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Responsible Conduct in Nanomedicine Research: Environmental Concerns beyond the Common Rule

Published online by Cambridge University Press:  01 January 2021

David B. Resnik
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The Common Rule (45 CFR 46, subpart A) is a set of regulations for protecting human participants in research funded by the Department of Health and Human Services (DHHS), which has been adopted in part by 17 federal agencies. It includes four different subparts: Subpart A (general protections for human research participants), Subpart B (additional protections for pregnant women, fetuses, and neonates), Subpart C (additional protections for prisoners), and Subpart D (additional protections for children). The Common Rule has not been significantly revised since 1981 although some significant changes may be forthcoming. The Food and Drug Administration (FDA) has adopted its own regulations for the protection of human participants, which are similar to the Common Rule in many key areas, such as the structure and function of the Institutional Review Board (IRB), and the criteria for approving research.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 40 , Issue 4 , Winter 2012 , pp. 848 - 855
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

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References

45 C.F.R. part 46, subpart A (2009).Google Scholar
45 C.F.R. part 46 (2009).Google Scholar
21 C.F.R. part 56 (2010).CrossRefGoogle Scholar
45 C.F.R. § 46.111(a)(1) (2009).Google Scholar
45 C.F.R. § 46.111(a)(2) (2009).Google Scholar
45 C.F.R. § 46.116 (2009).CrossRefGoogle Scholar
45 C.F.R. § 46.111(a)(7) (2009).Google Scholar
Kimmelman, J., Gene Transfer and the Ethics of First-in-Human Research: Lost in Translation (Cambridge: Cambridge University Press, 2009): at 1.CrossRefGoogle Scholar
National Nanotechnology Initiative, available at <http://www.nano.gov/> (last visited November 19, 2012).+(last+visited+November+19,+2012).>Google Scholar
Oberdörster, G. Oberdörster, E., and Oberdörster, J., “Nanotoxicity: An Emerging Discipline Evolving from Studies of Ultrafine Particles,” Environmental Health Perspectives 113, no. 7 (2005): 823–39, at 823.CrossRefGoogle Scholar
Resnik, D. B. and Tinkle, S. S., “Ethics in Nanomedicine,” Nanomedicine 2, no. 3 (2007): 345–350, at 345.CrossRefGoogle Scholar
Resnik, D. B. and Tinkle, S. S., “Ethical Issues in Clinical Trials Involving Nanomedicine,” Contemporary Clinical Trials 28, no. 4 (2007): 433–441, at 433.CrossRefGoogle Scholar
See Oberdörster, et al., supra note 10, at 823.Google Scholar
See National Nanotechnology Initiative, supra note 9.Google Scholar
Hoet, P. Brüske-Hohlfield, I., and Salata, O., “Nanoparticles – Known and Unknown Health Risks,” Journal of Nanobiotechnology 2, no. 1(2004): 12–27, at 12.CrossRefGoogle Scholar
Oberdörster, G., “Safety Assessment for Nanotechnology and Nanomedicine: Concepts of Nanotoxicology,” Journal of Internal Medicine 267, no. 1 (2010): 89–105, at 89.CrossRefGoogle Scholar
See Oberdörster, et al., supra note 10, at 823.Google Scholar
Allhoff, F. Lin, P., and Moore, D., What Is Nanotechnology and Why Does It Matter? (New York: Wiley-Blackwell, 2010): at 71.CrossRefGoogle Scholar
Resnik, D. B., “Is the Precautionary Principle Unscientific?” Studies in the History and Philosophy of Biology and the Biomedical Sciences 34, no. 2 (2003): 329–344, at 329.CrossRefGoogle Scholar
Elliott, K., “Nanomaterials and the Precautionary Principle,” Environmental Health Perspectives 119, no. 6 (2011): A240.CrossRefGoogle Scholar
Munthe, C., The Price of Precaution and the Ethics of Risk (Dordrecht: Springer, 2011): at 1.CrossRefGoogle Scholar
See Oberdörster, , supra note 16, at 89.Google Scholar
Yokel, R. A. and Macphail, R. C., “Engineered Nanomaterials: Exposures, Hazards, and Risk Prevention,” Journal of Occupational Medicine and Toxicology 21, no. 6 (2011): 7.CrossRefGoogle Scholar
See Yokel, and Macpail, , supra note 23, at 7.Google Scholar
Perry, M. and Hu, H., “Workplace Health and Safety,” in Frumkin, H., ed., Environmental Health: From Global to Local, 2nd ed. (New York: John Wiley and Sons, 2010): 729–767, at 729.Google Scholar
Occupational Health and Safety Administration, “Nanotechnology: OSHA Standards,” available at <http://www.osha.gov/dsg/nanotechnology/nanotech_standards.html> (last visited November 19, 2012).+(last+visited+November+19,+2012).>Google Scholar
National Institute for Occupational Health and Safety, “Nanotechnology,” available at <http://www.cdc.gov/niosh/topics/nanotech/> (last visited November 19, 2012).+(last+visited+November+19,+2012).>Google Scholar
Environmental Protection Agency, “Control of Nanoscale Materials under the Toxic Substance Control Act,” available at <http://www.epa.gov/opptintr/nano/> (last visited November 19, 2012).+(last+visited+November+19,+2012).>Google Scholar
Cranor, C., Legally Poisoned: How the Law Puts Us at Risk from Toxicants (Cambridge, MA: Harvard University Press, 2011): at 208.Google Scholar
Davies, J. C., Managing the Effects of Nanotechnology (Washington, D.C.: Woodrow Wilson International Center, 2006): at 1.Google Scholar
National Institutes of Health, Office of Biotechnology Activities, “Institutional Biosafety Committees,” available at <http://oba.od.nih.gov/rdna_ibc/ibc.html> (last visited November 19, 2012).+(last+visited+November+19,+2012).>Google Scholar
Gunsalus, C. K. Bruner, E. M. Burbules, N. C. Dash, L. Finkin, M. Goldberg, J. P. Greenough, W. T. Miller, G. A., and Pratt, M. G., “Mission Creep in the IRB World,” Science 312, no. 5779 (2006): 1441.CrossRefGoogle Scholar
Resnik, D. B. and Sharp, R., “Protecting Third Parties in Human Subjects Research,” IRB 28, no. 4 (2006): 1–7, at 1.Google Scholar
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report (Washington, D.C.: Department of Health, Education, and Welfare, 1979): at 1.Google Scholar
Beauchamp, T. and Childress, J., Principles of Biomedical Ethics, 6th ed. (New York: Oxford University Press, 2008): at 165.Google Scholar
Weir, T., Introduction to Tort Law, 2nd ed. (Oxford: Oxford Higher Education, 2006): at 29.CrossRefGoogle Scholar
Resnik, D. B., “Liability for Institutional Review Boards: From Regulation to Litigation,” Journal of Legal Medicine 25, no. 2 (2004): 131–184, at 131.CrossRefGoogle Scholar
See Weir, , supra note 36, at 29.Google Scholar
See Weir, , supra note 36, at 29.Google Scholar
See Allhoff, Lin, , and Moore, , supra note 18, at 71.Google Scholar
Sandler, R., Nanotechnology: The Social and Ethical Issues (Washington, D.C.: Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, 2009): at 1.Google Scholar
See Allhoff, Lin, , and Moore, , supra note 18, at 71.Google Scholar
Crichton, M., Prey (New York: Harper Collins, 2002): at 1.Google Scholar
Fleischman, A. Eckenwiler, L. Grady, C. Hammerschmidt, D. Levine, C., and Sugarman, J., “Dealing with the Long-Term Social Implications of Research,” American Journal of Bioethics 11, no. 5 (2011): 5–9, at 5.CrossRefGoogle Scholar
See Fleischman, et al., supra note 44, at 5.Google Scholar
Id.Google Scholar
World Medical Association, “WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects,” available at <http://www.wma.net/en/30publications/10policies/b3/> (last visited November 19, 2012).+(last+visited+November+19,+2012).>Google Scholar