Development, implementation and critique of a bioethics framework for pharmaceutical sponsors of human biomedical research.

Pharmaceutical human biomedical research is a multi-dimensional endeavor that requires collaboration among many parties, including those who sponsor, conduct, participate in, or stand to benefit from the research. Human subjects' protections have been promulgated to ensure that the benefits of such research are accomplished with respect for and minimal risk to individual research participants, and with an overall sense of fairness. Although these protections are foundational to clinical research, most ethics guidance primarily highlights the responsibilities of investigators and ethics review boards. Currently, there is no published resource that comprehensively addresses bioethical responsibilities of industry sponsors; including their responsibilities to parties who are not research participants, but are, nevertheless key stakeholders in the endeavor. To fill this void, in 2010 Eli Lilly and Company instituted a Bioethics Framework for Human Biomedical Research. This paper describes how the framework was developed and implemented and provides a critique based on four years of experience. A companion article provides the actual document used by Eli Lilly and Company to guide ethical decisions regarding all phases of human clinical trials. While many of the concepts presented in this framework are not novel, compiling them in a manner that articulates the ethical responsibilities of a sponsor is novel. By utilizing this type of bioethics framework, we have been able to develop bioethics positions on various topics, provide research ethics consultations, and integrate bioethics into the daily operations of our human biomedical research. We hope that by sharing these companion papers we will stimulate discussion within and outside the biopharmaceutical industry for the benefit of the multiple parties involved in pharmaceutical human biomedical research.