Journal of medical ethics
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Journal of medical ethics · Jun 2015
Quackery or quality: the ethicolegal basis for a legislative framework for medical innovation.
Innovative therapy is a matter of recent public interest, particularly following Lord Saatchi's Medical Innovation Bill. The purpose of the Bill is to encourage responsible innovation in medical treatment. We argue for the need to achieve a balance between the risks of medical innovation and patient safety considerations. ⋯ It is suggested that this model would provide safeguards for patients as well as define limits for doctors in the context of innovative therapy. Implementation and application of such therapy must be underpinned by due process and governance oversight, which could be provided through context-specific professional peer review. A combination of these ethicolegal principles would permit responsible medical innovation and maximise benefit in terms of therapy and patient-centred care.
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Journal of medical ethics · Jun 2015
FIGO's ethical recommendations on female sterilisation will do more harm than good: a commentary.
The International Federation of Gynecology and Obstetrics (FIGO) Committee for the Ethical Aspects of Human Reproduction and Women's Health advises against tubal occlusion (TO) performed at the time of caesarean section (CS/TO) or following a vaginal delivery (VD/TO) if this sterilisation has not been discussed with the woman in an earlier phase of her pregnancy. This advice is neither in accordance with existing medical custom nor evidence based. Particularly in less-resourced locations, adherence to it would deny much wanted one-off sterilisation opportunities to hundreds of thousands of women, many of whom have no reliable contraceptive alternative. ⋯ Consequently, where early TO counselling has been impossible, forgotten or deliberately omitted on pronatalist, traditional, financial, cultural or religious grounds, offering a perinatal sterilisation belatedly and in an unbiased, culturally sensitive manner is often verifiably better than not presenting that option at all, notably where high parity and uterine scars are particularly dangerous. Belated counselling, as will be demonstrated in this paper, saves many lives. The Committee's blanket rejection of belated counselling on perinatal sterilisation is therefore unjustified.
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Criminalisation of prostitution, and minority rights for disabled persons, are important contemporary political issues. The article examines their intersection by analysing the conditions and arguments for making a legal exception for disabled persons to a general prohibition against purchasing sexual services. It explores the badness of prostitution, focusing on and discussing the argument that prostitution harms prostitutes, considers forms of regulation and the arguments for and against with emphasis on a liberty-based objection to prohibition, and finally presents and analyses three arguments for a legal exception, based on sexual rights, beneficence, and luck egalitarianism, respectively. It concludes that although the general case for and against criminalisation is complicated there is a good case for a legal exception.
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Journal of medical ethics · May 2015
Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: a retrospective study.
The US Food and Drug Administration (FDA) issues warning letters to all research stakeholders if unacceptable deficiencies are found during site visits. Warning letters issued by the FDA between January 2011 and December 2012 to clinical investigators and institutional review boards (IRBs) were reviewed for various violation themes and compared to similar studies in the past. Warning letters issued to sponsors between January 2005 and December 2012 were analysed for the first time for a specific set of violations using descriptive statistics. ⋯ Failure to maintain minutes of meeting and to follow written procedures for continuing review were new substantial violations in warning letters issued to IRBs. Forty-six warning letters were issued to sponsors, the most common violations being failure to follow a monitoring schedule (58.69%), failure to obtain investigator agreement (34.78%), failure to secure investigators' compliance (30.43%), and failure to maintain data records and ship documents to investigators (30.43%). Appropriate methods for handling clinical trial procedural violations should be developed and implemented worldwide.
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Journal of medical ethics · May 2015
What would an environmentally sustainable reproductive technology industry look like?
Through the use of assisted reproductive technologies (ARTs), multiple children are born adding to worldwide carbon emissions. Evaluating the ethics of offering reproductive services against its overall harm to the environment makes unregulated ARTs unjustified, yet the ART business can move towards sustainability as a part of the larger green bioethics movement. By integrating ecological ethos into the ART industry, climate change can be mitigated and the conversation about consumption can become a broader public discourse. ⋯ First, endorsing a carbon capping programme that limits the carbon emissions of ART businesses will be proposed. Second, I will recommend that policymakers eliminate funded ARTs for those who are not biologically infertile. I will conclude the article by urging policymakers and all those concerned with climate change to consider the effects of the reproductive technologies industry in light of climate change and move towards sustainability.