Johnson & Johnson is strongly committed to ensuring that our employees have both the resources and training to help them address difficult and complex bioethical questions that may arise during the course of their day-to-day work. To address the complex ethical questions arising in the field of biological research, science and medicine, our global Johnson & Johnson Bioethics Committee (JJBC), sponsored by the Chief Medical Officer, serves as an advisory body to our worldwide teams on ethical issues. Composed of a diverse group of internal medical experts with training and experience in evaluating bioethical questions, the JJBC is responsible for advocating adherence to bioethical principles, providing an expert forum for teams to obtain guidance on bioethical issues, and for championing our commitment to ethical decision-making across the enterprise. JJBC is guided by the fundamental principles of bioethics, including beneficence, non-maleficence, autonomy and justice, and our Ethical Code for the Conduct of Research and Development.
Our advances in the field of bioethics in 2019 include:
Innovation in pre-approval access to investigational medicines: Our Compassionate Use Advisory Committee (CompAC) is a novel approach that Johnson & Johnson employs globally to provide a fair, ethical evaluation of compassionate use requests for specific investigational medicines for patients with serious or life-threatening diseases.
In December 2019, CompAC, an initiative we developed in collaboration with the New York University School of Medicine, was honored to be the winner of the Reagan-Udall Foundation 2019 Innovation Award. The Reagan-Udall Foundation selected CompAC because of the Foundation’s belief that these types of important healthcare decisions benefit from fair and ethical evaluation. CompAC is a novel approach that utilizes an external group of experts including physicians, ethicists and patient representatives to review compassionate use requests. CompAC offers a more consistent, transparent and equitable approach to navigating the challenges associated with pre-approval access while maintaining U.S. Food and Drug Administration oversight.
Responsibly sharing clinical trial data to improve public health: Sharing clinical trial data advances the science that is the foundation of medicine. By making clinical trial data available to other researchers and scientists, we enable them to test new hypotheses, answer new questions and potentially find new treatments. Most importantly, we honor the study participants by giving their data new life for the advancement of public health. Since 2014, Johnson & Johnson’s Office of the Chief Medical Officer has been working with the Yale University Open Data Access Project, also known as the YODA Project, to enable a consistent and objective approach for assessing external research proposals requesting the use of clinical trial data from our Pharmaceutical, Medical Devices or Consumer Health business segments. To date, more than 30 articles have been published using data shared through the YODA Project that would not have otherwise been possible. In this way, important research can stand on the shoulders of research that has already been conducted and participant data can continue to contribute to improving public health.
Johnson & Johnson is committed to ensuring the ethical treatment of animals used in laboratory settings to advance patient safety and wellbeing. Johnson & Johnson operating companies have policies and guidelines in place that assure the ethical and humane treatment of the animals and promote the use of non-animal alternatives whenever feasible. We support and participate in efforts to obtain regulatory acceptance of alternative testing methods. See our Humane Care and Use of Animals Policy.
In 2019, we maintained our ethical approach to the human care and use of animals by strictly upholding our animal care and use that are intended to meet or exceed all applicable regulations, including the “3R” Principles:
- Replacement: using alternative non-animal systems in place of live animal utilization whenever possible.
- Reduction: using the minimum number of animals possible to achieve maximum information without compromising animal welfare.
- Refinement: continually modifying procedures to limit animal discomfort and distress,
In 2019, we developed a fully functioning non-animal model to provide comprehensive training on our Medical Devices product portfolio, and developed 3D-printed anatomical models and virtual reality-based options for training residents and fellows in the use of our medical devices. We also updated our Consumer Health Safety & Care Commitment online resource with enhanced information on our position regarding cosmetic animal testing.