November 2024 SOCRA Source Journal - Journal - Page 80
CLINICAL RESEARCH MANAGMENT
How Parents/Legal
Guardians Perceive the
Informed Consent Form?
Preliminary Survey in an
Italian Pediatric Hospital.
2024 POSTER
PROGRAM
SPECIAL RECOGNITION AWARD WINNER
Nagua Giurici, MD
Giulia Schillani, Silvia Tommasi, Nevenka Medic,
Fatima Tizi, Barbara Bonifacio, Nagua Giurici.
Institute for Maternal and Child Health IRCCS
Burlo Garofolo, Via Dell’Istria 65/1, 34137Trieste, Italy
INTRODUCTION & PURPOSE: The informed consent form (ICF) is an essential document used during the consent
process. It provides potential subjects with the necessary information about the study they have been invited to take
part in.
Pediatric informed consent acquisition is a particularly delicate process since parents/legal guardians are consenting
for minors. Very few studies have so far investigated the ICF perception by parents/legal guardians in pediatric studies.
We therefore aimed to evaluate how the ICF is read, perceived and signed by the parents/legal guardians of children
involved in clinical trials at the Institute for Maternal and Child Health IRCCS Burlo Garofolo.
METHODS: Between May and July 2024, a survey was used to assess the way informed consents are read and
perceived by the parents/legal guardians of patients that were enrolled in clinical trials. Speci昀椀c questions were asked
for both the study ICF and privacy ICF which in this institution are two separate documents.
RESULTS: A total of 23 questionnaires were collected. Most were 昀椀lled out on the same day as ICF was signed.
13(57%) ICFs regarded interventional studies and 10(43%) observational studies. In all cases ICFs were administered
by physicians.
For study ICFs, 57% of the parents declared that they read the entire document prior to signing the study ICF while
43% read it only partially or did not read it at all. Privacy ICFs were more frequently not read compared to study ones.
The main reasons for not reading ICFs were because parents/legal guardians felt there was no need for reading it since
the study was well explained by the physician, the document was too complex, too long or due to lack of time.
For privacy ICFs, the main reason for not reading them was the fact that parents/legal guardians felt it was an
additional privacy consent they were singing in a setting where they have already signed several ones.
Nevertheless, 68% of participants thought the amount of information provided was adequate, 90% that the ICF
explained clearly and suf昀椀ciently the study and how data will be treated (86%). Almost everyone (96%) would prefer
both ICFs to be combined together in one single document.
57% of ICFs were signed by both parents, more often in case of interventional studies.
CONCLUSIONS: This survey shows that almost half of the parents/legal guardians of children involved in clinical trials
do not read the entire ICF prior to consenting the participation of their children.
Instead, they mainly rely on the information provided by the physician. In part this is due to the length and complexity
of the ICF. Parents/legal guardians are more likely not to read the privacy ICF compared to the study one. The length
and complexity of ICFs have increased over time in an attempt of ful昀椀lling regulatory and ethical requirements and
providing ever more information to parents/ legal guardians. Nevertheless, this could be a double-edged sword since
increased length and complexity could eventually bring less people to fully read and understand the ICF.
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SOCRA SOURCE © November 2024
