Consent for Medical Device Registries: Commentary on Schofield, B. (2013) The Role of Consent and Individual Autonomy in the PIP Breast Implant Scandal

Public Health Ethics 6 (2):226-229 (2013)
  Copy   BIBTEX

Abstract

The clinical introduction of medical devices often occurs with relatively little oversight, regulation and (long-term) follow-up. Some recent controversies underscore the weaknesses of the current regime, such as the complications surrounding the metal-on-metal hip implants and the scandal surrounding the global breast implant scare of silicone implants made by France's Poly Implant Prothese (PIP) Company. The absence of national registries hampered the collection of reliable information on the risks and harms of the PIP breast implants. To warrant long-term safety, a case can be made for mandatory post-marketing surveillance by means of the establishment of compulsory registries. In this edition of Public Health Ethics, Schofield calls for debate on how such a registry system should be initiated and maintained and how it would relate to the ethical requirement of consent. Here we use breast implant registries as a case to discuss whether and when a so-called ‘thick opt-out’ would be an appropriate method to include people in medical device registries. We conclude that a thick opt-out procedure for medical device registries is only justifiable in cases where inclusion does not involve burdens (or very low), when it does not involve a sensitive subject and when the data are stored anonymously (or at least not directly linked to the medical record). Otherwise, inclusion should be sought by means of an opt-in

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 76,215

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

Autonomy, Consent and the Law.Sheila McLean - 2009 - Routledge-Cavendish.
Ethical Issues in the Use of Implanted Medical Devices.Anne Moates - 2006 - Chisholm Health Ethics Bulletin 11 (3):9.

Analytics

Added to PP
2013-07-17

Downloads
94 (#132,771)

6 months
1 (#449,220)

Historical graph of downloads
How can I increase my downloads?

Author's Profile

Jacob Van
United States Air Force Academy

Citations of this work

No citations found.

Add more citations

References found in this work

Harm to Self.Joel Feinberg - 1986 - Oxford University Press USA.
Four essays on liberty.Isaiah Berlin - 1969 - Oxford University Press.
Harm to Self.Joel Feinberg & Donald Vandeveer - 1988 - Ethics 98 (3):550-565.
Rethinking research ethics.Rosamond Rhodes - 2005 - American Journal of Bioethics 5 (1):7 – 28.
Rethinking Research Ethics.Rosamond Rhodes - 2010 - American Journal of Bioethics 10 (10):19-36.

View all 9 references / Add more references