Consent, assent and randomised evaluations

Consent, assent and randomised evaluations
Discussion
Michael Sanders, Jack Summers, Vanessa Hirneis, Susannah Hume, Gabrielle McGannon
Policy Press, 9 June 2023
Abstract
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.

Editor’s note: Policy Press is a product of Bristol University.