The NIH has released guidance on how to apply the 2014 definition for a “clinical trial”. This guidance is a precursor to enforcement rather than a change in the definition. This will impact NIH proposal submissions and clinicaltrials.gov registration and reporting.
Why this matters? The NIH will be segregating funding opportunities for clinical trials. If your study meets the NIH Clinical Trial Definition, you MUST submit the proposal to the clinical trial RFA. If the proposal is submitted via UFIRST/Assist to the wrong RFA, it will not pass administrative review and will not be reviewed by the NIH study section. If your clinical trial is funded by the NIH, you must now meet the registration and reporting requirements of clinicaltrials.gov.
There are several key points that we want to highlight:
· Proposals submitted or with due dates on or after January 25, 2018 must use the new NIH FORMS-E application package. This updated application forms support will be available in UFIRST in late November 2018. The FORMS-E package will include questions addressing the NIH clinical trial definition.
· In defining your research as health-related human subject research, the NIH requires that you answer to the following four (4) questions on the FORMS-E application package:
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 that will be evaluated a health-related biomedical or behavioral outcome?
Answering YES to ALL four (4) questions categorizes your research as meeting the NIH Clinical Trial Definition.
It is highly recommended that you review the case studies provided by the NIH. The case studies can be reviewed at https://grants.nih.gov/policy/clinical-trials/case-studies.htm.
Who is here to help me understand these changes?
The Office of Clinical Research (OCR) is the University core office that will assist in the management of awards/contracts that meet the NIH Clinical Trial Definition. OCR can assist in pre-award budgeting for clinically-related research services.
Division of Sponsored Programs (DSP) is the University core office that will submit all of the proposals on the PI’s behalf. Any issues related to FORMS-E or UFIRST, DSP is the first point of contact.
Thanks and feel free to contact us for questions or clarification.
Assistant Vice President
Division of Sponsored Programs
Office of Research
UNIVERSITY of FLORIDA