Active and passive consent: a comparison of actual research with children.

Passive consent, which is ethically questionable, requires parents to sign and return a form if they refuse to allow their child to participate in research. Active consent requires parents to sign and return a form if they consent for their child to participate. To compare passive and active consent research projects, we evaluated 15 published examples (since 1995) of passive consent and the adjacent experimental article (active consent). Passive consent projects involved significantly higher response rates, more subjects, greater likelihood of being conducted in school rather than in clinical settings, but about the same age of participants as active consent projects. We recommend that: (a) Institutional Review Boards scrutinize all passive consent projects and consider whether the consent procedure is ethical for the research sample; (b) editors and reviewers examine all manuscripts for the consent procedure used; and (c) ethicists and researchers debate the appropriateness/ethics of passive consent.