Eli Lilly and Company’s bioethics framework for human biomedical research

Abstract

Current ethics and good clinical practice guidelines address various aspects of pharmaceutical research and development, but do not comprehensively address the bioethical responsibilities of sponsors. To fill this void, in 2010 Eli Lilly and Company developed and implemented a Bioethics Framework for Human Biomedical Research to guide ethical decisions. (See our companion article that describes how the framework was developed and implemented and provides a critique of its usefulness and limitations.) This paper presents the actual framework that serves as a company resource for employee education and bioethics deliberations. The framework consists of four basic ethical principles and 13 essential elements for ethical human biomedical research and resides within the context of our company's mission, vision and values. For each component of the framework, we provide a high-level overview followed by a detailed description with cross-references to relevant well regarded guidance documents. The principles and guidance described should be familiar to those acquainted with research ethics. Therefore the novelty of the framework lies not in the foundational concepts presented as much as the attempt to specify and compile a sponsor's bioethical responsibilities to multiple stakeholders into one resource. When such a framework is employed, it can serve as a bioethical foundation to inform decisions and actions throughout clinical planning, trial design, study implementation and closeout, as well as to inform company positions on bioethical issues. The framework is, therefore, a useful tool for translating ethical aspirations into action -to help ensure pharmaceutical human biomedical research is conducted in a manner that aligns with consensus ethics principles, as well as a sponsor's core values.

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

“…The discussion below highlights why these five elements were included, while the companion article 10 discloses the actual content of the framework (including these five elements).…”

“…The purpose of this paper is to describe how the framework was developed and implemented and to provide a critique based on four years of experience. A companion article 10 presents the complete content of the framework for the primary purpose of disclosing our ethical reflections and sharing a tool with pharmaceutical industry sponsors -although other sponsors may also find it useful. The purpose of both papers is to stimulate discussion among industry stakeholders regarding the ethical responsibilities of sponsors of pharmaceutical biomedical research.…”

Getting Started in Clinical Pharmacy Research

“…Limitation in the discussion section is also a self-reflection part, by self-diagnosing any deficiencies in the study designs that may impact the generalizability of your research. when pharmaceutical human biomedical research as a multi-dimensional endeavour requires a collaboration among many parties including industry sponsors, stakeholders, and third-party delegates (e.g., clinical research organization or academic research organization), industry sponsors need to develop control systems to address bioethical responsibilities such as independent ethic review, equitable selection of countries/ communities and participants, and public transparency [27][28][29]. Industry sponsors have the responsibility to manage the relationships with investigators and study sites in a manner that will enhance transparency and mitigate conflicts of interest and circumstances that could introduce bias into the clinical trial process [27,30].…”

Considerations for applying bioethics norms to a biopharmaceutical industry setting

“…There are scores of articles and a number of books [6][7][8][9][10][11] that examine and discuss industry 'ethics' broadly (including a mix of business ethics, corporate responsibility, legal compliance, and bioethics), and there is substantive bioethics literature on topics that relate to industry activities (for example, those listed in the introduction). However, there are a limited number of articles [12][13][14][15][16][17][18] and one book [19] that have explored how and why bioethics as a discipline is being applied within a biopharmaceutical industry context. Even with these efforts, none has defined the scope of biopharmaceutical bioethics nor described bioethically relevant characteristics of an industry setting.…”