title: Legal and ethical aspects of deliberate G-induced loss of consciousness experiments.
abstract: Informed consent is both a legal and accepted ethical prerequisite to nontherapeutic human experimentation. The informed consent obtained from the subject in G-LOC experimentation is in the same form as the risk disclosures used in high-G acceleration experiments. However, in high acceleration protocols G-LOC is a potential risk while in G-LOC experiments it is the result. The case law embodies three modern evidentiary standards (the "professional," "material fact," and "possible risks" tests) employed by common law courts when deciding whether the risk disclosures are sufficient to elicit the informed consent of the subject. Each standard is applied against the disclosures in the G-LOC protocol to determine if the elements of the requirement are met. The risk disclosures are wanting in specific identification under the three tests. The deficiency is the failure to inform the subject that G-LOC may result in a pathologic state of unconsciousness about which little is known. Without complete disclosure of this lacking state of medical knowledge, it is questionable whether informed consent can be given. If subjected to judicial scrutiny, the disclosures stated in the G-LOC protocol used in government sponsored research will probably be found deficient.
authors.affiliation: Human Systems Division (AFSC), Brooks Air Force Base, TX.
authors.forename: J G
authors.initials: JG
authors.lastname: Euretig
mesh_terms: D030881:Disclosure; D004992:Ethics, Medical; D006112:Gravitation; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D033281:Nontherapeutic Human Experimentation; D012106:Research; D035842:Research Subjects; D018570:Risk Assessment; D012307:Risk Factors; D035501:Uncertainty; D014474:Unconsciousness / Q000209:etiology