BACKGROUND: Satisfying ethical principles of voluntary consent within workflow constraints can be challenging, particularly for anesthesia research, where patients are met on the day of surgery. For parents, the added burden of being a surrogate decision maker may impact willingness to be approached for research on the day of surgery. Our aims were to determine parental attitudes to day of surgery approach for research consent and if study type had any influence. METHODS: We iteratively developed a questionnaire using stakeholder interviews regarding day of surgery approach for research consent. Particular attention was given to (a) research study designs, (b) previous research experience, and (c) types of surgeries. Participants were stratified according to a child's age, child's previous surgical experience, and any family research experience. Enrolment continued until saturation was reached. Interviews were transcribed and analyzed for themes. The final questionnaire included questions designed to determine parental perceptions of the appropriateness of the same day approach, and whether ethical principles would be satisfied if approached on the day of surgery. The second section presented a series of scenarios describing different study types designed to determine if studies with increasing levels of perceived risk would impact parental perception. RESULTS: Most parents reported that this approach would satisfy ethical principles for voluntary informed consent. Study type was not a determinant except for RCTs, where only half felt a day of surgery approach would be appropriate. The most cited reason for reluctance for RCTs was insufficient time to review details. Parents of younger children (61.1% infants, 56.2% toddlers) were more likely to prefer an alternative time of approach compared to teenagers (36%). CONCLUSIONS: The results of this study are reassuring for pediatric researchers, identifying majority acceptance for day of surgery research consent approaches for most studies. We identified subgroups who preferred alternative timing for approach. Alternate strategies are advised to target these subgroups. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04613505.
Caldeira-Kulbakas et al. (Thu,) studied this question.