Zusammenfassung

Research involving human subjects is a particularly delicate kind of research which requires justification both from an ethical and a legal point of view. The most important justification is based on consent. The individual’s freedom to decide autonomously about his participation in research by giving his consent is part of his constitutional liberty protected by fundamental rights. As all fundamental rights it is subject to restrictions by the law, but only within the limits of proportionality. Therefore, legal prohibitions of consent-based research should not be assumed lightly. For example, the position that data protection law does not allow for a so-called broad consent (covering the use of data, e.g., for medical research in general rather than merely for a specified project) is not very convincing. However, certain legal restrictions are justified by the overwhelming character of the informed consent process, meaning that due to the complexity of the subject matter and the shortness of time the research participant usually has little chance of understanding and measuring the full implications of his participation. In order to mitigate this problem, the consumer protection rules on the use of standard contract terms should be applied. Moreover, an important aspect is that the individual’s consent must be freely revocable. Therefore, informed consent documents do not only have to prepare the individual’s decision but also to enable him to rethink his decision afterwards. The quality of informed consent documents can be improved by the systematic development and use of templates.