Informed Consent for Comparative Effectiveness Research Should Include Risks of Standard Care

Author:

Shepherd Lois

Abstract

This paper explains why informed consent for randomized comparative effectiveness research (CER) must include risks of standard care. Disclosures of such risks are both legally and ethically required and, for reasons discussed in the paper, should remain so.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference80 articles.

1. Ensuring Transparency: Presenting the Trade-Offs Between the Research Treatment Options

2. 69. Menikoff, J. , “Disclosing Risks in Research Evaluating Standards of Care,” PowerPoint slide presentation presented at the Secretary's Advisory Committee on Human Research Protections, October 29, 2014.

3. “Legally Blind: The Therapeutic Illusion in the SUPPORT Study of Extremely Premature Infants,”;Annas;Journal of Contemporary Health Law and Policy,2013

4. 43. Letter from Michael A. Carome et al. to The Honorable Daniel R. Levinson, Inspector General U.S. Department of Health and Human Services, May 20, 2014, available at (last visited August 3, 2017) (detailing evidence of involvement of NIH in suspension of OHRP's compliance action against UAB).

Cited by 2 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. The CER Experiment;The American Journal of Bioethics;2020-01-02

2. Controversies in Clinical Research Ethics;Journal of Law, Medicine & Ethics;2017-09

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