Research teams may need to train study team members by having them conduct or experience procedures used in a research study, such as imaging exams, exercise testing, questionnaires, or other activities. Research teams may need to run through study procedures to calibrate or optimize equipment settings or build efficiency. When such activities are performed in preparation to conduct a study and no data are retained or analyzed for research purposes, they generally do not meet the regulatory definition of human research. That is, the preparatory activities are not systematic investigations designed to develop generalizable knowledge and do not use or analyze information about the individuals undergoing the activities. However, because study activities may involve physical or informational risks, there are situations in which training or preparatory activities that are not human research may still require IRB oversight.

Note that the FDA defines research differently. This guidance does not apply to use of drugs or use of devices that could pose a significant risk.

Training and preparatory activities that require IRB oversight

• Volunteers from the community undergoing procedures for the purpose of training research team members, optimizing visit workflows or equipment, etc.
• Procedures that involve physical or informational risks greater than those of daily life.
• Procedures that need to be performed repeatedly and systematically on people to demonstrate feasibility, optimize performance, or similar goals.
• Procedures that will retain and analyze information about the people undergoing those activities.

Research teams should describe these preparatory activities in their IRB submission, including how risks will be minimized and show individuals who will undergo these activities will be consented. A consent document should be submitted, but study teams should be cognizant of how template consent language may not accurately represent the activities volunteers are being asked to undergo (e.g., data is not being collected for a research use, individuals with access to the data may be more limited in scope)

Training and preparatory activities that do NOT require IRB oversight

• Low-risk activities involving members of the research team or other employees who are knowledgeable about the procedures and their risks and freely agree to undergo them.
• Activities conducted in departments or units that have policies governing non-research participation (e.g., training of study team members, calibrating equipment, developing and optimizing workflows) in procedures used in research studies.

In these situations, the principal investigator or supervisor is responsible for ensuring that employee participation (as volunteers undergoing procedures) is optional, that employees are familiar with the potential risks and risks are minimized, and that confidentiality is maintained when activities require health screening for safety reasons or generate health-related information.