Research ethics and assent in paediatric research — formative SAQs

SAQ 1 — Non-beneficial physiology study in children (10 marks)

A team proposes a non-beneficial study of disease physiology in school-age children. It requires two venepunctures the children would not otherwise undergo, and it cannot ethically be done in adults. The knowledge would be valuable to understanding the disorder. ^{[1] [3]}

Questions

1. Under the Subpart D risk-benefit categories, into which tier does this study fall, and what must the ethics committee find to approve it? (4 marks) ^{[1] [3]}
2. Distinguish parental permission, child assent and consent in this scenario, and state the age at which assent is typically sought. (3 marks) ^[2]
3. How should the team handle a child's dissent, and when (if ever) could assent or permission be waived? (3 marks) ^{[2] [3]}

Model answer

Risk-benefit tier and approval (4). Because the study offers the child no prospect of direct benefit and carries more than minimal risk, it falls into the Subpart D category of a minor increase over minimal risk with no direct benefit. The ethics committee may approve it only if the intervention presents experiences reasonably commensurate with the child's situation, the risk is a minor increase over minimal risk, and the knowledge is of vital importance to understanding or ameliorating the participant's disorder and cannot be obtained otherwise. Parental permission alone cannot make a greater-than-minimal-risk non-beneficial study acceptable. ^{[1] [3]}

Permission, assent and consent (3). The parents give informed permission (authorisation) for the child to participate; the child, from about age 7 and adapted to development, gives assent (affirmative agreement). Consent is the legal authorisation a competent older adolescent may give for themselves, which a younger child cannot. The terms must not be conflated. ^[2]

Dissent and waiver (3). A child's dissent to non-beneficial research is generally binding and must be recorded. An ethics committee may waive assent or parental permission only if the research is minimal risk, it could not practicably be carried out with permission, and participants' rights and welfare are protected. This study is greater than minimal risk, so a waiver would not apply. ^{[2] [3]}