P242: Update on a Biopharmaceutical Bioethics Consultation Service: 16-Year Descriptive Characteristics
Poster Presenter
Susan Watson
Associate Director, Bioethics
Eli Lilly and Company United States
Objectives
The objective of this presentation is to provide an update to 2 previous analyses of consultations completed by a biopharmaceutical bioethics consultation service.
Method
Data on the descriptive characteristics of a biopharmaceutical bioethics consultation service from 2008 to 2023 were entered into a web-based list in Microsoft SharePoint. At time of analysis, data were exported into an Excel spreadsheet and analyzed via the pivot table function or formulas.
Results
Over the 16-year period, 648 bioethics consultations were conducted by bioethics staff and a bioethics advisory committee, based on an established and published framework and other company bioethics guidance documents. The number of consultations per year varied from a low of 5 in 2008 to a high of 67 in 2022. Response time (days to provide advice) decreased from a mean of 35 days in 2008 to 8 days in 2023. The 5 most frequent consultation topics overall were: continued access to investigational medicines (n=73, 11%), human biological samples (n=62, 10%), patient rights (n=59, 9%), pediatrics (n=57, 9%), and informed consent (n=55, 8%). The topic with the greatest numerical increase in frequency since the 2019 analysis was conduct of clinical trial (+3%) and the topic with the greatest decrease was informed consent (-2%). About three-fourths of consultations (n=512, 79%) were specific to a company product (i.e., drug, device, or diagnostic), and the remainder were general bioethics questions. Most consultations (n=341, 53%) were handled by the full-time bioethics staff, while the rest involved partial or full bioethics committee participation. Limitations of this analysis included the classification of all consultations under a single primary topic, even though most consultations addressed multiple topics; this simplified the analysis but resulted in some loss of information.
Conclusion
Compared with prior analyses of 189 and 297 consultations, there have been changes in both the volume of consultations and the relative frequency of consultation topics. These changes likely reflect changes within both the industry (e.g., changes in laws and regulations, medical advances) and the bioethics community (e.g., updates to ethics guidelines). Results also show a sustained opportunity for bioethics consultation on research planning and decisions within this company. Future research might report characteristics of bioethics consultations received by other companies or compare bioethics consultation services across settings (industry, academic, hospital, government, etc.).
