Literature DB >> 17166777

Ethical issues in clinical trials involving nanomedicine.

David B Resnik1, Sally S Tinkle.   

Abstract

Nanomedicine shows tremendous promise for improving medical diagnosis, treatment, and prevention, but it also raises a variety of ethical concerns. Because of the paucity of data on the physicochemical properties of nanoscale materials in biological systems, clinical trials of nanomedicine products present some unique challenges related to risk minimization, management and communication involving human subjects. Although these clinical trials do not raise any truly novel ethical issues, the rapid development of nanotechnology and its potentially profound social and environmental impacts, add a sense of urgency to the problems that arise.

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Year:  2006        PMID: 17166777      PMCID: PMC2695593          DOI: 10.1016/j.cct.2006.11.001

Source DB:  PubMed          Journal:  Contemp Clin Trials        ISSN: 1551-7144            Impact factor:   2.226


  31 in total

1.  What makes clinical research ethical?

Authors:  E J Emanuel; D Wendler; C Grady
Journal:  JAMA       Date:  2000 May 24-31       Impact factor: 56.272

2.  Therapeutic misconception and the appreciation of risks in clinical trials.

Authors:  Charles W Lidz; Paul S Appelbaum; Thomas Grisso; Michelle Renaud
Journal:  Soc Sci Med       Date:  2004-05       Impact factor: 4.634

3.  How the US drug safety system should be changed.

Authors:  Brian L Strom
Journal:  JAMA       Date:  2006-05-03       Impact factor: 56.272

4.  Protecting third parties in human subjects research.

Authors:  David B Resnik; Richard R Sharp
Journal:  IRB       Date:  2006 Jul-Aug

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Authors:  P S Appelbaum; L H Roth; C W Lidz; P Benson; W Winslade
Journal:  Hastings Cent Rep       Date:  1987-04       Impact factor: 2.683

6.  Animal models of idiosyncratic drug reactions.

Authors:  Jacintha M Shenton; Jie Chen; Jack P Uetrecht
Journal:  Chem Biol Interact       Date:  2004-11-01       Impact factor: 5.192

Review 7.  Human relevance of animal carcinogenicity studies.

Authors:  S M Cohen
Journal:  Regul Toxicol Pharmacol       Date:  1995-02       Impact factor: 3.271

8.  Descriptions of benefits and risks in consent forms for phase 1 oncology trials.

Authors:  Sam Horng; Ezekiel J Emanuel; Benjamin Wilfond; Jonathan Rackoff; Karen Martz; Christine Grady
Journal:  N Engl J Med       Date:  2002-12-26       Impact factor: 91.245

Review 9.  Nanotoxicology: an emerging discipline evolving from studies of ultrafine particles.

Authors:  Günter Oberdörster; Eva Oberdörster; Jan Oberdörster
Journal:  Environ Health Perspect       Date:  2005-07       Impact factor: 9.031

10.  Ultrafine particles cross cellular membranes by nonphagocytic mechanisms in lungs and in cultured cells.

Authors:  Marianne Geiser; Barbara Rothen-Rutishauser; Nadine Kapp; Samuel Schürch; Wolfgang Kreyling; Holger Schulz; Manuela Semmler; Vinzenz Im Hof; Joachim Heyder; Peter Gehr
Journal:  Environ Health Perspect       Date:  2005-11       Impact factor: 9.031

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  19 in total

1.  Defining Nano, Nanotechnology and Nanomedicine: Why Should It Matter?

Authors:  Priya Satalkar; Bernice Simone Elger; David M Shaw
Journal:  Sci Eng Ethics       Date:  2015-09-15       Impact factor: 3.525

2.  Rethinking risk assessment for emerging technology first-in-human trials.

Authors:  Anna Genske; Sabrina Engel-Glatter
Journal:  Med Health Care Philos       Date:  2016-03

Review 3.  Ethics in nanomedicine.

Authors:  David B Resnik; Sally S Tinkle
Journal:  Nanomedicine (Lond)       Date:  2007-06       Impact factor: 5.307

Review 4.  Conscripts of the infinite armada: systemic cancer therapy using nanomaterials.

Authors:  David A Scheinberg; Carlos H Villa; Freddy E Escorcia; Michael R McDevitt
Journal:  Nat Rev Clin Oncol       Date:  2010-03-30       Impact factor: 66.675

Review 5.  Do nanomedicines require novel safety assessments to ensure their safety for long-term human use?

Authors:  Peter Hoet; Barbara Legiest; Jorina Geys; Benoit Nemery
Journal:  Drug Saf       Date:  2009       Impact factor: 5.606

6.  Ethical issues in nanomedicine: Tempest in a teapot?

Authors:  Irit Allon; Ahmi Ben-Yehudah; Raz Dekel; Jan-Helge Solbakk; Klaus-Michael Weltring; Gil Siegal
Journal:  Med Health Care Philos       Date:  2017-03

Review 7.  Recent advances in nanotherapeutic strategies for spinal cord injury repair.

Authors:  Young Hye Song; Nikunj K Agrawal; Jonathan M Griffin; Christine E Schmidt
Journal:  Adv Drug Deliv Rev       Date:  2018-12-22       Impact factor: 15.470

8.  Responsible conduct in nanomedicine research: environmental concerns beyond the common rule.

Authors:  David B Resnik
Journal:  J Law Med Ethics       Date:  2012       Impact factor: 1.718

9.  Recommendations for nanomedicine human subjects research oversight: an evolutionary approach for an emerging field.

Authors:  Leili Fatehi; Susan M Wolf; Jeffrey McCullough; Ralph Hall; Frances Lawrenz; Jeffrey P Kahn; Cortney Jones; Stephen A Campbell; Rebecca S Dresser; Arthur G Erdman; Christy L Haynes; Robert A Hoerr; Linda F Hogle; Moira A Keane; George Khushf; Nancy M P King; Efrosini Kokkoli; Gary Marchant; Andrew D Maynard; Martin Philbert; Gurumurthy Ramachandran; Ronald A Siegel; Samuel Wickline
Journal:  J Law Med Ethics       Date:  2012       Impact factor: 1.718

Review 10.  Nanomedicine in pulmonary delivery.

Authors:  Heidi M Mansour; Yun-Seok Rhee; Xiao Wu
Journal:  Int J Nanomedicine       Date:  2009-12-29
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