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Clinical Trials – EPF to release Position Paper on Informed Consent

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EPF is consulting our  members on a position paper that will provide recommendations for patient-centred implementation of the provisions of the new EU Clinical Trials Regulation (Regulation 536/2014). The survey focuses on informed consent and information to patients.

Informed consent remains a core prerequisite for enrolling any person in a clinical trial. It is a fundamental principle of medical ethics, enshrined in the Declaration of Helsinki and other international conventions and regulations. It is much more than a simple process to provide information to patients or to get a signature on a form. 

Regrettably there are large disparities across the EU both in terms of quality and quantity of the information provided to patients, and the quality of the consent process. Consent is still sometimes considered as a box to be ticked in order to get on with the research, rather than a vital means of patients’ empowerment.

Our recommendations will address the implementation of the EU Regulation, but will go beyond, for example to consider how technology can improve the consent process. Informed consent could be seen as a kind of “decision aid”, which should equip patients with as much information as they wish to have at any given time, in order to balance the associated benefits and risks in relation to their own situation and make an “enlightened decision”* whether to participate in research. Moreover, information should be accessible at all times throughout the trial, from the time of consent until the latest stage. (* In the words of the Nuremberg Code, 1947)

To ensure that this becomes reality, patient involvement needs to be embedded within the research process. EPF has previously called attention to the many ways in which patient involvement benefits research. We will call on all EU member states to implement the Recommendation in the new regulation to involve patients meaningfully in the assessment of clinical trials, by strengthening collaboration with the competent authorities and patient organisations and by involving patient representatives in ethics committees.

More information: EPF’s position on the lay summary of clinical trials results.

Contact: Kaisa Immonen-Charalambous, Director of Policy, kaisa.immonen-charalambous@eu-patient.eu