Table 2 Traffic-light system to mark changes in original IC documents

Green

Changes directly based on specific remarks from focus group participants; remarks had to come from at least two participants, preferably from different focus groups and no opposing views from other participants had been expressed. Example: “First sentence in third paragraph should be divided into two shorter sentences.”

Amber

Changes directly based on specific remarks from focus group participants; remarks from single participants or disagreement among different participants. Example: “I would prefer all headings for sub-paragraphs being statements instead of questions.” – “I disagree. I think, all headings should be put as questions.”. Also, changes which were based on unspecific but unambiguous feedback from focus group participants. Example: “Paragraph eight is very difficult to understand and should be revised.”

Red

Changes which were not directly indicated by test-readers but which were made to keep the style of the IC documents consistent. Example: “The term “Body-materials” in line 15 sounds strange to me” – The term was substituted by the more common term “Biomaterials” not only in line 15 but in the whole document. Or, changes which were made to address test-readers’ general concerns, misunderstandings or emotional reactions. Example: There seemed to be a “diagnostic misconception”, e.g. some test-readers supposed that donated biomaterials would be used for a complete genetic “check-up”. The respective paragraphs in the IC document were revised to prevent this misunderstanding.