decision maker understand the nature of the research and its prospective benefits and risks.

When young children are the subjects of research, they cannot give informed consent because they lack the maturity to make informed decisions; instead, their parent(s) or guardian(s) must give informed permission. In addition to parental permission, a child generally must assent to participate in the research when this is developmentally appropriate. Parental permission and the child’s assent when developmentally feasible are ethically appropriate because they show respect for children as persons. Although young children cannot be autonomous, their preferences can still be respected. In this report, “consent” is used to refer to the combination of parental permission and child assent.

Parental Permission

Informed permission from parents may be particularly problematic with regard to research on housing health hazards involving children. Often parents in such studies are poor, poorly educated, and members of ethnic groups that have suffered discrimination. They may have difficulties making informed decisions about their children’s enrollment in such research, particularly in light of problems that are known to occur in the research consent process. We discuss these issues in greater detail later in the chapter.

The Belmont Report (National Commission, 1978; see Chapter 3) identified the three elements of informed consent as information, comprehension, and voluntariness. However, as stressed in the report of the National Bioethics Advisory Commission (2001b, p. 98), “the actual procedures emphasize disclosure requirements, and in so doing may distort the understanding of the ethical principle of respect for persons.”

The federal regulations governing federally funded or conducted research involving humans outline a number of requirements for both the process of obtaining informed consent to participate in research and the substantive information that must be provided to a prospective participant.1 Researchers must allow sufficient opportunity for a prospective participant to consider the decision to participate and minimize the possibility of coercion or undue influence (45 CFR 46.116). The information must also be communicated to the potential participant in a language that is understandable to the participant; see Box 6-1 for the information that the regulations require be included in the consent process.


Informed consent is not required for research that is exempt from review and can be waived under certain limited conditions (see 45 CFR 46.117 (c)).

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