IRB regulations now incorporate the broad definition of “clinical trial” adopted by the National Institutes of Health (NIH). Substantial additional requirements apply to federally-funded clinical trials.
“Clinical trial” is defined in Section 102(b) of the revised IRB regulations (the 'Common Rule') 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 the interventions on biomedical or behavioral health-related outcomes.”
This is identical to the NIH definition, which that agency has interpreted quite broadly. Case studies issued by NIH describe certain fundamental health-related research previously assumed to be outside of the definition. For federally-funded research that meets the Common Rule definition of clinical trial, Principle Investigators (PIs) have one or more new compliance obligations, depending on the exact funding source.
To facilitate compliance with these additional requirements for clinical trials, approval letters will specify that a project meets the definition of a “clinical trial” when the IRB determines that this is the case, and summarize requirements that may apply as a result. If your study is a clinical trial you as the researcher are ultimately responsible for ensuring compliance with the obligations summarized here:
Any federal funding: For clinical trials supported by any type of federal funding (NIH, NSF, DOD, etc.), the PI is required to comply with the consent posting requirement described below. In addition, the IRB recommends that federally-funded researchers voluntarily comply with obligations described below that are mandatory only for NIH-funded researchers conducting a clinical trial:
- Consent form posting: The PI must post a copy of an IRB-approved consent form used for enrollment purposes to ClinicalTrials.gov after the study is closed to recruitment, but no later than 60 days after the last study visit by any subject. (See additional OHRP guidance on this topic.) Please note that the IRB office will not be able to remind PIs to fulfill this obligation in a timely manner.
NIH funding: If you are a PI who has or is seeking NIH funding for a clinical trial, you are responsible for meeting the following additional compliance obligations:
- Apply for the correct FOA: Certain NIH Funding Opportunity Announcements (FOAs) are applicable only to CTs or non-CTs. Applying for the wrong FOA may make your submission ineligible for funding.
- Registration and reporting on Clinicaltrials.gov: Clinical trials in competing applications and contract proposals submitted on or after January 18, 2017 must register, submit updates throughout the project, and post results information on Clinicaltrials.gov. Compliance with this requirement is expected to require a significant dedication of time and effort throughout the study. You should register your study on Clinicaltrials.gov as early as possible (e.g., concurrent with your IRB protocol submission, or right after obtaining IRB approval). The Cornell IRB staff are available to provide assistance if requested, but researchers are primarily responsible for complying with these obligations.
- Training in Good Clinical Practices (GCP): Starting January 1, 2017, those involved in the design, conduct, oversight, or management of a NIH clinical trial must be trained in GCP. As a condition of protocol approval, the Cornell IRB will require evidence that all study personnel listed on the protocol have completed GCP training within the last 3 years. NIH does not specify any particular GCP course. Cornell researchers may complete GCP training online through the CITI Program. Note that this training is in addition to basic IRB training required by the IRB.
- Consent form posting: This requirement is described above.
All other projects: Regardless of the funding status or source for your human subjects work, the Cornell IRB strongly recommends that you choose to follow the compliance practices required by NIH as a best practice. Publication in certain journals could be jeopardized if researchers fail to comply with these best practices.
Training in Good Clinical Practice (GCP): Researchers on a clinical trial must be trained in GCP. All study personnel listed on the protocol must have completed GCP training within the last 3 years. GCP training can be completed online through CITI and is in addition to the IRB training.