NIH Clinical Trial and FORMS-E Information

Page Updated: May 1st, 2018

NIH broadened its definition of clinical trial, and it may impact your applications (new, resubmission, or revision) and awards.

NIH's definition of clinical trial includes some research approaches not traditionally considered clinical trials. For example, many behavioral studies that focus on underlying mechanisms of development may now be considered clinical trials. Also, conducting experiments that involve human subjects may be considered a clinical trial. If you are conducting studies involving human subjects, it is critical that you understand this definition and determine whether it applies to your research. The definition impacts the proposal process, as well as requirements for training and reporting.

How do I know if my study is a clinical trial?

NIH has four questions that researchers need to answer to determine whether their study is a clinical trial. If you answer "yes" to each of these four questions, your research will be considered a clinical trial by NIH:

  1. Does the study involve human participants?
  2. Are the participants prospectively assigned to an intervention?
  3. Is the study designed to evaluate the effect of the intervention on the participants?
  4. Is the effect being evaluated a health-related biomedical or behavioral outcome?

Note that if the answers to the 4 questions are yes, your study meets the NIH definition of a clinical trial, even if...

  • You are studying healthy participants
  • Your study does not have a comparision group (e.g., placebo or control)
  • Your study is only designed to access the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
  • Your study is utilizing a behavioral intervention

Studies that involve secondary research with biological specimens or health information, or studies that are intended solely to refine measures are not considered clinical trials.

Here is a link that can help you determine if your research is a clinical trial: https://grants.nih.gov/ct-decision/index.htm. Also review the FAQs and case studies provided by the NIH Office of Extramural Research. Should you have questions about whether or not your study meets the NIH definition of a clinical trial, please contact the NIH program official listed in the Funding Opportunity Announcement or Notice of Award.

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

Applications: Beginning with applications 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. This is very important, as many activity codes have two Parent Announcements, one designated as "Clinical Trial Required" and the other designated as "Clinical Trial Not Allowed."
  • Provide additional information in the application, which will be subject to different and distinct review criteria for clinical trials. NIH has created a new form that consolidates all human subjects and clinical trials information in one place and expands information required for NIH-defined clinical trials. The form is included in the FORMS-E Application Package, which is available for use in Cayuse.

Given these changes, RSP encourages early submissions of applications, if possible, to mitigate any potential issues.

Reporting: If selected for funding, the trial will need to be registered and the results posted in the ClinicalTrials.gov system. UW-Madison support for this requirement is described here.

Training: All NIH-funded clinical trial investigators and staff who are involved in the design, conduct, oversight, and management of clinical trials must be trained in Good Clinical Practice (GCP). Good Clinical Practice Training is offered by UW-Madison through the UW CITI Portal. More information on GCP training is available here.

sIRB: NIH has also issued other policy updates involving the use of Single Institutional Review Board (sIRB) approaches for domestic, multi-site human subjects research. UW-Madison's policy on the use of a single Institutional Review Board for multi-site research is available here.

Details about all NIH updates/changes are available at https://grants.nih.gov/policy/clinical-trials.htm. Note that these policy updates/changes also apply to individuals conducting research through contracts.

Why is NIH making these changes?

As stewards of public funding, NIH is implementing these changes in support of its scientific and ethical obligation to ensure that the burden and risk that volunteers assume as research participants ultimately contributes to scientific knowledge. More discussion of the reasons for the policy changes is at: https://grants.nih.gov/policy/clinical-trials/why-changes.htm.