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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).

REFERENCES

1. McHaffie HE, Lyon AJ, Hume R. Deciding on treatment limitation for neonates: the parents’ perspective. European Journal of Pediatrics 2001;160:339–344.

2. Partridge JC, Martinez AM, Nishida H, et al. International comparison of care for very low birth weight infants: parents’ perceptions of counseling and decision-making. Pediatrics 2005;116(2):e263–e271.

3. Brinchmann B. What matters to the parents? A qualitative study of parents’ experiences with life-and-death decisions concerning their premature infants. Nursing Ethics 2002;9(4):388–404.

4. McHaffie HE, Laing IA, Parker M, McMillan J. Deciding for imperilled newborns: medical authority or parental autonomy? Journal of Medical Ethics 2001;27:104–109.

5. Bastek TK, Richardson DK, Zupancic JAF, Burns JP. Prenatal consultation practices at the border of viability: a regional survey. Pediatrics 2005;116(2):407–413.

6. Streiner DL, Saigal S, Burrows E, Stoskopf B, Rosenbaum P. Attitudes of parents and health care professionals toward active treatment of extremely premature infants. Pediatrics 2001;108(1):152–157.

7. Orfali K. Parental role in medical decision-making: fact or fiction? A comparative study of ethical dilemmas in French and American neonatal intensive care units. Social Science & Medicine 2004;58(10):2009–2022.

8. Lantos JD, Tyson JE, Allen A, et al. Withholding and withdrawing life sustaining treatment in neonatal intensive care: issues for the 1990s. Archives of Disease in Childhood: Fetal and Neonatal Edition 1994;71(3):F218–F223.



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