IMPORTANT changes in this year’s NIH guidance: Human Subjects Research

Story Date: Thu, 01 Feb 2018 15:23:58 EST

NIH has broadened its definition of clinical trial and it now includes some research approaches not traditionally considered clinical trials.  If you are conducting studies involving human subjects, it is very important that you understand this definition and determine whether it applies to your research.

Why is NIH making these changes?

  • As stewards of public funding, NIH is implementing these changes in support of their scientific and ethical obligation to ensure that the burden and risk that volunteers assume as research participants ultimately contributes to scientific knowledge, facilitates transparency and increases dissemination of data and conclusions. 

What is NIH’s definition of a clinical trial?

  • NIH definition of a clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”. 

Why is it important to know if you are proposing to conduct a clinical trial?

  • Correctly identifying whether your study is a clinical trial is crucial to complying with NIH policies, many of which are now in effect, such as registering and reporting all NIH supported clinical trials in ClincalTrials.gov and good clinical practice training.  As of January 25, 2018, your answer will be crucial to picking the appropriate NIH funding opportunity for your application, witting your research plan correctly and ensuring that your application includes all the information required for peer review.

How do I know if my research fits the definition of a clinical trial?

  • If you answer YES to the four questions below, your study is considered a clinical trial. 
    • Does your study…
      1. Have a health-related biomedical or behavioral outcome?
      2. Evaluate the effect of interventions on the human subjects?
      3. Prospectively assign human subjects to interventions?
      4. Involve one or more human subjects?
    • Use this easy decision tool from NIH:  https://grants.nih.gov/ct-decision/index.htm       

Why is this important?  What are the implications if my study is considered a clinical trial?

  • Beginning with application submitted on or after January 25, 2018, if your application involves a clinical trial, you must:
    • Submit the application through a Funding Opportunity Announcement (FOA) that accepts clinical trials.
    • Provide additional information in the application, which will be subject to different and distinct review criteria for clinical trials.

As always, feel free to contact Sponsored Programs with any questions at OSP@evms.edu.  For more information and links to additional NIH changes, please check out the Sponsored Program’s website under Grant News or the Overview of New NIH Policies on Human Subject Research (about 15 minutes).

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