FORM D. Instructions for Proposed Assent Form - Nonmedical IRB
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 use of a written assent form to document assent. 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). 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.
Documentation of assent is required for subjects aged 12-17, unless the requirement is waived by the IRB. For assent procedures involving enrollment of children in research, the informed consent template found in Section 2, Form C of the IRB application can be used as a guide for 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..."). If a child is age 6 to 11, attach an assent script to be followed when discussing the study with the child. Also, you must complete and attach Form W to your IRB application.
To develop an assent document for your study, use the suggestions and template provided below as a guide to ensure inclusion of required elements.
Sample Assent Form Elements
- brief statement of purpose;
- description of procedures (including duration);
- indication of the voluntary nature of agreeing to participate;
- description of pain or discomfort that may be experienced;
- brief explanation of alternatives;
- description of benefit, if any;
- description of compensation, if any; and
- offer to answer questions.
Other Suggestions for Assent Forms
- Limit the document to one page if possible.
- Attach schema or charts or pictures that might be helpful to the child.
- Use of larger type might also be helpful to young children.
- Studies involving older children or adolescents should include more information and may use more complex language than studies involving younger children.
Click HERE for links to the Assent Form Template. The WORD or RTF version may be saved to the location of your choice, and then used as a guideline while editing for your specific protocol.