In general, risks of participation in exercise testing are caused by the presence of known or unknown cardiovascular, pulmonary, or metabolic diseases. As such, investigators conducting research involving exercise testing must conduct screening procedures to identify the presence, signs, symptoms, and/or risk factors of such diseases in potential subjects.
For purposes of this guidance, subjects who screen positively for the presence, signs, symptoms, and/or risk factors of cardiovascular, pulmonary, or metabolic diseases will be considered and referred to as higher risk subjects, and appropriate safeguards must be conducted to avoid occurrence of adverse events and other risks.
Screening procedures must include the following, at a minimum, for all subjects:
- a questionnaire designed to discover the subjects health history and identify known symptoms and risk factors for cardiovascular, pulmonary, or metabolic disease
- pulse measurement to ensure that an unknown symptom or risk factor does not exist
- at least one blood pressure measurement to ensure that an unknown symptom or risk factor does not exist
The IRB application should include the following information regarding screening:
- list of proposed screening procedures
- justification if the screening process does not include the above minimum procedures
- whether subjects will be enrolled if the screening process determines them to be higher risk
- if the study is designed to test higher-risk subjects, an assessment of risk factors or diseases which make the population higher risk
Additional thoughts on risk stratification and screening may be found in the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription; however, investigators are not required to follow the recommendations therein.
It is the responsibility of the investigator to propose an appropriate plan for safeguarding subjects during the exercise intervention, given the proposed procedures and subject population. Some research involving higher risk subjects may require that the study team have access to physician supervision or other medical expertise during exercise intervention. In those situations, utilization of a local emergency response team (e.g., 911) may be appropriate, while other studies may necessitate a specified physician to be present onsite.
In order for the IRB to assess whether the proposed plan is appropriate, the investigator should include the following information in the IRB application:
- whether higher risk subjects will be enrolled and, if so, an assessment of the risk
- whether the investigators conducting the exercise intervention have been trained in CPR or other first aid, and, if so, the training received
- access to medical emergency equipment, if any, during the exercise intervention
- assessment of the local emergency response units and whether use of these units during an adverse event is appropriate
Unless additional concerns are raised, the IRBs may utilize the following guidance when determining whether exercise-related research should be considered minimal risk or greater than minimal risk. When making this determination, the IRB should consider the characteristics of potential subjects and the intensity of the proposed exercise intervention. For example, walking the length of a standard hallway would be considered minimal risk for most healthy subjects, but may be greater than minimal risk for elderly subjects or those recovering from knee surgery.
Minimal risk means that the probability or magnitude of harm or discomfort anticipated in the research is not greater in and of itself than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (as defined by 45 CFR 46.102(i)).
The following research should be considered minimal risk:
- sub-maximal exercise testing in healthy, asymptomatic subjects (not higher risk)
- research involving maximal and sub-maximal exercise testing in athletes
- research involving muscle stimulation; however, the IRB will need to make this determination on a case- by-case basis, considering the specific muscle group(s) to be stimulated and the method used to stimulate.
The following research should be considered greater than minimal risk:
- maximal exercise testing in non-athletes
- research that is intended to cause fatigue, exhaustion, or muscle soreness beyond that which would normally be experienced by the proposed subjects