Design, implementation and analysis of a quality assurance process for Informed Consents using the DZHK registry TORCH-DZHK1 as an example
Design, implementation and analysis of a quality assurance process for Informed Consents using the DZHK registry TORCH-DZHK1 as an example is drawing significant interest across the industry.
Author summary In clinical research, informed consent is essential to ensure that participants voluntarily agree to the use of their personal and medical data. Only when consent forms are complete and accurate can they truly reflect a participant’s decision and meet legal requirements. Despite its importance, the overall quality of informed consent documentation has rarely been studied and is often found to be insufficient. In this work, we describe the development of a structured approach to improve and monitor the quality of informed consent forms using a large cardiovascular research registry in Germany as an example. By systematically reviewing consent documents, we were able to identify common problems, such as missing information, inconsistencies, or invalid entries. Importantly, nearly all identified issues could be successfully corrected. In addition, targeted training sessions were provided to study staff to increase awareness of the importance of proper consent documentation and to prevent future errors. Our findings show that informed consent quality can be substantially improved through continuous quality control and education. This approach helps protect the rights of study participants, strengthens the legal reliability of consent documents, and supports the overall integrity of clinical research.
Experts suggest this could influence future trends and innovation in the sector.
More updates are expected as the story develops.
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