Background: One of the elementary prerequisites for medical research on and with humans is the patients' or probands' informed consent. To ensure informed consent, study participants must be-among other things-provided with high-quality information. We developed criteria to assess and evaluate the quality of various written patient information material. Methods: Based on a catalogue addressing 117 single criteria, we assessed the quality of 128 randomly selected documents from study proposals submitted to the ethical committee of Luebeck University in 2006. Each criterion refers to one of six quality areas (such as "readability and comprehensibility" or "potential benefit and harm"). Results: The documents on average satisfied half of the criteria with a range from 20-76% for single items. The area with the highest quality score was "consent form" (64%), while "potential benefit and harm" (35%) was the lowest. Material from drug trials showed a significantly higher quality than that from other study types. Only 21 out of 117 criteria were met in more than 80% of all relevant documents. Conclusion: The study provides evidence for significant deficits in the information material from basic and clinical research projects presented to one academic research ethics committee. Researchers need support in developing and writing informed consent documents. Our set of criteria could be used to make them more sensitive to the various demands involved.
|Translated title of the contribution||Improving the quality of written informed consent documents for (bio)medical research-empirical analysis of research ethics committee's application documents|
|Journal||Ethik in der Medizin|
|Number of pages||14|
|Publication status||Published - 09.2014|