Clinical Trials Informed Consent Paper

EPF has published a position paper recommending for patient-centred implementation of the provisions of the new EU Clinical Trials Regulation. Focusing on informed consent and information to patients, the paper outlines our vision on this central topic from a patient’s perspective. 

Informed consent is a core prerequisite for enrolling any person in a clinical trial. It is a patient’s right and a fundamental principle of medical ethics, enshrined in numerous international conventions and documents. It is not merely about providing information to the patient, or obtaining a signature on a form.

EPF sees informed consent as a process, a “decision aid”, that should enable a patient to make a meaningful decision – an enlightened decision in the words of the Nuremberg Code from 1947 – about whether or not to participate in a given study.

Regrettably, there are still great disparities across the EU, both in terms of the quality and quantity of the information provided to patients, and the effectiveness of the informed consent process. Consent is too often regarded as a box-ticking exercise, and patients, not surprisingly, often feel it serves the interest of researchers and hospitals rather than their own.  

The new Clinical Trials Regulation will be guiding clinical trials in the EU for many years. Meanwhile, the medical landscape is changing fast: innovation has potential to transform the lives of patients with serious, lifelong conditions; but resources are limited and need to be focused on innovation that provides real value. There is a pressing need for new kinds of partnerships – between researchers, regulators, academia, industry and patients – to move from doing research “on patients” to doing (better) research with patients.

As EPF has pointed out repeatedly, the patient community does not regard the ethical aspects of clinical trials as “a national issue”. On the contrary, in our view better European co-operation among all actors is essential to ensure the high ethical standards and quality of clinical trials in Europe, which we see as the key to ensuring Europe’s competitiveness.

We believe that merely in order to implement the relevant provisions of the Clinical Trials Regulation correctly, it is necessary to develop common guidance at EU level on the core elements and methodologies/good practice. This guidance should include recommendations on how the quality of the informed consent process can be assessed.

In addition:

• The European Commission should carefully monitor whether and how ethics committees ensure the participation of patients alongside lay persons in ethics reviews.
• We call for a mapping study funded under the health programme or Horizon 2020 to gain a better overview of the “state of the art” of patient involvement in ethics committees across the EU, which could include a compendium of good practices.
• There should be a better definition of the “broad consent” option contained in the regulation and how this is implemented, in partnership with patient organisations.
• Patient organisations’ experience and expertise should be better used and more widely shared. Their input should be recognised as a kind of expertise in its own right and resourced.
• As patient involvement should take place at a much earlier stage in clinical research than the ethics, review, we believe existing good practices of patient involvement in research prioritisation and co-design should be studied and made available for sharing.

More information:   

Read the paper here, and see our work on clinical trials here.

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