The Ethics of informed consent in novel treatment including a gender perspective

Specific Challenge

The exponential development of knowledge resulting from biomedical research challenges the ethics of informed consent. Patients, practitioners, researchers, health authorities and other stakeholders are confronted with the difficulty to reconcile their legal and administrative environment, biomedical ethics, Human Rights and the increasing global availability of new effective treatments. For some worldwide high mortality diseases, this includes an important gender dimension. In addition to the ethical and social aspects, the economic dimension and potential impact of this challenge on EU health budgets is very significant.

Scope

Although informed consent is the pillar of ethics in medical research, several cases with high public coverage have awakened society on the difficulty to simultaneously optimise the research objectives and the patients' wellbeing while limiting the various types of potential conflicts of interest. The proposed action shall study this complex and multidimensional ethics dilemma. The focus shall be on the involvement of patients in translational research and in clinical research based on existing and validated treatments. Similar type of clinical ethics challenges exists when physicians advise patients and have to handle financial aspects, notably the fact that some available effective treatments or tests are reimbursed or not (depending on the countries).

In this context, it is necessary to build up a set of guidelines helping the clinicians to find practical answers enabling the full respect of clinical ethics, in particular ensuring an actual informed consent for these patients involved or not in clinical studies. In order to be effective, the guidelines shall be elaborated with the active involvement of the different actors of the chain, from the clinical researchers/health practitioners and their institution to the health public authorities and the other actors of the health systems: the pharmaceutical industry, the patient groups etc. In order to increase the direct impact of the work, the general guidelines shall be applied to a minimum of two specific cases where the global availability of new treatments, tests/diagnosis tools challenge the clinical practice leading to different form of disparities. This shall include the additional complexity of the gender perspective and therefore be performed on at least one gender specific disease (e.g. breast/ovarian cancer).

The proposed action shall also analyse the use of social media and ICT technologies to facilitate the information supply and the interaction between the patients and the clinicians, particularly in cases where the optimal treatments become possible faster than through the institutional changes (public health measures) that make them available to society. The involvement of all relevant stakeholders is necessary for this step, including innovative industries and patients associations.

The Commission considers that proposals requesting a contribution from the EU of the order of EUR 3.8 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

This action allows for the provision of financial support to third parties in line with the conditions set out in Part K of the General Annexes.

Expected Impact

Taking into account the gender dimension, will increase the EU standards of clinical research ethics, in particular the quality of informed consent by developing practical guidelines supporting the work of clinicians while stimulating innovation and increase the use of effective new treatments.