Because the number of organs available for transplantation does not meet the needs of potential recipients, some have proposed that a potentially effective way to increase registration is to offer a self‐benefit incentive that grants a 'preferred status' or some degree of prioritization to those who register as potential donors, in case they might need organs. This proposal has elicited an ethical debate on the appropriateness of such a benefit in the context of a life‐saving medical procedure. In this paper (...) we review arguments and ethical concerns raised by scholars, and studies of views of members of the public regarding the prioritization incentive system. We also report on our study of the views of those involved in organ transplant and of other medical professionals in Israel, as over half a decade ago Israel implemented a prioritization incentive system. Bioethicists propose that key stakeholders' views can provide additional arguments and perspectives on controversial issues. Proponents justify the prioritization incentive drawing mainly on arguments related to its potential effectiveness, reciprocity and fairness. Opponents point to the fact that registering is not binding and not an actual donation, and raise concerns regarding equity, autonomy and gaming the system. Ethical concerns raised by the practitioners in the study were examined in light of scholars' arguments and actual registration and donation data. Practitioners involved in transplantation raised ethical concerns corresponding to those raised by scholars as well as additional concerns. They also challenged proponents' assumptions regarding the utility of the incentive system from their own experience and argued that proponents obscure the meaning of reciprocity. (shrink)

Organ transplantation has become a proven, cost-effective lifesaving treatment, but its promise is contingent on the number of available organs. The growing gap between the demand and supply results in unnecessary loss and diminished quality of life as well as high costs for surviving patients and health insurers. Twenty years after the enactment of the National Organ Transplantation Act, it is time to rethink the moral basis and overall design of organ transplantation policy. We propose a national plan for organ (...) transplantation insurance under which the federal government would assume responsibility for increasing the organ supply and would cover all costs associated with transplantation for patients not otherwise covered. (shrink)

Organ transplantation remains one of modern medicine's remarkable achievements. It saves lives, improves quality of life, diminishes healthcare expenditures in end-stage renal patients, and enjoys high success rates. Yet the promise of transplantation is substantially compromised by the scarcity of organs. The gap between the number of patients on waiting lists and the number of available organs continues to grow. As of January 2006, the combined waiting list for all organs in the United States was 90,284. Unfortunately, thousands of potential (...) organs are lost each year, primarily due to lack of consent to donation from the deceased before death, or from the family thereafter. Only fifty percent of potential donors – the “conversion” rate – become actual donors. The costs attributed to organ shortage are substantial – Medicare paid over $15.5 billion in 2002 for treating patients with end-stage renal-disease, who predominate on organ waiting lists. (shrink)

In addressing the creation and regulation of biobanks in different countries, a short descriptive introduction to the social and cultural backgrounds of each country is mandatory. The State of Israel is relatively young, and can be characterized as a multi-religious, multi-ethnic, multi-cultural society, somewhat similar to the American melting pot. The current population is 8.3 million, a sharp rise resulting from a 1.2 million influx of immigrants from the former Soviet Union in the 1990s. Seventyfive percent are Jewish, 20% Arabs, (...) and several other minorities. The birth rate is 3.8 per family, the highest in the Organization for Economic Cooperation and Development. (shrink)

In the United States, final amendments to the Federal Policy for the Protection of Human Subjects (“the Common Rule”) were published on January 19, 2017, and they will take effect on January 21, 2019. One of the most widely discussed provisions is that for the first time, federal regulations governing research with humans authorize the use of broad consent for future, unspecified research on individually identifiable biospecimens and associated data. Many questions have been raised about broad consent, including what effect (...) it will have on research and whether it adequately protects the interests of research participants.There are lessons to be learned for the U.S. and other countries by looking to countries that already have experience with broad consent for biobank collection and with the storage and subsequent use of the biospecimens and data. This article describes how broad consent works in five countries—Canada (in Quebec), Israel, Nigeria, Taiwan, and the United Kingdom—and with different types of biobanks: national biobanks, federated biobanks, and regional biobanks. Evaluating the provisions and challenges of the broad consent approaches in these countries can inform policies for this increasingly used approach to biobank regulation. (shrink)

Nanomedicine offers remarkable options for new therapeutic avenues. 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. Such a determination should have implications on regulatory processes and professional conducts and protocols in the future. (shrink)

Obtaining informed consent has typically become a stylized ritual of presenting and signing a form, in which physicians are acting defensively and patients lack control over the content and flow of information. This leaves patients at risk both for being under-informed relative to their decisional needs and of receiving more information than they need or desire. By personalizing the process of seeking and receiving information and allowing patients to specify their desire for information in a prospective manner, we aim to (...) shift genuine control over the informational process to patients. A new paradigm of Information on Demand, such as we suggest, would also enhance legal certainty, achieve greater congruence between the information patients want and the information they receive, and promote more meaningful patient-physician interactions, a desirable outcome that has been difficult to achieve by other means. (shrink)

In an explicit attempt to reduce physician paternalism and encourage patient participation in making health care decisions, the informed consent doctrine has become a foundational precept in medical ethics and health law. The underlying ethical principle on which informed consent rests — autonomy — embodies the idea that as rational moral agents, patients should be in command of decisions that relate to their bodies and lives. The corollary obligation of physicians to respect and facilitate patient autonomy is reflected in the (...) rules that have been created to implement consent procedures, especially those requiring disclosure of relevant information.However, there are many practical impediments to patient self-determination in health care decisionmaking. Well-meaning physicians often lack the time to live up to the ideal of facilitating genuine, informed deliberation with and by their patients, and many lack the motivation or skill to do so successfully. (shrink)