NIH Clarifies Clinical Research Trial Definition, Changes Requirements National Institutes of Health (NIH) efforts to clarify and implement the definition of a clinical research trial will affect NIH grant proposals submitted next year. As of 2014, a clinical trial is any clinical research study that: As of Jan. 25, 2018, grant proposals for any study that meets all ... News in Brief
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News in Brief  |   November 01, 2017
NIH Clarifies Clinical Research Trial Definition, Changes Requirements
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Research Issues, Methods & Evidence-Based Practice / Regulatory, Legislative & Advocacy / News in Brief
News in Brief   |   November 01, 2017
NIH Clarifies Clinical Research Trial Definition, Changes Requirements
The ASHA Leader, November 2017, Vol. 22, 12. doi:10.1044/leader.NIB5.22112017.12
The ASHA Leader, November 2017, Vol. 22, 12. doi:10.1044/leader.NIB5.22112017.12
National Institutes of Health (NIH) efforts to clarify and implement the definition of a clinical research trial will affect NIH grant proposals submitted next year.
As of 2014, a clinical trial is any clinical research study that:
  • Involves human participants.

  • Prospectively assigns participants to an intervention.

  • Is designed to evaluate the effect of the intervention on the participants.

  • Evaluates an effect that is a health-related biomedical or behavioral outcome.

As of Jan. 25, 2018, grant proposals for any study that meets all of these criteria must be submitted through a clinical trial-specific funding opportunity announcement and use updated application forms. Changes in the process include a new Human Subjects and Clinical Trials Information Form and a single institutional review board for multi-site research.
Two requirements remain: Clinical trial investigators must register with ClinicalTrials.gov at the beginning of the study and post updates and results, and they must complete good clinical practice training through NIH or another recognized clinical research professional organization.
There are special clinical-trial restrictions and considerations for institutional training awards, fellowship awards and career development awards.
The changes are part of an NIH effort to enhance the accountability and transparency of clinical research throughout the entire clinical trial lifecycle, from concept to results reporting.
For specific questions regarding a proposed clinical trial for the NIH National Institute on Deafness and Other Communication Disorders, contact the NIDCD Clinical Trials Program, trinh.ly@nih.
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November 2017
Volume 22, Issue 11