De Minimis Risk: A Proposal for a New Category of Research Risk
American Journal of Bioethics
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.
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
Bioethics and Medical Ethics | Philosophy
Rosamond Rhodes et al. and Abraham Schwab (2011).
De Minimis Risk: A Proposal for a New Category of Research Risk. American Journal of Bioethics.11 (11), 1-7.