Handling Worker and Third‐Party Exposures to Nanotherapeutics During Clinical Trials
dc.contributor.author | Ramachandran, Gurumurthy | en_US |
dc.contributor.author | Howard, John | en_US |
dc.contributor.author | Maynard, Andrew | en_US |
dc.contributor.author | Philbert, Martin | en_US |
dc.date.accessioned | 2013-02-12T19:00:36Z | |
dc.date.available | 2014-02-03T16:21:43Z | en_US |
dc.date.issued | 2012-12 | en_US |
dc.identifier.citation | Ramachandran, Gurumurthy; Howard, John; Maynard, Andrew; Philbert, Martin (2012). "Handling Worker and Third‐Party Exposures to Nanotherapeutics During Clinical Trials." The Journal of Law, Medicine & Ethics 40(4). <http://hdl.handle.net/2027.42/96288> | en_US |
dc.identifier.issn | 1073-1105 | en_US |
dc.identifier.issn | 1748-720X | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/96288 | |
dc.publisher | Blackwell Publishing Ltd | en_US |
dc.publisher | Wiley Periodicals, Inc. | en_US |
dc.title | Handling Worker and Third‐Party Exposures to Nanotherapeutics During Clinical Trials | en_US |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | en_US |
dc.subject.hlbsecondlevel | Law and Legal Studies | en_US |
dc.subject.hlbsecondlevel | Medicine (General) | |
dc.subject.hlbtoplevel | Government, Politics and Law | en_US |
dc.subject.hlbtoplevel | Health Sciences | |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.contributor.affiliationum | Dean of the School of Public Health and a Professor of Toxicology at the University of Michigan. | en_US |
dc.contributor.affiliationum | Director of the Risk Science Center; the Charles and Rita Gelman Risk Science Professor; and a Professor Environmental Health Sciences at the School of Public Health at the University of Michigan. | en_US |
dc.contributor.affiliationother | Director of the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services. | en_US |
dc.contributor.affiliationother | Professor in the Division of Environmental Health Sciences at the School of Public Health at the University of Minnesota in Minneapolis, MN. | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/96288/1/j.1748-720X.2012.00714.x.pdf | |
dc.identifier.doi | 10.1111/j.1748-720X.2012.00714.x | en_US |
dc.identifier.source | The Journal of Law, Medicine & Ethics | en_US |
dc.identifier.citedreference | See Murashov, supra note 8. | en_US |
dc.identifier.citedreference | Id. | en_US |
dc.identifier.citedreference | R. Kocher and N. R. Sahni, “Rethinking Health Care Labor,” New England Journal of Medicine 365 ( 2012 ): 1370 – 1372. | en_US |
dc.identifier.citedreference | U.S. Dept. of Labor (US DOL), Career Guide to Industries, “Health Care,” Bureau of Labor Statistics, 2006–2007 edition), at pp 231, < http://www.bls.gov/oco/cg/cgs035.htm > (last visited November 28, 2012) | en_US |
dc.identifier.citedreference | J. Lipscomb and B. Borwegen, “Health Care Workers,” in B. S. Levy and D. H. Wegman, eds., Occupational Health: Recognizing and Preventing Work‐Related Disease and Injury, 4th ed. ( Philadelphia: Lipppincott Williams & Wilkins, 2000 ): at 767–778; Centers for Disease Control (CDC), “Overview: Risks and Prevention of Sharps Injuries in Healthcare Personnel,” in Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program,” available at < http://www.cdc.gov/sharpssafety/ > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | Centers for Disease Control and Prevention & National Institutes of Health (CDC/NIH), Biosafety in Microbiological and Biomedical Laboratories: Centers for Disease Control and Prevention, 5th ed., 2009, National Institutes of Health, available at < http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | See NIOSH, supra note 16. | en_US |
dc.identifier.citedreference | National Institute for Occupational Safety and Health (NIOSH), Preventing Occupational Exposure to Antineoplastic and other Hazardous Drugs in Health Care Settings, 2004, available at < http://www.cdc.gov/niosh/docs/2004‐165/pdfs/2004‐165sum.pdf > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | See NIOSH, supra note 16; National Institute for Occupational Safety and Health (NIOSH), Workplace Solutions: Medical Surveillance for Health Care Workers Exposed to Hazardous Drugs, DHHS (NIOSH) Publication Number 2007–117 (2007); National Institute for Occupational Safety and Health (NIOSH), Workplace Solutions: Personal Protective Equipment for Health Care Workers Who Work with Hazardous Drugs, DHHS (NIOSH) Publication No. 2009–106 (2009); National Institute for Occupational Safety and Health (NIOSH), NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, DHHS (NIOSH) Publication Number 2010–167 (2010). | en_US |
dc.identifier.citedreference | B. D. Naumann, E. V. Sargent, B. S. Starkman, W. J. Fraser, G. T. Becker, and G. D. Kirk, “Performance‐Based Exposure Control Limits for Pharmaceutically Active Ingredients,” American Industrial Hygiene Association Journal 57 ( 1996 ): 33 – 42; World Health Organization (WHO), Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials, vol. 2 (including updates), Good Manufacturing Practices and Inspection, updated ed., Geneva, WHO, 2004, available at < http://whqlibdoc.who.int/publications/2004/9241546190.pdf > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | See NIOSH, supra note 50. | en_US |
dc.identifier.citedreference | See Murashov, supra note 8. | en_US |
dc.identifier.citedreference | L. Amass, W. Ling, T. E. Freese, C. Reiber, J. J. Annon, A. J. Cohen, D. McCarty, M. S. Reid, L. S. Brown, C. Clark, D. M. Ziedonis, J. Krejci, S. Stine, T. Winhusen, G. Brigham, D. Babcock, J. A. Muir, B. J. Buchan, and T. Horton, “Bringing Buprenorphine‐Naloxone Detoxification to Community Treatment Providers: The NIDA Clinical Trials Network Field Experience,” American Journal on Addictions 13 ( 2004 ): S42 – S66; F. Wood, H. Prout, A. Acharjya, J. Nuttall, K. Hood, and C. Butler, “Exploring the Ethical and Practical Challenges of Conducting Clinical Trials in Care Home Settings,” Trials 12, Supp. 1 (2011): A38; P. Abernethy, L. S. Schwartzberg, D. Li, D. Scott, and M. Hensley, “Feasibility of Conducting Home‐based Clinical Trials in Patients with Advanced Pancreatic Cancer,” Journal of Clinical Oncology 28, no. 15 (2010): May 20 Supplement, Abstract e14647; C. M. Sackley, C. J. Atkinson, and M. F. Walker, “Occupational Therapy in Nursing and Residential Care Settings: A Description of a Randomised Controlled Trial Intervention,” British Journal of Occupational Therapy 67, no. 3 (2004): 104–110; G. M. Lucas, C. W. Flexner, and R. D. Moore, “Directly Administered Antiretroviral Therapy in the Treatment of HIV Infection: Benefit or Burden?” AIDS Patient Care and STDs 16, no. 11 (2002): 527–535; J. S. Eisch, J. Colling, J. Ouslander, B. J. Hadley, and E. Campbell, “Issues in Implementing Clinical Research in Nursing Home Settings,” Journal of the New York State Nurses Association 22, no. 3 (1991): 18–22. | en_US |
dc.identifier.citedreference | See US DOL, supra note 45. | en_US |
dc.identifier.citedreference | K. Henriksen, A. Joseph, T. Zayas‐Cabán, “The Human Factors of Home Health Care: A Conceptual Model for Examining Safety and Quality Concerns,” Journal of Patient Safety 5, no.4 ( 2009 ): 229 – 236. | en_US |
dc.identifier.citedreference | A. Myers, R. C. Jensen, D. Nestor, and J. Rattiner, “Low Back Injuries among Home Health Aides Compared with Hospital Nursing Aides,” Home Health Care Service Quarterly 14 ( 1993 ): 149 – 155. | en_US |
dc.identifier.citedreference | R. Gershon, M. Pogorzelska, K. Qureshi, and M. Sherman, “Home Health Care Registered Nurses and the Risk of Percutaneous Injuries: A Pilot Study,” American Journal of Infection Control 36 ( 2008 ): 165 – 172; L. E. Danzig, L. J. Short, K. Collins, M. Mahoney, S. Sepe, L. Bland, and W. R. Jarvis “Bloodstream Infection Associated with Needleless Intravenous Infusion System in Patients Receiving Home Infusion Therapy,” Journal of the American Medical Association 273 (1995): 1862–1864; A. N. Do, B. J. Ray, S. Banerjee, A. F. Ilian, B. J. Barnett, M. H. Pham, K. A. Hendricks, and W. R. Jarvis, “Bloodstream Infection Associated with Needleless Device Use and the Importance of Infection‐Control Practices in the Home Health Care Setting,” Journal of Infectious Diseases 179 (1999): 442–448. | en_US |
dc.identifier.citedreference | See Gershon, supra note 69. | en_US |
dc.identifier.citedreference | See NIOSH, supra note 54. | en_US |
dc.identifier.citedreference | See Gershon, supra note 69. | en_US |
dc.identifier.citedreference | National Federation of Independent Business, “State by State Comparison of Worker's Compensation Laws,” available at < http://www.nfib.com/legal‐center/compliance‐resource‐center/compliance‐resource‐item/cmsid/57181 > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | D. Thassu, M. Deleers, and Y. Pathak, Nanoparticulate Drug Delivery Systems ( Informa Healthcare: New York, London, 2007. | en_US |
dc.identifier.citedreference | P. Boisseau and B. Loubaton “Nanomedicine, Nanotechnology in Medicine,” Comptes Rendus Physique 12, no. 7, ( 2011 ): 620 – 636. | en_US |
dc.identifier.citedreference | A. N. Moran, “Nanomedicine Lacks Recognition In Europe,” Nature Biotechnology 24, no. 2 ( 2006 ): 121. | en_US |
dc.identifier.citedreference | B. Kelly, “Nanomedicines: Regulatory Challenges and Risks Ahead,” 2010, at 14 – 17 available at < http://www.cov.com/files/Publication/8dc7cd17‐d1f6‐4290‐ac47‐2fde70df9c3b/Presentation/PublicationAttachment/e72f62ed‐f181‐47cd‐985a‐31fdd57d5bea/Nanomedicines%20Regulatory%20Challenges%20and%20Risks%20Ahead.pdf > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | See Boisseau and Loubaton, supra note 2. | en_US |
dc.identifier.citedreference | See Thassu et al., supra note 1; Boisseau and Loubaton, supra note 2; V. Murashov, “Occupational Exposure to Nanomedical Applications,” Nanomedicine and Nanobiotechnology 1, no. 2 (2009): 203–213. | en_US |
dc.identifier.citedreference | R. Singh, D. Pantarotto, L. Lacerda, G. Pastorin, C. Klumpp, M. Prato, A. Bianco, and K. Kostarelos, “Tissue Biodistribution and Blood Clearance Rates of Intravenously Administered Carbon Nanotube Radiotracers,” Proceedings of the National Academy of Sciences 103, no. 9 ( 2006 ): 3357 – 3362. | en_US |
dc.identifier.citedreference | National Science and Technology Council Committee on Technology Subcommittee on Nanoscale Science, and Technology (NSET), National Nanotechnology Initiative: Strategic Plan, Washington, D.C., 2011, available at < http://www.nano.gov/node/581 > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | M. Roco, O. Renn, and A. Jäger, “Nanotechnology Risk Governance,” in M. Roco, O. Renn, A. Jäger, eds., Global Risk Governance ( The Netherlands: Springer, 2008 ): 301 – 27, available at < http://www.springerlink.com/content/j102352637435844/ > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | M. Auffan, J. Rose, J.Y. Bottero, G. V. Lowry, J. P. Jolivet, and M. R. Wiesner, “Towards a Definition of Inorganic Nanoparticles from an Environmental, Health and Safety Perspective,” Nature Nanotechnology 4, no. 10 ( 2009 ): 634 – 641. | en_US |
dc.identifier.citedreference | M. Ferrari, “Cancer Nanotechnology: Opportunities and Challenges,” Nature Reviews Cancer 5, no. 3 ( 2005 ): 161 – 171, abstract available at < http://www.ncbi.nlm.nih.gov/pubmed/15738981 > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Science, Reporting Format for Nanotechnology‐Related Information in CMC Review, June 2010, available at < http://www.fda.gov/downloads/AboutFDA/CentersOffices/.../UCM214304.pdf > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | Occupational Safety and Health Administration (OSHA), “Safety and Health Tips: Nanotechnology,” available at < http://www.osha.gov/dsg/nanotechnology/nanotechnology.html > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | National Institute for Occupational Safety and Health (NIOSH), Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials ( 2009 ), available at < http://www.cdc.gov/niosh/docs/2009‐125/pdfs/2009‐125.pdf > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | A. D. Maynard, “Don't Define Nanomaterials,” Nature 475, no. 7354 ( 2011 ): 31, available at < http://www.nature.com/nature/journal/v475/n7354/full/475031a.html > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | A. D. Maynard and E. D. Kuempel, “Airborne Nanostructured Particles and Occupational Health,” Journal of Nanoparticle Research 7, no. 6 ( 2005 ): 587 – 614. | en_US |
dc.identifier.citedreference | See NIOSH, supra note 16; ISO, ISO TR 27628 Workplace Atmospheres—Ultrafine, Nanoparticles and Nano‐structured Aerosols —Inhalation Exposure Characterization and Assessment, 2006; D. R. Johnson, M. M. Methner, A. J. Kennedy, and J. A. Steevens, “Potential for Occupational Exposure to Engineered Carbon‐Based Nanomaterials in Environmental Laboratory Studies,” Environmental Health Perspectives 118, no. 1 (2010): 49–54; G. Ramachandran, M. Ostraat, D. E. Evans, M. M. Methner, P. O'Shaughnessy, J. D'Arcy, C. L. Geraci, E. Stevenson, A. D. Maynard, and K. Rickabaugh, “A Strategy for Assessing Workplace Exposures to Nanomaterials,” Journal of Occupational and Environmental Hygiene 8, no. 11 (2011): 673–685. | en_US |
dc.identifier.citedreference | Food and Drug Administration (FDA), “Investigational New Drug Application Process,” 2011, available at < http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | National Institutes of Health (NIH), “Understanding Clinical Trials,” 2007 < http://clinicaltrials.gov/ct2/info/understand#Q19 > (last visited November 28, 2012); see FDA, supra note 23. | en_US |
dc.identifier.citedreference | M. Kandlikar, G. Ramachandran, A. Maynard, B. Murdock, and W. Toscano, “Health Risk Assessment for Nanoparticles: A Case for Using Expert Judgment,” Journal of Nanoparticle Research 9, no. 1 ( 2007 ): 137 – 156. | en_US |
dc.identifier.citedreference | W. H. de Jong and P. J. A. Borm, “Drug Delivery and Nanoparticles: Applications and Hazards,” International Journal of Nanomedicine 3, no. 2 ( 2008 ): 133 – 149. | en_US |
dc.identifier.citedreference | P. H. M. Hoet, I. Bruske‐Hohlfield, and O. V. Salata, “Nanoparticles – Known and Unknown Health Risks,” Journal of Nanobiotechnology 2, no. 12 ( 2004 ): 15 pages, available at < http://www.jnanobiotechnology.com/content/pdf/1477‐3155‐2‐12.pdf > (last visited November 28, 2012); M. Geiser, B. Rothen‐Rutishauser, N. Kapp, S. Schurch, W. Kreyling, and H. Schulz, “Ultrafine Particles Cross Cellular Membranes by Nonphagocytic Mechanisms in Lungs and in Cultured Cells,” Environmental Health Perspectives 113 (2005): 1555–1560, available at < http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1310918/ > (last visited November 28, 2012); G. Oberdorster, E. Oberdorster, and J. Oberdorster, “Nanotoxicology: An Emerging Discipline Evolving for Studies of Ultrafine Particles,” Environmental Health Perspectives 113, no. 7 (2005): 823–839; M. A. Dobrovolskaia and S. E. McNeil, “Immunological Properties of Engineered Nanomaterials,” Nature Nanotechnology 2, no. 8 (2007): 469–478, available at < http://dx.doi.org/10.1038/nnano.2007.223 > (last visited November 28, 2012); D. B. Resnik and S. S. Tinkle, “Ethical Issues in Clinical Trials Involving Nanomedicine,” Contemporary Clinical Trials 28, no. 4 (2007): 433–441; G. Oberdörster, A. Elder, and A. Rinderknecht, “Nanoparticles and the Brain: Cause for Concern?” Journal of Nanoscience and Nanotechnology 9, no. 8 (2009): 4996–5007. | en_US |
dc.identifier.citedreference | C. M. Sayes, A. A. Marchione, K. L. Reed, and D.B. Warheit, “Comparative Pulmonary Toxicity Assessments of C60 Water Suspensions in Rats: Few Differences in Fullerene Toxicity in vivo in Contrast to in vitro Profiles,” Nano Letters 7 ( 2007 ): 2399 – 2406; K. Donaldson, P. J. Borm, G. Oberdorster, K. E. Pinkerton, V. Stone, and C. L. Tran, “Concordance Between in vitro and in vivo Dosimetry in the Proinflammatory Effects of Low Toxicity, Low Solubility Particles: The Key Role of the Proximal Alveolar Region,” Inhalation Toxicology 20 (2008): 53–62. | en_US |
dc.identifier.citedreference | A. Kroll, M. H. Pillukat, D. Hahn, J. Schnekenburger, “Current in vitro Methods in Nanoparticle Risk Assessment: Limitations and Challenges,” European Journal of Pharmaceutics and Biopharmaceutics 72 ( 2009 ): 370 – 377. | en_US |
dc.identifier.citedreference | E. Kuempel, C. Geraci, and P. Schulte, “Risk Assessment Approaches and Research Needs for Nanomaterials: An Examination of Data and Information from Current Studies,” Nanotechnology: Toxicological Issues and Environmental Safety and Environmental Safety ( 2007 ): 119 – 145. | en_US |
dc.identifier.citedreference | H. C. Fischer and W. C. W. Chan, “Nanotoxicity: The Growing Need For in vivo Study,” Current Opinions in Biotechnology 18 ( 2007 ): 565 – 571; M. E. McAuliffe and M. J. Perry, “Are Nanoparticles Potential Male Reproductive Toxicants? A Literature Review,” Nanotoxicology 1, no. 3 (2007): 204–210; V. Wiwanitkit, A. Sereemaspun, and R. Rojanathanes, “Effect of Gold Nanoparticles on Spermatozoa: The First World Report,” Fertility and Sterility 91, no. 1 (2009): e7‐e8, available at < http://www.sciencedirect.com/science/article/B6T6K‐4RB5BNR‐2/2/33a12feb54d3316276cbabaa2d9492b0 > (last visited November 28, 2012); A. A. Shvedova and V. E. Kagan, “The Role of Nanotoxicology in Realizing the ‘Helping without Harm’ Paradigm of Nanomedicine: Lessons from Studies of Pulmonary Effects of Single‐Walled Carbon Nanotubes,” Journal of Internal Medicine 267, no. 1 (2010): 106–18, available at < http://dx.doi.org/10.1111/j.1365‐2796.2009.02188.x > (last visited November 28, 2012). | en_US |
dc.identifier.citedreference | See Resnik and Tinkle, supra note 32. | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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