Informed consent: are researchers accurately representing risks and benefits?

Abstract

Changes in the scope of health research in the last 50 years require evidence to support assumptions about what constitutes harm and benefit to research participants. The aim of this study was to investigate the actual benefits and harm individuals experienced while participating in potentially distressing qualitative research. Data were collected via semi-structured interviews and subjected to thematic analysis. Five themes emerged: (i) motivation to participate, (ii) expectations of participation, (iii) sources of harm, (iv) mitigating harm and (v) benefits of participation. Results indicated that all participants benefited through participation in the qualitative research. Most participants also reported varying degrees of distress during the interviews, but did not consider this harmful. In contrast, dissemination of the findings did constitute an unexpected source of potential harm for the participants and researcher. It is concluded that for these participants, distress during qualitative interviewing is not in itself harmful, and that participant information sheets need to reflect the harms and benefits of participation more accurately in a user-friendly format. Furthermore, the sensitivity with which research is disseminated needs to be considered as a fundamental protection for participants from unwarranted criticism by third parties. Recommendations include that researchers conducting interviews have specific personal and professional attributes relevant to the participant group, and that transcripts/raw data should not be sent automatically to participants.