Because children and some adults with impaired consent capacity are not legally considered capable of providing consent, regulations do allow a parent or legally authorized representative (LAR) to give “permission” for the individual to participate when assent or “affirmative agreement” to participate is obtained from the child (or adult with impaired consent capacity). Depending on the risk level of the study, provisions may be necessary for permission from both parents.
As with the informed consent process, the assent process should also allow for an exchange of information between the investigator and the subject and afford ample opportunity for the subject to ask questions and consider whether or not to participate in the study. The IRB must determine whether and how assent must be documented, but in most cases, the IRB will require the use of a written assent form to document assent. When documentation of assent is required, the IRB-approved assent form shall be signed and dated by the subject or the subject's legally authorized representative, and a signed copy given to the subject or the subject's legally authorized representative.
The assent form should include a simplified version of the elements of informed consent. Note that the assent form should provide an explanation at a level appropriate to the subject's age, maturity, and condition of the procedures to be used, their meaning to the subject in terms of discomfort and inconvenience, and the general purpose of the research.
For assent procedures involving the enrollment of children in research, the informed consent template found in the "All Templates" menu option on the left-hand side of your E-IRB application can be used as a guide for the development of the parental permission form. Revise the template so that it is written from the perspective of the parent (i.e., "your child is being..."; and/or "...I voluntarily consent on behalf of my child..."). In addition, the following is one example of a Parent Permission for reference. If a child is aged 6 to 11, attach an assent script to be followed when discussing the study with the child. ORI provides a Sample Assent Script as a guide. Also, you must checkmark the "Children" attribute in the Subject Demographics section of your E-IRB application and complete the questions as prompted under the Children subsection.
When conducting research with children, the IRB recommends that you take the following issues into consideration in order to meet the highest standards of human research protection.
Consider:
- The child’s previous experience with illness and medical interventions. (Some children may be able to cope with the stress of research better than others as a result of previous experience with medicine. Younger, “less experienced” children may be unprepared for participation in medical research.)
- Are the proposed research interventions the least invasive (both physically and psychologically) in order to obtain the necessary data?
- Whenever feasible, appropriate studies should be conducted on animals, adults, and older children before young children are involved as research subjects.
- Whether personnel working with children are familiar with the State laws requiring the reporting of suspected abuse.
IRB approval for the assent form must be issued prior to use, and only consent/assent forms with a valid "IRB Approval" stamp can be used when enrolling subjects (unless a waiver from this requirement is approved by the IRB).
- To develop an assent document for your study, use the suggestions and templates provided as a guide to ensure important elements are included.
- For guidelines on when assent needs to be documented based on age and maturity, as well as parental permission requirements for research involving children, see the UK IRB Policy on Children in Research.
- Refer to the UK Impaired Consent Capacity Policy for guidelines on developing a plan that evaluates the level of impairment, given the context of the research. Researchers can respect even limited autonomy by obtaining participant assent and recognizing that individuals are always considered competent to refuse.
For definitions of "child/children", "legally authorized representative", "guardian", "assent", "permission", and discussion of emancipated individuals, assent, and waiver of parental permission, see the Informed Consent SOP [C3.0050].
Emancipated Minors: Under Kentucky state law, absent a court order, there are no classes of individuals under the age of 18 who are named as emancipated for all purposes. Consequently, if you plan to enroll some or all prospective subjects as emancipated, consult with UK Legal Counsel. UK legal counsel and include legal counsel’s recommendations in the IRB application.