Important Definitions
Children – persons who have 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.
For further questions about federal regulations related to children as research participants please view the following link to the Department of Health and Human Services.
Information for Parents
Children are considered a vulnerable population of human subjects because of their age physical and cognitive capacities. Therefore, the federal, state, and local governments have provided specific ethical protections of their rights as research participants.
Research involving children is divided into two categories: minimal risk (i.e. classroom observation, curriculum evaluation, and standardized testing) and greater than minimal risk research (experimental learning, interventions, etc.).
As a parent or guardian it is your responsibility to ensure your child’s wellbeing and safety. You will be asked to provide informed consent for your child’s participation in a research study. if your child is 7 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 to participation.
Additionally, you may consider asking or thinking about the following questions prior to 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 your child be removed from class?
- Does my child want to participate?
For questions about children as research participants please contact our office at utkirb@utk.edu or (865) 974-7697