What's Required by Law

As already mentioned in our discussion of informed consent, the Department of Health and Human Services' (DHHS) Regulations for the Protection of Human Subjects (Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects; also referred to as 45 CFR 46) set standards for the informed consent process, the formation and function of Institutional Review Boards, and many other protective measures. Subpart D of 45 CFR 46 specifies "[A]dditional DHHS Protections for Children Involved as Subjects in Research." Established in 1983 and reviewed in 1991, these additional protections apply to all research involving children and is conducted or supported by DHHS, which includes National Cancer Institute-sponsored clinical trials.

The Subpart D regulations assign Institutional Review Boards with the responsibility for ensuring that any clinical trials involving children meet the following criteria (Go directly to Subpart D if you'd prefer to read them in their entirety.):

• The research does not involve "greater than minimal risk."
  
• If it does present more than minimal risk, it must offer an "intervention or procedure that holds out the prospect of direct benefit" for the individual child, or "a monitoring procedure that is likely to contribute to [their] well-being." However, the IRB must ensure that the risk is justified by anticipated benefits, and that the risk-benefit ratio is "at least as favorable" as that of alternative approaches.
  
• If the research involves "greater than minimal risk and no prospect of direct benefit" to the child, it must be "likely to yield generalizable knowledge" about their disease or condition. The IRB is charged with ensuring that the level of risk is reasonable, and that the research will most likely provide important general information that leads to better understanding of the condition.
  
• Any other research that does not appear to meet these criteria but "presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children" must be considered by the IRB on a case-by-case basis, and must be approved by the Secretary of the Department of Health and Human Services.

These Federal regulations go on to state that "adequate provisions" must be made for soliciting the assent of children, when the IRB determines that they are capable of participating in such a process based on their age, maturity, and state of mind.