Ethical Issues in the Design of Patient Information Sheets for Research Purposes

Informed consent: are researchers accurately representing risks and benefits?

“…This study supports that significant benefits can be achieved by participants in qualitative research despite experiencing distress during the interview. When participants read the information sheet, some experienced apprehension owing to the legalistic jargon (23, 24). This suggests that some of the participants might have misconceptions about the research akin to those described by Fisher (7), indicating that even highly educated individuals might not have a full understanding of the protections afforded research participants.…”

“…Greater emphasis on how the research would explore both positive and negative aspects would have addressed this assumption. It has been suggested that people who are approached to participate in a research project want material that they can discuss with friends and family and that a question and answer format might be more accessible than a series of impersonal statements on an information sheet (24). This was the approach adopted in the original study with the question, ‘What are the possible disadvantages and risks of taking part?’ heading the information on potential risks.…”

“…Some of the professionals in this study found the informed consent sheets daunting. Strategies identified in the literature may help to overcome this and include gaining written consent after the interview when rapport and trust have developed (15), having participants review the consent form with the researcher (28), calculating the reading ease of information sheets (23) and providing information both orally and in writing (24). It is recommended that one or more of these strategies be adopted in obtaining informed consent, even if the participants are professionals with a high educational level.…”