In this module, you will explore how high-quality research design and methodology are the backbone of ethical research. It is not only a waste of time, effort, and resources to conduct methodologically unsound research, but it can put participants at unnecessary risk. As defined by the Tri-Council Policy Statement (TCPS),1 scholarly review of research is not beyond the scope and mandate of the Research Ethics Board (REB).

The level of scholarly review required will vary from study to study. If the research proposal has already undergone scientific peer review, then a scholarly review by the REB may not be necessary and would reduce duplication of work. If the research area is outside of the REB’s expertise, an ad hoc reviewer can be utilized to advise the Board. The scope of the REB is an important consideration, and the REB should not be as critical of the research methodology in comparison to the rigor of the ethics of the study. At a minimum, the research methodology should be robust enough that it answers the research question. While an area of research may not be of high interest to the REB, if it is methodologically and ethically sound, the REB should not reject the submission.

Additional methodological review may be mandated by some institutions. Depending on the institutional policies, the ethics review may not take place until after the methodological review has been completed. The REB may also use the outcome of a methodological evaluation to inform the ethics review. Whatever the institutional policies are regarding research initiation, they should not interfere with the functions of the REB.