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 the applicable 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 candidate institutions.
In addition, Lilly works with local ethics committees and/or health authorities, as appropriate, to ensure that conducting the proposed research in each location is scientifically and ethically justified. These decisions take into consideration:
- 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, and
- 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 he or she is 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 provides his or her assent to participate.