Research Involving Minors
Introduction
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. 45CFR46 Subpart D (Additional DHHS Protections for Children Involved as Subjects in Research) applies to all research involving children as subjects.
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Wards of the StateChildren who are wards of the State or any other agency, institution, or entity can be included in research approved under CFR 46.406 or 46.407 only if such research is (1) related to their status as wards; or (2) conducted in schools, camps, hospitals, institutions, or similar setting in which the majority of children involved as subjects are not wards. The IRB will require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child’s participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.
Emancipated Minors"Emancipated Minors" are deemed "emancipated" and treated as adults for all purposes. Definitions of the emancipated minor include those who are: 1) self-supporting and/or not living at home; 2) married; 3) pregnant or a parent; 4) in the military; or 5) declared to be emancipated by a court. Many states give decision-making authority (without the need for parental involvement) to some minors who are otherwise unemancipated but who have decision-making capacity ("mature minors") or who are seeking treatment for certain medical conditions, such as sexually transmitted diseases, pregnancy, and drug or alcohol abuse. The situations in which minors are deemed to be totally or partially emancipated are defined by statute and case law and may vary from state to state. Legal emancipation recognizes a special status (eg, independent living) or serious public and/or individual health problems that might not otherwise receive appropriate attention (eg, sexually transmitted disease).
Minor College StudentsYour research might involve actual children or college students just under the age of 18. Both are considered to be minors. Federal regulations define "children" as persons who have not attained the legal age for consent to treatments or procedures involved in the research. In Virginia, the legal age for consent is 18. Therefore, unless waived by the IRB, researchers must obtain parental permission and assent for all minors. The IRB supports the inclusion of college students who are minors in research; therefore, for very low risk research (e.g., low risk surveys) will typically waive the requirement for researchers to obtain signed and/or informed parental permission from their parents.
The University General Counsel at Virginia Tech has determined that college students under the age of 18 are not "Emancipated Minors" for purposes of participating as subjects in research. Therefore, any student under 18 years of age enrolled at the university may not be used/participate in a human subjects research project without first obtaining parental permission (unless waived) and the student's assent.
Suspected Child Abuse or NeglectIf you as a researcher ever suspect that a child is in danger due to abuse or neglect, you are obligated to contact the Department of Social Services and report the concern. This is in compliance with the mandatory reporting laws of the state of Virginia.
Determining Minimal RiskCentral to IRBs' consideration of research involving children is the determination of what constitutes minimal risk. Procedures that usually present no more than minimal risk to a healthy child include: urinalyses, obtaining small blood samples, EEGs, allergy scratch tests, minor changes in diet or daily routine, and/or the use of standard psychological or educational tests. Behavioral interventions likely to cause psychological stress and/or anxiety may exceed minimal risk.
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? When procedures involving greater than minimal risk to children are anticipated, are convincing scientific and ethical justifications given?
- Is the inclusion of normal volunteers justified?
- Do studies involving placebo controls place the child at greater risk by withholding from selected subjects potentially therapeutic research drugs or interventions?
- When possible, have appropriate studies been conducted on animals and adults first? Will older children be enrolled before younger ones?
- What is the age of majority in the state? Can a child consent to medical care for certain conditions, and, if so, at what age? What legal limits are there on the right of parents to consent on behalf of their children?
- Is permission of both parents necessary? Under what conditions may one of the parents be considered "not reasonably available"?
- Will efforts be made to ensure that parents' permission to involve their children in research studies is free from coercion, exploitation, and/or unrealistic promises?
- Are mechanisms in place to ensure that children are involved as research subjects in ways that do not undermine their dignity as young persons? Are provisions made that show respect for the developing rights of children, such as: (a) obtaining their assent, and, where appropriate, honoring their dissent; and (b) protecting their need for privacy and the confidentiality of information regarding them?
- Are there special problems that call for the presence of a monitor or advocate during consent procedures?
- Are special needs of adolescents such as counseling and confidentiality accounted for in the research design?
- Are there any special problems such as confidentiality and reporting that might arise in sensitive research about child abuse or sexual practices of teenagers?