One of the first activities of the PICASO project was to establish a set of ethical principles and guidelines for the project. This was highly prioritised by the project because the two project trials would involve real patients who would test and evaluate the PICASO solutions.
First of all, an initial analysis of the main ethical issues that were relevant for the project and in particular with respect to the involvement of patients in the trials was carried out. The analysis identified seven ethical issues that would need to be carefully considered and monitored during the project: Informed Consent; Autonomy; Dignity; Stigmatisation; Inclusion; Privacy and Data Protection; Clinical Incidental Findings. The list was by no means exclusive nor did it imply that other ethical issues would not be considered nor dealt with in the project. The issues should also not be seen as completely separated; they may be interlinked in various ways, as well as implicating other matters of an ethical nature. As these issues were considered the most relevant ethical issues, they are closely linked to the Ethical Principles.
Secondly, the Belmont Report was consulted as it represents a valuable reference for defining ethical principles for research involving human subjects. The Belmont Report was created in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research but it continues to be relevant.
As a result, four Ethical Principle were defined and implemented in the project:
- Respect for Persons
- Beneficence
- Justice
- Respect of Confidentiality and Privacy
In order to ensure that the consortium had a common understanding of the practical implications of the Ethical Principles, concrete examples of how the principles should be applied in the project were also described. The principles and their application were discussed with the PICASO Ethical Board prior to being finally agreed to by the consortium.
For more information on the project Ethical Principles please see deliverable D3.3 The PICASO Ethical Guidelines.