Competence to give informed consent for medical procedures

This study shows that referrals to psychiatry for evaluation for competence to give informed consent generally were made on patients who refused medical treatment. In this sample of referred patients, the only patients found to be incompetent to give informed consent were those with organic brain syndromes. No one with either schizophrenia or depression was found to be incompetent. It is possible that schizophrenic and depressed patients may generally be competent to give informed consent to medical treatment. This finding might be true notwithstanding the fact that many such patients have been found in other studies to be incompetent to consent to voluntary psychiatric treatment. For example, a patient may have delusions that others can read his mind and thoughts, but he still can understand that he needs dialysis for renal failure. Alternatively, it may be relatively rare that an emergency procedure is necessary before a patient's psychosis can be brought under control and consequently internists and surgeons themselves may prefer to wait. The significance of the results is unclear. Because of active interest in the doctrine of informed consent for psychiatric and medical patients by both physicians and attorneys and the few studies within this population, there is a strong need for more study regarding competence to give informed consent. Further study is especially important for psychotic patients for whom psychiatric consultation is not requested.(ABSTRACT TRUNCATED AT 250 WORDS)     

Research on medical records without informed consent

Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent.     

知情同意原则下医疗过失损害赔偿责任的几个问题--从一起患者知情同意纠纷案说起

知情同意原则所保护的客体是自我决定权.知情同意原则下的损害赔偿责任不同于医疗事故损害赔偿责任.二者不能互相否认.医方违反知情同意原则的责任是一种侵权损害赔偿责任.该责任的构成要件可包括(1)医师存在法定的告知义务;(2)医师未能将对患者的决定产生实质性影响的风险/信息告知患者;(3)在告知不充分的情况下,患者由于选择了当前的治疗方案而受到伤害;(4)医师的义务违反与患者的伤害之间存在因果关系.其中,告知义务是否充分的判断应以处于同样情境的一个理性患者所需作为主要的标准;对信息"实质性"的判定应看一个与患者处于同一位置的合理审慎之人在决定是否对所建议的治疗做出同意时会对某一事实赋加重要性或将该事实作为一"决定性"影响因素加以考虑;在因果关系存无的认定上,则要考虑若患者被充分告知实情他是否会做出不同的选择决定.     

知情同意原则下医疗过失损害赔偿责任的几个问题--从一起患者知情同意纠纷案说起

知情同意原则所保护的客体是自我决定权。知情同意原则下的损害赔偿责任不同于医疗事故损害赔偿责任。二者不能互相否认。医方违反知情同意原则的责任是一种侵权损害赔偿责任。该责任的构成要件可包括：(1)医师存在法定的告知义务；(2)医师未能将对患者的决定产生实质性影响的风险／信息告知患者；(3)在告知不充分的情况下，患者由于选择了当前的治疗方案而受到伤害；(4)医师的义务违反与患者的伤害之间存在因果关系。其中，告知义务是否充分的判断应以处于同样情境的一个理性患者所需作为主要的标准；对信息“实质性”的判定应看一个与患者处于同一位置的合理审慎之人在决定是否对所建议的治疗做出同意时会对某一事实赋加重要性或将该事实作为一“决定性”影响因素加以考虑；在因果关系存无的认定上，则要考虑若患者被充分告知实情他是否会做出不同的选择决定。