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Preterm Birth: Causes, Consequences, and Prevention
Food and Drug Administration specifically did not adopt the waiver of parental permission found in 45 CFR 46.408(c) (103). “Section 46.408(c) of DHHS [U.S. Department of Health and Human Services] subpart D allows an IRB [institutional review board] to determine that a research protocol is designed for conditions or for a subject population for which the permission of parents or guardians is not a reasonable requirement to protect the subjects.” This section has often been used by institutional review boards to waive the requirement for parental permission for research involving adolescents, provided that the research involved procedures that the adolescent could consent to under applicable state law.
Although most states include marriage as a condition that results in the emancipation of an adolescent from parental control, only two states (New Jersey and Wisconsin) mention pregnancy or previous birth. The ability to independently consent for research participation as an “expanded” view of emancipation may be reasonable, but this has not been addressed explicitly in state laws (104).
State laws usually contain provisions for a minor to consent to health care (so-called mature minor statutes), with pregnancy often included as a qualifying condition. In addition, states allow a minor to consent to treatments for specific disorders or conditions such as sexually transmitted diseases, family planning, and alcohol or drug abuse. However, the applicability of these statutes to the research setting is far from clear (104).
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