Davidhizar R, Wehlage D
J Adv Nurs. 1984 Jul;9(4):381-90. doi: 10.1111/j.1365-2648.1984.tb00387.x.
As nurses enter the field of research and design nursing studies, an awareness of the standards of informed consent becomes imperative. Informed consent is commonly considered to include providing the subject with adequate and understandable information regarding therapeutic and experimental procedures and ensuring subjects' competent understanding of this information. Providing information about a procedure is relatively easy but evaluating competency is often difficult. It is especially difficult with the subject who may suffer cognitive impairment, e.g. schizophrenia. Clients with schizophrenia have traditionally been a disenfranchised group. It is important they do not become neglected in nursing research because of concerns about competency to provide informed consent. This paper provides a discussion of the historical development of informed consent. Additionally, the legal standards of informed consent and the legally accepted standards of competency are elucidated. Four issues are considered: (a) evidencing a choice, (b) factual understanding of the issues, (c) rational manipulation of information, and (d) appreciation of the nature of the situation. These issues are related to a nursing research study designed by the senior author to test the beliefs of subjects with chronic schizophrenia.
随着护士进入研究领域并开展护理研究，了解知情同意的标准变得至关重要。知情同意通常被认为包括向受试者提供有关治疗和实验程序的充分且易懂的信息，并确保受试者能够充分理解这些信息。提供有关程序的信息相对容易，但评估受试者的理解能力往往很困难。对于可能患有认知障碍（如精神分裂症）的受试者来说尤其困难。传统上，精神分裂症患者一直是被剥夺权利的群体。重要的是，他们不应因担心提供知情同意的能力问题而在护理研究中被忽视。本文讨论了知情同意的历史发展。此外，还阐明了知情同意的法律标准和法律认可的能力标准。考虑了四个问题：（a）表明有选择，（b）对问题的事实性理解，（c）对信息的合理运用，以及（d）对情况性质的认识。这些问题与资深作者设计的一项护理研究相关，该研究旨在测试慢性精神分裂症患者的信念。
