Simon Monique, Habeck Matthias, Büttner Daniel, Habeck Uta, Nölling Torsten, Krause Mechthild, Brix Gunnar, Willich Normann, Wenz Frederik, Schmidberger Heinz, Debus Jürgen, Baumann Michael
Deutsches Konsortium für Translationale Krebsforschung (DKTK), Dresden, Deutschland.
Deutsches Krebsforschungszentrum (DKFZ), Heidelberg, Deutschland.
Strahlenther Onkol. 2015 Dec;191(12):909-20. doi: 10.1007/s00066-015-0914-3.
Application of ionizing radiation for the purpose of medical research in Germany needs to be approved by the national authority for radiation protection (Bundesamt für Strahlenschutz, BfS). For studies in the field of radiation oncology, differentiation between use of radiation for "medical care (Heilkunde)" versus "medical research" frequently leads to contradictions. The aim of this article is to provide principle investigators, individuals, and institutions involved in the process, as well as institutional review or ethics committees, with the necessary information for this assessment. Information on the legal frame and the approval procedures are also provided.
A workshop was co-organized by the German Society for Radiation Oncology (DEGRO), the Working Party for Radiation Oncology (ARO) of the German Cancer Society (DKG), the German Society for Medical Physics (DGMP), and the German Cancer Consortium (DKTK) in October 2013. This paper summarizes the results of the workshop and the follow-up discussions between the organizers and the BfS.
Differentiating between "Heilkunde" which does not need to be approved by the BfS and "medical research" is whether the specific application of radiation (beam quality, dose, schedule, target volume, etc.) is a clinically established and recognized procedure. This must be answered by the qualified physician(s) ("fachkundiger Arzt" according to German radiation protection law) in charge of the study and the treatments of the patients within the study, taking into consideration of the best available evidence from clinical studies, guidelines and consensus papers. Among the important parameters for assessment are indication, total dose, and fractionation. Radiation treatments applied outside clinical trials do not require approval by the BfS, even if they are applied within a randomized or nonrandomized clinical trial. The decision-making by the "fachkundigem Arzt" may be supported on request by an opinion given by the DEGRO Expert Committee for clinical trials.
An important aim for promoting clinical research and patient care in radiation oncology is to further professionalize planning and implementation of clinical trials in this field. Correct assessment, at an early stage, whether a trial needs to be approved by the BfS may reduce unnecessary costs and reduce the time needed for the approval procedure for those trials which need to be assessed by the BfS.
在德国，将电离辐射用于医学研究目的需经国家辐射防护机构（联邦辐射防护办公室，BfS）批准。对于放射肿瘤学领域的研究，区分辐射用于“医疗保健（Heilkunde）”还是“医学研究”常常引发矛盾。本文旨在为参与该过程的主要研究者、个人和机构以及机构审查或伦理委员会提供进行此项评估所需的信息。同时还提供了法律框架及批准程序的相关信息。
2013年10月，德国放射肿瘤学会（DEGRO）、德国癌症协会（DKG）的放射肿瘤学工作组（ARO）、德国医学物理学会（DGMP）以及德国癌症联盟（DKTK）共同组织了一次研讨会。本文总结了研讨会的结果以及主办方与BfS之间后续讨论的情况。
区分无需BfS批准的“医疗保健（Heilkunde）”和“医学研究”，在于辐射的具体应用（射束质量、剂量、方案、靶区体积等）是否为临床既定且认可的程序。这必须由负责该研究及研究中患者治疗的合格医师（根据德国辐射防护法为“专业医师”）根据临床研究、指南和共识文件中的最佳现有证据来回答。评估的重要参数包括适应证、总剂量和分割方式。临床试验之外应用放射治疗无需BfS批准，即便其在随机或非随机临床试验中进行。“专业医师”的决策可应要求得到DEGRO临床试验专家委员会给出的意见支持。
促进放射肿瘤学临床研究和患者护理的一个重要目标是进一步使该领域临床试验的规划和实施专业化。尽早正确评估一项试验是否需要BfS批准，可减少不必要的成本，并缩短那些需要BfS评估的试验的批准程序所需时间。
