The following update was released by the NIH in November 2018. Visit the ORS Compliance Requirements page for information and guidance on registering clinical trials.
NIH has broadened its definition of clinical trial, and it may impact your future applications (new, resubmission, or revision) and awards.
NIH’s definition of clinical trial now includes some research approaches not traditionally considered clinical trials. For example, many behavioral or biobehavioral 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 very important that you understand this definition and determine whether it applies to your research.
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. These questions may use terminology that has a different meaning than the typical meanings understood by certain research communities. It’s important to review the FAQs and case studies provided by the NIH Office of Extramural Research. If you answer “yes” to each of these four questions, your research will be considered a clinical trial by NIH:
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect being evaluated a health-related biomedical or behavioral outcome?
Here is a link that can help you determine if your research is a clinical trial: 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 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.
- Provide additional information in the application, which will be subject to different and distinct review criteria for clinical trials.
If selected for funding, you will need to designate individual(s) to serve as the responsible party for the trial and to register and post results in the ClinicalTrials.gov system.
NIH has also issued other policy updates involving Good Clinical Practice training requirements and the use of Single Institutional Review Board (sIRB) approaches for domestic, multi-site human subjects research. Details about all updates/changes are available at https://grants.nih.gov/policy/clinical-trials.htm.
Note: 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 our scientific and ethical obligation to ensure that the burden and risk that volunteers assume as research participants ultimately contributes to scientific knowledge. In addition, these changes facilitate transparency in how NIH conducts and supports human subjects and clinical trials research and increases dissemination of data and conclusions derived from NIH-conducted or -supported clinical trials. More discussion of the reasons for the policy changes is at: https://grants.nih.gov/policy/clinical-trials/why-changes.htm