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Ethical Conduct of Clinical Research Involving Children
Federal regulations usually require that parents provide permission for a child’s participation in research (45 CFR 46.408; 21 CFR 50.55). (Consistent with earlier chapters, the text refers to the regulations that apply to federally conducted or supported research as DHHS regulations to distinguish them from the similar but not identical FDA regulations.) As discussed further below, the regulations define children with reference to state laws establishing the legal age for consent to the treatments or procedures involved in the research. In general, the rules for informed consent listed in Box 5.1 also apply to permission. That is, parents or guardians are to be provided the same kinds of information and disclosures that would be provided to adults consenting to research in their own right. The regulations define parents as biological or adoptive. A guardian is someone who is appointed by a court and who can authorize medical care for a child.
Both parents must provide permission for the child to be included in research when research involves greater than minimal risk and does not hold out the prospect of direct benefit to the child. The regulations allow exceptions when one parent is dead, incompetent, not reasonably available, or not legally responsible for the child’s care. In these situations, permission from one parent will suffice.
Waiver of Parental Permission
Under certain circumstances when parental permission is not a reasonable requirement to protect a child, the DHHS regulations allow an IRB to waive parental permission—provided that an appropriate mechanism for protecting the child is substituted and the action is consistent with federal, state, and local laws (45 CFR 46.408(c)). As an example of a situation in which a waiver might be appropriate, the regulations cite only situations involving neglected or abused children. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter, the National Commission) mentioned several other circumstances in which parental or guardian permission might be waived, including when parents are incompetent to provide permission, when the research involves conditions for which state laws allow adolescents to be treated without parental consent, or when the research involves mature adolescents and only minimal risk (National Commission, 1977).
The DHHS regulations do not describe what additional protective procedures might be appropriate if parental permission is waived but only state that the choice will “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” (45 CFR 26.408(c)). One option is to appoint an independent research monitor or participant