Parental consent in paediatric clinical research

Abstract

Aims: To assess parental understanding and memorisation of the information given when seeking for consent to their child's participation to clinical research, and to identify the factors of significant influence on parents' decision making process. Methods: Sixty eight parents who had been approached for enrolling their child in a clinical oncology or HIV study were asked to complete an interview. Their understanding was measured by a score which included items required to obtain a valid consent according to French legislation. Results: Items that were best understood by parents were the aims of the study (75%), the risks (70%), the potential benefits to their child (83%), the potential benefits to other children (70%), the right to withdraw (73%), and voluntariness (84%). Items that were least understood were the procedures (44%), the possibility of alternative treatments (53%), and the duration of participation (39%). Less than 10% of the parents had understood all these points. Ten parents (15%) did not remember that they had signed up for a research protocol. Thirty three parents (48%) reported no difficulty in making their decision. Twenty four parents (38%) declared that they made their decision together with the investigator; 26 (41%) let the physician decide. Fifty four parents (78%) felt that the level of information given was satisfactory. Conclusion: There was an apparent discrepancy between parents' evaluation of the adequacy of the information delivered and evaluation of their understanding and memorisation. The majority of parents preferred that the physician take as much responsibility as possible in the decision making process.

Assessing the interest to participate in a dengue vaccine efficacy trial among residents of Puerto Rico

“…Perceived personal benefits from medical exams and treatment, and avoiding illness by being vaccinated as part of the trial were also found to be motivators, which is comparable to findings from Australia, 26 US, [28][29][30]35,39,40 and Europe. 27,31,32,36,42 Study participants confirmed they were at risk for dengue and thought a dengue vaccine would be beneficial. However, most would not participate and almost all would not allow their children to participate in a dengue vaccine trial.…”

“…[25][26][27][28] Contributing factors to recruitment and retention include lack of trust, inadequate knowledge, fear of side effects and risks, and clinical trial procedures. 25,26,[29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] Although studies have been conducted to understand cultural barriers to participation and retention in clinical trials, none have been conducted in Puerto Rico. [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] In addition, formative research regarding factors related to participation in placebo controlled, vaccine trials is lacking.…”

Processes in recruitment to randomised controlled trials of medicines for children (RECRUIT): a qualitative study

“…31,32,55,65 However, the relationship between anxiety, vulnerability and trial decisions may be mediated or moderated by factors such as trust in medical research 66 and the parent-practitioner relationship. 23,56,[67][68][69][70] The practicalities of trial participation are less commonly mentioned; 71 this may reflect the fact that most studies have been conducted in neonatology and oncology, when the child is usually in hospital at the time of the trial approach.…”

“…Particularly common worries for parents when considering a trial are that their child might be randomised to the treatment arm that they perceive to be less effective 50,55 and the responsibility that they would feel if the child later deteriorated. 56 Nevertheless, parents do perceive several benefits of trial participation for their own child, such as receiving extra medical attention. [57][58][59][60] Such benefits can be influential in their decision.…”

Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

“…7,[12][13][14] In a study by Chappuy in which the parents were asked about their knowledge regarding the items included in the informed consent document, only a minority (21%) of parents were found to fully understand all items. 15 …”