risk but is not expected to benefit the child participant, the regulations require that investigators secure permission from both parents. If the IRB determines that research involves no more than minimal risk or that it holds out the prospect of direct benefit to the child, the IRB may decide that the permission of one parent is sufficient. Permission from one parent is also sufficient if that parent is legally responsible for the care and custody of the child or when the other parent has died or is unknown, incompetent, or not reasonably available. Chapter 5 describes circumstances in which the DHHS but not the FDA regulations provide for exceptions to the parental permission requirement.

Child Assent Although children cannot legally consent to participation in research, the regulations provide for children’s agreement or assent to research participation. The regulations do not describe the information that must be provided to children but rely on IRBs to use their discretion in judging assent provisions. Researchers must seek a child’s assent unless the IRB determines that

  • the children to be involved (as a group or individually) are not capable of providing assent, given their age, maturity, or mental state;

  • the research has a prospect of an important direct benefit for the child that is possible only in the research context; or

  • the research involves circumstances that would allow waiver of consent for adults.

As noted previously in Box 3.2, federal regulations on human research protections define children in terms of state laws defining the legal age at which an individual can consent to the treatments or procedures involved in the research. The legal age of majority is now 18 in all states except Mississippi (age 21) and Nebraska and Alabama (both age 19).2Chapter 5 and Appendix B discuss when those below the age of majority may agree to participate in research without permission from a parent or other authorized adults, for example, when they are accorded the status of emancipated or mature minors. They also consider special requirements related to research participation by children who are wards of the state.

2  

In Mississippi, a person age 18 or over can consent to medical or surgical care. In Alabama, a statute permits minors to consent to medical or surgical treatment at age 14. See Appendix B.



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