Issues in Law & Medicine最新文献

The purpose of this article is to examine one potential factor that might negatively impact female fertility, namely induced abortion. While there appears to be a general consensus that there is no association between abortion and infertility, amongst the publications that do exist there is nevertheless evidence to the contrary. Moreover, given the variety of reasonable grounds for a link, and the insufficient attention to the subject by researchers, a re-examination of the field is warranted. Abortion, whether surgical or medical, is one of the most common medical procedures undertaken by women, so even a small effect could influence large numbers of women, and therefore couples.

If it were known that abortion was an underlying cause of infertility, it would be an ethical and legal requirement for medical professionals to inform women before consent is obtained. A case could even be made that if research were inconclusive, inadequate or preliminary, women should nevertheless be informed.

In South Korea, the Bioethics and Safety Act sets a five-year embryo storage limit and does not allow for an extension of the storage period upon embryo creators' requests. No legislative document states the intent of this restrictive law, and no academic paper has assessed whether it is reasonable. In a 2010 decision, the Constitutional Court of Korea declared that this law's restrictions on embryo creators' will is legitimate. The court provided four reasons frequently raised to support such restrictions in other countries: the increased social burden of maintaining frozen embryos, embryos' post-thawing viability, remaining embryos' misuse risks, and similar legislations in other countries. This article challenges this position based on an analysis of the Korean context and technological developments. It finds that, by allowing embryo creators to extend the storage beyond the five-year limit, Korea's social burden-the costs related to infertility treatments and the low birth rate-may be reduced. It also reports that biotechnology advancements have addressed post-thawing viability-related issues; furthermore, embryo misuse risks can be addressed via other regulatory options. Moreover, this article lists other legislation that allow for extensions of the embryo storage period based on the creators' will and these laws' legislative intent. Thus, this article concludes that the Bioethics and Safety Act should be revisited based on Korea's current social context and up-to-date technologies' adaptability.

Legal cases involving "assisted suicide" and euthanasia have dramatically increased over the past decades. European news is filled with hard cases involving people whose experiences of pain and suffering are used to advance the cause of further decriminalization. Another kind of case, however, is gaining public attention and revealing the fallacious narrative of death as a human right. These are cases of people who live where such practices are already legal, but who may have preferred life over death were the practice criminally sanctioned. A suicide case from the Netherlands will be the starting point for a broader reflection on the existence of a "right to die," and on the soundness of an alternative "duty to care."

Creating a parallel between a Dutch case of "death by starvation" and a recent Italian constitutional judgment (which led to a partial decriminalization-or exemption from punishment-of some forms of assisted suicide) the author aims to show that: a) there is inevitably an international dimension to the problem, b) laws shape human behavior, and they do so internationally. What once was prohibited, and later decriminalized, has gradually become tolerated, welcomed, and is now entertained as a human right. A right to die, however, contradicts the very basis of our common living.

After presenting the facts of a suicide recently committed by a Dutch teenager, the author will focus on Netherland's norms regarding assisted suicide and euthanasia, and the specific medical guidelines that apply to the so-called "choice to stop eating and drinking so as to hasten the end of life (SED)." In the third chapter, the author will underscore the importance of intent, and address the radical difference that exists between an act of suicide and the choice to refuse treatment. The author then analyzes the relevant criminal provisions in Italian legislation, which prohibit euthanasia and assisted suicide, with a particular focus on the recent decision n. 242/2019, issued by the Italian Constitutional Court. This judgment relaxed the existing ban on assisted suicide and thereby compromised Italy's absolute protection of life by adopting an overly broad understanding of individual autonomy. In the final chapter, the author defends the idea that only where autonomy is combined with solidarity individual liberties are justly ordered, and human rights effectively protected. This solidarity, implicit in norms such as "Bad Samaritan Laws" that impose legal duties to rescue, is not mere altruism, but a form of self-love, as it creates the beneficial conditions of harmony and friendliness among citizens.

Since the U.S. Supreme Court issued its landmark decision in 1973 to legalize abortion, over 60 million preborn have been killed by elective abortion. While alive in the womb, these preborn are abandoned and not protected under current law. But once aborted, their body parts are a highly esteemed and prized commodity amongst certain members of the scientific community. Moral discourse is disregarded for the sake of science. The public have been lulled and lured into believing that this practice must continue in order to understand and develop cures for some of the most debilitating diseases of our day. But they are mistaken. This practice is not necessary, especially in light of numerous noncontroversial alternatives. Here, we expose and consider the false and misleading claims regarding human fetal tissue (HFT) in research from scientific, legal, and ethical points of view. We endeavor deeply to understand the depth of the injustice in this practice and what forces promote and maintain it; and by revealing and understanding these forces, we set forth how these inhumane practices can be ended. An accurate portrayal of the history of HFT use in research is provided, along with a close examination of the current state of this practice under existing laws. The serious societal implications are also discussed, which will worsen beyond comprehension if these practices are allowed to continue. The timeliness of this information cannot be overstated, and a thorough understanding is paramount for anyone who desires to know the facts about HFT in research and medicine and its detrimental impact for humanity.

Between 2002 and 2016, 806 million medical devices were recalled. When approving a device, the FDA employs advisory boards organized by medical specialty (e.g. cardiovascular) to make approval recommendations. Previous work has demonstrated high numbers of recalled orthopedic and cardiovascular devices; however, no prior studies have controlled for the number of approvals by advisory board. The purpose of this study is to identify device fields at higher risk for safety problems. This study compares specialty-specific, approval-adjusted recall rates of high-risk medical devices from 2002 to 2016 by utilizing publicly available FDA data on recalls and approvals. Devices approved under general hospital (113), anesthesiology (98), and cardiovascular (98) advisory boards constituted 71% of all class I recalls. For devices approved via the more rigorous pre-market approval pathway, those under the purview of the general hospital (0.25 recalls/approval, 95% CI 0.15 - 0.41) advisory board had a significantly higher rate than average (p<0.05). For 510(k) cleared devices, microbiology (6.0 recalls/clearance, 95% CI 3.4 - 10.6), anesthesiology (0.04 recalls/clearance, 95% CI 0.03 - 0.04), general hospital (0.02 recalls/clearance, 95% CI 0.02 - 0.02), and cardiovascular (0.010 recalls/ clearance, 0.009 to 0.015) advisory boards had significantly higher recall rates than average (p<0.05). Future regulatory resources should be directed towards device areas and approval pathways that pose a higher risk for safety problems.

The current ethical and legal standards for human subjects research do not adequately address human gene editing technologies, because scientific advancements in this field have outpaced regulatory policy. The Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technique allows the rewriting of life's code, but is fraught with scientific and ethical quandaries. In particular, the genetic alteration of human embryos in vitro in China has caused worldwide repercussions. It is hard to predict the long-term effects of proposed edits, which raises an inquiry about whether it is appropriate for humans to purposely alter any aspect of their genetic future. Genome editing is moving too quickly for processes of critical reflection, such as law and regulation, to keep pace. The ethical, legal and social implications of the use of these technologies in humans remain uncertain. The resultant tension within the existing framework calls into question the underlying values on which moral and legal norms repose. This article explores the implications for law, ethics, regulation and health policy. Balancing potential benefits against the risk of unintended harms will shape perspectives on whether and how to use these technologies. Responsible engagement with decision makers and stakeholders, among other things, will promote transparency, confer legitimacy, and improve policy making.