Informed Consent for Comparative Effectiveness Research Should Not Consider the Risks of the Standard Therapies That Are Being Studied as Risks of the Research

Journal of Law, Medicine and Ethics 45 (3):365-374 (2017)
  Copy   BIBTEX

Abstract

There is a debate at the highest levels of government about how to classify the risks of research studies that evaluate therapies that are in widespread use. Should the risks of those therapies be considered as risks of research that is designed to evaluate those therapies? Or not? The Common Rule states, “In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research.” ). By contrast, the Office of Human Research Protections, in a proposed “guidance” states, “The reasonably foreseeable risks of research include already-identified risks of the standards of care being evaluated as a purpose of the research.”.In this paper, I argue that the Common Rule got it right and OHRP got it wrong. When treatments are in widespread use, the risks of those treatments are ever-present for all patients. By enrolling in formal studies that use rigorous methods to compare one treatment with another and that carefully monitor outcomes and adverse events, patients are protected from the risks of idiosyncratic practice variation. Their risks are decreased, rather than increased.If OHRP's approach becomes the law of the land, patients will be misinformed about the relative risks of treatment and research in ways that undermine autonomy rather than promoting it and that make truly informed consent impossible.

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 86,605

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Can informed consent to research be adapted to risk?Danielle Bromwich & Annette Rid - 2015 - Journal of Medical Ethics 41 (7):521-528.
Equipoise and Nonmedical Risks.Brandon Boesch - 2014 - American Journal of Bioethics 14 (4):16-18.
Limits to research risks.F. G. Miller & S. Jofe - 2009 - Journal of Medical Ethics 35 (7):445-449.
Do Unknown Risks Preclude Informed Consent?David Rudge - 2003 - Essays in Philosophy 4 (2):110-118.

Analytics

Added to PP
2017-10-25

Downloads
15 (#777,719)

6 months
2 (#528,188)

Historical graph of downloads
How can I increase my downloads?

Citations of this work

Controversies in Clinical Research Ethics.Robert M. Sade - 2017 - Journal of Law, Medicine and Ethics 45 (3):291-294.

Add more citations