David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Bioethics 27 (9):508-513 (2013)
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)|
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
Sharon Kaur & Choong Yeow Choy (2012). Ethical Considerations in Clinical Trials: A Critique of the ICH-GCP Guideline. Developing World Bioethics 12 (3):20-28.
Marek Czarkowski (2006). The Protection of Patients' Rights in Clinical Trials. Science and Engineering Ethics 12 (1):131-138.
Dorota Switula (2000). Principles of Good Clinical Practice (GCP) in Clinical Research. Science and Engineering Ethics 6 (1):71-77.
Danielle Laudy (2009). End of Life Pediatric Research: What About the Ethics? [REVIEW] Journal of Academic Ethics 7 (1-2):87-91.
Charles Weijer, Characterizing the Population in Clinical Trials: Barriers, Comparability, and Implications for Review.
Jeremy Sugarman (2004). Using Empirical Data to Inform the Ethical Evaluation of Placebo Controlled Trials. Science and Engineering Ethics 10 (1):29-35.
Franklin G. Miller & Howard Brody (2002). What Makes Placebo-Controlled Trials Unethical? American Journal of Bioethics 2 (2):3 – 9.
Joan Box (2004). Placebos and the UK Medical Research Council — and the Consumer Perspective. Science and Engineering Ethics 10 (1):95-101.
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.
Margaret B. Liu (2010). A Clinical Trials Manual From the Duke Clinical Research Institute: Lessons From a Horse Named Jim. Wiley-Blackwell.
David Buchanan & Franklin G. Miller (2005). Principles of Early Stopping of Randomized Trials for Efficacy: A Critique of Equipoise and an Alternative Nonexploitation Ethical Framework. Kennedy Institute of Ethics Journal 15 (2):161-178.
Simon Woods & Pauline Mccormack (2013). Disputing the Ethics of Research: The Challenge From Bioethics and Patient Activism to the Interpretation of the Declaration of Helsinki in Clinical Trials. Bioethics 27 (5):243-250.
Audrey R. Chapman & Courtney C. Scala (2012). Evaluating the First-in-Human Clinical Trial of a Human Embryonic Stem Cell-Based Therapy. Kennedy Institute of Ethics Journal 22 (3):243-261.
Added to index2011-11-09
Total downloads12 ( #135,156 of 1,101,812 )
Recent downloads (6 months)9 ( #28,656 of 1,101,812 )
How can I increase my downloads?