The study and data collection conformed to all local laws and were compliant with the principles of the Declaration of Helsinki
and had the approval of the Hospital Ethics Committee.
World Medical Organization, Declaration of Helsinki
, in British Medical Journal 313 (1996): 1448-49.
Since its original formulation, the Declaration of Helsinki
has undergone seven revisions and two clarifications, with the most recent revision being in October 2013.
WMA's Revised Declaration of Helsinki
to Be Circulated for Further Debate and Approval.
The effort to revise the Declaration of Helsinki
and the CIOMS Guidelines has sparked a sometimes vitriolic debate centering on the use of placebo controls.
The National Health Act does not legally enforce compliance with the Declaration of Helsinki
guidelines when conducting clinical trials in SA.
To ascertain the extent of similarities and differences in the guidance documents relevant to clinical research in South Africa, we compared the following documents: International Conference on Harmonisation: E6 Consolidated Guidelines for Good Clinical Practice, 1996 (ICH GCP); (2) SA GCP 2006;1 Declaration of Helsinki
(2004) as incorporated in SA GCP 2006 (World Medical Association at its 55th General Assembly, Tokyo, 2004); (3) Declaration of Helsinki
(2008) (World Medical Association at its 59th General Assembly, Seoul, 2008); (4) Ethics in Health Research: Principles, Structures and Processes (Department of Health 2004--'ethical guidelines' for the purpose of this paper); (5) the Constitution of the Republic of South Africa (1996); (6) and the National Health Act 61 of 2003.
Food and Drug Administration, the WHO, and the World Medical Association Declaration of Helsinki
(World Medical Association 2002).
Particularly disappointing is the failure to enumerate the conceptual flaws of the Declaration of Helsinki
In April 2008, the US Food and Drug Administration (FDA) published its controversial decision to abandon the Declaration of Helsinki
(DoH) as an ethical guideline when conducting, and reviewing data from, clinical trials performed outside the USA.