• Katie O'Hearn, Florence Cayouette, Saoirse Cameron, Dori-Ann Martin, Anne Tsampalieros, Kusum Menon, and Canadian Critical Care Trials Group.
• Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada.
• Pediatr Crit Care Me. 2023 Apr 1; 24 (4): e179e189e179-e189.

ObjectivesSurvey of four stakeholder groups involved in defining and obtaining assent for research in Canadian PICUs to better understand their perspectives and perceived barriers to assent.DesignCross-sectional survey.SettingFourteen tertiary-care pediatric hospitals in Canada.ParticipantsResearch Ethics Board Chairs, pediatric critical care nurses, research coordinators, and researchers.InterventionsNone.Measurements And Main ResultsA total of 193 participants responded. Thirty-seven percent (59/159) thought it was "Never/Almost Never" (59/159, 37%) feasible to obtain assent during the first 48 hours of PICU admission, and 112 of 170 (66%) indicated there are unique barriers to assent at the time of enrollment in PICU studies. Asking children for assent was most frequently rated as Important/Very Important for interviews/focus groups with the child (138/180, 77%), blood sample collection with a needle poke for research (137/178, 77%), and studies involving genetic testing with results communicated to the child/legal guardian (134/180, 74%). In two scenarios where a child and legal guardian disagreed about study participation, most respondents indicated that whether the child should still be enrolled would depend on the patient's age (34-36%), and/or the risk of the study (24-28%). There was a lack of consensus over how the assent process should be operationalized, and when and for how long children should be followed to seek assent for ongoing study participation. Most stakeholders (117/158, 74%) thought that children should have the opportunity to decide if their samples could stay in a biobank once they are old enough to do so.ConclusionsThere was an overall lack of consensus on the feasibility of, and challenges associated with, obtaining assent at the time of study enrollment and on how key aspects of the assent process should be operationalized in the PICU. This highlights the need for guidelines to clarify the assent process in pediatric critical care research.Copyright © 2022 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.

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