Without a medical school, Miami University has not historically conducted clinical trial research. But that will likely change beginning January 25, 2018, and it’s not because Miami’s researchers are changing what they’re doing. Rather, it’s because the National Institutes of Health (NIH), the world’s largest funder of biomedical research, is changing its definition of a clinical trial.
NIH defines a clinical trial as:
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo of other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
This definition was adopted in 2014. A 2016 initiative by NIH to enhance its stewardship over clinical trials led to the development of new policies based on that definition. These policies will be in effect for applications to NIH solicitations with due dates of January 25, 2018 and after. Beginning on that date, many of Miami’s NIH-funded behavioral researchers, in particular, may suddenly find themselves conducting clinical trials, even though their work may not have met that definition in the past.
Of course, recognizing when a study does meet NIH’s definition of a clinical trial is the first step for any Miami biomedical or behavioral researcher applying to NIH for funding. To help with this, NIH has devised a decision tree:
For those whose work does meet the NIH’s definition, the second step is understanding certain implications of conducting NIH-funded clinical trial research, including:
- The requirement for PIs to respond to a funding opportunity that specifically allows for the submission of clinical trial applications.
- The requirement to complete a new human subject and clinical trial information form that will be included in the updated application package (FORMS-E). According to Mike Laurer, NIH’s Deputy Director for Extramural Research, this form “consolidates into a single location information on human subjects that is currently scattered across a number of forms.” NIH has produced a video that guides applicants through the new form.
- The expectation for NIH grantees to participate in “Good Clinical Practice” training.
- The introduction of updated peer review criteria for clinical trial applications.
- The requirement to register and report on all NIH-supported clinical trials in ClinicalTrials.gov.
NIH’s “Overview of New NIH Policies on Human Subjects Research and Clinical Trials” video provides an overview of the upcoming changes. Additional information — including case studies and FAQs — is available on NIH’s “Clinical Trial Requirements” website. NIH encourages prospective applicants who still have questions after reviewing the information on the website to contact their program officers. Miami University researchers can also contact their OARS representative for guidance.
Written by Heather Beattey Johnston, Associate Director of Research Communications, Office for the Advancement of Research and Scholarship, Miami University.
Photos by Miami University Photo Services.