Ethical issues in nanomedicine: Tempest in a teapot?

Med Health Care and Philos (2016)
Authors: Irit Allon, Ahmi Ben-Yehudah, Raz Dekel, Jan-Helge Solbakk, Klaus-Michael Weltring, Gil Siegal
“As methods in nanomedicine advance, ethical questions conjunctly arise. Nanomedicine is an exceptional niche in several aspects as it reflects risks and uncertainties not encountered in other areas of medical research or practice. Nanomedicine partially overlaps, partially interlocks and partially exceeds other medical disciplines. Some interpreters agree that advances in nanotechnology may pose varied ethical challenges, whilst others argue that these challenges are not new and that nanotechnology basically echoes recurrent bioethical dilemmas. The purpose of this article is to discuss some of the ethical issues related to nanomedicine and to reflect on the question whether nanomedicine generates ethical challenges of new and unique nature.”
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The Paradigm of the Paradox: Women, Pregnant Women, and the Unequal Burdens of the Zika Virus Pandemic

The American Journal of Bioethics, Volume 16, Issue 5, 2016
Authors: Lisa H. Harris, Neil S. Silverman & Mary Faith Marshall
“Three paradoxes characterize the Zika virus pandemic and clinical and policy responses to it: …In this editorial, we examine and critique each of these paradoxes and reflect on the burdens that they inflict on women, especially pregnant women. International responses to the pandemic, and more specifically to the paradoxes embedded in these responses, have the potential to either advance reproductive justice or exacerbate existing reproductive injustice.”
Find editorial here.

Federal Research Regulations for the 21st Century

N Engl J Med 2016; 374:1205-1207March 31, 2016DOI: 10.1056/NEJMp1600511
Authors: Bernard Lo, M.D., and Mark Barnes, J.D., LL.M.
“Innovative research combining analysis of biospecimens, detailed clinical information, and real-time data from mobile devices has enormous potential for improving patient care, but this research raises ethical dilemmas that current federal human-subjects regulations, known as the Common Rule, do not adequately address. Eighteen federal agencies have proposed extensive revisions to these regulations,1 the first major overhaul in 25 years. Although the Common Rule needs to be updated and improved, we believe the notice of proposed rule making (NPRM) has serious conceptual failures.”
Find article here.

Unit 731 and moral repair

J Med Ethics doi:10.1136/medethics-2015-103177
Authors: Doug Hickey, Scarllet SiJia Li, Celia Morrison, Richard Schulz, Michelle Thiry, Kelly Sorensen
“Unit 731, a biological warfare research organisation that operated under the authority of the Imperial Japanese Army in the 1930s and 1940s, conducted brutal experiments on thousands of unconsenting subjects. Because of the US interest in the data from these experiments, the perpetrators were not prosecuted and the atrocities are still relatively undiscussed. What counts as meaningful moral repair in this case—what should perpetrators and collaborator communities do decades later? We argue for three non-ideal but realistic forms of moral repair…”
Find abstract here.

French drug trial had three major failings, says initial report

BMJ 2016;352:i784
Author: Nigel Hawkes
“Three major shortcomings have been identified in the drug trial that led to the death of a volunteer last month, the French health minister, Marisol Touraine, has said. Administration of the drug being tested continued even after the first volunteer had fallen ill, Touraine said at a press conference on 4 February. …The second error was not to inform these volunteers of what had happened the previous evening, to give them the chance to withdraw their consent. The third had been not reporting the incident to the French national medicines safety agency (ANSM) until four days after the first volunteer had been admitted to hospital.”
Find extract here.

Migraine doctor loses appeal against findings of dishonesty

BMJ 2015;351:h6351
Author: Clare Dyer
“A High Court judge has upheld two findings of dishonesty by the Medical Practitioners Tribunal Service against a leading headache specialist in the conduct of a clinical trial.  Andrew Dowson, director of headache services at King’s College Hospital in London, appealed to the High Court after he was suspended for four months last February for a “serious breach of professional standards.”1”
Find extract here.

Young People’s Experiences of Participation in Clinical Trials: Reasons for Taking Part

The American Journal of Bioethics, Volume 15, Issue 11, 2015
Authors: Malou Luchtenberga, Els Maeckelberghea, Louise Locockb, Lesley Powellc & A.A. Eduard Verhagena
“Given the lack of knowledge about safety and efficacy of many treatments for children, pediatric clinical trials are important, but recruitment for pediatric research is difficult. Little is known about children’s perspective on participating in trials. The purpose of this study was to understand the experiences and motivations of young people who took part in clinical trials. This is a qualitative interview study of 25 young people aged 10–23 who were invited to take part in clinical trials.”
Find abstract here and related commentaries here.

End in sight for revision of US medical research rules

The Lancet, Volume 386, No. 10000
Author: Susan Jaffe
“US health officials expect to update 25-year-old regulations on human participation in research by the end of next year. Susan Jaffe, The Lancet’s Washington correspondent, reports.  After proposing massive changes 4 years ago to rules first issued in 1991 protecting people participating in research studies, federal health officials produced yet another revision earlier this month and say the effort to update the rules is on a fast track.”
Find article here.

UK scientists apply for licence to edit genes in human embryos

Nature, 18 September 2015
Authors: Daniel Cressey, Alison Abbott& Heidi Ledford
“Scientists in London have asked for permission to edit the genomes of human embryos — a request that could lead to the world’s first approval of such research by a national regulatory body. Kathy Niakan, a researcher affiliated with the Francis Crick Institute, London’s new £700-million (US$1.1-billion) biomedical-research centre, said on 18 September that she is proposing to use gene editing to provide “fundamental insights into early human development”.
Find article here.