As we explained in the June 7, 2017 article “Clinical Trial or Not a Clinical Trial? Know the Answer Before You Apply,” you must correctly identify whether your proposed project is a clinical trial (CT). Fail to identify an applicable project as CT research and your application will be missing required CT-related elements.
A mistake in the other direction: Incorrectly labeling your project a CT because the research leverages data or samples from a CT.
NIH does not consider studies that involve secondary research with biological specimens or health information to be CTs. When applying to fund such a study, you should provide a short description of the source of the data or samples while being clear that the proposed research is not a CT.
CT Decision Tool for Ancillary Studies
Use the decision tool at Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial? to determine whether your project should be labeled CT research. Answer the four questions considering the secondary study only; not the work being done in the parent project.
Unless the ancillary study adds another prospectively assigned intervention to patients or a subpopulation of patients within the larger clinical trial, it is unlikely to meet all criteria of NIH’s Definition of a Clinical Trial.
For practical examples, read case studies 42a, 42b, 42c, and NIDCR 1 at NIH Definition of Clinical Trial Case Studies.
Your Project May Be Human Subjects Research
Although not a CT, your project may still qualify as Human Subjects (HS) Research.
Refer to Decision Tool: Am I Doing Human Subjects Research? to determine whether HS are involved. That will help you complete 1. Are Human Subjects Involved? on the G.500 - PHS Human Subjects and Clinical Trials Information form correctly.
TIP: Check "Yes" even if the proposed project is exempt from regulations for the Protection of Human Subjects.
Remember, you can perform HS research without the project also qualifying as CT research. Rely on NIH’s application guide for further instruction.
- NIH’s December 7, 2018 revisions (see Significant Changes) clarify who must complete certain attachments in Section 2 - Study Population Characteristics.
- Consider what you’re proposing to study when preparing Section 3 - Protection and Monitoring Plans, as opposed to the CT parent project from which you obtained the data or samples.
- Do not complete items in Section 4 - Protocol Synopsis or Section 5 - Other Clinical Trial-Related Attachments if your study isn’t a CT. If you use 4.1 Brief Summary and related sections to describe your non-CT project, error notifications will appear on your application.
For other helpful resources, read Human Subjects and Clinical Trials Information Form and the updated Annotated Form Sets for NIH Grant Applications - FORMS-E Series.