Adequacy, coherence and cohesion in Informed Consent

Minors are traditionally left out of bureaucracy for protection reasons until they trespass the threshold of adulthood set by the law. Consequently, adults must provide decisions in their place taking into account their best interest. Even so, the increasing amount of subjects under 18 participating in research programs in the recent years has highlighted the importance of involving children and ensuring the compliance of the legal and ethical obligations around these processes.

Framed in the V ANCEI Congress – The Research Ethics Committees: “Combining social utility of research, regulatory changes and new technologies”, held in Valencia on May 17th and 18th and as part of the i-CONSENT investigation development, researchers have bought into the spotlight the debate regarding the conditions that make an Informed Consent valid and binding.

A review presented during the seminar, based on an exhaustive comparison of the existing ethical-legal framework and scientific literature, states that there are still some problems identifying the common ethical standards and reveals that there are other issues still “in construction”. In addition to what is said (content and quantity), there are other aspects that need to be harmonized. Within other:

  • Who says it and how (skills of the person who informs and continuity and adaptation of information throughout the study)
  • By what means (method /format used, information order, etc.)
  • What the subject wants to know

The legal framework has to mirror a consensus between legislators, experts, researchers, parents or tutors and minors. Adequacy, coherence and cohesion in Informed Consent and a criteria uniformity are essential to ensure research progress.

In spite of this, we can’t ignore the importance of personalising each specific process and adapting Inform Consent to the subject’s characteristics through culturally and age adapted tools, inclusive messages, etc.

The conclusions have been elaborated by FISABIO, Lluis Alcanyís Hospital Paediatric Services, LUMSA Università di Romaá and Universidad Católica de Valencia.

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