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Increasingly, many such IRBs are adopting the ‘Rule of Sevens,’ which has formed part of common law for centuries and divides a child’s life into three sections: birth to seven, seven to fourteen, and fourteen to twenty one years old. Before 7 years old children are said to lack the cognitive development necessary for autonomous decision-making. At age 7 years children are considered able to distinguish right from wrong. Adolescents 14 years old and above are legally and socially accountable for their actions. Although not law, meaning physician can choose to ignore it, the rule of sevens is recommended by organizations including the American Academy of Pediatrics and in some areas, such as the state of California, has been written into local law.[4]



Non-assent and controversy

Although the premise of pediatric consent using the rule of sevens is widely used and recognized as a practicable and ethical solution, it is not difficult to cite instances where it should not or has not applied, for example:

A child under 7 years old who is vehemently uncooperative with an aspect of a trial (such as a painful or uncomfortable assessment) may be removed from the trial by an investigator, i.e. be privilege to dissent.[10][11]
A child over 7 years old who declines treatment for a devastating childhood illness and is therefore in mortal danger, might have their dissent overridden and have treatment forced upon them.[12]
A child over 14 years old may be able to provide their own informed consent, independent of their parents.[13] The legal precedent is that as an emancipated minor they may consent to any medical procedure they see fit (E.g., Carter v. Cangello, 105 Cal App 3d 348, 164 Cal Rptr 361, 1980; Lacey v. Laird, 139 NE 2d 25, Ohio 1956)[non-primary source needed]
A child who does not wish to undergo treatment, and nor do their parents wish treatment for them, may be ordered to do so by the courts under child neglect laws.[14][13]

There have been instances where the failure to obtain proper assent (or even parental consent) has been directly opposed to the interests of the patient. In late 2000, the Washington Post broke the story of a 10-year-old girl who died during a meningitis clinical study conducted in Kano, Nigeria, by the drug giant Pfizer.[15] The story described the slow death of the girl while researchers, who were testing Pfizer’s antibiotic Trovan (trovafloxacin), monitored her dying without modifying her treatment. The Post also alleged other such corporation-sponsored experiments “in Africa, Asia, Eastern Europe, and Latin America” that were “poorly regulated,” “dominated by private interests” and “far too often betray” their promises to research subjects and consumers. The trial was performed without informed consent.

Initially, Pfizer successfully argued in court both that there was no international norm requiring its physicians to obtain informed consent for clinical trials and that any lawsuit brought against them relating to the trial should be tried in Nigerian courts, not U.S. courts. Pfizer abandoned this second claim in 2006, when a Nigerian Ministry of Health internal report was made public that concluded the study violated Nigerian law, the Declaration of Helsinki, and the United Nations' Convention on the Rights of the Child. The Nigerian government then filed both criminal and civil lawsuits against Pfizer in Nigeria. A settlement in this case has reportedly been reached, but the details of the agreement have not yet been made public. The Nigerian families have also gone to the U.S. Court of Appeals for the Second Circuit, winning the right to have the case tried in a US court. The central allegation is that “Pfizer, working in partnership with the Nigerian government, failed to secure the informed consent of either the children or their guardians and specifically failed to disclose or explain the experimental nature of the study or the serious risks involved” or to inform them that alternative treatment proven to be effective was immediately available from Médecins sans Frontières at the same facility.[16]
http://en.wikipedia.org/wiki/Informed_assent


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