Clinical Trials in Medical Rehabilitation

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Recently published federal rules and requirements for clinical trials

  • NIH DIrector's Statement: Update on NIH’s efforts to address sexual harassment in science
    In this statement released February 28, 2019, the NIH senior leadership announced the actions they were taking as they await the Working Group of the Advisory Council to the Director (ACD) on Changing the Culture to End Sexual Harassment recommendations and other input to strengthen thier efforts. These thems include: demonstrating accountability and transparency; clarifying expectations for institutions and investigators to ensure a safe workplace and inform the agency; providing clear channels of communication to NIH; and listening to victims and survivors of sexual harassment and incorporating their perspectives into future actions.
  • Statement on Article Publication Resulting from NIH Funded Research
    To help protect the credibility of papers arising from its research investment, NIH encourages its stakeholders, including grantees, contractors, intramural researchers, and librarians, to help authors: 1) adhere to the principles of research integrity and publication ethics; 2) identify journals that follow best practices promoted by professional scholarly publishing organizations; and 3) avoid publishing in journals that do not have a clearly stated and rigorous peer review process.
  • Clinical Trial Requirements for Grants and Contracts
    NIH is launching a series of initiatives that are rolling out in 2017-2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the whole clinical trial lifecycle from concept to results reporting. Learn more about these changes and how they will affect your research.
  • Clinical Trials: Special Considerations for Career Development, Fellowship, Training, and Research Education Programs (NOT-OD-18-001) (Published November 6, 2017)
    The purpose of this notice is to provide prospective applicants for career development, NRSA fellowships or training grants, and research education grants advanced information about the upcoming funding opportunity announcements (FOA), expected dates of FOA issuance, and application due dates. As indicated in NOT-OD-17-043, effective January 25, 2018, all grant applications with plans to conduct independent clinical trials must be submitted in response to an FOA which specifically states that independent clinical trials are allowed.
  • Policy Supporting the Next Generation Researchers Initiative (NOT-OD-17-101) (Published August 31, 2017)
    This policy amends the definitions of, and policies supporting, early stage investigators (ESIs). In addition, it creates a new policy for early established investigators (EEIs), previously referred to as mid-career investigators, and describes how NIH will monitor the implementation of the policy to determine the impact on ESI and EEI diversity in the NIH portfolio.
  • Federal Policy for the Protection of Human Subjects (Published January 19, 2017)
    The Department of Health and Human Services has updated the Common Rule for Protection of Human Subjects. This will impact specific policies and programs in NIH and implementation as of January 21, 2019, including review of the grant application by the IRB, posting of consent document, and categories of exempt research.
  • Inclusion Across the Lifespan - Policy Implementation (Published December 19, 2017)
    The purpose of this policy is to ensure individuals are included in clinical research in a manner appropriate to the scientific question under study so that the knowledge gained from NIH-funded research is applicable to all those affected by the researched diseases/conditions. The policy expands the Inclusion of Children as Participants in Clinical Research Policy to include individuals of all ages. The policy also clarifies potential justifications for age-based exclusion criteria, and requires participant age at enrollment to be provided in progress reports The policy applies to all grant applications submitted on or after January 25, 2019. Until then, ongoing research and grant applications/proposals are subject to the Inclusion of Children in Clinical Research Policy.
  • Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020 (Published July 10, 2019)

    In response to recommendations from the Advisory Committee to the NIH Director and the National Science and Technology Council's Working Group on Research Business Models that federal agencies adopt tools and approaches to simplify applicant reporting and improve the tracking of career outcomes, NIH introduced the option for PD/PIs and other users to associate an ORCID identifier with their eRA Commons Personal Profile in 2017. Since that time, more than 30,000 eRA Commons Profiles have been linked to ORCID iDs. ORCID iDs are unique, persistent digital identifiers that distinguish individual investigators and can be used to connect researchers with their contributions to science over time and across changes of name, location, and institutional affiliation.  These free identifiers are assigned and maintained by the non-profit organization ORCID.

    In addition, more than 7,000 journals now use ORCID iDs and, with the permission of users, can automatically populate ORCID user accounts with their citations when they publish. Federal grant applicants can also link their ORCID accounts with SciENcv (Science Expert Network Curriculum Vitae), to simplify the creation of biosketches for grant applications.

NIH Medical Research Initiatives

Journal Articles

Bamman MM, Cutter GR, Brienza DM, Chae J, Corcos DM, et al. Medical Rehabilitation: Guidelines to Advance the Field with High-Impact Clinical Trials Arch Phys Med Rehabil. 2018 Aug 24. pii: S0003-9993(18)31113-4. doi: 10.1016/j.apmr.2018.08.173. [Epub ahead of print] PMID: 30148997.

Ronald L. Wasserstein, Allen L. Schirm & Nicole A. Lazar (2019) Moving to a World Beyond “p < 0.05” The American Statistician, 73:sup1, 1-19, DOI:10.1080/00031305.2019.1583913/

NIA Clinical Research Study Investigator's Toolbox

This tool box provides researchers and their study teams with a central source of materials to plan studies, incorporate consistent processes, collect accurate data, and maintain appropriate safety oversight.

NIH Reporter

Learn about active NIH funded medical rehabilitation research projects.

Access the list on the NIH RePORT website.

Recently published on ClinicalTrials.gov

May 13, 2020
Long Term Functional Outcomes of COVID-19 Patients Treated by Rehabilitation Services viaTelehealth
Conditions:   SARS-CoV 2;   SARS Pneumonia
Intervention:   Behavioral: Therapy Intervention
Sponsor:   University of Missouri-Columbia
Not yet recruiting
May 20, 2020
Optimizing Cognitive Remediation
Conditions:   Schizophrenia;   Stress Disorders, Post-Traumatic
Intervention:  
Sponsor:   VA Office of Research and Development
Not yet recruiting
May 13, 2020
Prism Adaptation in Left Brain Stroke
Conditions:   Aphasia;   Spatial Neglect;   Stroke
Intervention:   Behavioral: Prism Adaptation Treatment
Sponsor:   VA Office of Research and Development
Not yet recruiting
May 25, 2020
Hemodynamic Effects of Aquatic vs. Land Exercise in Patients With Orthostatic Hypotension
Condition:   Orthostatic Hypotension
Intervention:   Other: Physical Therapy
Sponsor:   University of Texas at Austin
Not yet recruiting
May 12, 2020
BFR Therapy in Patients With Rotator Cuff Tears
Condition:   Blood Flow Restriction
Interventions:   Device: Blood Flow Restriction Therapy;   Procedure: Traditional Therapy
Sponsor:   Henry Ford Health System
Not yet recruiting
May 13, 2020
Brain Injury Coping Skills - Telemedicine: Phase II
Conditions:   Traumatic Brain Injury;   Coping Skills;   Caregivers
Intervention:   Behavioral: Brain Injur Coping Skills - Telemedicine
Sponsor:   Devan Parrott
Recruiting
May 15, 2020
BFRT in Adolescents After ACL Reconstruction
Condition:   Anterior Cruciate Ligament Rupture
Intervention:   Device: Blood Flow Restriction Training
Sponsor:   Children's Healthcare of Atlanta
Not yet recruiting
May 21, 2020
Effects of Combination Exercise on Fatigability in Veterans With Chronic Kidney Disease
Condition:   Chronic Kidney Disease Predialysis
Intervention:   Behavioral: Combination Exercise
Sponsor:   VA Office of Research and Development
Not yet recruiting
May 20, 2020
Securing Employment and Economic Keys to Stability for Persons With Disabilities
Condition:   Employment
Interventions:   Behavioral: Center for Independent Living SEEKS Team;   Other: Usual Care
Sponsors:   Communication Institute International, Inc.;   Colorado School of Public Health;   University of Colorado, Denver
Not yet recruiting
May 18, 2020
Cold Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
Condition:   COVID-19
Interventions:   Device: MLS Laser;   Other: Regular Inpatient Medical Care
Sponsor:   Lowell General Hospital
Recruiting
View all on ClinicalTrials.gov

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