Federal IRB regulations allow certain categories of research involving no more than minimal risk to be reviewed through Exempt or Expedited procedures. Research that involves greater than minimal risk, or does not meet expedited criteria, requires review by the full IRB.
Research Involving Physical Exercise
Statutory Background
Definitions
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research is no greater than those ordinarily encountered in daily life or during routine physical or psychological tests.
A physical exercise study includes any research that engages participants in physical activity, including but not limited to walking, cycling, cardiovascular training, balance or flexibility exercises, resistance training, or sport-specific tasks.
Guidance
Guidance for investigators and IRB reviewers on the ethical conduct of research involving physical activity and exercise to ensure appropriate protection of participants while facilitating efficient IRB review.
Research Variables for Risk Assessment of Physical Activity
- Level of Physical Exertion and Risk: The intensity, duration, and type of exercise.
- Participant/subject Population: Health status, age, vulnerability of participants.
- Environmental and Safety Issues: Supervision of study, availability of medical personnel, and procedures established for unforeseen circumstances.
- Purpose of the Research: How exercise is used as an intervention, assessment, or physical challenge.
- Research Design: Such as deception, invasive procedures, and criteria to screen out high-risk subjects.
Resources for Measuring/Grading the Level of Physical Activity Intensity
- Centers for Disease Control (CDC)
- Minnesota Department of Health Activities Defined by Level of Intensity
- The American College of Sports Medicine (ACSM) has updated its prescreening algorithm to identify individuals who should receive medical clearance before initiating an exercise program (see the Research in Motion Blog). Protocols involving participants identified as requiring medical clearance may need a study physician to be involved.
Tips for Investigators Submitting Protocol Applications Involving Physical Activity
- Consult ORI or UK IRB staff early if there is uncertainty regarding the appropriate level of review (exempt, expedited, or full).
- Provide a clear description of the exercise intervention, including intensity, frequency, duration, and supervision; cite recognized resources for grading exercise intensity. For training studies, describe alignment with ACSM or National Strength and Conditioning Association (NSCA) guidelines.
- Include appropriate pre‑screening procedures to demonstrate participants’ ability to safely perform the proposed physical activity.
- Clearly describe monitoring and safety measures, such as heart rate and blood pressure monitoring, supervision, and emergency response procedures.
- Use informed consent language that clearly explains exercise‑related risks, participant rights, and withdrawal procedures.
- Reassess risk and safeguards if the protocol is modified to include higher‑intensity exercise, at‑risk populations, or increased potential for harm.