How to Obtain Informed Consent for a Children's Research Study
- 1). Educate parents, guardians and children on all aspects of the research study. Clarify the purpose of the research and what role the children will play. Outline how your research will be collected, the length of the assignment, other parties involved and why the study is necessary. Answer any questions that the parents and children have. Begin discussing the study and disseminating educational information at least one month before you need the consent to allow time for the parents and guardians to consider their answers.
- 2). Distribute research-study materials, pamphlets, fliers, videos and any other necessary supplemental educational information. Use layman's terms in all documents and avoid scientific or academic language. Write all handout information at or below an eighth-grade reading level. Provide translated documentation to guardians and potential participants who do not speak English.
- 3). Provide a copy of the consent form to parents and guardians. Give them time to look over the form and share it with others such as family, physicians and lawyers. Encourage them to ask questions or voice concerns at any time so you can answer or clarify them before they give consent. Inform them that children over the age of seven may also need to assent to the procedure, even though they cannot give legal consent.
- 4). Guarantee parents and guardians that the children are at no more than a minimum level of risk --- at any time or for any reason --- throughout the entire study. Remind parents and guardians that disclosure of any of the participants' identifying information, such as names or addresses, requires additional written consent.