Declaration of Helsinki. Recommendations guiding medical doctors in biomedical research involving human subjects.
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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.
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In Britain doctors and others concerned with the treatment of offenders in prison may consult the Butler Report (see Focus, pp 157) and specialist journals, but these sources are concerned with the system in Britain only. In America the situation is different, both in organization and in certain attitudes. Dr Peter L Sissons has therefore provided a companion article to that of Dr Paul Bowden (page 163) describing the various medical issues in prisons. The main difference between the treatment of offenders in prisons in America and in Britain lies in the nature of the federal system which means that each state may operate a different system in a variety of prisons and prison medical services are as various. Nationally, the prison systems are 'structured to treat and cure the offender'. Therefore it follows that the prison medical officer is only one of the professionals concerned with this 'cure' of the offender. This principle also applies to any form of research: medical research in prisons is part of a programme which covers a wide field of social and judicial research. The prison medical officer (where there is one) has of course to look after sick prisoners, and the American idea of 'cure' is also expressed in the need for more corrective surgery where, for example, it is necessary to remove physical impediments to social rehabilitation. But a doctor is only found on the staff of those institutions which are large: in the smaller prisons there may be only first-aid facilities, and no specially appointed doctor in the community. Moreover medicines are often dispensed by medical auxiliaries who are sometimes prisoners themselves. Finally, in America prisoners are regularly invited to volunteer as subjects for medical and social research for which they are paid. In short, although it is hoped to 'cure' a prisoner he is a criminal first and a patient second.
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