Ethics and Risk Communication
John H. Fielder, Ph.D., Villanova University, Villanova, PA
While the primary ethical issue in risk communication is the patient's right to be given the appropriate information needed to make informed health care decisions, in actual circumstances there are many other factors that complicate notification. This is especially true when the notification is done by a federal agency, such as FDA. Notification of patients and health care professionals about problems with medical devices must take into consideration the interests of a number of different stakeholders, the significance of Type I and Type II errors, lack of information and its change over time, the wide range of devices and things that can go wrong with them, boundary issues, amount of evidence needed, public vs. expert perceptions of risk, and defining levels of harm, risk, and evidence. More fundamentally, notification can proceed from a scientific outlook or a clinical one, which will radically shift the approach to the issues listed above.