Ethicovigilance in clinical trials

Bioethics 27 (9):508-513 (2013)
Abstract
This article provides an ethical critique of the Good Clinical Practice (GCP) and Declaration of Helsinki (DoH) documents. While the previous criticisms of GCP are entirely correct, there is much more wrong with the document than has previously been acknowledged, including a circular definition and an astonishing vagueness about ethical principles. In addition to its failure to provide adequate ethical protection of participants, the procedurally dense nature of GCP lends itself to a box-ticking culture where important ethical issues are overlooked because they are not ‘mentioned on the form’. In contrast, the DoH is a much more effective ethical document, but actually goes too far in one respect. It transpires that the best ethical guidelines for clinical research would be neither over-prescriptive in regard to particular ethical issues (as the DoH is) nor neglectful of them (as GCP is); correctly framed ethical principles will provide sufficient protection to participants while also ensuring a culture of ethicovigilance in clinical trials
Keywords Placebos  law  regulation  research ethics  good clinical practice
Categories (categorize this paper)
Options
 Save to my reading list
Follow the author(s)
My bibliography
Export citation
Find it on Scholar
Edit this record
Mark as duplicate
Revision history Request removal from index
 
Download options
PhilPapers Archive


Upload a copy of this paper     Check publisher's policy on self-archival     Papers currently archived: 12,068
External links
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
Through your library
References found in this work BETA

No references found.

Citations of this work BETA

No citations found.

Similar books and articles
Maurie Markman (2004). The Research Misconception. International Journal of Applied Philosophy 18 (2):241-252.
Sven Ove Hansson (2006). Uncertainty and the Ethics of Clinical Trials. Theoretical Medicine and Bioethics 27 (2):149-167.
Analytics

Monthly downloads

Added to index

2011-11-09

Total downloads

12 ( #135,156 of 1,101,812 )

Recent downloads (6 months)

9 ( #28,656 of 1,101,812 )

How can I increase my downloads?

My notes
Sign in to use this feature


Discussion
Start a new thread
Order:
There  are no threads in this forum
Nothing in this forum yet.