The ethics committees act in accordance with the Radiation Protection Act (StrlSchG).
Here you will find information and assistance for submitting studies to one or more ethics committees involving radioactive materials and/or ionizing radiation.
The medical application of radioactive substances and/or ionizing radiation in the context of research projects can itself be the subject of research. Far more frequently, however, it is used as a so-called “companion diagnostic” for testing the safety or efficacy of a treatment procedure (e.g., a medical product or a medical device), which is why for many research projects a regular review as a clinical trial according to the AMG or MPG or other biomedical studies must also be conducted in parallel.
The radiation application is carried out with the so-called justifying indication (§ 83 StrlSchG), i.e. the person concerned would receive the same radiation application even without study participation.
For these research projects, there are no special requirements under radiation protection act for the evaluation by the ethics committee. In this case, review is given in accordance to the common rules of ethics reviews for either clinical trials with medical products/medical devices or other biomedical studies.
The use of radiation is carried out as “accompanying diagnostics” on sick persons of full age (subject to notification according to §32 StrlSchG).
In the case of these research projects, the ethics committee must examine whether they are ethically justifiable in accordance with § 36 Para. 3 StrlSchG and must issue a statement in accordance with the points No. 1-5 listed there. In the case of multi-center studies, the statement of one ethics committee is sufficient. This statement must be submitted to the competent authority (Federal Office for Radiation Protection, BfS) as part of the notification documents.
The radiation application is itself the subject of the research or is carried out as “accompanying diagnostics” on minors or healthy subjects (subject to approval according to § 31 StrlSchG).
In the case of this research project, the ethics committee must examine whether it is ethically justifiable in accordance with § 36 Para. 3 StrlSchG and must issue an statement in accordance with the points No. 1-5 listed there. For multi-center studies, the statement of one ethics committee is sufficient. This statement is to be submitted to the Federal Office for Radiation Protection as part of the approval documents.
Applications for the review of research projects involving the use of radioactive substances and/or ionizing radiation should clearly state how this is classified. In the case of an application in the context of a clinical trial of a medicinal product, this classification should be made in the Annex to Module 2.