Paper Short Abstract

We investigated if and how qualified statisticians were consulted by human research ethics committees in Australia. We encountered a stark variance in attitudes and practice, with statisticians being called both “critical” and “not needed for 99.9% of applications”.

Paper Abstract

Currently, much medical research is wasted due to errors in the study design or analysis. Errors can be reduced by consulting qualified statisticians with expertise in a wide range of study designs and methods. Ethical review is an ideal stage to consider study design, however, we do not know how many statisticians are providing their expertise to ethics committees.

We approached all human research ethics committees in Australia with questions on their access to qualified statisticians. Sixty percent of committees had access to a qualified statistician, either as a full committee member or as a non-member who could be consulted when needed, but this result dropped to 35% after accounting for statistical qualifications. Many committees rely on “highly numerate” researchers instead of qualified statisticians, as they viewed research experience and advanced statistical training as equivalent. Some committees did not feel the need for a statistician, as they believed it was the institution's job to ensure good study design. Other committees believed that researchers could be trusted to submit robust study designs. There was a common belief that statistical review only applied to selected study designs, and that “simple” or “small” studies did not need scrutiny. We estimated that around 5,200 applications per year were seen by a qualified statistician across all committees combined, whilst around 8,000 were not.

We found a stark variance in views and practices across Australia. Current ethics review processes risk approving studies that at best waste resources and at worst cause harms due to flawed evidence.