To all Investigators proposing human subjects research to the NIH,
For NIH submissions with due dates on or after January 25, 2018, it is imperative to make an accurate determination of whether your study meets the NIH definition of a clinical trial. The NIH has broadly defined a “clinical trial” resulting in stringent requirements—some are listed below:
- Submissions must be made to clinical-trial-specific FOAs
- Requires use of new FORMS-E application package
- Requires detailed study-level data on new human subjects & clinical trial form
- Requires GCP training every 3 years
- Requires registration and results reporting in ClinicalTrials.gov
- Must include statement on posting of clinical trial information in grant application
- Must include ClinicalTrials.gov service center fee in budget section of grant application
We highly recommend that you contact your NIH Program Officer to confirm whether your study meets the NIH definition of a clinical trial due to the extensive requirements, and severe consequences if not met. Please plan ahead & contact your RAS if you have any questions about the process.
NOTE: Effective January 25, 2018, all new applications for multi-site studies (not just clinical trials), with all domestic sites carrying out the same protocol, are required to use a single IRB.
- Must include single IRB plan in grant application
- If Emory is lead or coordinating site responsible for IRB review, must obtain quote from independent IRB & include in budget section of grant application
- Contact the Emory IRB for other single IRB requirements & help to facilitate the process
For more details, visit the NIH website at https://grants.nih.gov/policy/clinical-trials.htm.
With Best Regards,
Office of Research Administration