Table 2 International guidelines on the involvement of minors in health research
International Guideline | Assent | Requirements for parental consent | Re consent at age of adulthood | Emancipated Minors | Waiver of Assent/Parental Consent |
|---|---|---|---|---|---|
Declaration of Helsinki | All vulnerable populations | Consent required from a legally authorized representative | Not specified | Not specified | Not specified |
CIOMS Guidelines | Tailored to the child’s or adolescent’s level of maturity | A parent or a legally authorized representative | Re-consent when a minor reaches the legal age of maturity during the research | Not specified | A REC may waive requirements for assent/parental consent if: •The research would not be feasible or practicable to carry out without the waiver •The research has important social value, and the research poses no more than minimal risks to |
UNESCO Declaration on Bioethics and Human Rights | Generic-all vulnerable populations | Not specified | Not specified | Not specified | Not specified |
International Council for Harmonisation’s Guideline for Good Clinical Practice. 2017 | Age of assent should be consistent with local legal requirements Minors of appropriate intellectual maturity should sign and date either the assent or informed consent form | Parental consent should be obtained in accordance with regional laws or regulation | informed consent for continued participation is required once a child reaches the age of legal consent | Emancipated or mature minors (defined by local laws) may give autonomous consent | Not specified |