Public participation in medical policy-making and the status of consumer autonomy: the example of newborn-screening programs in the United States.

OBJECTIVES: State newborn-screening programs collectively administer the largest genetic-testing initiative in the United States. We sought to assess public involvement in formulating and implementing medical policy in this important area of genetic medicine.
METHODS: We surveyed all state newborn-screening programs to ascertain the screening tests performed, the mechanisms and extent of public participation, parental access to information, and policies addressing parental consent or refusal of newborn screening. We also reviewed the laws and regulations of each state pertaining to newborn screening.
RESULTS: Only 26 of the 51 state newborn-screening programs reported having advisory committees that include consumer representation. Fifteen states reported having used institutional review boards, another venue for public input. The rights and roles of parents vary markedly among newborn-screening programs in terms of the type and availability of screening information as well as consent-refusal and follow-up policies.
CONCLUSIONS: There is clear potential for greater public participation in newborn-screening policy-making. Greater public participation would result in more representative policy-making and could enhance the quality of services provided by newborn-screening programs.