To protect the rights and welfare of human subjects, all projects involving human subjects research will require additional documentation and safety measures, which may include a safety officer, IRB approval, human subjects protection plan, data and safety monitoring plan, Federal Wide Assurance, and certification of human subjects research training prior to release of project funds. Although IRB approval is not required at time of submission, the application must include human subjects research and exemptions information. NIH offers a decision tool that provides additional guidance on how to answer application questions on human subjects research.
Projects including any component that constitutes a clinical trial as defined by NIH are not eligible for funding in the third annual (2023) a2 Pilot Awards competition. NIH defines a clinical trial as any 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.
Note that under this definition, it does not matter if your study includes only one intervention that all participants undergo—if you plan to evaluate the effect of any intervention (e.g., interaction with software, use of a device, completion of training) on a health-related biomedical or behavioral outcome in one or more human subjects, then your study is considered a clinical trial and is not eligible for funding in the third annual (2023) a2 Pilot Awards competition. Feasibility studies that evaluate how usable, acceptable, or scalable a product is in order to inform technology development but do not evaluate its effect on a health-related biomedical or behavioral outcome are eligible for funding. Additional guidance on how NIH defines clinical trials can be found here.
IRB review is not required until finalists are selected following Round 2 of the application process. If the pilot project does not include an institution with its own IRB, the AITC will direct the pilot project to either utilize a commercial IRB or work with the AITC’s IRB (in which case an AITC team member will serve as the Investigator of Record and work with the pilot project PI to submit the IRB application).
The IRB preparation process can begin as soon as finalist notifications are delivered. Finalists are strongly encouraged to begin the IRB process at this stage as IRB submission is required prior to the execution of a subaward agreement and IRB approval is required before project work or invoicing can begin. No-cost extensions of projects are allowable, should IRB review and approval delays occur.