Children (or minors) are considered a vulnerable research population because their intellectual and emotional capacities are limited and they are legally incompetent to give valid consent. Special procedures and considerations are required by the Federal regulations.
Children are 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. In the state of Maryland, individuals are adults and of legal age (released from parental authority), when one attains the age of 18 years. Children or minors are those individuals who have not attained the age of eighteen years.
Assessing risk
Federal regulations state the IRB has the authority to review and approve, require modifications in (to secure approval), or disapprove all research activities. At the same time, the IRB must review degree of risk associated with the research. Risks to subjects are to be reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research.
When the IRB is assessing risk to children participating in research and evaluating a protocol application proposing to involve children, the IRB will consider the following issues:
- Is the participation of children as research participants justified in this particular instance?
- Has every effort been made to ensure that a parent is present when the research intervention is conducted? This will not only comfort the child but will enable the parent to exercise the right to end the child’s participation in the research project at any time. Investigators should note that in some cases (e.g. research into sensitive personal matters, physical examinations of adolescents, research into abuse, etc.) it may not be appropriate to have a parent present. If a parent will not be present during the course of the project, has the investigator clearly stated why in the protocol?
- Are the personnel involved in the research, and the facility in which the research will be conducted, knowledgeable about and sensitive to the physical and psychological needs of the children and their families?
- Have the investigators taken into account the child-participant’s previous experience with illness and medical interventions? Some children may be able to cope with stresses of research better than others as a result of previous experiences with medicine. Younger, “less experienced” children may be unprepared for participation in a research study.
- How the investigator determined the number of children to be enrolled for the study. Investigators should justify the number of subjects they propose to study.
- Whether the proposed techniques are the least invasive (physically and psychologically) in order to obtain the information for the study.
- Have the investigators clearly defined how the assent of the child-participants will be obtained?
- If this research question can be addressed initially in adults, has this work been conducted? If so, have results from this adult research benefit, or at least, not be harmful to children?
Obtaining consent and assent for participation
In almost all cases, written consent from a parent or legal guardian must be obtained if the research involves children under the age of 18. Investigators need to consider how they will handle confidentiality if such situations should they arise. The permission and/or assent form should describe plans for disclosure—or non-disclosure—of such information to parents, legal authorities, and the subjects themselves.
UMBC Consent Templates
Parent /Guardian Consent | Instructions
Minor (Child) Assent | Instructions
Waiver of Parent/Guardian Permission
A waiver of the requirement for parent/guardian permission is permitted under 45 CFR 46.408(c) when it is not a reasonable requirement to protect subjects. 46.408(c) requires the substitution of another mechanism to protect the subjects. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.
One cannot obtain a waiver of parental consent for research that involves more than minimal risk unless the research involves issues of child abuse or neglect or other situations where obtaining parental permission might increase the risks to the child participants. In such cases parental consent may be waived. However, the investigator must supply an appropriate mechanism and justification for obtaining consent from someone serving as an advocate for the child.
In situations where the protocol involves more than minimal risk, parental consent alone may NOT be sufficient. A recent ruling by the Maryland state appeals court (downloadable in .pdf format, Grimes v. Kennedy Krieger – 366 Md. 29) affects how researchers in Maryland may conduct research with children that involves more than minimal risk. Although this ruling pertained to medical research, UMBC investigators, who plan to involve children in more than minimal risk studies, must carefully design protocols that will sufficiently provide protections from potential research harms. That is, investigators cannot use a placebo control group if a more effective intervention is available. Protocol submissions involving such activities will require full board review.