In Chaps. 5, 6, 7, 8, 9, and 10 I examined various ethical and policy issues pertaining to research with human subjects through the lens of five principles—respect for autonomy and dignity, non-maleficence, beneficence, justice, and trust. Along the way, I also discussed how federal regulations, agency guidance, and professional codes apply to those issues and mentioned recent changes to the Common Rule. In this chapter I will turn my focus to critiques of the current oversight system and recent changes to the regulations. At the end of Chap. 2, I raised the issue protectionism and suggested the determining the right level of protection for human subjects requires one to balance conflicting values, i.e. protection of human welfare and rights vs. the advancement of scientific knowledge. In this chapter, I will consider how regulatory reform efforts achieve this balance.
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