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Table 2 Practical challenges for the systematic and transparent revision of informed consent documents

From: An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent

Challenges Questions to answer for the revision of IC documents
Dealing with feedback or suggestions from different numbers of participants Are suggestions expressed repeatedly by multiple individuals in different interviews or focus groups more important than suggestions made by just one test reader?
Dealing with participants’ conflicting opinions on the same topic How can test readers’ conflicting opinions be addressed, e.g., if some participants think sub-headlines should be formulated as questions, while others prefer declarative sentences? Which suggestion should be used when conflicting opinions about the same topic have been expressed?
Trade-off between different reasonable suggestions How can different well-reasoned but irreconcilable suggestions be addressed, e.g., if participants on the one hand suggest to abbreviate the whole text to make it more readable to everybody, while on the other hand, they want some topics to be explained in more detail or they ask for additional pieces of information?
Dealing with feedback or suggestions that do not seem reasonable to the authors How should suggestions be handled that do not seem reasonable, i.e., that would not seem to increase objective understanding, or do not assist prospective research participants with their autonomous decision, e.g., when a particular test reader is interested in more background information on some rather marginal topic? And how can one systematically decide which suggestions are reasonable and which are not?
Making changes transparent and replicable How can revisions in general and decisions in the abovementioned cases in particular be made transparent and accountable to others?