Ethics, Stewardship, and Laboratory Tests with Unproven Clinical Benefit

Course overview

Clinical laboratories often receive orders for tests that are outside the mainstream of clinical testing. Some of these are new/emerging tests for which there simply isn’t a lot of clinical experience. Some are research biomarkers that are primarily of interest to bench scientists. Some are panels or algorithms designed largely in response to marketing considerations. What these all have in common is a lack of clinical evidence demonstrating clinical utility, i.e. therapeutic benefit for patients as a consequence of the tests. How should clinical labs evaluate requests for such tests? Historically many laboratories have approached these requests from a financial and/or logistical perspective, approving the tests as long as they don’t overly burden the local laboratory (and provided that they are performed in a CLIA-licensed setting). This presentation will present an additional framework for consideration, namely bioethics. What is the ethical impact of such testing on the individual patient as well as on society as a whole? And how can potentially useful – but still unproven – laboratory tests be introduced into clinical settings in an ethically consistent manner? Learning Objectives: 1. Describe the main ethical principles presented in the Belmont Report and the Declaration of Geneva. 2. Describe the primary ethical tradeoffs involved in use of lab tests that lack evidence of clinical utility. 3. Describe ethically sound ways to introduce new tests into clinical settings.