Human Subjects Research

Guidelines for protocols involving physical activity and exercise

The risks to subjects from physical activity and exercise relate very closely to the intensity of the exercise and the health of the individuals. Materials have been prepared to help IRB members and researchers better understand those risks. All IRB applications need to provide sufficient information so IRB members can determine risk and understand precautions taken by researchers to protect subjects. The following information should be included in the application:

  • How the researcher will determine coronary artery disease risk level of subjects performing aerobic or strength exercise.
  • How researcher will monitor intensity of exercise.
  • Signs (e.g., blood pressure > ?) that will prevent subject from beginning exercise or will stop the activity once it has begun.
  • Training/experience of researcher to execute protocol safely.

Please consider reviewing Things to Consider, Sample Language for Consent Forms, and appropriate Decision Trees before submitting the IRB application.

Application Resources

Decision Trees for Determining Risk and Review Level

There are five decision trees that cover exercise protocols. One for children and youth (<18 years old), and four for adults over 18 years of age with separate trees for:  aerobic, strength or resistance, flexibility, and balance or mobility exercise. Each of the decision trees is organized according to the following topic areas:  exercise intensity, health screening, subject risk level, recommended action, and level of IRB review.  For each mode of exercise, the intensity of exercise is the first key decision to be made, followed by the health risk of the exerciser. By moving from left to right, determine the level of exercise intensity and the required subject screening. With information gathered from the appropriate screening form, determine subject risk which will lead to the recommended action regarding physician involvement and safety procedures. This stepwise progression leads ultimately to the recommended IRB review level:  expedited or full board.

Each decision tree focuses on a specific type of exercise. If subjects will perform more than one type of exercise, then each relevant decision tree will need to be consulted to determine the best course of action.