Sonia Roberts

This is the final paper in a four-part series which addresses the methodology of research studies under ethical review. The focus is on study conduct, governance and peer review. The nature and adequacy of peer review as a mechanism for assessing the study design and analysis are discussed. The paper argues that a properly constituted and functioning research team is crucial to the ethical conduct of a study and that an ethical review of methodology should extend beyond study design and analysis to a concern with data collection, storage and availability, and publication. While ethical review committees cannot monitor study conduct, they can ensure that the protocol pays sufficient attention to appropriate monitoring structures and personnel.

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.

This is the third 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 representativeness of study participants, the size of the study and data analysis. Differences between best practices in qualitative and quantitative research are highlighted. The paper argues that, while lack of representativeness may not be unethical, the ethical implications of unnecessary restrictions on eligibility should be considered by committees. Studies that are either too small or too big can pose problems. Research teams need to have the necessary competence to enable an appropriate analysis focused on the main objectives and interpreted in the context of the limitations of the study design.