FDA abandons the declaration of Helsinki : the effect on the ethics of clinical trial conduct in South Africa and other developing countries
Date
2012-12
Authors
Burgess, L. J.
Pretorius, D.
Journal Title
Journal ISSN
Volume Title
Publisher
Health and Medical Publishing Group (HMPG)
Abstract
Four years ago, the US Food and Drug Administration (FDA) ceased compliance with the Declaration of Helsinki (DoH) (2000 revision and
all subsequent revisions) for conduct of clinical trials outside its borders. It instead ruled that compliance with the Good Clinical Practices
(GCP) of the International Conference of Harmonization (ICH) is sufficient. However, the ICH-GCP guidelines do not address certain ethical
requirements stipulated in the DoH, such as the use of placebos v. standard therapy, post-trial access to treatment and other benefits for
participants; public disclosure of trial design; publication of trial results; and disclosure of conflicts of interest.
The FDA’s adoption of less morally stringent guidelines could encourage pharmaceutical companies to take ethical short cuts. It could also
have practical consequences for trial ethics in developing countries, especially where research ethics committees may not be promoting
high standards of protection for participants in clinical trials, due to lack of financial and human resources.
Pharmaceutical companies may also pressurise research ethics committees to relax guidelines and legislation, in order to facilitate future
clinical trials in developing and emerging countries that lack the resources to conduct their own clinical research on epidemics such as HIV/
AIDS, which have devastating effects on their populations.
Description
The original publication is available at http://www.sajbl.org.za/
Keywords
Medical ethics, Pharmaceutical ethics
Citation
Burgess, L. J. & Pretorius, D. 2012. FDA abandons the declaration of Helsinki: The effect on the ethics of clinical trial conduct in South Africa and other developing countries. South African Journal of Bioethics and Law, 5(2):87-90, doi:10.7196/SAJBL.222.