Drug trials must not abuse peoples’ rights, European Bishops tell EU

Drugs trials necessary but must respect the vulnerable

Drugs trials are necessary before drugs come to market, but those conducting them have ethical duties to obtain consent and respect the rights of those from developing countries, says a statement on behalf of all Catholic Churches in the European Union.

COMECE, the Commission of the Bishops’ Conferences of the European Union, issued the statement through its Bioethics committee in response to the EU Proposal for “A Regulation on clinical trials on medicinal products for human use’ which aims at re-launching clinical research within the EU while at the same time ensuring protection to participants as well as the reliability of the acquired data. The European Commission proposed regulation which will be submitted to a vote of the European Parliament next 29 May

The statement on Ethical assessment of clinical trials on medicinal products: Respect and protection of vulnerable persons and populations  was released by COMECE this week in English and French.

Importance of consent

“Many people who are unable to give consent as well as people from less-developed countries often participate in clinical trials.” The COMECE statement asks how we can better protect them and vulnerable populations against abuse in the process.

The COMECE bioethics team conclude that  EU proposal could go further in the protection of the people concerned. A spokesperson said:

“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. ”

Key ethical concerns and principles

The COMECE team underlined some principles which they feel should be implemented in the proposed EU Regulation :

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 ethical issues.”

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, especially in developing countries

“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 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.” This underlines the importance of full and informed consent.

Benefits to the person incapable of consent

“Trial medicinal products should 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”. ”

The full statement on Ethical assessment of clinical trials on medicinal products: Respect and protection of vulnerable persons and populations is available in English and French

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