Overview How Does Assent Differ From Consent Process for Obtaining Child Assent and/or Parental/Guardian Permission Assent from Children or Minors • Permission from Parents or Guardians • Documentation of Assent and/or Parental Permission Children Under 7 • Children 7 12 • – Adolescents 13 - 17 • Re-Assent and Consent at Youth and Adult Milestones Waiver of Child Assent Waiver of Parental Permission Legal Exceptions Permitting Certain Minors to Consent Emancipated Minors • Self-Sufficient Minors • Minors 12 Years or Older • Exceptions Outside of Colorado • References Overview Research with children involves more complex considerations with respect to assuring the voluntary participation of research participants than research with adults. As described below, there are issues of assent, consent, and parental permissions that must be considered. Federal regulations do not provide many specifics but they do include parental permission requirements, also discussed below. The Federal regulations also charge that for soliciting the assent of the children, when in the judgment of “adequate provisions [be] made the IRB the children are capable of the ages, maturity, and providing assent…[taking] into account psychological state of the children involved” [45 CFR 46.408]. How Does Assent Differ from Consent? Though children do not have the legal capacity to to participate in research, they should be involved “consent” in the process if they are able to to them and/or by reading a simple form “assent” by having a study explained about the study, and then giving their verbal choice about whether they want to participate or not. They may also provide a written assent if they are older. Circumstances in which a child's assent may be unnecessary or inappropriate are discussed below under Waiver of Child’s Assent. Process for Obtaining Child Assent and/or Parental/Guardian Permission The Process
Overview How Does Assent Differ From Consent Process for Obtaining Child Assent and/or Parental/Guardian Permission • Assent from Children or Minors • Permission from Parents or Guardians Documentation of Assent and/or Parental Permission • Children Under 7 • Children 7 – 12 • Adolescents 13 - 17 Re-Assent and Consent at Youth and Adult Milestones Waiver of Child Assent Waiver of Parental Permission Legal Exceptions Permitting Certain Minors to Consent • Emancipated Minors • Self-Sufficient Minors • Minors 12 Years or Older • Exceptions Outside of Colorado References Overview Research with children involves more complex considerations with respect to assuring the voluntary participation of research participants than research with adults. As described below, there are issues of assent, consent, and parental permissions that must be considered. Federal regulations do not provide many specifics but they do include parental permission requirements, also discussed below. The Federal regulations also charge that “adequate provisions [be] made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent…[taking] into account the ages, maturity, and psychological state of the children involved” [45 CFR 46.408]. How Does Assent Differ from Consent? Though children do not have the legal capacity to “consent” to participate in research, they should be involved in the process if they are able to “assent” by having a study explained to them and/or by reading a simple form about the study, and then giving their verbal choice about whether they want to participate or not. They may also provide a written assent if they are older. Circumstances in which a child's assent may be unnecessary or inappropriate are discussed below under Waiver of Child’s Assent. Process for Obtaining Child Assent and/or Parental/Guardian Permission The Process
guidance_child_assent_parental_permission.docx