Newborn screening: should explicit parental consent be required?

Abstract

Newborn screening, the first population-based metabolic screening program has been universally conducted for several decades. With the advent of genetic technologies, many genetic/metabolic disorders can be detected pre-symptomatically but might be untreatable. Since the benefits and risks of screening tests on newborns are not fully known, newborn screening programs confront both legal and ethical challenges. This article aims to explore the following questions: (1) Is explicit parental consent required? (2) What level of consent should be sought? and (3) Is screening in the absence of explicit consent legally defensible? This article considers: (1) the introduction of newborn screening, (2) the conditions under which it is conducted (voluntary vs. mandatory), (3) the argument over whether explicit parental consent is required, (4) the conditions under which implied consent may be assumed, and (5) the principles of informing parents. This article concludes that implied consent is not acceptable except for traditional routine screening. Healthcare professionals should provide information about the known benefits and risks of testing and recognize the parental right of refusal. Finally, since the absence of explicit parental consent to newborn screening is not legally defensible, children's advocates should lobby for legislation permitting it in the absence of explicit consent in specific circumstances.