Methodological Considerations in Ethical Review — 2.: Are the Study Aims Justified and is the Design Appropriate?

Abstract

This is the second of four papers to be published in Research Ethics Review in 2009 that address methodological issues of relevance to research ethics committees. It focuses on three issues: the appropriateness of the research question, the different types of study design available, including both qualitative and quantitative, and the need for, and choice of, a control group. The paper argues that these issues are key to ethical consideration since inappropriate design may not be salvageable and can lead to unusable data, in which case the risks and burdens to participants would be unjustified.