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.

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.

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.

International scope of biomedical research ethics review.

Many countries consider long-term implications for society.

[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.

EHRA Expert Consensus Statement on the management of cardiovascular implantable electronic devices in patients nearing end of life or requesting withdrawal of therapy.

The purpose of this Consensus Statement is to focus on implantable cardioverter-defibrillator (ICD) deactivation in patients with irreversible or terminal illness. This statement summarizes the opinions of the Task Force members, convened by the European Heart Rhythm Association (EHRA) and the Heart Rhythm Society (HRS), based on ethical and legal principles, as well as their own clinical, scientific, and technical experience. It is directed to all healthcare professionals who treat patients with implanted ICDs, nearing end of life, in order to improve the patient dying process. This statement is not intended to recommend or promote device deactivation. Rather, the ultimate judgement regarding this procedure must be made by the patient (or in special conditions by his/her legal representative) after careful communication about the deactivation's consequences, respecting his/her autonomy and clarifying that he/she has a legal and ethical right to refuse it. Obviously, the physician asked to deactivate the ICD and the industry representative asked to assist can conscientiously object to and refuse to perform device deactivation.

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.

An account of collective actions in public health.

Aggregated health decisions by individuals are of paramount importance to public health professionals and policymakers, especially in situations where collective participation is a prerequisite for achieving an important public health goal such as herd immunity. In such circumstances, concerted action often falls short of the common good through lack of sufficient participation. Collective action problems are traditionally attributed to rational egoists seeking to promote their interests and enjoy a "free ride." We call attention, however, to the behavioral features of collective action and their implications for solving public health policy problems.

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.

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.

Role of diagnosis-specific information sheets in parents' understanding of emergency department discharge instructions.

OBJECTIVES: To investigate the contribution of diagnosis-specific information sheets at discharge from the emergency department on parental understanding of the discharge instructions. METHODS: The study group consisted of a convenience sample of parents of children discharged home from the emergency department of an urban tertiary care pediatric facility (n=95). At discharge by the physician, all were given a disease-specific information sheet to accompany the physician's discharge instructions. Thereafter, the parents were asked to complete the same 13-item questionnaire used in our previous study, covering demographics, level of anxiety, and quality of physician's explanation, in addition to a description, in their own words, of their child's diagnosis and treatment instruction and an indication of their preferred auxiliary method of delivery of information. The findings were compared with the study group in the first phase study (n=287) who did not receive the disease-specific information sheet. The BMDP statistical package was used for the analysis. RESULTS: No statistically significant differences between the two groups in age, sex, and education, level of anxiety before or after the emergency department visit, or time of day were observed. Full understanding of the diagnosis was noted in 73% of the parents who received the information sheet and 72% of the parents in our previous study who did not. Corresponding rates of understanding of the treatment instructions were 92% and 82%. On statistical analysis, the distribution of the diagnosis-specific information sheet significantly improved parental understanding of the treatment instructions (P=0.025), but not of the diagnosis (P=0.54). CONCLUSIONS: Although overall parental understanding of emergency department discharge instructions is good, understanding of the treatment instructions can be further improved with the use of diagnosis-specific information sheets.

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.

The great auricular nerve; does it penetrate the parotid gland? An anatomical and microscopical study.

UNLABELLED: Conflicting opinions exist in the literature regarding the exact anatomical course of the great auricular nerve. The aim of this work was to study the pathway of its anterior branch and endings in relation to the parotid gland. MATERIAL AND METHODS: Thirty-seven specimens were dissected from 19 fresh adult cadavers and studied including the parotid gland at the region of the termination of the anterior branch of the nerve. The causes of death were not due to pathology in the parotid region. All the specimens were fixed in formaldehyde, serially cut, stained by haematoxylin and eosin, and examined by light microscope. RESULTS: In most of the glands (21/37 = 57%), there was no evidence of well-organized nerve fibres of the great auricular nerve inside the parotid gland. In a few (5/37 = 13%), nerve fibers were seen to penetrate the interlobular septa and in 30% of the cases (11/37) nerve bundles were found deep in the gland along side small ducts and close to thin-walled blood vessels. CONCLUSION: These findings prove that there are anatomical variations of the endings of the anterior branch of the great auricular nerve. The significance of nerve bundles deep in the gland along ducts and near vessels remains to be explored.

Do parents understand emergency department discharge instructions? A survey analysis.

BACKGROUND: Understanding discharge instructions is crucial to optimal healing but may be compromised in the hectic environment of the emergency department. OBJECTIVES: To determine parents' understanding of ED discharge instructions and factors that may affect it. METHODS: A convenience sample of parents of children discharged home from the ED of an urban tertiary care pediatric facility (n = 287) and a suburban level II general hospital (n = 195) completed a 13 item questionnaire covering demographics, level of anxiety, and quality of physician's explanation. Parents also described their child's diagnosis and treatment instructions and indicated preferred auxiliary methods of delivery of information. Data were analyzed using the BMPD statistical package. RESULTS: Full understanding was found in 72% and 78% of the parents at the respective centers for the diagnosis, and in 82% and 87% for the treatment instructions (P = NS between centers). There was no statistical correlation between level of understanding and parental age, gender, education, level of anxiety before or after the ED visit, or time of day. The most contributory factor to lack of understanding was staff use of medical terminology. Parents suggested further explanations by a special discharge nurse and written information as auxiliary methods. CONCLUSIONS: Overall, parental understanding of ED discharge instructions is good. However, there remains a considerable number (about 20%) who fail to fully comprehend the diagnosis or treatment directives. This subset might benefit from the use of lay terminology by the staff, institution of a special discharge nurse, or use of diagnosis-specific information sheets.

[Western bio-ethics--Israel between North America and Europe].

In an attempt to re-structure and formulate western bio-ethics in the '80's, the four principles of beneficence, non-maleficence, autonomy and justice were promulgated in North America and the United Kingdom. Extensive criticism was leveled against this endeavor, as being erroneous in principle or substantially inadequate. Furthermore, European opponents of this effort claimed that the Continent's 'true' set of values greatly differs from those of North America, hence negating attempts for global bio-ethics based on these principles. In this review the principles of modern American bio-ethics are presented and criticisms presently deliberated in Europe are introduced, while offering alternative principles. Israel's unique position is demonstrated by its legislation on issues such as the national health system, organ transplantation, the right to refuse medical treatment and stem cell research, all confirming that Israel begs to differ. We conclude that European values have much in common with Israel's tradition and culture, commending due modification of our ethical conceptions and training programs. The coming years should be characterized by constant dialogue between the proponents of European and American values, while Israel's individual standpoint is maintained.

Treating acute anaemia in a Jehovah's Witness in Israel: an innovative approach to a medical and legal challenge.

A person's right to control his or her own body, expressed through the concept of informed consent to medical treatment, has gained worldwide acceptance. Nevertheless, this right may conflict with the state's interest in preserving life in cases where patients refuse treatment in medical emergencies. This paper examines the management of treating acute anaemia in a Jehovah's Witness in Israel who refused blood transfusion on religious grounds. The medical and legal ramifications are discussed in light of the Israeli Patients' Rights Law of 1996. This law established statutory ethics committees which may, under defined conditions of emergency or threat to life, approve treatment against the patient's will. This power, previously vested in the courts, should be used only in extreme circumstances while, in general, patients' wishes and beliefs must be respected. Sensitivity to the legal and ethical aspects involved deserves greater emphasis in medical school curricula.