Briken Peer, Müller Jürgen L, Berner Wolfgang, Bödeker Rolf-Hasso, Vollmann Jochen, Kasperk Christian, Koller Matthias
Institut für Sexualforschung und Forensische Psychiatrie, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Deutschland.
Asklepiosklinik für Forensische Psychiatrie Göttingen, Georg August Universität Göttingen, Rosdorfer Weg 70, 37081, Göttingen, Deutschland.
Nervenarzt. 2017 May;88(5):480-485. doi: 10.1007/s00115-017-0301-7.
A testosterone-lowering medication is relatively commonly used as a form of treatment for sexual offenders with severe paraphilic disorders in German forensic psychiatric hospitals; however, a double-blind, controlled and randomized study, which investigates the efficacy of this medication, is still lacking.
This article describes the process from the planning to the rejection of a clinical trial over the period from 2009 to 2015.
Despite the careful planning with an interdisciplinary team and giving special consideration to the complex legal situation, the Federal Institute for Drugs and Medical Devices (BfArM) rejected the proposed trial in a brief formal letter with reference to the German Drug Law (§ 40 para. 1 p. 3 nr. 4 AMG). The ethics committee of the Hamburg Medical Association considered that clinical research is basically not possible with patients detained in a forensic psychiatric hospital.
In the opinion of the authors, the described facts illustrate how legal regulations that should protect vulnerable groups in medical research, in a specific case can lead to the fact that a therapy form relevant to the corresponding patient group cannot be scientifically investigated.
在德国法医精神病医院，降低睾酮水平的药物相对常用于治疗患有严重性偏好障碍的性犯罪者；然而，一项调查该药物疗效的双盲、对照和随机研究仍然缺乏。
本文描述了2009年至2015年期间从临床试验的规划到被拒的过程。
尽管与跨学科团队进行了精心规划，并特别考虑了复杂的法律情况，但联邦药品和医疗器械研究所（BfArM）在一封简短的正式信函中，参照德国药品法（《药品法》第40条第1款第3页第4项）驳回了拟议的试验。汉堡医学协会伦理委员会认为，对被拘留在法医精神病医院的患者进行临床研究基本上是不可能的。
作者认为，所述事实表明，本应在医学研究中保护弱势群体的法律法规，在特定情况下可能导致无法对与相应患者群体相关的治疗形式进行科学研究。
