How distressing is it to participate in medical research? A calibration study using an everyday events questionnaire

Abstract

Objectives: To investigate how distressing participating in medical research is perceived to be, compared to everyday events. Design: Anonymous questionnaire. Setting: Scotland and New Zealand. Participants: One hundred members of the Scottish general public, 94 University of Auckland students, 22 New Zealand Ministry of Health ethics committee members. Main outcome measures: Distress ratings made on a 0-10 scale for everyday events and common medical research procedures. Results: Both general population and student samples generally rated the distress caused by participating in various medical research procedures as low or very low. Most research procedures were rated less than the distress caused by not being able to find a car park at a supermarket. In contrast, the ethics committee members rated the distress caused by most of the medical research procedures at a significantly higher level than the ratings of the student and general population samples. Ethics committee members overestimated the distress caused by interview or questionnaire assessments (M = 203.31%, SE = 11.42, 95% CI [179.79, 226.83]) more than medical testing for research (M = 158.06%, SE = 12.33, 95% CI [132.66, 183.46], p = 0.04) and everyday events (M = 133.10%, SE = 7.80, 95% CI [117.03, 149.16], p < 0.001). Conclusions: Common medical research procedures are not rated as particularly distressing by the general public, and ethics committees may be adopting an over-protective role when evaluating research applications that involve the use of questionnaire or survey methodology.