As guidance for social and behavioral science researchers developing consent processes for a new research protocol or revising consent documents for an existing protocol, the IRB has created several consent document templates for study types commonly submitted to the IRB. The templates contain the information considered by the IRB to constitute the basic elements of informed consent such as descriptions of research procedures or activities and reasonably foreseeable risks and benefits associated with participation in a study. These templates are provided as guidance for you to use when constructing your consent documents.
If you plan to use a template to build your consent documents, you will need to tailor the template to your specific protocol, i.e., adding to areas that pertain to your research and deleting items that are not applicable to your study.
If you experience any difficulty accessing the templates or have suggestions on ways to improve the templates, please contact the SBS IRB staff by telephone at (773) 834-7835 or email at email@example.com.
Consent, Parental permission, and Assent Form Templates
- Consent Template (for use with adult research participants)
- Consent Template - Amazon Mechanical Turk study
- Debriefing Statement Template (when deception/incomplete disclosure is used)
- Parental Consent Form for Child's Participation in Research
- Sample Assent Form, with child's signature, for children ages 7 and older (NOTE: this is an example that is designed to be used with a range of ages, but you may need to develop more than one version of an assent form/script -- for example, a separate assent form for teenagers that is more detailed may be appropriate)
- Sample Child Assent Script (for verbal assent)
- Functional Magnetic Resonance Imaging (fMRI) consent template language (to be inserted in the appropriate sections of the consent form)
- Release Form for Sharing of Photographs, Audio-recordings, and/or Video-recordings beyond the research team
Model consent form language for specific circumstances:
- If your study will include focus groups, please include the following language (or similar wording) in your consent form: “Although we ask everyone in the group to respect everyone’s privacy and confidentiality, and not to identify anyone in the group or repeat what is said during the group discussion, please remember that other participants in the group may accidentally repeat what was said.”
- In studies in which researchers will be probing for or are likely to elicit information about child abuse or neglect, the following statement (or a variation of it) should be included: "If we learn about current or ongoing child abuse or neglect, we will report this to the appropriate authorities."
- If you wish to ask participants to consent to future contact about additional research studies, please include check boxes for participants to accept or decline to be contacted about other studies in the future.
When conducting research with children, consider whether only the child, or both the child and the parent (or guardian), will be research participants. For example, if you will ask the parent to fill out a questionnaire about the family's income, parents' educational background, what languages are spoken in the home, and also ask the child to participate in research tasks, the parent and child may both be research participants. In such cases, you would need to obtain the parent's consent to the parent's own participation in the research, the parent's permission for the child to participate, and (if appropriate) the child's assent to participate in the research. A combined form to obtain the parent's consent to the parent's own participation and permission for the child to participate is often appropriate in such situations, so long as you clearly explain which research tasks pertain to the parent and which tasks pertain to the child and clearly document the adult's consent to his/her own participation and permission for his/her child to participate.
Child Assent: "Assent" means a child's affirmative agreement to participate in research. Mere failure to object does not constitute assent. (45 CFR 46.402(b)). This means the child must actively show his or her willingness to participate in the research, rather than just complying with directions to participate and not resisting in any way. The explanation of the research should be tailored to the age and developmental capabilities of the children who are being asked to participate in the research. If your study will include children in a wide age range, you need to consider what is an appropriate assent process for the various ages of children in your study.
The regulations on human subjects research permit the IRB to waive assent if the capability of some or all of the children is so limited that they cannot reasonably be consulted. So, for example, if a study will include very young children who would not be able to understand and give meaningful agreement to participate in a study, the researcher can request that the IRB waive the assent requirement for children who would not have the capability to provide meaningful assent.
The process of asking a child to participate in research should be carefully planned and implemented, using age-appropriate language and methods, for any child who is capable of understanding and providing assent. If a child is considered capable of being involved in the informational process (regardless of age), at least a simple verbal explanation of what will happen to him/her and the opportunity for questions and discussion should be given. An appropriate assent form should be used when feasible -- assent forms should be written at a level of education and maturity appropriate to the youngest potential subjects in the age range, and the information delivered using suitable methods. In most cases, 7 years of age is a reasonable minimum for a child with normal cognitive development to be capable of participating in a meaningful written assent process.
Research with adolescents: Depending on the complexity of the study and the condition/capacity of the adolescent participants, an adolescent assent form may be very similar to the parent permission form or it may need to be somewhat simpler than the adult's form. In situations where the parental permission form will be identical to the adolescent assent form, the researcher may propose using one parental permission/child assent form, with signature lines for both the parent and the adolescent.