Permission and Assent for Research with Children Who Have Cerebral Palsy

Cerebral palsy is a group of disorders that affect a child’s ability to control muscles as a result of nonprogressive brain injury to the growing brain.¹ The condition impairs motor control and creates other difficulties in sensation, perception, cognition, communication, and behavior.² Because of progressive musculoskeletal problems, children with cerebral palsy often have physical deformity and developmental disabilities that affect function. Children with cerebral palsy also grow slower than children who do not have the disorder and have different growth patterns.³

A growth chart was developed in 2011 specifically for use with children who have cerebral palsy.⁴ To adapt this chart for use locally in Malaysia, a researcher designed a two-phase study and received approval from a research ethics committee (REC) for phase 1, and then subsequently, through an amendment, for phase 2. In phase 1, after obtaining parental permission, the researcher collected height, weight, and other body measurements from children with cerebral palsy at a selected hospital where the children received care. Before beginning the second phase of the study, the research team added a set of questionnaires to assess the knowledge, attitudes, and practices of parents and caregivers of children with cerebral palsy as well as to collect data regarding their daily food intake. The phase 2 amendment, which was approved by the REC, only included the new questionnaires and updated protocol.

After reviewing the amended study protocol, a doctor at the hospital where phase 1 was being conducted prohibited the research team from conducting additional research, since the study team had previously only requested parental/guardian permission to collect the basic biometrics from children and did not also obtain permission from parents/guardians nor assent from the children for the additional components.