The clinical research has undergone a significant cultural transformation: from a model centered exclusively on healthcare professionals and scientists, it has moved toward forms of active patient participation, recognizing their role as co-producers of knowledge.
This shift raises profound questions, not only on the level of ethics, understood as a set of rules and duties, but also of ethicality—that is, the human, relational, and value-based quality of the processes involved.
Ethics and Ethicality: A Necessary Distinction
Both approaches are important: respecting norms for informed consent, privacy, scientific integrity, and ethical committee review falls under ethics, while ethicality refers to a value-driven and relational concept, focused on listening, trust, and patient empowerment.
Engaged research as patient-centered requires a transformation of the concept of research ethics:
- From control to collaboration: the focus shifts from merely protecting the patient to a continuous dialogue that acknowledges the experiential expertise of patients.
- From formal respect to relational care: ethicality is expressed in the building of trust-based relationships and transparency about the purpose of research.
Participatory research means ethics in action.
In participatory clinical research, patients are not just subjects to be protected but active stakeholders: they contribute to defining research outcomes, help in understanding phenomena in their everyday complexity, and take part in evaluating the impact of a clinical study. This requires a qualitative leap:
- Beyond formal consent: ethics does not end with signing a form, but demands a relationship based on trust and ongoing transparency.
- Beyond procedural compliance: ethicality requires responsible action, recognizing the human and experiential value of patient contributions.
The challenge of equity
A key element of distinction in participatory research is the representativeness: who are the patients involved? Are they only the most informed, or also those living in vulnerable conditions?
Ethicality demands that participation be inclusive, accessible, and meaningful:
A study can be ethically compliant but ethically poor if it lacks listening, reciprocity, and authenticity to participants’ contributions.
The absence of ethicality also emerges when patients are not adequately trained or enabled to participate on equal footing. In these cases, the relationship loses meaning, even when all the formal rules are respected.
Toward a New Ethical Paradigm
To bridge the gap between ethics and ethicality, substantial proposals should include:
- Co-production of research protocols
- Inclusion of patients in ethics committees
- Assessment of the social and experiential impact of research
- Joint training of researchers and patients on ethical issues
Ethics and ethicality are not in opposition, but two complementary dimensions of the same responsibility. The first provides the boundaries and rules of the game; the second ensures its soul.
In truly participatory research, it is not enough to respect the rules: we must act with integrity, openness and profound respect for the patient's otherness. Only in this way can science not only be valid but also just.