Research Involving Children

Information for parents

Federal, state, and local governments have provided specific ethical protections of children’s rights as research participants. For further information about relevant federal regulations, visit the Department of Health and Human Services Research with Children FAQ.

As a parent or guardian, it is your responsibility to ensure your child’s well-being and safety. You will be asked to provide informed consent for your child’s participation in a research study. If your child is seven years old or older and able to comprehend the research study, they too will likely be asked to assent to participate. All consent and assent forms are required to list the benefits and risks of participation.

Research involving children is categorized as either minimal risk (for example, classroom observation, curriculum evaluation, and standardized testing) or greater than minimal risk (for example, experimental learning, interventions, etc.).

Consider asking or thinking about the following questions before agreeing to your child’s participation:

• What are the direct benefits?
• What are the risks?
• Is the data being collected sensitive?
• How much time is required?
• Do the researchers know my child’s identity? If so, how is it protected?
• Does the study require that my child be removed from class?
• Does my child want to participate?

Important Definitions

• Child: A person who has not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted.
• Permission: The agreement of parent(s) or guardian(s) to the participation of their child or ward in research.
• Assent: A child’s affirmative agreement to participate in research. Failure to object should not be construed as assent.
• Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Contact the HRPP

For questions about children as research participants, contact UT’s Human Research Protection Program at [email protected] or 865-974-7697.