Research Involving Children

Information for Parents

Many types of research studies use children as subjects, some examples include: studies about learning styles, early language, social development, and literacy. Children are considered a vulnerable population of human subjects because of their special physical and cognitive capacities.  Therefore special ethical and regulatory considerations protect their rights.

Research involving children is divided into two categories: minimal risk research (classroom observation, curriculum evaluation, and standardized testing analysis) and greater than minimal risk research (experimental learning techniques, sensitive data collection, and therapeutic interventions).  Many studies of greater than minimal risk should provide the prospect of a direct benefit to a child. Otherwise, these studies are approved to use this vulnerable population as subjects because it presents a reasonable opportunity to further our understanding, or our ability to prevent, or alleviate a serious problem affecting the health or welfare of children. These studies may include an intervention or procedure that attempt to replicate actual, or expected psychological, social, or educational situations.

As the child’s 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 the research study.  Moreover, if your child is able comprehend the research study they too will likely be asked to assent to participate.  It is important for investigators to acquire the assent of children to the extent possible as well as the informed consent and permission of parents. It is the responsibility of the Principal Investigator (leader of the research project) to provide you with this information.  However, it is your responsibility to ask any questions you may have about your child’s involvement.

Since each child is a unique individual it is up to you to consider if participation is right for your child. It is paramount for parents to weigh the risks and benefits to your child before entering your child into a study as a research participant.  All consent forms are required to list the risks and benefits of the study.  Pay close attention to this information as you review the consent form.

Additionally, here are some items you’ll want to think about while contemplating your child’s participation:

  • What is being asked of your child?
  • What are the direct benefits?
  • What are the risks?
  • Is the data being collected sensitive (i.e. ask about sex, drugs, or criminal behavior)?
  • How much time is required?
  • Do researchers know my child’s identity?
  • How is my child’s identity protected?
  • Transportation issues
  • Does the study require that your child be removed from class?
  • Does my child want to participate?
  • What are the advantages (or disadvantages) of participating (or not participating)?

Important definitions of terms frequently used in consent forms with children as human subjects, according to the Office of Human Subjects Research of the National Institutes of Health, include:

  • Assent means a child’s affirmative agreement to participate in research. Failure to object should not be construed as assent.
  • Benefit is a valued or desired outcome.
  • Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under applicable law of the jurisdiction in which the research will be conducted. Generally the law considers any person under 18 years old to be a child (laws may vary by state).
  • Risk is the probability of harm (physical, emotional, social or economic). Both probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only minimal risk.
  • Minimal Risk means that 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. A list of procedures which may be considered minimal risk are provided in 45 CFR 46 (page 17) and the NIH Multiple Project Assurance (MPA), Appendix J.
  • Permission is the agreement of parent(s) or guardian(s) to the participation of their child or ward in research.”

More information on the use of children in research can be found at the Office of Human Subjects Research website.

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