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Ethical Considerations of Access to Investigational Medicines

January 18 - 1:30 pm - 3:00 pm

This lecture is co-sponsored by the Research Ethics Consultation Unit of the Division of Clinical Research and the Harvard Medical School Center for Bioethics. Please register here to receive the Zoom details.

During the development of new medicines, manufacturers and research sponsors may be confronted with a decision about whether to provide access to a medicine that has not yet been approved for use by a health authority. This question can arise during the conduct of clinical trials when there is a gap between the end of a trial and when the medicine is available to be prescribed. Or it may come up as a request for “compassionate use” when a patient is facing a life threatening condition for which there are no available treatments. This talk will explore the ethical considerations underpinning these decisions and the importance of considering the various stakeholder perspectives.

Karla G. Childers, BA, MSJ, MSBE, Head, Bioethics-based Science & Technology Policy, Office of the Chief Medical Officer at Johnson & Johnson

Karla Childers joined Johnson & Johnson (J&J) in October 2013 in the Office of the Chief Medical Officer where her primary responsibility has been leading and coordinating various ethics-based, science and technology policy projects. Her longest running responsibility has been the support and coordination of Johnson & Johnson’s Clinical Trial Data Transparency Initiative, including the management of the Yale University Open Data Access (YODA) Project data sharing collaboration.

Ms. Childers is the Chair of the J&J Bioethics Committee, which serves as an internal forum providing advice on bioethical questions within J&J. She is responsible for the management and conduct of that committee and relevant bioethics consultations. She serves as a bioethics subject matter expert for various internal and external science and technology policy work and coordinates the internal bioethics educational program sponsored by the Office of the Chief Medical Officer.

Ms. Childers has also been actively engaged outside J&J in various R&D and ethics-based work. She has volunteered in the Drug Information Association (DIA) in various roles for the past decade, including the Annual Meeting Program Committee, Annual Meeting Steering Committee, and most recently co-founded the DIA Bioethics Community. She served three years on the Public Responsibility in Medicine & Research (PRIM&R) planning committee for the Advancing Ethical Research (AER) conference and continues to be an active speaker and member for PRIM&R. Most recently, she joined the board of FASPE (Fellowships at Auschwitz for the Study of Professional Ethics).