Recently published federal rules and requirements for clinical trials
- 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 U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.
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.
Learn about active NIH funded medical rehabilitation research projects.
Access the list on the NIH RePORT website.
Recently published on ClinicalTrials.gov
- November 17, 2017
- Text Message Intervention to Improve Cardiac Rehab Participation
- Conditions: Myocardial Infarction; Percutaneous Coronary Intervention; Coronary Artery Bypass Surgery; Heart Valve Repair or Replacement; Heart Transplant; Left Ventricular Assist Device; Chronic Stable Angina; Chronic Stable Heart Failure
Intervention: Behavioral: Text Messaging Intervention
Sponsors: University of Washington; John L. Locke Jr. Charitable Trust
- November 17, 2017
- Use of MoTrack Therapy in At-Home Hand Rehabilitation
- Condition: Hand Injuries
Intervention: Device: MoTrack Therapy
Sponsor: Johns Hopkins University
- November 21, 2017
- Spatial Neglect and Delirium After Stroke
- Conditions: Stroke; Delirium; Spatial Neglect
Interventions: Diagnostic Test: Confusion Assessment Method; Diagnostic Test: Behavioral Inattention Test; Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Florida Mental Status Examination; Diagnostic Test: Montreal Cognitive Assessment; Diagnostic Test: Geriatric Depression Scale; Diagnostic Test: Kessler Foundation Neglect Assessment Process
Sponsors: Kessler Foundation; New York University School of Medicine
- November 16, 2017
- Cranial Electrical Stimulation (CES) as Treatment for Insomnia in Patients With Subacute Stroke
- Conditions: Cerebrovascular Accident; Sleep Disorder
Intervention: Device: CES
Sponsor: University of Texas Southwestern Medical Center
View all on ClinicalTrials.gov
- November 17, 2017
- Testosterone and Long Pulse Stimulation After SCI
- Condition: Spinal Cord Injury
Interventions: Device: Testosterone and LPWS; Drug: Testosterone and standard NMES
Sponsors: VA Office of Research and Development; Hunter Holmes McGuire VA Medical Center
Not yet recruiting