The varying perceptions of a statistician’s value, from “critical” to “not needed for 99.9% of applications”: A national study of human research ethics committees

Currently, much health and medical research is wasted due to inappropriate study design oranalysis. Study designs could be improved using an expert review from a qualified statistician.The ethical review process is an ideal stage for this input; however, we do not know how manyethics committees in Australia have access to a qualified statistician. To answer this question, weapproached all human research ethics committees in Australia.Sixty percent of committees had access to a qualified statistician, either as a full committeemember or as a non-member who could be consulted when needed, but this dropped to 35% afteraccounting for statistical qualifications. Many committees rely on “highly numerate” researchersin place of qualified statisticians, as they viewed research experience and advanced statisticaltraining as equivalent. Committees without access to statisticians tended to locate responsibilityfor study design with other parties, including researchers, trial sponsors, and institutions. Somecommittee chairs viewed formal statistical input as essential to the work of the committee;however, there was also a common belief that statistical review was only applicable to somestudy designs, and that “simple” or “small” studies did not need review. We encountered asurprising variance in practice and attitudes towards the use of statisticians on research ethicscommittees. The current high number of research studies receiving approval without statisticalreview risks approving studies that will in the best-case waste resources and in the worst-casecause harms due to flawed evidence.