Title

De Minimis Risk: A Proposal for a New Category of Research Risk

Document Type

Article

Document Subtype

Editorial/Essay/Column

Publication Date

11-2011

Publication Source

American Journal of Bioethics

Volume

11

Issue

11

Inclusive pages

1-7

DOI

10.1080/15265161.2011.615588

Peer Reviewed

yes

Abstract

In this article the authors reflect on regulations which have been developed to protect research subjects and data in research which uses human subjects. They suggest that regulations related to informed consent and privacy protection are burdensome in research which uses human subjects. They argue that a new category of research risk must be established which informs research subjects of the level of risk that they will be exposed to by participating in the research.

Keywords

Informed consent (Medical law), medical genetics, tissue banks, quality assurance, research subjects (Persons), research, capacity & disability (Law), research-- Moral & ethical aspects, institutional review boards (Medicine), government regulation, medical care -- Quality control moral & ethical aspects safety measures

Disciplines

Bioethics and Medical Ethics | Philosophy

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