Minimum Requirements for Screening/Monitoring
- Experiments involving human subjects in exercise activities require
- Pertinent medical history, and when indicated by unusual/abnormal responses in the history, pertinent physical examination.
- Assurance, in the protocol, of apparatus safety and procedures to minimize risk.
- Description, in the protocol, of observation methods.
- Specific delineation, in the protocol, of criteria for termination of experiment.
- Description, in the protocol, of physical condition of subjects.
- Resting EKG for subjects who are exposed to greater risk than that experienced in everyday life.
- Written, informed consent.
- Experiments involving exposure to foreign substance require the following, in addition to exercise requirements:
- Resting EKG, regardless of risk.
- Pulmonary function screening tests when foreign substance is to be inhaled.
- Documentation of acceptable industrial standards, where they exist, for exposure to the foreign substance.
- Experiments involving work to exhaustion or 85% of predicted maximum heart rate for age and sex require in addition to exercise requirements
- Staff certified to provide emergency medical treatment and appropriate emergency supplies.
- Experiments involving invasive techniques
- Invasive techniques such as venipuncture, and experiments involving topical application of apparatus or substance designed to significantly alter or manipulate any physiologic function should be performed by a certified medical professional (i.e., nurse, medical technician, or MD) where or when specific medical guidelines have been established for this procedure. Personnel should be described in the protocol, including applicable degrees/licenses/certifications. Special handling procedures must be detailed when there is contact with bodily fluids (i.e. disposable syringes, double gloving, etc.).
- Adverse Post - experimental consequences
- In those instances where the principal investigator could reasonably anticipate adverse symptoms following the experiment, necessary precautions will be taken, and appropriate personnel will be available for a reasonable period of time.