Applying Bioethical Principles to Place-Based Communities and Cultural Group Protections: The Case of Biomonitoring Results Communication

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The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies. The Health and Human Services regulations, 45 CFR part 46, include four subparts: Subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children. The Common Rule outlines the basic provisions for Institutional Review Boards, human subjects protections based mostly on the Belmont Principles (beneficence, nonmaleficence, respect for autonomy, and justice) and Assurances of Compliance. Most federal agencies and all academic institutions that hold federal funding must abide by the Common Rule.

See Harrison , supra note 20, at 4.

See Foster , supra note 3.

See Foster , supra note 3, at 139.

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See National Bioethics Advisory Committee, supra note 36, at 4.

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Id., at 5.

Id., at 6.

See Morello-Frosch , supra note 5; Adams C. Brown P. Morello-Frosch R. Brody J. G. Rudel R. Zota A. Dunagan A. Tovar S. P. , “Community Context in Report-back of Personal Exposures,” Journal of Health and Social Behavior 52, no. 2 (2011): 180–196; Altman R. Morello-Frosch R. Brody J. Rudel R. Brown P. Averick M. , “Pollution Comes Home and Gets Personal: Women's Experience of Household Toxic Exposure,” Journal of Health and Social Behavior 49, no. 4 (2008): 417–435; and Brody J. G. Morello-Frosch R. Zota A. Brown P. Perez C. Rudel R. , “Linking Exposure Assessment Science with Policy Objectives for Environmental Justice and Breast Cancer Advocacy: The Northern California Exposure Study,” American Journal of Public Health 99, Supp. 3, no. 53 (2009): S600–608.

Id. ( Adams ).

See Brody , supra note 46, at S607.

A precautionary benefit derives from the “precautionary principle,” described in Raffensberger C. Tickner J. , ed., Protecting Public Health and the Environment: Implementing the Precautionary Principle (Washington, D.C.: Island Press, 1999). Raffensberger Tickner describe the precautionary principle which proposes that we take preventive action in the face of uncertain harmful effects from toxic exposures; those who create these risks should have the responsibility to study and prevent these risks; alternatives to these toxic exposures should be developed; and public participation and increasing transparency should be part of the decision-making around these risks.