b. Assent

Children and those individuals who are not competent to provide consent should be given the opportunity to assent to participate in the research project.  Assent is a knowledgeable agreement to participate in the project.  Adequate provisions should be made for soliciting the independent, non-coerced assent from children or cognitively impaired persons who are capable of a knowledgeable agreement.

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 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 parental or legally authorized representative permission.

An Assent Document is used when the investigator recruits subjects who, by age or circumstance, are not able to give legally effective informed consent.  When legally effective informed consent cannot be obtained, the investigator should obtain the "assent" of the child or cognitively impaired subject.  This form documents the child’s or cognitively impaired subject's knowledgeable agreement, or assent, to participate in a research project.  The investigator should respect the decision of a child or cognitively impaired subject not to participate, even when the parent or legally authorized representative gives permission, unless specifically instructed otherwise by the IRB.

The regulations do not specify a certain age at which assent must be sought, but for most studies, the IRB suggests obtaining assent beginning at about age seven.  In certain studies involving treatment for an illness or condition that is available only in the context of research study, the IRB may determine that the assent of the child is not necessary.

The IRB must determine and document whether assent is required of all children in the research, some of the children in the research or that assent is not required of any of the children in the research.

For studies involving children, the IRB may recommend that this form be used with children, but it may also be used when teenagers are being recruited to enhance their comprehension if the study involves complicated procedures.  Investigators are asked to select and describe plans for the assent process for children/minors in the HawkIRB application. 

Options for assent procedures include the following:

1. Children/minors will sign an assent or consent document
2. Children/minors will be given an assent or consent document to read, but will provide only verbal assent
3. Children/minors will be given only a verbal description of the study and asked to assent verbally
4. No assent procedure because some or all of the children/minors do not have the capability to assent or their capability is so limited that they cannot reasonably be consulted to provide assent
5. 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
6. No assent procedure because although children are capable of assenting, we are requesting a waiver of assent (NOTE: must be minimal risk study for children and request must be justified in writing by answering questions to follow)

When using an Assent form, the child or cognitively impaired adult should sign the Assent to indicate knowledgeable agreement (assent) to participate.  In addition, the parent/guardian or legally authorized representative should sign the full Informed Consent Document to document his/her permission for the child or cognitively impaired adult to participate.

A template Assent Document is available as a choice on the Consent/Assent attachments page of HawkIRB.