Ethics and Good Practices
This article was originally published in RAJ Devices
Executive Summary
Declaration of Helsinki revision tightens up on tissue R&D consent
Declaration of Helsinki revision tightens up on tissue R&D consent
The World Medical Association has adopted a revised version of the Declaration of Helsinki, which it says will increase protection for people taking part in clinical research1. The declaration, which sets out ethical principles for medical research involving human subjects, now features requirements on consent for research involving blood, tissues and DNA. It also requires clinical trials to be registered in a publicly accessible database2.
On the practice of comparing new experimental treatments to placebos rather than existing treatments, the revised declaration specifies that this may be done “only in very limited circumstances where patients who are given placebos will not suffer any serious or irreversible harm”.
The WMA says that, in reaffirming “its controversial stand against practices that open the door to exploitation of research subjects, particularly in developing countries”, it has refused to bow to pressure from industry and government regulatory agencies.
References
1. WMA press release, 20 October 2008
2. The Regulatory Affairs Journal - Devices, 2008, 16(5), 325-326