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Hastings Center Report

From the Editor: Learning Health Systems, Informed Consent, and Respect for Persons

Abstract:

Several pieces in the Hastings Center Report’s May-June 2022 issue concern research ethics issues that arise in learning health care systems. In the lead article, Stephanie Morain and colleagues propose a new ethical framework for pragmatic clinical trials (PCTs), which are trials embedded in clinical care. Their framework consists of eight dimensions of demonstrating respect for patients enrolled in PCTs. In the second article, Robert Steel argues that patients being treated in a learning health care system can be required to participate in a clinical trial even if the risk to them is more than minimal. If they wish to refuse, they must either forgo treatment in the system or seek it elsewhere. Three commentaries explore various dimensions of Steel’s argument. A third article in the issue turns in a different direction, to assumptions in bioethics about the quality of lives lived with disability. The authors, Debjani Mukherjee, Preya Tarsney, and Kristi Kirschner, find much that needs to change and offer recommendations for improvements at multiple levels.

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