When and Why Is Research without Consent Permissible?

The view that research with competent adults requires valid consent to be ethical perhaps finds its clearest expression in the Nuremberg Code, whose famous first principle asserts that “the voluntary consent of the human subject is absolutely essential.” In a similar vein, the United Nations Interna...

Full description

Saved in:
Bibliographic Details
Published in:The Hastings Center report 2016-03, Vol.46 (2), p.35-43
Main Authors: Gelinas, Luke, Wertheimer, Alan, Miller, Franklin G.
Format: Article
Language:English
Subjects:
Bioethics
Deception
Federal regulation
Health insurance
Health Services Research - ethics
Human Experimentation - ethics
Human Experimentation - legislation & jurisprudence
Human Experimentation - standards
Human subjects
Humans
Informed consent
Informed Consent - ethics
Intensive care units
Legal consent
Medical research
Morality
Patient care
Patient Simulation
Physicians
Quality Improvement - ethics
Randomized Controlled Trials as Topic - ethics
Research studies
Simulations
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:The view that research with competent adults requires valid consent to be ethical perhaps finds its clearest expression in the Nuremberg Code, whose famous first principle asserts that “the voluntary consent of the human subject is absolutely essential.” In a similar vein, the United Nations International Covenant on Civil and Political Rights states that “no one shall be subjected without his free consent to medical or scientific experimentation.” Yet although some formulations of the consent principle allow no exceptions, others hold that informed consent is not always strictly necessary for ethical research. The U.S. federal regulations known as the “Common Rule,” which govern research with human subjects, lists several conditions for waiving consent. However, neither guidance documents on the ethics of clinical research nor the literature in bioethics contains a general justification of research without consent. The purpose of this paper is to advance a justificatory framework that will explain why research without consent is permissible in paradigmatic cases and that can be useful in analyzing cases about which there is (or is likely to be) disagreement. We argue that research without consent can be justified on two grounds: if it stands to infringe no right of the participants and obtaining consent is impracticable, or if the gravity of the rights infringement is minor and outweighed by the expected social value of the research and obtaining consent is impracticable.
ISSN:0093-0334
1552-146X
DOI:10.1002/hast.548