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

Current Medical Research and Opinion
Luann E Van CampenRobert J Levine

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 b...Continue Reading

References

May 20, 2000·JAMA : the Journal of the American Medical Association·E J EmanuelC Grady
Dec 14, 2002·Science·UNKNOWN Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries
Feb 21, 2004·The Journal of Infectious Diseases·Ezekiel J EmanuelChristine Grady
Mar 11, 2011·Journal of Trauma & Dissociation : the Official Journal of the International Society for the Study of Dissociation (ISSD)·UNKNOWN International Society for the Study of Trauma and Dissociation
Oct 26, 2011·Clinical Trials : Journal of the Society for Clinical Trials·Sonia S AnandSalim Yusuf
Oct 22, 2013·JAMA : the Journal of the American Medical Association·UNKNOWN World Medical Association

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Citations

Sep 2, 2015·Current Medical Research and Opinion·Luann E Van CampenRobert J Levine
Jan 16, 2020·Human Vaccines & Immunotherapeutics·Tatjana PoplazarovaThomas Breuer
Mar 27, 2021·BMC Medical Ethics·Luann E Van CampenUNKNOWN Biopharmaceutical Bioethics Working Group

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