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Regulatory Reform

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Book cover The Ethics of Research with Human Subjects

Part of the book series: International Library of Ethics, Law, and the New Medicine ((LIME,volume 74))

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Abstract

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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Notes

  1. 1.

    OHRP will provide a list safeguards for protecting the confidentiality of human subjects data.

  2. 2.

    The IRB chair can do a limited review of these safeguards to ensure that they adequately protect privacy and confidentiality (45 CFR 102d2).

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  1. National Institutes of Health, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA

    David B. Resnik

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Resnik, D.B. (2018). Regulatory Reform. In: The Ethics of Research with Human Subjects. International Library of Ethics, Law, and the New Medicine, vol 74. Springer, Cham. https://doi.org/10.1007/978-3-319-68756-8_11

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