Consent, assent and randomised evaluations

Background: Randomised trials have been on the rise in social policy over the last decade and a half, particularly in areas working with young people and vulnerable adults. Informed consent is an important principle for ethics committees governing research conducted by universities. Aims and objectives: We consider the arguments for and against opt-in consent by parents, and opt-out assent, when it comes to trials taking place, particularly in schools. Methods: We review what is known about this from a methodological standpoint. Findings: We find that extant evidence suggests that requiring opt-in consent, rather than assent, to participation, risks reducing the ethical standards of trials by minimising participation; and by potentially risking disclosure of sensitive information about a child's life to their parents. Moreover, there are important equity considerations, with more vulnerable groups likely to be excluded from research findings under an opt-in framework. Discussion and conclusion: We conclude that the ethical argument for assent rather than consent is compelling under some circumstances, and should be considered on a case-by-case basis. Precautions must always be taken to safeguard participants.