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.
- ethics (see medical ethics)
- medical ethics
- public health
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Contributors MQW led the research team in the writing of phase I grant; designed the online data collection system; conducted the data analysis; reviewed and approved the final draft of this manuscript. AFY contributed to the writing of the phase I grant; administered and managed the online data collection system; contributed to the data analysis; reviewed and approved the final draft of this manuscript. RVK initially conceived of the project and research design method; contributed to the writing of this phase I grant; wrote the first draft of this manuscript.
Funding This work was supported by a grant from the Office of Research Integrity (ORI) of the U.S. Department of Health and Human Services (DHHS). Grant No. 1 ORIIR150017-01-00.
Competing interests None declared.
Ethics approval This pilot study was approved by the IRB at the University of Maryland School of Public Health and by the IRB at New York University as an Expedited Review category involving minimal risk for the subjects.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Technical appendix, statistical code and dataset are available from MQW (Department of Behavioral and Community Health, University of Maryland School of Public Health) via his email: firstname.lastname@example.org.
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