Expanding newborn screening programmes and strengthening informed consent

Abstract

Part I offers the context to the claim that informed consent requirements need to be strengthened to the extent that newborn screening conveys more disadvantages relative to the advantages. This includes a discussion of the Dutch debate on expanding newborn screening. From this discussion it becomes apparent that the interpretation and application of the relevant screening criteria are disputable for an expanded programme. In the debate, opinions varied on what the appropriate expansion is, yet there was remarkable consensus on the point that expansion increased the importance of the informed consent procedure. The controversy surrounding expanded newborn screening is thought to provide reasons for a larger emphasis on thorough informed consent. In order to assess the SIC claim, part II develops a framework to understand the normative role of informed consent. It aims at answering the questions of what informed consent is, how it can be normatively justified, and how it establishes its normative purpose. Part III looks at three features of newborn screening that complicate the application of informed consent requirements in newborn screening procedures. All three features may affect the standards of the required consent. Part IV returns to the claim that informed consent procedures should be strengthened when the newborn screening programme expands. This part examines ways in which this strengthening could be realized and how the claim could best be defended. It is argued that the SIC claim is not necessarily true, and that different forms of strengthening informed consent for newborn screening may be undesirable.