Attempting to standardise ethical review within the complexity of health-related research

Abstract

Researchers in medicine, allied disciplines and elsewhere submit research proposals to an ethical review board before research commences. This paper argues that the effectiveness of review relies on reviewers using discernment and judgement when applying standardised review criteria so that they accommodate the full range of research projects. With reference to ethics literature, the paper identifies five imperatives in the development of review guidelines and processes. It examines case composition and analysis, and explores interactions between professional developers, researchers and reviewers to illustrate problems in the review process. It refers to the ethical review system in New Zealand and the report to parliament: Inquiry into Improving New Zealand’s Environment to Support Innovation through Clinical Trials (Health Committee 2011). Seeking to gain for New Zealand a competitive edge in clinical research, this report made 19 recommendations to improve the climate for clinical trials, ethical review included, in this country. The connection between these two case studies is the common endeavour to standardise the ethical review exercise, review systems and review processes. Cases with commentary are a recommended addition to guidelines documents to present research within its context and to demonstrate the complexity that a standardised ethical review does not always address.