Clinical trials and appropriateness of information verification

  • Claudia Casella | claudia.casella@unina.it Dipartimento di Scienze Biomediche Avanzate, Università degli Studi di Napoli Federico II, Napoli, Italy.
  • Claudio Buccelli Dipartimento di Scienze Biomediche Avanzate, Università degli Studi di Napoli Federico II, Napoli, Italy.
  • Adriana Scuotto Dipartimento di Scienze Biomediche Avanzate, Università degli Studi di Napoli Federico II, Napoli, Italy.
  • Emanuele Capasso Dipartimento di Scienze Biomediche Avanzate, Università degli Studi di Napoli Federico II, Napoli, Italy.

Abstract

In evaluating experimental protocols, Territorial Ethics Committees pay careful attention to the “Information Sheet” (in abbreviation: IS) to be submitted to patients, in order to verify its effectiveness and correctness of formulation, to the end of obtaining patients’ declaration of awareness, and unequivocal, free self-determination to participate in the proposed trials. It should be noted, however, that frequently the IS is drawn up with technical term and therefore not only is it inappropriate, but, in case of damages, it also appears as a sort of “waiver” of liability both for the investigator and for the sponsor, rather than an instrument of effective protection of patients. In this context, a statistical-cognitive survey was conducted on the data of the Ethics Committee of the University of Naples Federico II, concerning 1076 research protocols they examined in the period from 2012 to 2016. The survey showed that, also due to the widespread incidence of defensive medicine, the IS given to patients in profit- type protocols consisted of an average number of pages considerably higher than that of the no-profit clinical trials. This is a considerably important observation since the prolixity of the ISs – which sometimes are even longer than 40 pages - and their frequent lexical obscurity contrast with the message of essential clarity, which a free and conscious participation in the experimental trial must be based upon. Therefore, the activity carried out by Territorial Ethics Committees is strongly appreciated, as they play, among others, the irreplaceable role of guaranteeing the as-high-as-possible comprehensibility of the IS, precisely to protect patients’ right to decision-making autonomy, also in the delicate matter of clinical trials.

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Published
2020-04-20
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Original Articles
Keywords:
clinical trials, informed consent, right to self-determination, Territorial Ethics Committees, defensive medicine, UE Regulation n. 536/2014
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  • PDF (Italiano): 11
How to Cite
Casella, C., Buccelli, C., Scuotto, A., & Capasso, E. (2020). Clinical trials and appropriateness of information verification. Medicina E Morale, 69(1), 11-22. https://doi.org/10.4081/mem.2020.605