Ingrid Klingmann outlines the objectives and work of the PARADIGM Ethics Expert Panel

Patient engagement, by definition, is the meaningful and active collaboration of patients, patient advocates, patient representatives and/or carers in the decisions and judgements within the medicine lifecycle with all other relevant stakeholders involved. PARADIGM, an IMI project, aims at developing a framework of consensus-based recommendations on ethically-sound patient engagement practices, processes and tools, as well as on methods to measure and demonstrate the added value of innovative and effective approaches to patient engagement.

In this kind of project, outcomes are typically developed in dedicated work teams and ethically relevant outcomes are finally reviewed by an internal ethics or multi-stakeholder advisory committee. As all planned outcomes in PARADIGM are of ethical importance, the public-private Consortium decided to choose an approach of “applied ethics”; this means an “Ethics Expert Panel” (EEP) was formed consisting of ethically experienced employees from the participating consortium partner organisations, who are otherwise not engaged in the project, as well as external ethics experts from ethics committees and academic institutions. 

The members of the EEP have three main tasks:

  1. We are assigned to the different work teams, providing ongoing ethical competence to the work teams’ brainstorming, social research, solution finding and document creation activities to ensure:   
  • reliable detection of ethical issues inherent in patients’ engagement in the development and access to new treatments;
  • objective consideration of all stakeholders’ considerations, needs and expectations
  • collaboration in and management of the PARADIGM project in line with ethical values like fairness, respect, transparency, beneficence, and equal rights;
  • development of deliverables which have been subject to careful ethical considerations.
  1. As the independent Ethics Expert Panel, we developed the Ethical Framework for collaboration within the Consortium. We also developed and supervise the Declaration of Interest process for all Consortium members and create the PARADIGM Code(s) of Conduct in close collaboration with one of the work teams to ensure integration of all PARADIGM-generated knowledge and expertise.
  2. In the case of conflicts between the work teams, or difficult ethical questions which cannot be solved within the work team and the contribution of the EEP member in that group, the EEP is supposed to provide the appropriate ethical solution based on its combined ethical and legal expertise, as well as the 14 values defined in the Ethical Framework.    

With this “applied ethics” approach, the PARADIGM Consortium wants to ensure that all work teams think about the ethical conditions and requirements in patient engagement early and continuously, and are bringing a new ethical rigour to the collaboration of patients, pharmaceutical industry, regulators, HTA bodies and all other involved stakeholders.


Ingrid Klingmann, MD, PhD

Chair of the PARADIGM Ethics Expert Panel

Chairman of the European Forum for Good Clinical Practice (EFGCP)