Note: Duke requires individuals interacting with minors to complete training: https://forms.hr.duke.edu/minors/training/
Children are persons who are considered minors by law. This means they have not reached the legal age of consent at the site where the research will be conducted.
It is possible that a nation, territory, or locality may have no legal definition of age of consent. In such cases, researchers will have to rely on community standards.
In the United States, state law dictates the age of consent. In most states, such as North Carolina, the age is 18.
Unless an IRB determines that parental permission can be waived, the child’s parent or legal guardian is responsible for providing permission for their child to take part in research. This happens before the child participates in research.
There are two fundamental steps in every parental permission process:
- Providing the information that parents need to decide whether to allow their children to participate in the research.
Parental permission forms should include all the elements of consent. Parents also should be given the opportunity to ask questions.
Parental permission form should address the parents, for example:
- “Your child will read four vignettes about conflicts that happen on the playground. After each vignette your child will be asked about what they read.”
- “With your permission, I will record your child’s responses, but not his or her name.”
- “Do you give permission for your child to be in this study?”
- Documenting parents’ permission for their children to take part in the study.
Documentation is a signed parental permission form, including the child’s name.
Waiving Parental Permission
A waiver of parental permission means that parents are not provided any information about the study and are not asked to provide permission for their child to participate.
The IRB must consider four criteria when determining whether to approve a waiver of parental permission:
- There is no more than minimal risk to participants.
- The waiver will not affect participants’ rights and welfare.
- It would be impracticable to conduct the research without the waiver.
- If appropriate, the parents will be provided information about the study.
- The research could not practicably be carried out without such information or biospecimens in identifiable format.
Alternatively, securing parental permission may not be culturally appropriate or in the best interests of the children.
The following are examples of situations in which a waiver of parental permission may be appropriate:
- In some cultures, school principals are expected to make decisions about student participation in research even though the parents live nearby.
- Some classroom studies may be not be able to get valid results unless all children participate, for example, a study using socio-metric measures.
- Provided that appropriate mechanisms to protect children are in place, an IRB may determine that parental permission is not a reasonable requirement or would introduce risk to children as participants of research. For example, it would not be reasonable to require parental permission to interview teenagers who are runaways and have severed ties with their families.
In some cases, after a waiver of parental permission has been secured, parents may be notified by the researchers before the study begins. This notification provides parents with information about the study and instructions about how to let the researcher know they do not want their children to participate. The notification process cannot be used unless a waiver of parental permission has been secured.
Parental permission can never be waived if the researchers want access to children’s educational records. The records are protected by law and a written authorization from the parents must be secured, usually incorporated into the parental permission form.
Waiving the Documentation of Parental Permission
Although it is the norm to obtain written parent permission, the regulations do provide criteria to allow documentation of parental permission to be waived.
One of three criteria must be met for a waiver of documentation of parental permission to be approved:
- The consent form would be the only record with the participants’ name, and the main risk of harm would be a breach of confidentiality.
Example: A study about the effect of possible deportation on academic performance and stress on middle school students. Researchers would not ask parents to sign a form explaining the study, though they would explain the study to the parents in person.
- The study involves activities that would otherwise not require written consent if the activities were not a part of research.
Example: A study asking minors to complete an online survey. The parental permission form, with a link to the survey, could be emailed to the parents. The survey would include assent information. Parents who agree their child could participate would forward the link to their child.
- The participants are members of a distinct cultural group or community in which signing forms is not the norm.
Example: A study in a tribal community in which asking participants to sign documents is considered culturally uncharacteristic, and would cause participants to be distrustful of the researcher’s intentions. The research otherwise presents no more than minimal risk, and the researcher will indicate in their field notes that a participant provided consent.
Children provide assent when they actively indicate they would like to participate. The absence of dissent does not constitute assent.
There are no regulations requiring specific content in a child assent process. Assent processes should be appropriate for the children’s age, maturity, and cultural background.
More than one child assent process may be needed for studies that involve children of varying ages. For example, a simple oral script would be needed for young children while an assent form comparable to an adult consent form would be appropriate for high school students, .
Waiving Child Assent
The IRB may decide that child assent is not required because the child is not capable of providing assent.
Even if children are capable of providing assent, the requirement to secure assent may be waived by an IRB, for example in a cultural context in which children are not expected to make independent decisions about research participation. Securing parental permission would be sufficient.
Documentation of assent is not required. In consultation with the researcher, the IRB will determine if documentation of child assent would be appropriate.
When Parents Are Also Participants
If parents are also asked to participate in the study, parental permission can be combined with the consent form. The combined form needs to be clear that the researcher is asking parents to:
- Consent to participate in the study
- Give permission for their children to participate in the study.
The form should explain the activities of both the parent and the child. It may be appropriate to clarify that even if the parent participates, the child does not have to (and vice versa).
See this link for samples.