Reshaping the review of consent so we might improve participant choice

Abstract

Consent is one necessary foundation for ethical research and it’s one of the research ethics committee’s major roles to ensure that the consent process meets acceptable standards. Although on Oxford ‘A’ REC (an NHS Research Ethics Committee based in the UK) we’ve been impressed by the thought and work put into this aspect of research ethics, we’ve continued to have concerns about the suitability and effectiveness of consent processes in supporting decision making, particularly for clinical trials. There’s poor understanding of what people want to help them decide; current processes don’t provide the best grounding for informed consent and there’s inadequate public involvement. We’ve also found a lack of proportionality with researchers failing to adapt consent procedures in proportion to the burdens and consequences of the study. As a result, people are often not best helped to make an informed choice when asked to join a research study. To address these concerns, we considered how we might improve this aspect of research ethics review. Recognising the central importance of the dialogue between the volunteer and researcher, we’ve drawn up a model or flowchart of what we deem good consent practice, proposing consent should be built around four simple steps: Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues. Step 2: Explaining all the details of the study using the detailed Participant Information Sheet. Step 3: After a gap, if necessary, reviewing and checking understanding. Step 4: Reaching agreement and recording consent. These steps, we believe, could help all involved and this article lays out ways we might improve participant choice while complying with accepted principles and current regulations.