The Declaration of Helsinki (DoH), adopted by the World Medical Association (WMA) in 1964 is widely recognized as a core standard for ethical research involving human subjects.
The DoH is the loadstone, the North Star if you will that guides physicians, governments and industry in the area of ethical advice on doing medical research on human subjects.
Integral to the important protections the DoH provides research subjects is the requirement that “The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins.”
As previously reported in this blog, the WMA is in the process of evaluating the DoH to determine if revisions are needed. These revisions would not be to change underlying principles, but to provide more guidance to those doing research in an increasingly complicated and changing world. To that end an expert conference was held last month in Cape Town, South Africa and another is scheduled the end of this month in Tokyo, Japan.
Concurrent with this, the European Commission is proposing a revision of its Clinical Trials Directive (2001/20/EC) that if adopted by the European Union (EU) Parliament represents a change that puts the ethical principles for clinical research at great risk.
The EU Clinical Trials Directive is based on and supplemented by a set of internationally recognized scientific quality standards in the interest of the safety, reliability and ethical acceptability of clinical research involving human subjects. This Directive builds on the set of ethical principles embodied in the DoH.
The European Commission proposed revision COM (2012) 369 makes a number of unfortunate changes to the directive of 2001; the most egregious of which is to omit the specific requirement for ethics committees to give prior approval of clinical research trials.
This proposal undermines the protection of research subjects and researchers and the scientific quality and trust in clinical research that ethics committees have helped to guarantee. This is the case not only in the EU but also in non-EU countries that use the Clinical Trials Directive as a guide for research in their countries.
In addition, the proposed regulation stipulates the requirement of a “therapeutic benefit”. This requirement is a misconception about research since a therapeutic benefit can hardly ever be guaranteed.
The proposed regulation also provides unreasonably short timelines for Member States (of the EU) to assess and review applications. Shortening the time for careful consideration before approval of research trials risks missing defects in protocols and putting research subjects in danger.
And finally, the proposed regulation provides that the decision of the reporting Member State for multi-country trials, as to whether the conduct of a clinical trial is acceptable, is generally binding for all other Member States concerned. Any disagreement of the Member States about the conclusion of the reporting Member State is permissible only under very narrow provisions. Such an approach may lead to sponsors of clinical trials seeking locales for approval of their protocols in places with less rigorous requirements (ethics shopping). And worse, it may force Member States to grant or accept market authorization based on ethically or scientifically unacceptable trials.
The draft regulation, COM (2012) 369 has been submitted to three committees of the European Parliament for consideration. They are the committees on Environment, Public Health and Food Safety.
Such regulations are the most direct form of EU law. If adopted they have binding legal force throughout every Member State on a par with national laws.
Because of great concerns about the potentially dangerous consequences of this document being enacted into law, the WMA and the Standing Committee of European Doctors (CPME) this week sent letters to the members of the three committees of Parliament expressing our concerns.
The concluding paragraphs of the WMA letter read:
“……the WMA is deeply concerned that the current draft regulation leads to a significant paradigm shift that risks putting economic interests before ethics, rigour and most significantly patient safety. In addition, in view of the scope of this regulation, applying as it does to Member States and also to third countries, its effects might be unpredictable and detrimental for research, the development of safe and ethically developed medicine, and most importantly, dangerous for research subjects and patients in Europe and elsewhere.
We urge you to revise the current proposal and stand ready to discuss this further with the appropriate personnel to achieve an optimal outcome for the people for whom we care.” (Full version of letter is available here)