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Item Building a Central Repository for Research Ethics Consultation Data: A Proposal for a Standard Data Collection Tool(ACTS, 2015-08-01) Cho, Mildred K.; Taylor, Holly; McCormick, Jennifer B.; Anderson, Nick; Barnard, David; Boyle, Mary B.; Capron, Alexander M.; Dorfman, Elizabeth; Havard, Kathryn; Reider, Carson; Sadler, John; Schwartz, Peter H.; Sharp, Richard R.; Danis, Marion; Wilfond, Benjamin S.; Department of Philosophy, IU School of Liberal ArtsClinical research ethics consultation services have been established across academic health centers over the past decade. This paper presents the results of collaboration within the CTSA consortium to develop a standard approach to the collection of research ethics consultation information to serve as a foundation for quality improvement, education, and research efforts. This approach includes categorizing and documenting descriptive information about the requestor, research project, the ethical question, the consult process, and describing the basic structure for a consult note. This paper also explores challenges in determining how to share some of this information between collaborating institutions related to concerns about confidentially, data quality, and informatics. While there is much still to be learned to improve the process of clinical research ethics consultation, these tools can advance these efforts, which, in turn, can facilitate the ethical conduct of research.Item Collaborative biostatistics and epidemiology in academic medical centres: A survey to assess relationships with health researchers and ethical implications(Wiley, 2022-06-14) Devick, Katrina L.; Gunn, Heather J.; Price, Lori Lyn; Meinzen-Derr, Jareen K.; Enders, Felicity T.; Perkins, Susan M.; Schulte, Phillip J.; Biostatistics and Health Data Science, Richard M. Fairbanks School of Public HealthThe role of collaborative biostatisticians and epidemiologists in academic medical centres and how their degree type, supervisor type and sex influences recognition and feelings of respect is poorly understood. We conducted a cross-sectional survey of self-identified biostatisticians and epidemiologists working in academic medical centres in the United States or Canada. The survey was sent to 341 contacts at 125 institutions who were asked to forward the survey invitation to faculty and staff at their institution and posted on Community sections of the American Statistical Association website. Participants were asked a variety of questions including if they felt pressured to produce specific results, whether they had intellectual and ethical freedom to pursue appropriate use of statistical methods in collaborative research and if they felt their contributions were appropriately recognized by collaborators. We received responses from 314 biostatisticians or related methodologists. A majority were female (59%), had a doctorate degree (52%) and reported to a statistician or biostatistician supervisor (69%). Overall, most participants felt valued by their collaborators, but that they did not have sufficient calendar time to meet deadlines. Doctoral-level participants reported more autonomy in their collaborations than master's level participants. Females were less likely to feel recognized and respected compared with males. The survey results suggest that while most respondents felt valued by their collaborators, they have too many projects and need more time to critically review research. Further research is needed to understand why response differs by sex and how these responses fluctuate over time.