Clinical trials are necessary before any new medicine is put on the market. However, many people who are unable to give consent as well as people from less-developed countries often participate in such trials. So how can we better protect these people and vulnerable populations against abuse? The European Commission has proposed a regulation which will be submitted to a vote of the European Parliament next 29 May. The COMECE bioethical experts consider that the proposal could go further in the protection of the people concerned.
On 17 July 2012, the EU Commission published a proposal for a ‘Regulation on clinical trials on medicinal products for human use’ which aims at relaunching clinical research within the EU while at the same time ensuring the highest level of protection to participants as well as the reliability of the acquired data. The proposal will be submitted to the vote of the Members of the ENVI Committee of the European Parliament next 29 May.
The COMECE Secretariat welcomes this proposal for a Regulation as it goes in the right direction. The COMECE Reflection Group on Bioethics has monitored the issue from the launch of the public consultation by the European Commission and publishes today its Opinion on this proposal for a Regulation. The COMECE experts underline some principles which should be duly implemented in the Regulation currently under discussion:
• Volunteering
The appreciation of the value of voluntary participation in research projects for the good of the community: granting financial incentives to any person agreeing to take part in some medical research therefore raises a key ethical issue.
• Protecting those particularly vulnerable
A key ethical consideration for research carried out on human subjects is that of respecting and protecting particularly vulnerable people and populations who could be unduly used as easily-exploitable objects for experiments.
• Benefits for the population concerned
Clinical research with a disadvantaged or vulnerable population or community is justified only if it responds to its health needs and priorities and if it is likely that such a population or community will benefit from the results of the research.
• Security of the participants to tests
The subject of the research may agree to become involved in a research protocol that does not fully respond to the individual’s own interests but will do so for the good of others, in the “medical interest of the community” and consequently for the “common good”, insofar as the patient’s physical or psychological integrity is not endangered.
• Benefits to the person incapable of consent
Trial medicinal products may not be given to persons who are not capable of giving their consent except in cases where the same results cannot be obtained by resorting to persons capable of giving their consent and if the foreseeable benefits/predictable risks ratio is to their advantage.
• Ethics of testing in emergency situations
As for clinical trials in emergency situations, the only acceptable research is specific research on individuals placed in such a situation that one may have good grounds for anticipating a direct benefit with regard to their condition and that would present a minimal risk and only impose a minimal burden. It is also important to give a sufficiently precise definition of the terms “minimal risk” and “minimal burden”.
Other elements of preoccupation and of analysis are developed further in the Opinion of the COMECE Reflection Group on Bioethics ‘Ethical assessment of clinical trials on medicinal products: Respect and protection of vulnerable persons and populations’ which is available in English and French and can be downloaded here.