The following guidance has been adopted by the Human Subjects Office in order to provide guidance for investigators and IRB members on conduct and review of research involving exercise testing and training. In general, the main points of discussion and possible contention during IRB review include:
- Screening for appropriate participation
- Appropriate safeguards during exercise intervention
- Determining whether the research is minimal risk or greater than minimal risk
While investigators and IRB members agree that exercise testing does involve risk, there is very little data about the actual level or incidence of the risk and whether those risks can be fully prevented by any level of protection procedures. Bright-line rules regarding appropriate screening procedures and required safeguards for all exercise-related research are impossible to identify. As such, the IRBs will assess each protocol involving exercise testing individually and determine appropriate requirements on a case-by-case basis, taking into consideration study subjects, procedures, and possible risks.
Minimum expectations for exercise-related research are described below; however, the IRBs may request additional requirements. In addition, investigators are welcome to propose and justify alternative procedures or safeguards if the expectations below are inappropriate for particular protocols.
Screening for appropriate participation
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 to ensure that an unknown symptom or risk factor does not exist
- at least one blood pressure test 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.
Appropriate safeguards during exercise intervention
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
Identifying minimal risk vs. greater than minimal risk research
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.
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
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)).