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Assent Process
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The foundation for human subjects research is informed consent. But some participants are not able to give legally effective informed consent for research participation, including children and some adults with certain health conditions or cognitive impairment. The Code of Federal Regulations provides a path for researchers to obtain consent from a parent/legal guardian or a Legally Authorized Representative (LAR) and for these individuals to indicate their willingness (assent) to participate in a research project.
The assent document is a simplified version of the Informed Consent Document, written in a language that can be understood by potential subjects themselves. The assent process is the interaction or conversation between the child, young adult or adult who lacks capacity to give informed consent.
The UI IRB template Assent Document is available in the dropdown menu of the Consent/Assent section of the Attachments page in HawkIRB.
Investigators are asked to select and describe plans for the assent process; for impaired adults (Section VI.31 and Section VI.34) and for children/minors (Section VII.D.31).
Types of Assent Procedures
Researchers may propose one or more methods of obtaining and documenting assent depending on the age and cognitive ability of the potential subject. Assent procedures may vary within a study when subjects have different abilities.
Options include the following:
- Sign an assent or consent document
- Receive assent or consent document to read, but provide only verbal assent
- Receive only a verbal description of the study and assent verbally
- No assent procedure because some or all subjects do not have the capability to assent, or their capability is so limited that they cannot reasonably be consulted to provide assent
- No assent procedure because the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children/minors and is available only in the context of the research
- No assent procedure because although children are capable of assenting, the researcher requests a waiver of assent (NOTE: This is only an option for minimal risk, with proper justification.)
Documentation of Assent
When a study uses an assent process, the child or cognitively impaired adult may sign the Assent Document to indicate agreement (assent) to participate. If they are able to read and understand the contents, older minors and more competent adults can indicate assent to participate by signing the full Informed Consent Document.
The parent/legal guardian or legally authorized representative should sign the full Informed Consent Document to document permission for the child or cognitively impaired adult to participate.
IRB Policies Regarding Assent
The UI IRB provides the following guidance:
Refusal to Assent
If the person from whom assent is sought refuses, the person should not be enrolled, even if the parent or legally authorized representative gives permission. Alternatively, if the person from whom assent is sought agrees to participate, the person may not be enrolled if the parent/legal guardian or Legally Authorized Representative does not give permission. In rare circumstances, depending on the nature of the study and the age and circumstances of the child, the IRB may waive the requirement for permission from the parent/legal guardian.
Age of Assent
The regulations do not specify a certain age at which assent must be sought, but most minor subjects are able to give assent beginning at about age seven. For minors and cognitively impaired adults, the decision about whether to obtain assent depends on the abilities of the potential subject.
Waiver of Assent
In treatment studies, a researcher may request not to obtain assent from the child or adult who lacks capacity to consent, so the parent can decide whether the child should participate.
For additional information, see the UI IRB Standard Operating Procedures and Researcher Guide, Section II, Part 11.B.i.b (Assent)