Helmchen Hanfried
Klinik für Psychiatrie und Psychotherapie, CBF, Charité - Universitätsmedizin Berlin.
Psychiatr Prax. 2014 Jul;41 Suppl 1:S31-7. doi: 10.1055/s-0034-1369939. Epub 2014 Jul 1.
This review presents the results of a book 1 on ethical problems of clinical research in psychiatry and its framework. The requirement of societally necessary research can be satisfied only if every research patient is appropriately protected against risks and burdens. A clinical research intervention is acceptable only if - its benefit-risk-relationship is reasonable and justified, and - the patient's informed consent is valid. Basic and only unsatisfactorily solved questions are related to the capacity to consent and to problems in the evaluation of the benefit-risk-relationship, particularly of individual versus societal benefits and risks.
本综述介绍了一本关于精神病学临床研究伦理问题及其框架的著作的研究结果。只有当每个研究患者都得到适当保护,免受风险和负担时,社会必要研究的要求才能得到满足。只有当——其效益-风险关系合理且正当,并且——患者的知情同意有效时,临床研究干预才是可接受的。基本且尚未得到充分解决的问题涉及同意能力以及效益-风险关系评估中的问题,特别是个体与社会的利益和风险。