There is often difficulty in creating a distinction between a human subjects study and a clinical trial. In an effort to provide clarity between the two, NIH has defined a Clinical Trial as "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.
Additionally, to help researchers determine whether or not their human subjects research study meets the NIH definition of a clinical trial, the NIH website provides helpful tools including an interactive decision tool, which links to case studies and FAQs, and a decision tree to guide researchers through the questions that will determine if the study is a clinical trial.
The NIH has developed a new application form to consolidate all Human Subjects and Clinical Trial related information into one place which will be included in the new FORMS-E Application packages.
This new application form will be required for all applications with due dates on or after January 25, 2018.
The IRB of record for all NIH-funded clinical trials will be an external/central IRB. It is important that the PI discuss the IRB plan with Sponsored Programs at the proposal development stage of the proposal application. The PI must budget the costs associated with the central IRB. If the project is awarded, the Research Integrity Office will provide instructions to submit to an external IRB.
All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, as per the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information for competing applications and contract proposals submitted on or after 1/18/2017.
For any questions you may have about accounts, registration, updating and reporting on ClinicalTrials.gov please contact Research Integrity at 561-297-1383 or FAU PRS Administrator Dr. Ximena Levy at firstname.lastname@example.org.
For more information, including tutorials on how to navigate through the new form, visit the NIH New Human Subjects and Clinical Trial Information Form webpage.