Children as Research Participants

The IRB Process

Risk


The ethical mandate of IRBs is to protect the rights and welfare of human research subjects. IRBs are obligated to ensure that research studies do not endanger the safety or well-being of human subjects or undermine public confidence in the conduct of research. The special vulnerability of children makes consideration of involving them as research subjects particularly important. To safeguard their interests and to protect them from harm, special ethical and regulatory considerations are in place for reviewing research involving children.

DEFINITIONS

Assent: A child's affirmative agreement to participate in research. Mere failure to object should not be construed as assent.

Children: Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted.

Emancipated Minor: A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law, but who are entitled to treatment as if they had by virtue of assuming adult responsibilities, such as self-support, marriage or procreation. (See also: Mature Minor.)

Guardian: An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care.

Mature Minor: Someone who has not reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes (e.g., consenting to medical care). Note that a mature minor is not necessarily an emancipated minor. (See also: Emancipated Minor.)

Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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 example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.

Permission: The agreement of parent(s) or guardian to the participation of their child or ward in research.

Risk: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant.

IRB CONSIDERATIONS

Analysis of Probable Risks, Possible Benefits, and Associated Discomforts

IRBs reviewing research involving children as subjects must consider the benefits, risks, and discomforts inherent in the proposed research and assess their justification in light of the expected benefits to the child-subject or to society as a whole. In calculating the degree of risk and benefit, the IRB weighs the circumstances of the subjects under study, the magnitude of risks that may accrue from the research procedures, and the potential benefits the research may provide to the subjects or class of subjects.

See the section on obtaining consent from children for additional considerations.

POINTS TO CONSIDER

  • Does the research have an identifiable prospect of direct benefit to the individual child participant? Can that benefit be achieved through alternative means?
  • Does the research have an identifiable prospect of risk to the individual child participant? What safeguards are proposed to minimize these risks?