The Lilly Bioethics Program: A Global Framework
In 1999, Lilly became one of the first pharmaceutical companies to establish a standing bioethics committee to systematically identify, evaluate and communicate bioethics issues. In 2008, Lilly took its first steps toward a more dedicated approach to bioethics by establishing the Lilly Bioethics Program. This program devotes full-time resources to the area and is committed to promoting excellence in ethics. The Program is an independent organizational unit within Lilly with a dedicated senior leader: the Vice President of Global Patient Safety and Bioethics. The Program's full-time staff, with graduate training in bioethics, is responsible for the Program's development, oversight and deliverables. Support for the program also comes from the Lilly Bioethics Advisory Committee (BEAC) and the Lilly Bioethics Network (BEN).
The Lilly Bioethics Program is designed to address the increasingly complex ethical challenges of global pharmaceutical Research & Development (R&D) in today's fast-paced biotechnology environment. The Program is a global framework that governs the full sweep of Lilly's R&D activities. It promotes ethical research and drug development, safeguards the integrity of the scientific process, and protects patients' well-being. The purpose of the Program is to assist employees in identifying and addressing bioethical issues related to Lilly Research Laboratory's (LRL) R&D activities. The Program staff also consults other groups within Lilly on bioethical matters related to other aspects of the company's business.
The Bioethics Program comprises four core activities:
- Developing company positions on key bioethics issues
- Consulting with internal Lilly staff
- Conducting internal education and training on bioethics
- Contributing to internal collaborative projects that integrate bioethics into R&D operations, as well as external projects that contribute to the advancement of the field of bioethics as it relates to pharmaceutical applications.
The Lilly Bioethics Advisory Committee
The Lilly BEAC is a cross-functional volunteer committee comprised of senior-level individuals from various functional areas within and outside of R&D, including medical, patient safety, discovery research, veterinary resources, legal, corporate affairs, and global brand development. Membership also includes two external academic bioethicists. Members are asked to take basic training in bioethics, provide bioethics consultations, and offer input into company bioethics projects, such as development of Lilly’s official position on a bioethics issues.
Positions developed by the BEAC inform the policies, standards, procedures, and practices of Lilly Research Laboratories, our global R&D group. Employees involved in clinical research participate in training in these areas, and take refresher courses when policies, standards, and procedures are updated.
The BEAC runs an internal Bioethics Consultation Service to help Lilly employees identify and address bioethics issues related to Lilly Research Laboratories R&D activities. This committee consults on specific ethical concerns; clarifies Lilly bioethics positions and how to apply them to workplace situations, and facilitates discussion of hypothetical or historical cases.
The Lilly Bioethics Network
Recently, the Bioethics Program launched the Lilly Bioethics Network, or BEN. The BEN is an informal, voluntary, virtual community of Lilly staff who are interested in developing their knowledge and skills in bioethics. Participation includes training opportunities, and attendance at lectures, seminars, case discussions, and other activities sponsored by the Bioethics Program.
Bioethics Specialist Team (BEST) & Bioethics Specialist Development Program
The Bioethics Specialist Team (BEST), a sub-group of the BEN, is comprised of Lilly employees with specialized knowledge and skills in bioethics and an on-going commitment to develop in this area. BEST members support the Bioethics Program through participation in bioethics activities and projects.
The Bioethics Specialist Development Program is an internal six-month experiential training program designed to help Lilly employees identify and respond to bioethics issues specifically related to their functional role in the company and pharmaceutical industry. Bioethics Specialists may become members of the BEST after the initial six months, and continue to work on bioethics projects related to their functional area.
Bioethics Framework for Human Biomedical Research
In 2010, to provide researchers with guiding principles and practical tools, Lilly developed a bioethics framework specifically to describe and evaluate the ethics of developing, conducting, analyzing and disclosing results from studies involving human subjects. The framework incorporates ethics principles from widely recognized global guidelines and scholarly literature, including, but not limited to: The Belmont Report, The Declaration of Helsinki, the Council for International Organizations of Medical Sciences' International Ethical Guidelines, and The International Conference on Harmonisation's Guideline for Good Clinical Practice.
Lilly’s Bioethics Positions
Flowing out of the Framework, the Lilly Bioethics Program develops bioethics positions on relevant and emerging topics, including the following:
Protecting Research Subjects’ Rights in Clinical Trials
Our Bioethics Framework is the basis for a single global standard that Lilly applies to the conduct of clinical trials worldwide. Our practices are consistent with the Pharmaceutical Research and Manufacturers of America’s Principles on Conduct of Clinical Trials, in addition to following the laws and regulations of the country or countries in which a study is conducted.
Lilly is a global company serving the medical needs of a global population. In choosing locations worldwide to conduct clinical trials, Lilly considers the local prevalence of the disease under study and the medical research capabilities of the institutions under consideration.
In addition, Lilly works with local ethics committees and health authorities to ensure that conducting the proposed research in each location is scientifically and ethically justified. These decisions take into consideration the following:
- the risks and benefits for research participants
- the potential for the research to yield important scientific advances
- the relevance of the research to local health needs
- intent to register the drug in the host country
In applying these considerations, Lilly places paramount importance on the safety and well-being of the individual research participants. Taken together, this external and internal guidance helps researchers access thoughtful, informed, consistent advice on ethical questions that relate to the design, planning, and implementation of clinical trials, and to the timely disclosure of research results.
One key aspect of protecting research participants is the informed consent process, designed to respect an individual’s autonomy and protect an individual’s freedom of choice. Each patient or volunteer who wishes to participate in Lilly-sponsored research is informed both verbally and in writing of the purpose, methods, and possible risks and benefits of a study, as well as the fact that they are free to withdraw from the study at any time and for any reason.
The decision to volunteer for a study must be an individual choice, free from undue influences that might persuade a person to consent to greater than reasonable risk. To help ensure this, it is Lilly’s policy that the promise of payments of money or other rewards not be so large as to unduly influence a prospective subject’s decision. The individual’s consent to participate in a study is documented by a signature of agreement. In the case of an individual who is not capable of giving informed consent, including children, the consent of a legally authorized representative may be obtained on behalf of that individual, provided that the study participant is willing to participate.