P303: Evolution of a Bioethics Oversight Program in the Healthcare Industry
Poster Presenter
Nanci Horovitz
Director, Bioethics, Policy, & Partnerships
Johnson & Johnson United States
Objectives
The pharma industry faces increasing demand for bioethics guidance as R&D teams navigate complex scientific, regulatory, & societal expectations. Yet, few companies have established internal structures to shape policy, education, & ethical decision-making across rapidly evolving areas of innovation.
Method
Analysis of bioethics requests, and historical documentation, enabled the examination of the various mechanisms that provide increased bioethics support capacity. Operational metrics and example case studies will be presented.
Results
Bioethics oversight within the healthcare company has evolved into a formal research ethics committee, led by a trained bioethicist. The program provides enterprise-wide guidance on ethical issues through consultative services, policy development, & education, all grounded in the company’s Ethical Code of Conduct for R&D, which was developed in 2002. This framework formalized the company’s commitment to integrating bioethics into R&D practices. Central to the program is the Bioethics Committee, which offers expert input on complex ethical questions.
To enhance accessibility, the program introduced “offline reviews” & “curbside consultations” as streamlined alternatives to full committee meetings, enabling timely, practical guidance on sensitive topics while maintaining rigorous ethical oversight. Topics may be closed following review or escalated for further committee discussion. The program effectiveness is then assessed through engagement, responsiveness, & the integration of bioethics advice into decision-making across the organization.
Through the implementation of alternative consultation mechanisms, the Bioethics Committee completed 366 curbside consultations and 36 offline reviews between 2020 and 2025. As the number of alternative mechanisms increased, the number of full committee reviews remained stable & did not proportionally increase. These mechanisms demonstrated improved accessibility & responsiveness for R&D teams, enabling timely, informal discussions on sensitive ethical topics without compromising rigor or oversight.
Conclusion
The growing demand for ethical guidance in research and development underscores the need for dedicated bioethics expertise within organizations to ensuring our innovations are grounded in integrity, transparency and a deep responsibility to those we serve. Embedding a trained bioethicist and structured consultation mechanisms enables timely, practical guidance while maintaining ethical rigor. This model can be replicated by other institutions to expand capacity, strengthen oversight, and ensure ethical considerations are integrated throughout product development. By pairing bioethics expertise with scientific oversight, organizations can foster responsible innovation and uphold patient-centered values at every stage of research and decision-making.
Formal documentation for requests is essential to ensure that bioethics guidance is thorough, consistent, and aligned with healthcare industry practices. These process and system improvements, along with continued bioethics policy development, and implementation of a formalized bioethics training program will support the anticipated increased volume of bioethics requests into the future.
