for chronic pain impacting outcomes that may include pain reduction, medication use, ADL, and QoL

• Substance use disorder, particularly opiates, on long-term outcomes from Traumatic Brain Injury


• RR&D mission: generate knowledge and innovations to advance the rehabilitative health and care of Veterans and the nation. In support of this mission, RR&D strives to effectively integrate preclinical, clinical and applied rehabilitation research and translate research results into practice.

• Scientific Program areas:– Spinal Cord Injury/Disorders and Pain

– Regenerative Rehabilitation

– Brain Health and Injury

– Musculoskeletal Health and Function

– Sensory Systems and Communication Disorders

– Behavioral Health and Social Reintegration

– Rehabilitation Engineering, Prosthetics/Orthotics

– Chronic Medical Conditions and Aging

https://www.rehab.research.va.gov/guid/meritreview.html

Rehabilitation Research and Development (RR&D) Scientific Program Areas

47

27

77

7538

70

4625

# FY18 RR&D Applications


ORD Funding Eligibility• Principle Investigators must

– Hold VA 5/8ths salaried appointment when funded (promise of appointment sufficient to apply)

• Co-Investigators– No minimum on VA appointment

• Proposed research must be– Conducted at a VA facility

– Relevant to Veterans (e.g. pediatric disorders likely not appropriate)

• Submitting a Letter of Intent (LOI) is often the first step in the review process


ORD Award Types

VA is an intramural research program, no “granting” authority • Merit Awards (I01)

– Up to 4 years, $275M/year, $1.1M($350K allowed in 1 year if within other limits)

• Small Projects in Rehab Research (SPiRE)* (I21)

– 1-2 years, $100K/year

• Career Development Program (IK1*, IK2)

– Up to 5 years of salary support, project funds

• Research Career Scientists (IK6)

– 5 - 7 years, salary support

• Research Award Enhancement Program/Centers* (I50)

– 5 years, $315 or $900K/yr

• Other

– Fellowships, Special Recognition * RR&D only award

220

55

73

2417 16

FY18 RR&D # Active Awards

13%23%

22%16%

26%33%

0

50

100

150

200

1 2 1 2 1 2

# Apps

RRD Funding Success ‐ Last 2 Cycles

SubmittedFunded

SPiRE Merit Career




CDA Award Types: Eligibility and Conditions

CDA-1 (RR&D only) CDA-2 HBCU-RSTP

Cliniciansalary

9 calendar monthsplus 1/8th from VAMC

6-9 calendar monthsplus 1/8th from VAMC

6-9 calendar months plus 1/8th from VAMC

Non-clinician salary

7.5-12 calendarmonths



Project funds

None – work with mentor

$65K/yr for independent work

$65K/yr for independent work

Award duration

Up to 2 years 3-5 years 3-5 years

Eligibility Max of 2 years beyond completion of training

Max of 5 years beyond completion of training

CDA-2 plus mentors at both HBCU and VA


Resources

• Contact VA colleagues, mentors, and program staff

• VA site research office (they submit applications on behalf of the PI)

• ORD website http://www.research.va.gov/– Important Resources

– Submission Guidelines

– Eligibility Requirements

– Links to RFAs on ORD intranet (if not VA, candidate can obtain from VA mentor/co-investigator)

• Search NIH RePORTER http://report.nih.gov/and Clinical Trials.gov http://clinicaltrials.gov/ for VA funded studies


• Handbooks: select under General ORD Policieshttps://www.research.va.gov/resources/policies/

• Career Development Programhttps://www.research.va.gov/funding/cdp.cfm

• Rehabilitation Research & Development https://www.rehab.research.va.gov/

• Health Services R&Dhttps://www.hsrd.research.va.gov/

• Biomedical Laboratory R&Dhttps://www.research.va.gov/services/blrd/default.cfm

• Clinical Science R&Dhttps://www.research.va.gov/services/csrd/default.cfm

Contacts


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National Center for Medical Rehabilitation Research,

National Institutes of Health

Theresa Cruz, PhD



National Institutes of Health

• Mission: Seek fundamental knowledge about the nature & behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability

• Organizationally constituted by the Office of the Director and 27 Institutes and Centers

2017 Total Funding ($M)

National Center for Medical Rehabilitation Research

• Established in 1990 within NICHD to promote rehabilitation research within the NIH, coordinate efforts of the ICs, and promote collaboration with other federal agencies.

• Provide for funding of research projects, career development, small business grants, and research infrastructure.

• Lead for:• Trans NIH Medical Rehabilitation

Coordinating Committee• Rehabilitation Research Plan• Federal Interagency Coordination

NIH Research Plan on Rehabilitation1) Rehabilitation Across the Lifespan

2) Community and Family

3) Technology Use and Development

4) Research Design and Methodology

5) Translational Science

6) Building Research Capacity and Infrastructure

https://www.nichd.nih.gov/publications/pubs/Documents/NIH_ResearchPlan_Rehabilitation.pdf

Applying to the NIH

• Majority of funds are directed to investigator-initiated applications

• Funding decisions are largely drive by peer review scores

• Three annual due dates: early February, June, and October

• Electronic submissions with a timeline of about 9 months from submission to funding

• Ensure you are directing your proposal appropriately

• Which Institute supports this area of research• Which study section has the most appropriate

expertise

NIH Review Criteria

• Significance

• Investigator

• Innovation

• Approach

• Environment

• New policies: Rigor & Reproducibility



Resubmissions

• Do not retreat after a single submission….• Build in time for resubmission• Make sure you understand the message in the summary statement:

• Did they “get” the proposal?• Were they interested?• Which are the major and which are the minor crticisms?• Do they really want to see it again?

• Talk to NIH staff• Let colleagues/mentors read the critiques and give feedback• Don’t rush the response – only one resubmission – take the time to improve and

update the application• Be collegial in response

Funding Opportunities*

• http://grants.nih.gov/grants/funding/funding_program.htm - *For full listing & description

• https://researchtraining.nih.gov – For links to research training, career guidance, and strategy

F•Fellowship•Individual Awards (NRSA)

K•Career Development

•Individual•Institutional

R•Research Projects

P•Program Project

•Center Grants

U•Cooperative Agreements

Specific Funding Opportunity Announcements

• Research To Address Sleep Disorders in the Context of Medical Rehabilitation (R01): March 29, 2019

• NICHD Research Education Programs (R25): May 25, 2019

• NCMRR Early Career Research Award (R03): March 29, 2019

• NOITP: P2C

Clinical Trials Policy

Clinical Trials: Why the changes?

BMJ. 2012; 344: d7292. Published online 2012 Jan 3. doi: 10.1136/bmj.d7292

NIH Might Consider Your Human Subjects Research to be a Clinical Trial

Does your study… Involve one or more human subjects?

Prospectively assign human subject(s) to intervention(s)?

Evaluate the effect of intervention(s) on the human subject(s)?

Have a health-related biomedical or behavioral outcome?

If “yes” to ALL of these questions, your study is considered a clinical trial

Unsure how to answer the questions? We have a tool that can help! https://grants.nih.gov/ct-decision/



Why do I need to know whether my study is a clinical trial?

• It impacts whether you need to:√Respond to a clinical-trial specific FOA (Due dates on or after

January 25, 2018)√ Take Good Clinical Practice Training√ Address additional review criteria specific for clinical trials (study

timeline & milestones)√Use new Application Packages (FORMS-E; due dates on or after

January 25, 2018)√Register and report your clinical trial in ClinicalTrials.gov (effective for

applications due on/after January 18, 2017)

Find the Right Funding Opportunity Announcement (FOA)

How to determine if an FOA accepts clinical trials?

1. Refer to Section II. Award Information

2. Indicated in FOA title (new FOAs only)

Tip: Check your FOA at least 30 days before the due date for any updates

All clinical trial applications MUST be submitted to an FOA that allows clinical trials

Due Dates on or after January 25,

2018

Good Clinical Practice (GCP) Training

All NIH-funded investigators involved in the conduct, oversight or management of clinical trials

Investigators are expected to receive Good Clinical Practice training

To assure the safety, integrity, and quality of clinical trials

Through a class or course, academic training program, or certification from a recognized clinical research professional organization

Effective January 2017. Training should be refreshed every 3 years

Who:

What:

How:

When:

Why:

See https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm

Clinical Trial Specific Review CriteriaNOT-OD- 17-118

FOAs will include additional criteria:Scored Review Criteria

Significance

Investigator

Innovation

Approach

Environment

Additional Review Criteria Study Timeline & Milestones

Read the FOA carefully and be sure your

application addresses the review criteria appropriately

Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov

All clinical trial applications requesting support for a trial that will be initiated on/after January 18, 2017

Register and report the results of trials in ClinicalTrials.gov

Increase the availability of information about clinical trials and their results to the public in a timely manner

Effective for applications due on/after January 18, 2017

Who:

What:

When:

Why:

See https://grants.nih.gov/policy/clinical-trials/reporting/steps htm

Single Institutional Review Board (sIRB) Policy for Multi-site Research

Domestic multi-site non-exempt human subjects research studies will require a single IRB of record

Key Dates

• Grants: Applications due on or after January 25, 2018

• Contracts: Solicitations published starting January 25, 2018

Exceptions

• sIRB not applicable for Career Development (K), Research Training (T), or Fellowship (F)

See https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm



But what about Basic Experimental Studies with Humans (BESH)?

Learn more at https://grants.nih.gov/grants/policy/faq_clinical_trial-specific_FOAs.htm?select=guide#5700

New date: September 24, 2019

Scope of New FOAs

FOAs designated as “Basic Experimental Studies with Humans”

Studies that prospectively assign human participants to

conditions (i.e., experimentally manipulate independent

variables) and assess biomedical or behavioral outcomes in

humans for the purpose of understanding the fundamental

aspects of phenomena without specific application towards

processes or products in mind.

Comparing FOA Types

• Basic Experimental Studies with Humans Required• Studies that prospectively assign humans to conditions for the purpose of

understanding the fundamental aspects of phenomena

• Clinical Trial Required• Prospective studies with humans conducted with specific applications towards

processes or products in mind, including FDA Phase 0 or 1 studies

• Mechanistic clinical trials (i.e., studies that examine the mechanisms by which an intervention works)

• Safety and efficacy studies

• Clinical Trial Not Allowed• Observational studies with human participants

Delayed Enforcement: What it means

• Delayed enforcement of registration and reporting in ClinicalTrials.gov for basic experimental studies involving humans

• NIH still expects registration and results reporting

• Providing recipients the flexibility to report results on other portals instead of ClinicalTrials.gov.

• Delay through September 24, 2019

Resources• NCMRR webpage: https://www.nichd.nih.gov/about/org/ncmrr/

• Join the Rehabilitation Research Listserv: https://www.list.nih.gov; rehab-nih

• NIH Homepage: www.nih.gov

• NIH Clinical Trials page: https://grants.nih.gov/policy/clinical-trials.htm

• NIH Reporter: Database of all NIH-funded grants searchable by topic or institution/locale http://projectreporter.nih.gov/reporter.cfm

• Center for Scientific Review: Study section descriptions and rosters www.csr.nih.gov

• Videos on NIH Peer Review: http://cms.csr.nih.gov/ResourcesforApplicants/InsidetheNIHGrantReviewProcessVideo.htm

• NIH Guide for Grants and Contracts (weekly notification) http://grants.nih.gov/grants/guide/listserv.htm

• NIH SBIR/STTR Notification: Send email to [email protected] with the following text in the message body: subscribe SBIR-STTR your name.

Questions



NIA’s Mission: To improve the health and well‐being of older Americans through research

Support and conduct high‐quality research on: Aging processes Age‐related diseases Special problems and needs of the aged

Foster the development of research and clinician scientists in aging.

Develop and maintain state‐of‐the‐art resources to accelerate research progress

Disseminate information on health and research advances and on new directions for research

NIA Strategic Directions for Research on Aginghttps://www.nia.nih.gov/about/aging‐well‐21st‐century‐strategic‐directions‐research‐aging

Understanding the Dynamics of the Aging Process GOAL A: Better understand the biology of aging and its impact on the prevention, progression, and

prognosis of disease and disability

GOAL B : Better understand the effects of personal, interpersonal, and societal factors on aging, including the mechanisms through which these factors exert their effects.

Improving the Health, Well‐Being, and Independence of Adults as They Age GOAL C : Develop effective interventions to maintain health, well‐being, and function and prevent

or reduce the burden of age‐related diseases, disorders, and disabilities.

GOAL D : Improve our understanding of the aging brain, Alzheimer’s disease, related dementias, and other neurodegenerative diseases. Develop interventions to address Alzheimer’s and other age‐related neurological conditions.

GOAL E : Improve our understanding of the consequences of an aging society to inform intervention development and policy decisions

GOAL F : Understand health disparities and develop strategies to improve the health status of older adults in diverse populations

Supporting the Research Enterprise GOAL G : Support the infrastructure and resources needed to promote high quality research.

GOAL H : Disseminate information to the public, medical and scientific communities, advocates and patient organizations, and policy makers about research and interventions.

$1,046 $1,172 $1,198

$1,596

$2,049

$2,577

$3,080

$0

$500

$1,000

$1,500

$2,000

$2,500

$3,000

$3,500

2013 2014 2015 2016 2017 2018 2019*

Dollars (in m

illions)

NIA AppropriationsFiscal Years 2013‐2019

NIA Base Additional AD Funds

Opportunities in Aging and Alzheimer’s Disease and Alzheimer’s–Related Dementias (AD/ADRD)

• PAR‐18‐878: Late Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age‐related Cognitive Decline (R01 Clinical Trial Required)

• PAR‐18‐877: Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age‐related Cognitive Decline (R01 Clinical Trial Optional)

• PAR‐18‐519: Sensory and motor system changes as predictors of preclinical Alzheimer’s disease (R01 Clinical Trial Not Allowed)

• PAS‐18‐030: Improving Quality of Care and Quality of Life for Persons with Alzheimer’s Disease and Related Dementias at the End of Life (R01 Clinical Trial Optional)



FOA Title

PAR‐18‐588 (SBIR) Assistive Technology for Persons with Alzheimer's Disease and Related

Dementias and Their Caregivers (R43/R44 ‐ Clinical Trials Optional)

PAR‐18‐587 (STTR) Assistive Technology for Persons with Alzheimer's Disease and Related

Dementias and Their Caregivers (R41/R42 ‐ Clinical Trial Optional)

PAR‐18‐186 (SBIR) Development of Socially‐Assistive Robots (SARs) to Engage Persons with

Alzheimer's Disease (AD) and AD‐Related Dementias (ADRD), and their

Caregivers (R43/R44 Clinical Trial Optional)

PAR‐18‐185 (STTR) Development of Socially‐Assistive Robots (SARs) to Engage Persons with

Alzheimer's Disease (AD) and AD‐Related Dementias (ADRD), and their

Caregivers (R41/R42 Clinical Trial Optional)

PAR‐18‐329 (SBIR) Technology to Detect, Monitor and Assess Daily Functions in Individuals

with Cognitive Decline, Alzheimer's Disease and/or Alzheimer's Disease

Related Dementias (AD/ADRD) (SBIR R43/R44 Clinical Trial Not Allowed

PAR‐18‐326 (STTR) Technology to Detect, Monitor and Assess Daily Functions in Individuals

Small Business Funding Opportunities in Aging and Alzheimer’s Disease and Alzheimer’s–Related Dementias (AD/ADRD)

https://www.nia.nih.gov/research/nia‐small‐business‐funding‐opportunities

FOA Title

PAR‐17‐067 (SBIR) Tools for Clinical Care and Management of Alzheimer's Disease (AD) and

its Comorbidities (R43/R44)

PAR‐17‐066 (STTR) Tools for Clinical Care and Management of Alzheimer’s Disease (AD) and

its Comorbidities (R41/R42)

PAS‐18‐187 (SBIR) Advancing Research on Alzheimer's Disease (AD) and Alzheimer's‐

Disease‐Related Dementias (ADRD) (R43/R44 Clinical Trial Optional)

PAS‐18‐188 (STTR) Advancing Research on Alzheimer's Disease (AD) and Alzheimer's‐

Disease‐Related Dementias (ADRD) (R41/R42 Clinical Trial Optional)

PAR‐18‐512 (SBIR) Testing Lifespan/Healthspan‐Extension Interventions in the Models of

Alzheimer's Disease (AD/ADRD) (SBIR R43/R44 Clinical Trial Not Allowed)

PAR‐18‐514 (STTR) Testing Lifespan/Healthspan‐Extension Interventions in the Models of

Al h i ’ Di (AD/ADRD)(STTR R41/R42 Cli i l T i l N All d)

Small Business Funding Opportunities in Aging and Alzheimer’s Disease and Alzheimer’s–Related Dementias (AD/ADRD)


Translational Research Small Business Funding Opportunities: Divisions of Aging Biology and Geriatrics and Clinical Gerontology

• T2 Translational Research on Aging: Small Business Innovation Awards (R43/R44) PAR‐18‐184

Advance availability of novel devices, products, health care practices and programs to benefit the lives of older adult

Dissemination of results from clinical studies into everyday clinical practice and health decision making in geriatric medicine

• Development of new techniques for enhancing research productivity in aging research; for example: data mining approaches


Resources

• NIA Divisions and funding opportunities: www.nia.nih.gov

• NIA BLOG: www.nia.nih.gov/research/blog• sign up for notifications of newly released information on funding announcements, funding policy, career development awards etc

• NIH Funding Opportunities http://grants.nih.gov• NIH List Serv: sign up for weekly notifications of newly released PA’s & RFAs ( $$ Find Funding)

• NIH Research Portfolio Online Reporting Tools (RePORT)

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PANEL DISCUSSION

www.pollev.com/drscal



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ReferencesGoldstein MS, Scalzitti DA, Craik RL, Dunn SL, Irion JM, Irrgang J, Kolobe TH, McDonough CM, Shields RK. The revised research agenda for physical therapy. Phys Ther. 2011 Feb;91(2):165-74.

Goldstein MS, Scalzitti DA, Bohmert JA, Brennan GP, Craik RL, Delitto A, Field-Fote EC, Magistro CM, Powers CM, Shields RK. Vitalizing practice through research and research through practice: the outcomes of a conference to enhance the delivery of care. Phys Ther. 2011 Aug;91(8):1275-84.

White NT, Delitto A, Manal TJ, Miller S. The American Physical Therapy Association's top five choosing wisely recommendations. Phys Ther. 2015 Jan;95(1):9-24.

Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, Delitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on Research Standards for Chronic Low Back Pain. PhysTher. 2015 Feb;95(2):e1-e18.

Harabin AL, Kiley JP. How the National Heart, Lung, and Blood Institute (NHLBI) develops research priorities and supports critical care research. Phys Ther. 2012 Dec;92(12):1489-93.

Schindler-Ivens S, Struhar J, Jermé MG. Has the Foundation for Physical Therapy advanced the body of knowledge? Phys Ther. 2013; 93(6): 718-20.

Resnik L, Freburger JK. Health services research: physical therapy has arrived! Phys Ther. 2015; 95(12): 1605-07.

Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, DHHS. (2016). NIH Research Plan on Rehabilitation (NA). Washington, DC: U.S. Government Printing Office. Available online at https://www.nichd.nih.gov/publications/pubs/Documents/NIH_ResearchPlan_Rehabilitation.pdf#search=NIH_ResearchPlan_Rehabilitation. Accessed March 13, 2017.

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