TY - JOUR
T1 - Identifying bioethical issues in biostatistical consulting
T2 - Findings from a US national pilot survey of biostatisticians
AU - Wang, Min Qi
AU - Yan, Alice F.
AU - Katz, Ralph V.
N1 - Funding Information:
Following our successful completion of this phase I pilot study, our research team submitted a phase II grant that was funded by the Office of Research Integrity at the US Department of Health and Human Services to conduct a follow-up phase II full-sized study which is currently underway, again in collaboration with the ASA. The findings from that phase II full-sized study will serve to more definitively describe both the frequency and severity of bioethical violations requested during biostatistical consultations, as well as guide the development of future educational bioethical training modules targeted at university-based clinical research training programme and their directors as well as to encourage and develop means for research universities and companies to improve their institutional environmental efforts regarding job and publication pressures to reduce the frequency of these bioethical violation requests.
Funding Information:
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.
Publisher Copyright:
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
PY - 2017/11/1
Y1 - 2017/11/1
N2 - 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.
AB - 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.
KW - ethics (see medical ethics)
KW - medical ethics
KW - public health
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U2 - 10.1136/bmjopen-2017-018491
DO - 10.1136/bmjopen-2017-018491
M3 - Review article
C2 - 29146653
AN - SCOPUS:85049906671
SN - 2044-6055
VL - 7
JO - BMJ open
JF - BMJ open
IS - 11
M1 - e018491
ER -