Professor Jay Smart and a student look at a screen during testing related to psychology research.

NIH offers a new resource for behavioral and social scientists

A student places EEG machine equipment on a subject's head. Posters depicting the anatomy of the brain are in the background.

In response to recently expanded clinical trial requirements for behavior and social interventions, National Institutes of Health (NIH) has released a new resource for behavioral and social science researchers. The Clinical e-Protocol Writing Tool includes a template that leads the writer through the process of preparing a research protocol involving human subjects.

The Writing Tool requires the user to set up a new log in. Once in the system, the user can find a link to instructions for each subsection of a protocol. Newer investigators may find the examples linked to the subsections to be particularly helpful, although examples are not currently provided for all subsections.

According to William Riley, Director of the NIH Office of Behavioral and Social Sciences Research, the Writing Tool “allows users to seamlessly send and edit protocol information directly to clinicaltrials.gov.” It can also help with developing IRB applications.


Written by Amy Hurley Cooper, Assistant Director of Proposal Development, Office for the Advancement of Research and Scholarship, Miami University.

Photos by Miami University Photo Services.

 

Clinical trial definition has implications for NIH applications

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:

Title: Decision Tree for NIH Clinical Trial Definition. Question 1: Does the study involve human participants research? A No answer leads to the conclusion that the study is NOT a clinical trial. A yes answer leads to Question 2: Are participants prospectively assigned to an intervention? A No answer leads to the conclusion that the study is NOT a clinical trial. A yes answer leads to Question 3: Is the study designed to evaluate the effect of the intervention on the participants? A No answer leads to the conclusion that the study is NOT a clinical trial. A yes answer leads to Question 4: Is the effect being evaluated a health-related biomedical or behavioral outcome? A No answer leads to the conclusion that the study is NOT a clinical trial. A yes answer leads to the conclusion that this study is a clinical trial.

(The NIH website offers a printable version and an interactive version of the 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:

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.