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Table 3 Conceptual model for the development of understandable informed consent documents

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

Steps in the process of informed consent (IC) development Action to take Objectives
Writing of IC documents Involve multidisciplinary expert groups in design of IC documents − Ensure completeness and correctness of given information
− Make sure legal and ethical requirements are met
Involve communications experts and/or apply guidelines for how to design understandable written information − Increase readability and understandability for lay people
Testing original IC documents Identify the IC documents’ target population and develop strategies for recruiting test readers − Make sure to recruit testers who are able to unveil or anticipate prospective research participants’ potential problems of understanding (depending on the IC documents’ actual target population, this could be members of the general public, lay patients, or expert patients)
− Avoid systematic biases in groups of participants (e.g., according to education, age, sex)
Clarify relevant concepts for testing: ‘understanding’ − Make testing results reliable and comparable to other testings (using the same concepts)
− Adapt testing methods to applied concepts
Quantitative element (questionnaire/quiz): test objective understanding; assess how easy it is to find and understand particular pieces of information − Ensure the most important pieces of information are easy to find and understand
− Take information from questionnaires for systematic preparation of focus groups or individual interviews
Qualitative element (focus groups/individual interviews): assess subjective understanding, emotional reactions, and/or general understandability; discuss original IC documents with test readers − Validate and complement results of questionnaires
− Identify reasons for problems of understanding
− Assess participants’ impression of completeness and balance of given information
− Identify emotional reactions and misunderstandings
− Learn about participants’ suggestions for improving IC documents
Systematic summary of test readers’ feedback and suggestions − Use as preparation for systematic revision
− Identify consensual and conflicting opinions
− Prioritize and organize potential changes in original document
Revising original documents Develop rules to deal with different kinds of feedback − Allow for systematic revision, not primarily based on authors’ experiences and personal taste
Track revisions and explicitly link changes to feedback − Make revisions and arguments for changes transparent and reasonable
− Ensure changes actually address test readers’ needs and suggestions
− Increase legitimacy of changes
Involve original authors of IC documents and/or other experts − Ensure the revised document still gives all relevant information
− Ensure all given information is correct and meets legal and ethical requirements
While making changes: apply guidelines for clear writing or involve communications experts − Ensure standards for clear writing are met in revised version
Evaluating/re-testing revised documents Quantitative element (questionnaire/quiz): test objective understanding for revised documents (as many iterations as necessary) − Retest how easy to find and to understand most important pieces of information are in revised version
− Take information from questionnaires for systematic preparation of focus groups or individual interviews
− If necessary: revise and retest
Qualitative element (focus groups/individual interviews): assess subjective understanding, emotional reactions, and/or general understandability for revised documents (as many iterations as necessary) − Evaluate changes to original document
− Ensure the most urgent needs and suggestions have been addressed
− Validate revised version
− Identify additional feedback and suggestions
− If necessary: revise and retest
Quantitative element: test final version against the original version by means of randomized survey − Systematically evaluate the quality of the revised IC document in comparison to the original version