Informed Consent

The Ethics Committee: for Technology, Social Sciences and Humanities (CETCH) values ethical conduct in research and has therefore undertaken the task to draw up a guide of good practices for securing a free and informed consent in research. 

The Ethics Committee: for Technology, Social Sciences and Humanities (CETCH) recommends reading and reflecting over which practices must be considered in any research. 

A MODEL FOR FREE AND INFORMED CONSENT

The signing of a declaration of Free and Informed Consent (FIC) is an expression of the autonomy and freedom of people who have agreed to take part in a research, in line with respect for their fundamental rights. As such, the signing of a free and informed consent assumes that the people who agree to take part in the research have the capacity to decide to do so and they have all the necessary conditions in order to make that decision in a free and informed manner, and they can revoke their consent at any moment during the research. It is up to the researchers to provide clear, rigorous and sufficient information on all aspects regarding participation in the research. 

The process of acquiring a declaration of FIC must occur within the framework of a relationship of mutual trust, preferably on a written document, duly signed and written in a language accessible to the participants. This document should include two fundamental parts: an informative and a declarative part. 

Informative Part 

• Information on the type of study - title, objectives, methodology, identity of the researchers, and institutional framework. 
• Information on the type of participation intended - duration, commitments, possible benefits and/or risks. 
• Information on anonymisation and data protection, during and after the study, in accordance with the General Data Protection Regulation (GDPR) - guarantees of confidentiality and privacy, including reference to procedures to be take in special and unforeseeable situations. 
• Information about the person to contact in case of doubts; Name and contact details of the Data Protection Office (DPO), when applicable. 
• Information in a footnote that after the signing by the researchers' representative and by the participant, each party receives an original of the signed document (FIC). 

Declarative Part 

• Declaration of consent by the participant or legal representation (if the participant is a minor or incapacitated). 
• Space for the date and signatures of the researcher and the participant. 

NOTES 

1. Acquiring the declaration of free and informed consent from people who, for whatever reason, are unable to make a free and informed decision (underage children and adolescents, adults with psychologically disabling illnesses, mental disabilities or deprivation of freedom) should be obtained from their legal representatives. In these cases, whenever possible, the FIC declaration should be accompanied by a declaration of Free and Informed Agreement obtained from the participants. 
2. Where applicable, the FIC declaration should be obtained from the institution(s) or official body(ies) involved in the study. 
3. In case of electronic consent or e-consent, the principles and protocols of the conventional FIC are maintained, based on the adoption of effective security standards in the use of technologies.