If an investigators study involves human subjects and is funded in some way by the National Institutes of Health (NIH), the study could be considered a “clinical trial” based upon NIH’s definition. If the study does meet the definition and the application was submitted to NIH on or after 1/18/2017, the study has additional requirements.
NIH’s Definition of a Clinical Trial
NIH broadened their definition of a clinical trial to “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.”
This definition only applies to studies funded in some way by NIH.
Determining if a Study is an NIH-Defined Clinical Trial
NIH has four questions to help determine if a study meets their definition:
- 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?
NIH has additional information including case studies, frequently asked questions and a decision tree on NIH’s Clinical Trial Definition page. Assistance is also available from humansubjects@boisestate.edu.
NIH Clinical Trial Requirements
A study meeting the NIH definition and funded, in whole or part, by NIH requires:
- Submitting of a dissemination plan
- Completing training in Good Clinical Practice (GCP)
- Registering and reporting at ClinicalTrials.gov
These requirements went into effect for applications submitted on or after January 18, 2017, and the expectation of meeting these requirements should be included in the terms and conditions of the award if they apply.
Dissemination Plan
NIH requires applicants submit a dissemination plan outlining how the study will be registered and summary information reported to ClinicalTrials.gov. A dissemination plan may be as simple as the following:
This trial will be registered in ClinicalTrials.gov. The PI will report trial results to ClinicalTrials.gov according to NIH policies. The IRB consent form will state trial information and results will be posted on ClinicalTrials.gov. Boise State University has an internal policy to ensure clinical trials registration and results reporting occur in compliance with policy requirements. Results of this study will be disseminated via peer reviewed professional conference presentations and publications. Example Dissemination Plan
Good Clinical Practice (GCP) Training
NIH expects NIH-funded investigators and clinical trial staff involved in the conduct, oversight, or management of an NIH clinical trial to receive training in Good Clinical Practice (GCP). This training is in addition to human subjects training. GCP training covers elements of study design, conduct, recording, and reporting. Clinical trial staff are considered those responsible for study coordination, data collection, and data management. For more information, refer to the NIH GCP Training page.
Boise State utilizes the CITI Program for GCP training and offers a few different courses. You can add GCP training to your account by clicking ‘Add a Course’ under the main menu when you are logged in to CITI. If you need information about see, please see our CITI Training FAQ page or reach out to humansubjects@boisestate.edu.
ClinicalTrials.gov Registration and Reporting
A study meeting the definition of an NIH Clinical Trial must be registered and results reported through ClinicalTrials.gov. In most instances, the study’s principal investigator (PI) will be responsible for the registration and results reporting for their study. The University is allowed one account with ClinicalTrials.gov. ORC administers the account. A PI must request an a user account through ORC.
Submission Requirements
The PI must do the following via ClinicalTrials.gov:
- Register clinical trial no later than 21 days after enrolling the first subject;
- Update the clinical trial record at least once every 12 months;
- Report summary results not later than a year after clinical trial completion (last day data collected from subject)
ORC can assist the PI, in coordination with the Office of Sponsored Programs (OSP), with the submission requirements and associated documentation.
To set up an account or for more information, contact humansubjects@boisestate.edu.