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61 result(s) for "Procurement of organs, tissues, etc. Government policy."
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Opportunities for Organ Donor Intervention Research
The organ donation and transplantation system strives to honor the gift of donated organs by fully using those organs to save and improve the quality of the lives of their recipients. However, there are not enough donated organs to meet the demand and some donated organs may not be recovered, some recovered organs may not be transplanted, and some transplanted organs may not function adequately. Organ donor intervention research can test and assess interventions (e.g., medications, devices, and donor management protocols) to maintain or improve organ quality prior to, during, and following transplantation. The intervention is administered either while the organ is still in the deceased donor or after it is recovered from the donor but before it is transplanted into a recipient. Organ donor intervention research presents new challenges to the organ donation and transplantation community because of ethical questions about who should be considered a human subject in a research study, whose permission and oversight are needed, and how to ensure that such research does not threaten the equitable distribution of a scarce and valuable resource. Opportunities for Organ Donor Intervention Research focuses on the ethical, legal, regulatory, policy, and organizational issues relevant to the conduct of research in the United States involving deceased organ donors. This report provides recommendations for how to conduct organ donor intervention research in a manner that maintains high ethical standards, that ensures dignity and respect for deceased organ donors and their families, that provides transparency and information for transplant candidates who might receive a research organ, and that supports and sustains the public's trust in the process of organ donation and transplantation.
Medical Governance
Governments throughout the industrialized world make decisions that fundamentally affect the quality and accessibility of medical care. In the United States, despite the absence of universal health insurance, these decisions have great influence on the practice of medicine. InMedical Governance, David Weimer explores an alternative regulatory approach to medical care based on the delegation of decisions about the allocation of scarce medical resources to private nonprofit organizations. He investigates the specific development of rules for the U.S. organ transplant system and details the conversion of a voluntary network of transplant centers to one private rulemaker: the Organ Procurement and Transplantation Network (OPTN). As the case unfolds, Weimer demonstrates that the OPTN is more efficient, nimble, and better at making evidence-based decisions than a public agency; and the OPTN also protects accountability and the public interest more than private for-profit organizations. Weimer addresses similar governance arrangements as they could apply to other areas of medicine, including medical records and the control of Medicare expenditures, making this timely and useful case study a valuable resource for debates over restructuring the U.S. health care system.
Deemed consent: assessing the new opt-out approach to organ procurement in Wales
In December 2015, Wales became the first country in the UK to move away from an opt-in system in organ procurement. The new legislation introduces the concept of deemed consent whereby a person who neither opt in nor opt out is deemed to have consented to donation. The data released by the National Health Service (NHS) in July 2017 provide an excellent opportunity to assess this legislation in light of concerns that it would decrease procurement rates for living and deceased donation, as well as sparking an increase in family refusals. None of these concerns have come to pass, with Wales experiencing more registered donors, fewer family refusals and more living donations. However, as the number of actual donors has dropped slightly from a high level, the situation must be monitored closely in the years to come.
Is the commercialisation of human tissue and body material forbidden in the countries of the European Union?
The human body and its parts are widely perceived as matters beyond commercial usage. This belief is codified in several national and European documents. This so-called ‘no-property rule’ is held to be the default position across the countries of the European Union. However, a closer look at the most pertinent national and European documents, and also current practices in the field, reveals a gradual model of commercialisation of human tissue. In particular, we will argue that the ban on commercialisation of body material is not as strict as it may appear at first sight, leaving room for the commercial practice of tissue procurement and transfer. We argue for more transparent information for patients and tissue donors, an intensified ethical debate on commercialisation practices, and a critical review of current normative principles.
Opt-out organ donation without presumptions
This paper defends an ‘opt-out’ scheme for organ procurement, by distinguishing this system from ‘presumed consent’ (which the author regards as an erroneous justification of it). It, first, stresses the moral importance of increasing the supply of organs and argues that making donation easier need not conflict with altruism. It then goes on to explore one way that donation can be increased, namely by adopting an opt-out system, in which cadaveric organs are used unless the deceased (or their family) registered an objection. Such policies are often labelled ‘presumed consent’, but it is argued that critics are right to be sceptical of this idea—consent is shown to be an action, rather than a mental attitude, and thus not something that can be presumed. Either someone has consented or they have not, whatever their attitude to the use of their organs. Thankfully, an opt-out scheme need not rest on the presumption of consent. Actual consent can be given implicitly, by one's actions, so it is argued that the failure to register an objection (given certain background conditions) should itself be taken as sign of consent. Therefore, it is permissible to use the organs of someone who did not opt out, because they have—by their silence—actually consented.
Non-Heart-Beating Organ Transplantation
Non-heart-beating donors (individuals whose deaths are determined by cessation of heart and respiratory function rather than loss of whole brain function) could potentially be of major importance in reducing the gap between the demand for and available supply of organs for transplantation. Prompted by questions concerning the medical management of such donors-specifically, whether interventions undertaken to enhance the supply and quality of potentially transplantable organs (i.e. the use of anticoagulants and vasodilators) were in the best interests of the donor patient-the U.S. Department of Health and Human Services asked the Institute of Medicine to examine from scientific and ethical points of view \"alternative medical approaches that can be used to maximize the availability of organs from [a] donor [in an end-of-life situation] without violating prevailing ethical norms...\" This book examines transplantation supply and demand, historical and modern conceptions of non-heart-beating donors, and organ procurement organizations and transplant program policies, and contains recommendations concerning the principles and ethical issues surrounding the topic.
Normative consent and opt-out organ donation
One way of increasing the supply of organs available for transplant would be to switch to an opt-out system of donor registration. This is typically assumed to operate on the basis of presumed consent, but this faces the objection that not all of those who fail to opt out would actually consent to the use of their cadaveric organs. This paper defuses this objection, arguing that people's actual, explicit or implicit, consent to use their organs is not needed. It borrows David Estlund's notion of ‘normative consent’ from the justification of political authority and applies it to the case of organ donation. According to this idea, when it is wrong to withhold consent to something, the moral force of that lack of consent may be null and void. If it is wrong of a person to refuse to donate their cadaveric organs to others, then it may be that their actual consent is not needed. This supports an opt-out system, which provides protection for those who have genuine reasons to refuse donation, and spares the worries as to what the deceased would actually have wanted.
Organ Procurement and Transplantation
Each day, nearly 60 Americans receive a transplanted kidney, liver, or other organ-a literal \"second chance at life\"-but 11 others die waiting for an organ transplant. The number of donors, although rising, is not growing fast enough to meet the increasing demand. Intended to improve the current system of organ procurement and allocation, the \"Final Rule,\" a 1998 regulation issued by the U.S. Department of Health and Human Services, sparked further controversy with its attempts to eliminate the apparent geographic disparities in the time an individual must wait for an organ. This book assesses the potential impact of the Final Rule on organ transplantation. It also presents new, original analyses of data, and assesses medical practices, social and economic observations, and other information on: access to transplantation services for low-income populations and racial and ethnic minority groups; organ donation rates; waiting times for transplantation; patient survival rates and organ failure rates leading to retransplantation; and cost of organ transplantation services.