privacy, confidentiality, consent, assent, permission, undue influence, best interests, qualitative research, COVID-19, qualitative research, decision-making
Involvement of children in clinical research typically requires parent or guardian approval (permission), and, when the child is capable, the child’s affirmative agreement (assent).1 Clinical research involving children is complex and can be challenging because of many factors. These include difficulties in determining a child’s decision-making capacity and knowing that decisions are being made in line with the best interests of the child.2 It is commonly recommended that the assent process vary according to a child’s neurodevelopmental and cognitive stage.3 In some studies involving self-reports, it can also be challenging to collect data without parents or other caregivers unduly influencing what children report.
A researcher in a country in Southeast Asia interviewed a 14-year-old girl and her father regarding the role and participation of children in research. Because of enforced physical distancing during the COVID-19 pandemic, the interview was conducted via a virtual video communication platform. During the interview, the girl’s father expressed that his children are usually not allowed to make decisions independently. The child’s father requested to be present during her interview with the researcher, and she looked to him for assurance before she responded to each question asked. The researcher noticed that for some questions, the child’s father had whispered something to her before she replied. At a clinic visit 2 weeks later, the child informed the researcher that she was uncomfortable with her father's presence during the previous interview, explaining that her father had not allowed her to make any decisions because she was very young.
Following that experience, the researcher conducted an interview with another child, a 12-year-old boy, and interviewed his mother separately. The child was extremely quiet during the interview, refusing to respond to any questions despite many attempts by the researcher. After interviewing the child’s mother, the researcher learned from her that the child is naturally anxious and felt insecure without her presence during the interview.
Questions
How would you articulate the main ethical challenge(s) facing the researcher in this study?
Would it be appropriate for the researcher to ask the 14-year-old girl’s father to leave the interview room to prevent him from influencing her response? Can a researcher decide on the presence of accompanying parents or other people during an interview with a child?
As noted, the presence or absence of a parent or guardian during an interview may cause a child to feel threatened or insecure. What could a researcher do to assure voluntary research participation and address both of these issues?
Can you think of any research scenarios in which parental consent may be waived (not required) for research involving children? What are some best practices for such research to help ensure autonomous authorization and/or research decision-making that is in the best interests of children?
