Vulnerability as a Regulatory Category in Human Subject Research

Journal of Law, Medicine and Ethics 37 (1):12-18 (2009)
  Copy   BIBTEX


The concept of vulnerability has long played a central role in discussions of research ethics. In addition to its rhetorical use, vulnerability has become a term of art in U.S. and international research regulations and guidelines, many of which contain specific provisions applicable to research with vulnerable subjects. Yet, despite the frequency with which the term vulnerability is used, little consensus exists on what it actually means in the context of human subject protection or, more importantly, on how a finding of vulnerability should affect the process of research ethics review.The Common Rule, the centerpiece of the U.S. human subject protection regulations, uses the word vulnerable three times. First, it provides that institutional review boards that regularly review research involving a vulnerable category of subjects should consider including one or more individuals who are knowledgeable about and experienced in working with these subjects.



    Upload a copy of this work     Papers currently archived: 74,509

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

Vulnerability as a Regulatory Category in Human Subject Research.Carl H. Coleman - 2009 - Journal of Law, Medicine and Ethics 37 (1):12-18.
A Regulatory Argument Against Human Embryonic Stem Cell Research.S. Napier - 2009 - Journal of Medicine and Philosophy 34 (5):496-508.
The Perils of Protection: Vulnerability and Women in Clinical Research.Toby Schonfeld - 2013 - Theoretical Medicine and Bioethics 34 (3):189-206.
De Minimis Risk: A Proposal for a New Category of Research Risk.Abraham Schwab - 2011 - American Journal of Bioethics 11 (11):1-7.


Added to PP

7 (#1,036,201)

6 months
2 (#278,199)

Historical graph of downloads
How can I increase my downloads?