Concordance of International Regulation of Pediatric Health Research.

OBJECTIVE: To assess the comparability of international ethics principles and practices used in regulating pediatric research as a first step in determining whether reciprocal deference for international ethics review is feasible. Prior studies by the authors focused on other aspects of international health research, such as biobanks and direct-to-participant genomic research. The unique nature of pediatric research and its distinctive regulation by many countries warranted a separate study. STUDY DESIGN: A representative sample of 21 countries was selected, with geographical, ethnic, cultural, political, and economic diversity. A leading expert on pediatric research ethics and law was selected to summarize the ethics review of pediatric research in each country. To ensure the comparability of the responses, a 5-part summary of pediatric research ethics principles in the US was developed by the investigators and distributed to all country representatives. The international experts were asked to assess and describe whether principles in their country and the US were congruent. Results were obtained and compiled in the spring and summer of 2022. RESULTS: Some of the countries varied in their conceptualization or description of one or more ethical principles for pediatric research, but overall, the countries in the study demonstrated a fundamental concordance. CONCLUSIONS: Similar regulation of pediatric research in 21 countries suggests that international reciprocity is a viable strategy.

Israeli Position Paper: Triage Decisions for Severely Ill Patients During the COVID-19 Pandemic. Joint Commission of the Israel National Bioethics Council, the Ethics Bureau of the Israel Medical Association and Representatives from the Israeli Ministry of Health.

OBJECTIVES: This document provides an English translation of the Israeli Joint Commission's national guidelines for triaging severely ill patients during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: Four subcommittees of medical, legal, ethical-social, and religious experts developed the general principles and practical medical criteria for triaging scarce life-saving resources. RESULTS: The guidelines provide an overview of general principles as well as pragmatic medical criteria and a practical triage protocol to be followed should the healthcare system be overwhelmed due to COVID-19. Issues covered include triggers for activating the guidelines, guiding ethical, legal, and religious principles, equity in access, fair distribution, transparency, consistency, palliation, medical policy prioritization, problem-solving mechanisms, and public trust. CONCLUSIONS: The Israeli consensus document and pragmatic medical triage protocol offer a societal and medical roadmap for allocating scarce resources during the COVID-19 pandemic or other disasters.

Promoting organ donation registration with the priority incentive: Israeli transplantation surgeons' and other medical practitioners' views and ethical concerns.

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.

[FORCE-FEEDING OR LIFE-SAVING? - DEALING WITH HUNGER STRIKES IN ISRAEL].

INTRODUCTION: Force feeding of fasting hunger-striking prisoners is the subject of considerable controversy in Israel and elsewhere, posing a direct conflict between two basic ethical values: that of human life and respect for autonomy. The Israel Medical Association, as well as the World Medical Association, has taken the position that force feeding of such prisoners is an act of torture and is therefore unethical. However this paper presents an opposing view, which recently became the law in Israel, that, whereas the rights of prisoners to decree a hunger strike as a form of protest should be respected, if the prolongation of the strike reaches a stage of clear and present danger to the life and health of a prisoner, the saving of the prisoner's life must take precedence over considerations of autonomy. The paper present the steps that should be taken, including extensive and empathic efforts to persuade the prisoner to end his/her fast; gaining the approval of a hospital's ethics committee; and gaining the approval of a district court judge; the feeding is to be carried out in the most humane and sensitive manner as befitting a lifesaving procedure for any patient. This position is consistent with Israel's Basic Law: Human Dignity and Liberty, Israel's Patient Rights Law, Israel's "Do not stand idly by your fellow man's blood" Law, with several Israeli court decisions and in keeping with the dominant Israeli culture. Finally, instructions for physicians who object to such measures are discussed, ascertaining the freedom of conscience as well as preserving the life of the hunger-strikers.

Medical Malpractice Implications of Clinical Practice Guidelines.

Clinical practice guidelines aim to improve medical care by clarifying and making useful recommendations to providers. Although providers should account for patients' unique characteristics when determining a treatment plan, it is generally perceived as good practice to follow guidelines when applicable. This is of interest in malpractice litigation, where it is essential to establish a standard of care to evaluate the performances of providers. Although the opinions of expert witnesses are used to determine standards of care, guidelines are expected to play a leading role. Guidelines alone should not establish a legal standard but may help inform this discussion in the courtroom. Therefore, it is incumbent that excellent, practical, and timely guidelines are continually created and updated in a transparent way. These guidelines must be very clear and underscore the various strengths of recommendation based on the quality of available evidence.

On the verge of shared decision making in Israel: Overview and future directions.

Israel has a universal-national healthcare system and a progressive health policy legislation which, together, provide its residents with high-level healthcare services and either free or highly subsidized coverage without any pre-existing conditions. However, it is surprising that shared decision making (SDM) practices and policy are not an integral part of Israel's healthcare system. The purpose of this overview is to describe the gap between the organizational-infrastructure compatibility of Israel's universal healthcare policy and the efforts needed to advance SDM as part of routine healthcare practice. Review of recent research and education initiatives will be described as well as recommendations for policy and clinical practice.

Ethical issues in nanomedicine: Tempest in a teapot?

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.

Medical Information Exchange: Pattern of Global Mobile Messenger Usage among Otolaryngologists.

OBJECTIVE: Information technology has revolutionized health care. However, the development of dedicated mobile health software has been lagging, leading to the use of general mobile applications to fill in the void. The use of such applications has several legal, ethical, and regulatory implications. We examined the experience and practices governing the usage of a global mobile messenger application (WhatsApp) for mobile health purposes in a national cohort of practicing otolaryngologists in Israel, a known early adaptor information technology society. METHODS: Cross-sectional data were collected from practicing otolaryngologists and otolaryngology residents via self-administered questionnaire. The questionnaire was composed of a demographic section, a section surveying the practices of mobile application use, mobile health application use, and knowledge regarding institutional policies governing the transmission of medical data. RESULTS: The sample included 22 otolaryngology residents and 47 practicing otolaryngologists. Of the physicians, 83% worked in academic centers, and 88% and 40% of the physicians who worked in a hospital setting or a community clinic used WhatsApp for medical use, respectively. Working with residents increased the medical usage of WhatsApp from 50% to 91% (P = .006). Finally, 72% were unfamiliar with any institutional policy regarding the transfer of medical information by personal smartphones. DISCUSSION: Mobile health is becoming an integral part of modern medical systems, improving accessibility, efficiency, and possibly quality of medical care. IMPLICATIONS FOR PRACTICE: The need to incorporate personal mobile devices in the overall information technology standards, guidelines, and regulation is becoming more acute. Nonetheless, practices must be properly instituted to prevent unwanted consequences.

Genomic Databases and Biobanks in Israel.

Large-scale biobanks represents an important scientific and medical as well as a commercial opportunity. However, realizing these and other prospects requires social, legal, and regulatory conducive climate, as well as a capable scientific community and adequate infrastructure. Israel has been grappling with the appropriate approach to establishing such a repository, and debates over the governance, structure, finance, and mode of operation shed a bright light on the underlying social norms, civic engagement and scientific clout in steering a governmental response to pressing medical needs. The article presents the backdrop of the Israeli scene, and explores the reasons and forces at work behind the current formulation of the Israeli National Biobank, MIDGAM.

Child protection decisions to substantiate hospital child protection teams' reports of suspected maltreatment.

The present study focuses on the way child protection officers (CPOs) in Israel assess suspected abuse and neglect (SCAN) reports made by hospital child protection teams (CPTs), to determine whether the alleged maltreatment is substantiated. The study was conducted in six medical centers and included 358 reports investigated by CPOs for SCAN. A structured questionnaire was completed by hospital CPTs to capture all relevant information on each child referred to the CPTs. Structured phone interviews were conducted with each of the CPOs who received a CPT report. Bivariate associations and multivariate logistic regressions were conducted to estimate the substantiation rate of cases reported by CPTs and the types of maltreatment substantiated, as well as to identify case characteristics of the child and the family that were associated with the CPOs' substantiation decision. CPO follow-up investigations revealed a substantiation rate of 53.5%. The maltreatment type most commonly substantiated was neglect. The case characteristics associated with substantiation included socio-demographic background, parents' health and functioning, previous contact with social services, characteristics of the hospital referral, medical findings and an assessment of the parents' behaviors. The findings of the study highlighted the importance of cooperation between the health and welfare services and the policy makers. This cooperation is essential for identifying early signs of maltreatment. Enhanced cooperation and effective information transfer between various professionals would help prevent or at least reduce the recurrence of maltreatment and would ensure that the children and their families are treated appropriately.

Making the case for directed organ donation to registered donors in Israel.

BACKGROUND: The number of deceased donor organ donations in Israel is lower than average when compared to other Western World countries. To address the organ gap, the 2008 Organ Transplantation Law provides new interventions, including important incentives to donors (and their families). The most notable of these was granting priority to registered donors (i.e., people on the waiting list who signed a donor card). The current study presents the normative arguments as well as the first documentation of public attitudes in Israel towards another possible incentive - allowing individuals to influence the allocation of their organs by permitting them to designate, to direct their donated organs [DD] to other registered donors, instead of the current allocation based primarily on medical criteria. METHODS: A structured phone survey of 695 Israelis was conducted during Feb-March 2012. The sample is representative of the Israeli society in terms of age mix and gender, with adequate representation of the Arab and ultra-orthodox Jewish subgroups. RESULTS: Among all Israelis, 68% stated a willingness to donate their organs, but only 16% reported to have already signed a donor card. 85% stated their interest in receiving an organ if the need arises. Overall, 64% of respondents felt that DD to a group of others who have registered as donors is justified, and the rate was remarkably higher in the Arab group (84%), and lower in the religious and ultraorthodox Jewish groups (52% and 50% respectively). CONCLUSIONS: The majority of the Israeli public supports organ donation and its proven benefits. Thus, organ recovery policy should be grounded in a strong communitarian strategy as we all stand to benefit from cooperation. However, current legislation and practices are modeled on individual disposition based on an opt-in legal framework. DD allows personal choices of to-be donors that might interfere with social interests, principles, and values such as equal access to care (i.e. organs) or justice. However, based on the result of this survey, the conceptual case of DD to other registered donors should be viewed more favorably (while the details should be addressed in future analyses), as DD is not expected to be rejected by the public at the outset. From a normative perspective, it is possible to support an allocation scheme that allows DD to other registered donors, where individual preferences that promote just sharing of the burden (donating organs) as well as the benefits (receiving an organ) of transplantation medicine are respected. Yet, DD to other registered donors should be understood and portrayed as a transition step towards a more communitarian model, and as a signal of solidarity by sharing organs as a public good rather than as an exercise of a quasi-property right.

Predicting the decisions of hospital based child protection teams to report to child protective services, police and community welfare services.

This study examines judgments made by hospital-based child protection teams (CPTs) when determining if there is reasonable suspicion that a child has been maltreated, and whether to report the case to a community welfare agency, to child protective services (CPS) and/or to the police. A prospective multi-center study of all 968 consecutive cases referred to CPTs during 2010-2011 in six medical centers in Israel. Centers were purposefully selected to represent the heterogeneity of medical centers in Israel in terms of size, geographical location and population characteristics. A structured questionnaire was designed to capture relevant information and judgments on each child referred to the team. Bivariate associations and multivariate multinomial logistic regressions were conducted to predict whether the decisions would be (a) to close the case, (b) to refer the case to community welfare services, or (c) to report it to CPS and/or the police. Bivariate and multivariate analyses identified a large number of case characteristics associated with higher probability of reporting to CPS/police or of referral to community welfare services. Case characteristics associated with the decisions include socio-demographic (e.g., ethnicity and financial status), parental functioning (e.g., mental health), previous contacts with authorities and hospital, current referral characteristics (e.g., parental referral vs. child referral), physical findings, and suspicious behaviors of child and parent. Most of the findings suggest that decisions of CPTs are based on indices that have strong support in the professional literature. Existing heterogeneity between cases, practitioners and medical centers had an impact on the overall predictability of the decision to report. Attending to collaboration between hospitals and community agencies is suggested to support learning and quality improvement.

[Information technology in medicine - some legal observations].

Information Technology (IT) and computing capabilities are revolutionizing the practice of medicine in an unprecedented way. Some current legal and ethical concerns evolving from this revolution are addressed, pointing to the emerging concepts in Israeli jurisprudence, which regards medical IT as an important contribution to patient empowerment, to medical risk management and in managing the resources of a national health system.

Shared decision-making in Israel: status, barriers, and recommendations.

Shared decision making (SDM) - involving patients in decisions relevant to their health - has been increasingly influential in medical thought and practice around the world. This paper reviews the current status of SDM in Israel, including efforts to promote SDM in the legislation and healthcare system, its influence in medical training and the national health plans, and funding for SDM-related research. Published studies of SDM in Israel are also reviewed. Although informed consent and patients' right to information are regulated by Israeli law, little provision is made for SDM. Further, there are few organized programs to promote SDM among medical professionals or the public, and governmental support of SDM-related research is minimal. Nonetheless, patients have begun to influence litigation in both formal and informal capacities, medical schools have begun to incorporate courses for improving physician-patient communication into their curricula, and the largest national health plan has initiated a plan to increase public awareness. A review of the limited research literature suggests that although patients and physicians express a desire for greater patient involvement, they often have reservations about its implementation. Research also suggests that despite the positive effects of SDM, such an approach may only infrequently be applied in actual clinical practice. In conclusion, though not actively promoting SDM at present, Israel's universal coverage and small number of health plans make rapid, widespread advances in SDM feasible. Israeli policymakers should thus be encouraged to nurture burgeoning initiatives and set plausible milestones. Comparing the status of SDM in Israel with that in other countries may stimulate further advancement.

Personalized disclosure by information-on-demand: attending to patients' needs in the informed consent process.

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.

Telemedicine: licensing and other legal issues.

The growth of information technology and telecommunications has created promising opportunities for better, faster, more accessible, barrier-free health care; telemedicine (TM). The feasibility of many TM projects depends on resolving legal issues. Mastering technical issues or providing training remain important benchmarks for implementation of TM, but legal issues constrain progress. This article identifies the key legal issues, maps current legislation, and offers a forecast of necessary steps to expedite the dissemination of TM.

The status of shared decision making and citizen participation in Israeli medicine.

WHAT ABOUT POLICY REGARDING SDM? Though informed consent and patients' right to information are regulated by Israeli law, there is a low level of formal activities focused on shared decision making (SDM) in Israel. Further, there are few organized programs to promote SDM among medical professionals or the public, and governmental support of SDM-related research is minimal. WHAT ABOUT TOOLS - DECISION SUPPORT FOR PATIENTS? The Israeli government does not have a program on development of patient decision aids. WHAT ABOUT PROFESSIONAL INTEREST AND IMPLEMENTATION? Nonetheless, patients have begun to influence litigation in both formal and informal capacities, medical schools have begun to incorporate courses for improving physician-patient communication into their curricula, and the largest national health plan has initiated a plan to increase pubic awareness. Funding for researching and promoting SDM is not centrally allocated, and studies show that despite the positive effects of SDM, such an approach is infrequently applied in actual clinical practice, and initiatives to promote SDM (e.g., decision aids) are in their infancy. WHAT DOES THE FUTURE LOOK LIKE? In conclusion, though not actively promoting SDM at present, Israel, with its governmentally regulated universal coverage with good access to high-level services possesses all the requisite elements for rapid, widespread advances in SDM in future years.