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Ethical Challenges in Child Research & Criminal Justice

Children and people incarcerated under the United States criminal justice system are considered vulnerable populations when used as subjects of human research. Due to the comprehension level of young children and the involuntary confinement of prisoners, neither population is in a suitable position to give full, uncoerced consent to participate. Federal research regulations have special ethical considerations in place for these populations.

  1. Minimal Risk in Children's Research

    • Title 45, Part 46 of the Code of Federal Regulations, or 45 CFR 46, governs the inclusion of children in human research. The regulation dictates that an ethics committee independent of the study, referred to in the industry as an institutional review board, known as the IRB, assesses study proposals for risk. Specifically, studies cannot be IRB-approved until it is deemed that the risk of participation is not greater than risks children face in daily life routines. The Food and Drug Administration's Center for Drug Evaluation and Research developed an industry guidance for studying drugs in pregnant women. If the women were already taking prescription medication for preventive or therapeutic care, then minimal risk is assumed.

    Equitable Selection of Children

    • A second mandate of 45 CFR 46 is that institutional review boards are responsible to assess proposed study designs for the equitable selection of participants during the recruitment process. This rule seeks to ensure that all children are privy to the benefits of the research and proposes that children of both genders and minority populations be included during the study's recruitment.

    Assents and Consents

    • A third ethical consideration is permission to conduct research. Researchers obtain written permission to conduct investigations of children through the signing of informed consent documents by parents or legal guardians. Federal regulation, 45 CFR 46, also mandates that children be informed of the research and be allowed to make a decision of participation if old enough to understand. If a child agrees to participate, then a second signature indicating the child's assent to participate is also required on the informed consent document.

    Minimal Risk for Prisoners as Human Subjects

    • The ethical protection of prisoners is governed by 45 CFR 46 Subpart C. Studies of prison structures, incarceration and/or criminal behavior among prisoners must be deemed by institutional review boards to pose minimal risk and only minor inconvenience to the daily lives of prisoners as human subjects. For this population, minimal risk is defined as a low probability of harm in comparison to the risk of harm gained from normal daily prison encounters.

    Benefit Versus Harm

    • Further, 45 CFR 46 Subpart C mandates that research with prisoners as human subjects must be of conditions that affect prisoners in large numbers. A great benefit to a class of people outweighs minimal harm to a set of individuals in this ethical principle. Studies with prisoners as human subjects must seek to bring benefit to the entire prison population after results are obtained.

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