Hope, Hope Against Hope and Therapeutic Misconception in Clinical Trials: How Much Does it Matter?
Presented by: Dr. Ernest Prentice, Associate Vice Chancellor at University of Nebraska Medical Center
This presentation will address informed consent to participate in clinical trials in the context of a patient’s hope, hope against hope and therapeutic misconception. Therapeutic misconception will be defined with emphasis on the process of consent. The concept will be further explored using examples of historically significant clinical research where therapeutic misconception and scientific justification in support of the research became major ethical issues.
- Therapeutic misconception is a common occurrence, which may invalidate informed consent.
- Investigators have both a regulatory and an ethical obligation to appropriately address therapeutic misconception without compromising a patient’s hope.
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Dr. Ernest D. Prentice is the Associate Vice Chancellor for Academic Affairs at the University of Nebraska Medical Center and is the IO for both the Human Research Protection Program and the Animal Care and Use Program. Previously he served as the Executive Chair of the IRB and, for over 26 years, served as the Co-Chair of the IRB.
Dr. Prentice is a frequent contributor to the literature on the ethics and regulation of both human and animal research, and he is a frequent speaker at meetings on various aspects of research ethics. Dr. Prentice also serves as a consultant to universities, hospitals and law firms in the private sector, and he is often a member of national panels and writing groups addressing various aspects of research ethics and regulatory oversight of research.
Currently, Dr. Prentice is the Chair of the CITI External Advisory Board, a member of the Board of Directors for Schulman Associates IRB and the ACRP Board of Trustees. He is also the immediate past-President of the Scientists Center for Animal Welfare (SCAW). From 2003-2007, Dr. Prentice served as the Chair of the Health and Human Services Secretary’s Advisory Committee on Human Research Protection (SACHRP).