Identifying bioethical issues in biostatistical consulting: findings from a US national pilot survey of biostatisticians.

OBJECTIVES: The overall purposes of this first US national pilot study were to (1) test the feasibility of online administration of the Bioethical Issues in Biostatistical Consulting (BIBC) Questionnaire to a random sample of American Statistical Association (ASA) members; (2) determine the prevalence and relative severity of a broad array of bioethical violations requests that are presented to biostatisticians by investigators seeking biostatistical consultations; and (3) establish the sample size needed for a full-size phase II study.

DESIGN: A descriptive survey as approved and endorsed by the ASA.

PARTICIPANTS: Administered to a randomly drawn sample of 112 professional biostatisticians who were ASA members.

PRIMARY AND SECONDARY OUTCOME MEASURES: The 18 bioethical violations were first ranked by perceived severity scores, then categorised into three perceived severity subcategories in order to identify seven 'top tier concern violations' and seven 'second tier concern violations'.

RESULTS: Methodologically, this phase I pilot study demonstrated that the BIBC Questionnaire, as administered online to a random sample of ASA members, served to identify bioethical violations that occurred during biostatistical consultations, and provided data needed to establish the sample size needed for a full-scale phase II study. The No. 1 top tier concern was 'remove or alter some data records in order to better support the research hypothesis'. The No. 2 top tier concern was 'interpret the statistical findings based on expectation, not based on actual results'. In total, 14 of the 18 BIBC Questionnaire items, as judged by a combination of 'severity of violation' and 'frequency of occurrence over past 5 years', were rated by biostatisticians as 'top tier' or 'second tier' bioethical concerns.

CONCLUSION: This pilot study gives clear evidence that researchers make requests of their biostatistical consultants that are not only rated as severe violations, but further that these requests occur quite frequently.