The Helsinki Declaration is a very important document regarding the protection of patients’ rights in clinical trials and one of the fundamental sources of operational principles for every ethics committee. Although they have been updated, the international guidelines for ethics committees continually fail to address certain issues pertaining to the protection of patients’ rights in clinical trials. These issues include, most significantly, the method of electing ethics committees (a free, secret ballot should be preferred to direct (...) appointment), the avoidance of conflict of interest during the election of ethics committee members, and the necessary insurance coverage for the participants of clinical trials. Polish law should, on the other hand, be developed in such way as to not limit the effectiveness of ethics committees in protecting patients’ rights in clinical trials. The ideal solution would be to draft a uniform law concerning not only clinical trials, but all medical experiments. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting. (shrink)

This book proposes an alternative to the consent model which is currently at the heart of patient self-determination and which is shown here to have fundamental flaws that constrain its effectiveness. The proposed model is a property model in which the patient’s bodily integrity is protected from unauthorised invasion, and their legitimate expectation to be provided with the relevant information to make an informed decision is taken to be a proprietary right. This model enables the courts to overcome the requirement (...) to prove causation in consent cases and offers a complementary approach to patient self-determination. (shrink)

The world famous Eltroxin saga of 2009–2011, which ignited heated public debates in Europe, Canada, and Australia, reveals the problematic nature of standalone autonomy protection cases. Eltroxin is a life-sustaining thyroid hormone replacement medicine used by millions worldwide; it was reformulated in 2008, and around 10% of patients were badly affected. Poor communication and lack of professional information triggered public hysteria as a global wave of complaints about harmful side effects, including hair loss, weight gain, extreme fatigue, headaches, diarrhoea, (...) and heightened heart rates, flooded the media. Israeli Eltroxin users (around 250 thousand people) were similarly unaware. Following many media reports and ministerial regulations, a high-profile consumer class action was launched against Perrigo, the distributor. Ten years of court proceedings culminated in a compensation settlement of approximately US$ 14 million. This relatively low sum covered the injuries of those patients who were physically affected; compensation for standalone autonomy injuries to all patients (who were denied information about changes to their life-sustaining medicine) was refused. The monetary settlement and court decision were hugely disappointing to the class plaintiffs, and a negative signal was sent to the proponents of consumers' and patients' personal autonomy. However, the class action still marked a positive change in pharmaceutical protocols for relations between health authorities, commercial pharmacy entities, and patients/consumers as seen by the proactive communication around a subsequent Eltroxin reformulation in 2020 in Israel, Europe, and South Africa (Aspen Pharmacare, 2020).1 This paper highlights the vast potential value of consumer class action proceedings, and pharmaceutical consumer (patient) class actions in particular, for public welfare and private autonomy. The paper will explain leading Israeli case law related to consumer autonomy protection in tort law and will argue that this law still holds the unique protection of autonomy as a basic human right and accordingly recognises harm to autonomy as a viable form of damage. Additionally, it illustrates why and how consumer protection class actions are an important tool for protection of human rights in general and of patients' rights in particular. (shrink)

Despite recommendations from the Cartwright Report ethical review by health ethics committees has continued in New Zealand without health practitioners ever having to acknowledge their dual roles as health practitioners researching their own patients. On the other hand, universities explicitly identify doctor/research-patient relations as potentially raising conflict of role issues. This stems from the acknowledgement within the university sector itself that lecturer/research-student relations are fraught with such conflicts. Although similar unequal relationships are seen to exist between health researchers and their (...) patients, the patient/subjects are not afforded the levels of protection that are afforded student/subjects. In this paper we argue that the difference between universities and health research is a result of the failure of the Operational Standard Code for Ethics Committees to explicitly acknowledge the vulnerability of the patient and conflict of interests in the dual roles of health practitioner/researcher. We end the paper recommending the Ministry of Health consider the rewriting of the Operational Standard Code for Ethics Committees, in particular in the rewriting of section 26 of the Operational Standard Code for Ethics Committees. We also identify the value of comparative ethical review and suggest the New Zealand's Health Research Council's trilateral relationship with Australia's NHMRC (National Health and Medical Research Council) and Canada's CIHR (Canadian Institute of Health Research) as a useful starting point for such a process. (shrink)

Despite recommendations from the Cartwright Report ethical review by health ethics committees has continued in New Zealand without health practitioners ever having to acknowledge their dual roles as health practitioners researching their own patients. On the other hand, universities explicitly identify doctor/research-patient relations as potentially raising conflict of role issues. This stems from the acknowledgement within the university sector itself that lecturer/research-student relations are fraught with such conflicts. Although similar unequal relationships are seen to exist between health researchers and their (...) patients, the patient/subjects are not afforded the levels of protection that are afforded student/subjects. In this paper we argue that the difference between universities and health research is a result of the failure of the Operational Standard Code for Ethics Committees to explicitly acknowledge the vulnerability of the patient and conflict of interests in the dual roles of health practitioner/researcher. We end the paper recommending the Ministry of Health consider the rewriting of the Operational Standard Code for Ethics Committees, in particular in the rewriting of section 26 of the Operational Standard Code for Ethics Committees. We also identify the value of comparative ethical review and suggest the New Zealand's Health Research Council's trilateral relationship with Australia's NHMRC (National Health and Medical Research Council) and Canada's CIHR (Canadian Institute of Health Research) as a useful starting point for such a process. (shrink)

BackgroundThe European Charter of Patients' Rights (ECPR) presents basic patients' rights in health care. We analysed the characteristics of patients' complaints about their rights submitted through the official complaints system and to a non-governmental organization in Croatia.MethodsThe official system for patients’complaints in Croatia does not have a common pathway but offers different modes for addressing patient complaints. In this cross-sectional study, we analysed the reports about patients’ complaints from the official regional committees sent to the Ministry (...) of Health. We also analysed the complaints received by the Croatian Association for the Protection of Patient’s Rights (CAPR) and mapped them to the ECPR.ResultsThe aggregated official data from the Ministry of Health in 2017 and 2018 covered only 289 individual complaints from 10 out of 21 counties. Complaints were most frequently related to secondary and tertiary healthcare institutions and details were not provided. CAPR received a total of 440 letters, out of which 207 contained 301 complaints about violations of patients’ rights in 2017–2018. The most common complaint was the Right of Access to health care (35.3%) from the ECPR, followed by the Right to Information (29.9%) and the Right to Safety (21.7%). The fewest complaints were about the Right to Complain (1.9%), Right to Innovation (1.4%), Right to Compensation (1.4%), and Right to Preventive Measures (1.0%).ConclusionsReporting and dealing with patients’ complaints about violations of their patients’ rights does not appear to be effective in a system with parallel but uncoordinated complaints pathways. Mapping patient's complaints to the ECPR is a useful tool to assess the perception of patients’ rights and to plan actions to improve the complaints system for effective health care. (shrink)

Uses a social contingency analysis derived from behavioral psychology to compare research and practice. The components of a contingency (occasion, behavior, and consequence) present in a variety of research, treatment, and educational situations are discussed. Subjective terms such as intent, coercion, and consent are analyzed by means of a behavioral approach. Implications include the possible value of a collegial, symmetrical relationship between the professional and the individual in both research and practice domains. Such a relationship is consistent with current dissatisfaction (...) with the social fiduciary model of contractual relations between professionals and individuals. According to this model, one party exercises powers in fulfillment of a trust from the other party. There has been increasing rejection on the part of the public of this "let-us-do-the-driving," "you're-in-good-hands-with-Allstate" orientation adopted by some professionals. The suggested alternative approach, a social contractual model, has the advantage of recognizing this rejection. (39 ref) (PsycINFO Database Record (c) 2012 APA, all rights reserved). (shrink)

The Patient Protection and Affordable Care Act (ACA) sets in motion a wide range of programs that substantially affected the health system in the United States and signify a moderate but important regulatory shift in the role of the federal government in public health. This article briefly addresses two interesting policy paradoxes about the ACA. First, while the legislation primarily addresses health care financing and insurance and establishes only a few initiatives directly targeting public health, the ACA nevertheless has (...) the potential to produce extensive public health benefits across the United States population by improving access to health care and services and reducing cost. Essentially, the ACA does not take the explicit form of a public health law but instead strives to advance public health indirectly through its effects. Second, while the ACA does not establish a right to health — or even a right to health insurance — in the United States, it does set in motion a number of significant structural and normative changes to United States law that comport with the attainment of the right to health. Most significantly, key provisions of the bill are designed to improve availability, accessibility, acceptability, and quality of conditions necessary for health, and to prompt the government to respect, protect, and fulfill these conditions. These developments mean that, to a degree, the United States essentially has undertaken the same types of legal and policy steps that a country would be required to take to uphold the right to health without actually recognizing the right to health in any formal or legally binding way.Despite these dual paradoxes and the upside potential for public health improvements resulting from the ACA, the public health impact of the law remains uncertain and will be decided by numerous subsequent regulatory and implementation decisions. The ACA authorizes multiple federal agencies to engage in rulemaking, a process that will largely dictate the systemic and health impacts that will become its legacy. This reality opens up ample opportunity to bolster public health aspects and interpretations of the law, and to simultaneously augment the corresponding components of the right to health. (shrink)

The passage of the Patient Protection and Affordable Care Act in March 2010 represents a significant turning point in the evolution of health care law and policy in the United States. By establishing a legal infrastructure that seeks to achieve universal health insurance coverage in the United States, the ACA targets some of the major impediments to accessing needed health care for millions of Americans and by extension attempts to strengthen the health system to support key determinants of health. (...) Yet, like many newly passed legislative provisions, the ultimate effects and significance of the ACA remain uncertain. Those charged with implementing the ACA face formidable obstacles — indeed, some of the same obstacles that have been erected to impede other major pieces of social legislation in the past — including entrenched political opposition, constitutional challenges, and what will likely be a prolonged struggle over the content and direction of how the law is implemented. As these debates continue, it is nevertheless important to begin to assess the impact that the ACA has already had on health law in the United States and to consider the likely effects that the law will have on public health going forward. (shrink)

This article discusses the rights of patients who are attending hospital for the most common laboratory examinations and who may also be taking part in research studies. A distinction is made between five kinds of rights to: protection of privacy, physical integrity, mental integrity, information and self-determination. The data were collected ( n = 204) by means of a structured questionnaire specifically developed for this study in the clinical chemistry, haematological, physiological and neurophysiological laboratories of one randomly (...) selected university hospital in Finland. The analysis of the data was statistical. On the whole, patients’ rights were realized reasonably well. This was most particularly the case with protection of privacy, as well as with the rights of physical and mental integrity. The rights to information and self-determination were less well realized. There are various steps that health care professionals and organizations can take to make sure that patients can enjoy their full rights, by counselling the patient, by giving opportunities to plan the examinations in advance, and by arranging a sufficient number of small examination rooms. (shrink)

This book is a comprehensive and unique text and reference in medical ethics. By far the most inclusive set of primary documents and articles in the field ever published, it contains over 100 selections. Virtually all pieces appear in their entirety, and a significant number would be difficult to obtain elsewhere. The volume draws upon the literature of history, medicine, philosophical and religious ethics, economics, and sociology. A wide range of topics and issues are covered, such as law and medicine, (...) truth-telling by the physician, research, population policy, genetics, abortion, dying, and individual rights in medical care. The selections span the centuries, beginning with material from the works of Hippocrates, continuing through Thomas Percival, John Stuart Mill, and Claude Bernard, down to modern commentators like Henry K. Beecher, Walsh McDermott, David L. Bazelon, Paul Freund, H. L. A. Hart, John Rawls, Paul Ramsey, Richard McCormick, Rashi Fein, and Bernard Barber. The text has eight major divisions, beginning with sections on the ethical dimensions of the physician-patient relationship in history; the moral bases of medical ethics; and regulation, compulsion, and protection of the consumer in clinical medicine and public health. Each of these sections includes key essays that appear for the first time. All of the book's major divisions contain primary documents: codes such as the Hippocratic Oath, Medieval Law for the Regulation of Medicine, and the first as well as the most recent code of the American Medical Association; court decisions, including those on Karen Quinlan and on abortion in the United States and West Germany; government documents such as the statement of the National Commission on the Protection of Human Subjects, the Tuskegee Syphilis Report, the British Parliamentary debate on euthanasia, and the Council of Europe on rights of the sick and dying; and various published guidelines such as the Harvard Medical School brain death criteria, the American Hospital Association on patient's rights, and Pope Pius XII on the prolongation of life. Cases that illustrate moral dilemmas are provided for discussion purposes. Each section is preceded by a succinct editor's introduction. The documents and essays are of practical value for practitioners and students in medicine, law, ethics, and counselling, and for individual patients and groups concerned with medical care. Through encompassing divergent viewpoints, the essays and primary documents were selected to encourage humane practices and deepen understanding of the multiple traditions that shaped and do shape the development of medicine. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December (...) 1948;Bearing in mind the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (shrink)

Definition of the problem. Voluntary active euthanasia is, in certain circumstances, morally permissible and should be permitted by law. Autonomous persons may have a fundamental interest in experiencing ”death in dignity” in accordance with their own preferences. This interest is protected by the concept of human dignity assumed by German law. Some prerequisites being met, the moral and legal autonomy right to determine the time and manner of one’s own death includes a right to secure active euthanasia from a willing (...) physician, and a physician’s acceding to the patient’s request be may morally the right thing to do. Arguments and conclusion: Most arguments against the justifiability of voluntary active euthanasia unveil their weakness when scrutinized. However, insofar as legalized voluntary active euthanasia would be subject to intolerable abuse, our policy options are dilemmatic, and the concept of human dignity as it has been taken for granted in German legal discourse, is questioned. There is no option other than seeking safety in legal procedures for every single case. (shrink)

Adherence to ethical principles in clinical research and practice is becoming topical issue in China, where the prevalence of mental illness is rising, but treatment facilities remain underdeveloped. This paper reports on a study aiming to understand the ethical knowledge and attitudes of Chinese mental health professionals in relation to the process of diagnosis and treatment, informed consent, and privacy protection in clinical trials.

This paper addresses ethical concerns emanating from the practice of using patients for health care education. It shows how some of the ways that patients are used in educational strategies to bridge theory-practice gaps can cause harm to patients and patient-practitioner relationships, thus failing to meet acceptable standards of professional practice. This will continue unless there is increased awareness of the need for protection of human rights in teaching situations. Unnecessary exposure of patients, failing to obtain explicit consent, (...) causing harm to vulnerable or disadvantaged groups and inappropriate use of information, though normally regarded as unacceptable professional practices, may go unrecognised in meeting educational needs, widening rather than narrowing theory-practice gaps. (shrink)

The recent confirmation of the constitutionality of the Obama administration’s Patient Protection and Affordable Care Act (PPACA) by the US Supreme Court has brought to the fore long-standing debates over individual liberty and religious freedom. Advocates of personal liberty are often critical, particularly in the USA, of public health measures which they deem to be overly restrictive of personal choice. In addition to the alleged restrictions of individual freedom of choice when it comes to the question of whether or (...) not to purchase health insurance, opponents to the PPACA also argue that certain requirements of the Act violate the right to freedom of conscience by mandating support for services deemed immoral by religious groups. These issues continue the long running debate surrounding the demands of religious groups for special consideration in the realm of health care provision. In this paper I examine the requirements of the PPACA, and the impacts that religious, and other ideological, exemptions can have on public health, and argue that the exemptions provided for by the PPACA do not in fact impose unreasonable restrictions on religious freedom, but rather concede too much and in so doing endanger public health and some important individual liberties. (shrink)

This article argues that the Supreme Court’s decision in Dobbs is likely to impact medical decision-making by pregnant patients in a variety of contexts. Of particular concern are situations where a patient declines treatment recommended for its potential benefit to the fetus and situations where treatment is withheld due to potential risk to the fetus. The Court’s elevation of fetal interests, combined with a history of courts using abortion jurisprudence to guide their reasoning in compelled treatment cases, means that Dobbs (...) has the potential to limit patient autonomy in a wide array of clinical settings. The article calls on professional medical associations to issue ethical guidance affirming the duty to respect the medical self-determination of pregnant patients. (shrink)

The first part of this paper examines the practice of informed treatment decisions in the protective medical system in China today. The second part examines how health care professionals in China perceive and carry out their responsibilities when relaying information to vulnerable patients, based on the findings of an empirical study that I had undertaken to examine the moral experience of nurses in practice situations. In the Chinese medical ethics tradition, refinement [jing] in skills and sincerity [cheng] in relating to (...) patients are two cardinal virtues that health care professionals are required to possess. This notion of absolute sincerity carries a strong sense of parental protectiveness. The empirical findings reveal that most nurses are ambivalent about telling the truth to patients. Truth-telling would become an insincere act if a patient were to lose hope and confidence in life after learning of his or her disease. In this system of protective medical care, it is arguable as to whose interests are being protected: the patient, the family or the hospital. I would suggest that the interests of the hospital and the family members who legitimately represent the patient's interests are being honoured, but at the expense of the patient's right to know. (shrink)

Responding to mounting public concern about the shift to managed care, legislation to grant patient protections has dominated the health policy agenda over the past two years. Although some policies, such as laws on maternity length of stay, can be easily dismissed as “body part by body part” micromanagement of medical practice, other initiatives offer substantive, new rights to patients across the spectrum of care. At both the state and the federal levels, the right of enrollees to appeal a (...) denial of treatment or to file grievances about other plan decisions has emerged as a centerpiece of patient protection legislation. Grievance and appeal rights have been embraced as a way to empower patients, to enhance access to treatment, and to improve the quality of care by providing an external mechanism to review treatment denials. (shrink)

Background:Promoting patients’ rights is essential for defining the standards of clinical services within a country. Given their responsibilities, nurses can be the primary target for research to investigate the issue of patients’ rights within a healthcare system. As such, assessing the knowledge of nurses about patients’ rights is an essential step toward improving the quality of healthcare in limited resource settings like Sudan.Objectives:We aimed to assess the level of knowledge about patients’ rights among the nursing staff (...) at Friendship Teaching Hospital in Sudan.Methods:This hospital-based cross-sectional study was carried out at the Friendship Teaching Hospital in Sudan. We surveyed the totality of nurses (95) at the hospital using an amended survey. The data were analyzed in SPSS software using descriptive and inferential statistics.Ethical consideration:The study was approved by the Research Unit of Khartoum Ministry of Health and the Hospital administration. All respondents gave verbal consent prior to participating in the study.Results:Only 48.4% of the participants knew about the existence of the Sudanese Charter of patients’ rights. Nonetheless, our analysis found that 65.8% of nurses had acceptable level of knowledge (scored more than 75% of the total knowledge score) of patients’ rights, and none of the participant scored less than 50% of the total knowledge score. Finally, we found no statistical association between the knowledge score and demographic data, educational level, whether the participant knows about the existence of the Charter or not and a number of other factors.Conclusion:Nurses’ lack of knowledge about the existence of the Sudanese Charter of patients’ rights adopted in 2009 rights confirms the need for further efforts by Ministry of Health to promote the document. Furthermore, further research is needed to investigate the disconnect between nurses’ lack of knowledge about the existence of the charter and their awareness of the rights within the charter as well as the actual implementation of rights. (shrink)

This article explores the very limited cases historically in the twentieth century when human rights was used in American policy debate as a defending principle for the provision of government-guaranteed universal healthcare. It discusses these cases and examines various reasons as to why this is so, noting the major emphasis in American political culture on negative rather than positive liberty. It examines the shift in political culture from the Roosevelt, Truman, and Johnson eras that embraced social and economic (...) class='Hi'>rights and defined them as such to the post-Reagan era when conservative ideologies were ascendant. These ideologies reject the legitimacy of social and economic rights and remain dominant in the United States. It comparatively situates the American refusal to consider universal healthcare a human right with European affirmations of such a right and to those found in various treaties of international law. Finally, it analyzes how Barack Obama’s Patient Protection and Affordable Care Act—while not adopting the rhetoric of human rights does, functionally, enable as a matter of public policy an entitlement to healthcare. (shrink)

This article discusses the rights of patients who are attending hospital for the most common laboratory examinations and who may also be taking part in research studies. A distinction is made between five kinds of rights to: protection of privacy, physical integrity, mental integrity, information and self-determination. The data were collected (n = 204) by means of a structured questionnaire specifically developed for this study in the clinical chemistry, haematological, physiological and neurophysiological laboratories of one randomly selected (...) university hospital in Finland. The analysis of the data was statistical. On the whole, patients’ rights were realized reasonably well. This was most particularly the case with protection of privacy, as well as with the rights of physical and mental integrity. The rights to information and self-determination were less well realized. There are various steps that health care professionals and organizations can take to make sure that patients can enjoy their full rights, by counselling the patient, by giving opportunities to plan the examinations in advance, and by arranging a sufficient number of small examination rooms. (shrink)

As Next Generation Sequencing technologies are increasingly implemented in biomedical research and care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice. In a first step we clarify some central concepts such as “raw data”; in a second (...) step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one’s raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data. In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom. Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects’ legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations. (shrink)

The European Convention on Human Rights has been incorporated into UK domestic law. It gives many rights to patients within the National Health Service. This article explores the concept of patients’ right to privacy. It stresses that privacy is a basic human right, and that its respect by health professionals is vital for a patient’s physical, mental, emotional and spiritual well-being. I argue that health professionals can violate patients’ privacy in a variety of ways. For example: the right (...) to enjoy their property; the right to protect their medical and personal information as confidential; the right to expect treatment with dignity during intimate care; and the right to control their personal space and territory. Some preliminary evidence indicates that many health care practitioners, including nurses, are presently unaware of the articles of the Convention and the implications of the Human Rights Act 1998. In order to prevent litigation for breaches of patients’ privacy, it is advocated that universities and other educational institutions, the Government and NHS trusts should help to produce a clear educational strategy and protocols so that students and practitioners are well informed in this field. Although 41 European countries are presently the signatories of the European Convention on Human Rights, including the UK, it is important to stress that the principles discussed in this article are applicable world-wide. (shrink)

Background: For patients admitted to hospital both pastoral care and privacy or confidentiality are important. Rules related to each have come into conflict recently in the US. Federal laws and other rules protect confidentiality in ways that countermand hospitals’ methods for facilitating access to pastoral care. This leads to conflicts and poses an unusual type of dilemma—one of conflicting values and rights. As interests are elements necessary for establishing rights, it is important to explore patients’ interests in privacy (...) compared with their desire for attention from a cleric.Aim: To assess the willingness of patients to have their names and rooms included on a list by religion, having that information given to clergy without their consent, their sense of privacy violation if that were done and their views about patients’ privacy rights.Methods and participants: 179 patients, aged 18–92 years, admitted to hospital in an acute care setting, were interviewed and asked about their preferences for confidentiality and pastoral support.Results: Most patients did not want to be listed by religion; 58% did not think hospitals should give lists to clergy without their consent and 84% welcomed a visit by their own clergy even if triggered from a hospital list.Conclusions: Values related to confidentiality or privacy and pastoral care were found to be inconsistent and more complicated than expected. Balancing the right to privacy and the value of religious support continue to present a challenge for hospitals. Patients’ preferences support the importance of providing balance in a way that protects rights while offering comprehensive services. (shrink)

The Civil Code of Lithuania re-established enterprise (business) as a self-sufficient object of civil rights and introduced several legal transanctions with it, the so- called asset deals (sale-purchase of enterprise and lease of enterprise). Since every transfer of enterprise comprises the transfer (delegation) of debts to the new owner, the legal regulation on asset deals must be orientated to the protection of creditors’ rights. However, the legal practice showed that the existing legal regulation regarding asset deals, in (...) particular the mechanism of the protection of creditors’ rights, is complex, and thus unappealing to legal practitioners. Therefore, this research focuses on an analysis of the legal regulation of the mechanism of the protection of creditors’ rights applicable to asset deals and its impact on the civil turnover of enterprise as an object of civil rights. In order to thoroughly examine the problem of the efficient mechanism of the protection of creditors’ rights, the national legal regulation is analysed in comparison to the legal systems of France, Germany and Russia. (shrink)

Background Protecting a person’s right to privacy and confidentiality is important in healthcare services. As future health professionals, nursing students should bear the same responsibility as qualified health professionals in protecting patient privacy. Objectives To investigate nursing students’ practices of patient privacy protection and to identify factors associated with their practices. Research design A cross-sectional study design was adopted. A two-part survey was used to collect two types of data on nursing students: (1) personal characteristics, including demographics, clinical experience (...) and use of information and communication technology and social media and (2) practice of patient privacy protection, collected using the Patient Privacy Scale. Participants and research context: A total of 319 nursing students aged 18 or above, studying pre-registration nursing programmes and who had attended at least one block of clinical placement, were recruited from a university in Hong Kong. Ethical considerations The study received ethical approval from the Survey and Behavioural Research Ethics Committee of the Chinese University of Hong Kong. The participants were informed of the study aim and written consent was obtained before completing the survey. Findings: The mean total score on the Patient Privacy Scale was 119.7 out of 135. Nursing students who were regular users of Instagram and those who had never taken photographs with patients and hence did not need to obtain patient consent were associated with better practices of patient privacy protection (higher total scores on the Patient Privacy Scale). Conclusions The findings improve our understanding of nursing students’ practice of patient privacy protection and the associated factors. This will inform the development and revision of current strategies to enhance nursing students’ practice of patient privacy protection, especially their use of social media. (shrink)

Objective The aim of this study was to examine the development of the implementation of patient rights and the practical course of patient rights legislation in Edirne, as well as the verbal and written applications to relevant departments between 2004 and 2008. Methods The present study was a descriptive, retrospective and cross-sectional study. The data of the study were obtained by retrospectively reviewing records of written complaints to patient rights units and on-site solutions between 2004, the year (...) of establishment of these units, and 2008. Results The incidence of written and verbal complaints were calculated to be 23.1 in 100 000 and 137.9 in 100 000, respectively. The increase was 102.2% for on-site solutions, whereas it was calculated as 97.8% for written applications. It was noticed that the rate of violation judgements was high (42.5% (17/40)) in the first year the Edirne State Hospital patient rights committee was established. Conclusions Possible problems encountered during the presentation of health services can be solved by the implementation of patient rights under the legislative guarantee. The implementation of patient rights should be considered as reflections of a socialised government on health services. (shrink)

Background: Medical confidentiality underpins the doctor–patient relationship and ensures privacy so that intimate information can be exchanged to improve, preserve, and protect the health of the patient. The right to information applies to the patient alone, and, only if expressly desired, can it be extended to family members. However, it must be remembered that one of the primary tenets of family medicine is precisely that patient care occurs ideally within the context of the family. There may be, then, certain occasions (...) when difficulties will arise as to the extent of the information provided to family members.Objectives: This study aimed to describe family doctors’ attitudes to confidentiality and providing patient information to relatives as well as their justifications for sharing information.Method: A descriptive postal questionnaire was self-administered by family doctors.Results: Of 227 doctors, 95.1% provided information to a patient’s family and over a third disclosed information to others without prior patient consent.Conclusions: The findings reveal that family doctors should pay more attention to their patients’ rights to information, privacy, and confidentiality, and reflect very carefully on the fine balance between this and the occasional need for the support and collaboration of family members in delivery of care. Emphasis should be placed on ethics and legal problems during undergraduate education and in-service training of doctors. (shrink)

The system of the European Convention on Human Rights created in 1950 is still regarded as the most important and effective regional system for the protection of human rights in the whole world. However, the experience of the European Court of Human Rights (ECHR) has clearly showed that the steady growth in the number of cases brought before the ECHR makes it increasingly difficult to keep the length of proceedings within the acceptable limits and to maintain (...) the effectiveness of the ECHR. This aspect is becoming extremely important due to the fact that the European Union (EU) will join the Convention system in the near future. The legal basis for the EU accession to the Convention system has been made possible after the entering into force of the EU Lisbon Treaty on 1 December 2009, and, from the Convention’s perspective, the new Protocol No. 14 to the Convention, which entered into force on 1 June 2010, and which, in Article 17 (amending Article 59 of the Convention), stipulates that the EU may accede to this Convention. (shrink)

Xenotransplantation is defined as “any procedure that involves the transplantation, implantation, or infusion into a human recipient of either live cells, tissues, or organs from a nonhuman animal source, or human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.” Xenotransplantation has been viewed by desperate patients and their surgeons as a solution to the problem of the paucity of human organs available for transplantation. Foes of xenotransplantation argue that (...) the use of animal organs degrades the human race and should be avoided.In this paper, we briefly review the cultural context of xenotransplantation and explore the infectious disease risk of xenotransplantation. The United States Code of Federal Regulations requires life-long surveillance of a xenotransplantation recipient due to the largely unknown risk of novel infectious disease transmitted across species, known as xenogeneic infectious disease. We argue that despite being in the interest of protecting the public health, the imposition of lifelong surveillance requirements on xenotransplant recipients effectively abrogates the right to withdraw from a clinical trial after the transplantation has taken place. Moreover, we argue that a waiver of the right to withdraw should be made explicit in the interest of full disclosure, out of respect for the research subject’s right of self-determination. (shrink)

The aim of this paper is to analyze the protection offered to parties, participants and third parties during enforcement, as one of the most important requirements of the enforcement procedure. Having in mind that bailiffs except for implementing enforcement, they are also competent to determine the means by which creditors’ claims will be fulfilled. The realization of the creditors’ claims does not mean use of any kind of measure or enforcement procedural activity. In this context the authors review ways (...) in which debtors and their family members can be protected during enforcement actions, such as measures of exclusion and restriction of enforcement on the debtor’s items and income. Furthermore, the authors elaborate other legal and important ways for protection of parties, participants and third parties, such as opposition to illegality and complaints provided by the Law on Enforcement. In this regard, results of this research have shown that the RNM is making efforts to create a more effective enforcement system, which includes guarantees not only for the protection of the creditor and the debtor as a party, but also for the participants and third parties. From the enforcement experiences of citizens were reported dissatisfaction and complaints of citizens regarding the performance of bailiffs, namely taking the necessary means of subsistence form them. To avoid this situation Amendments on the Law on Enforcement in 2020 were brought, so the legal framework was clarified in terms of measures for exclusion and restriction of enforcement. This resulted in the prevention of economic damage of debtors and their family, because now no action can be taken if the debtor has an average salary or pension. Extraordinary legal remedies in enforcement proceeding are excluded, but there are other safeguards that are related to enforcement process but are not regulated by the Law on Enforcement. (shrink)

Nurses who attend patients with psychiatric disorders often encounter ethical dilemmas and experience difficulties in making the right decision. The present study aimed to evaluate the decisions of psychiatric nurses regarding their duty to warn third parties about the dangerousness of the patient, the need for compulsory hospitalization, and the competence of patients. In total, 111 nurses working in the field of psychiatry in Turkey completed a questionnaire form consisting of 33 questions. The nurses generally assessed the decision-making competency of (...) the patient correctly. However, their decisions regarding whether the patient should be compulsorily hospitalized and their understanding of their duty to warn/protect were less consistent. A significant relationship was found between the decisions of the psychiatric nurses and their work experience, them having children, and them having postgraduate education in psychiatric nursing. The nurses stated their desire to be part of the team that decided on ethical problems in psychiatry. (shrink)

Many people who have reached the age of majority still qualify as financial dependents of their parents, and may be registered as dependents on their parents’ medical schemes. This poses a practical conundrum, because major persons enjoy complete autonomy over their bodies to choose healthcare services as they please, including informational determination. However, their sensitive health information may end up being disclosed in the accounts rendered to their parents, as main members of medical schemes, thereby breaching their informational privacy, medical (...) confidentiality and possibly also damaging personal relationships. On the other hand, medical schemes must ensure that they strictly manage the business of their hospitalisation to ensure that they can adhere to their contractual and legal medical insurance obligations. Both major but financially dependent patients and medical schemes have good legal grounds to defend their respective positions. In this article, we will analyse and clarify the applicable legal and ethical grounds by considering medical confidentiality, the Protection of Personal Information Act, the Consumer Protection Act and the Medical Schemes Act and rules. We shall conclude with recommendations to accommodate the interests of both parties. (shrink)

Questions about the dignity of the human person give rise to many of the most central and hotly disputed topics in bioethics. In _A Defense of Dignity: Creating Life, Destroying Life, and Protecting the Rights of Conscience_, Christopher Kaczor investigates whether each human being has intrinsic dignity and whether the very concept of "dignity" has a useful place in contemporary ethical debates. Kaczor explores a broad range of issues addressed in contemporary bioethics, including whether there is a duty of (...) "procreative beneficence," the ethics of ectopic pregnancy, and the possibility of "rescuing" human embryos with human wombs or artificial wombs. _A Defense of Dignity_ also treats issues relevant to the end of life, including physician-assisted suicide, provision of food and water to patients in a persistent vegetative state, and how to proceed with organ donation following death. Finally, what are the duties and prerogatives of health care professionals who refuse in conscience to take part in activities that they regard as degrading to human dignity? Should they be forced to do what they consider to be violations of the patient's well being, or does patient autonomy always trump the conscience of a health care professional? Grounded in the Catholic intellectual and moral tradition, _A Defense of Dignity_ argues that all human beings from the beginning to the end of their lives should be treated with respect and considers how this belief should be applied in controversial cases. "_A Defense of Dignity_ provides a skillful, informed, and clear philosophical analysis, from a natural law perspective, of a range of controversial, and sometimes complex, bioethical questions concerning the beginning and end of life. Few authors approach bioethics from a natural law perspective, and few do it as well as Christopher Kaczor. The book should be of interest not only to natural law philosophers and their students, but also to anyone interested in bioethics." —_John Keown, Georgetown University__ "Moral questions at the beginning and ending of life and controversies over liberty of conscience are among the most vexing and important issues of our day. Christopher Kaczor brings his characteristic moral seriousness and philosophical good sense to his treatment of these issues, all of which implicate the key concept of human dignity. This eminently readable collection will provide an invaluable resource for educators and students alike." — Christopher Tollefsen, University of South Carolina_ “Indispensable. Kaczor untangles the various meanings of human dignity to undertake a reexamination of the most serious and difficult issues in medical ethics. The book combines clarity with philosophical precision, faithfulness to Catholic teaching with a thorough engagement with critics." —_J. Budziszewski, University of Texas at Austin_. (shrink)

Nurses who attend patients with psychiatric disorders often encounter ethical dilemmas and experience difficulties in making the right decision. The present study aimed to evaluate the decisions of psychiatric nurses regarding their duty to warn third parties about the dangerousness of the patient, the need for compulsory hospitalization, and the competence of patients. In total, 111 nurses working in the field of psychiatry in Turkey completed a questionnaire form consisting of 33 questions. The nurses generally assessed the decision-making competency of (...) the patient correctly. However, their decisions regarding whether the patient should be compulsorily hospitalized and their understanding of their duty to warn/protect were less consistent. A significant relationship was found between the decisions of the psychiatric nurses and their work experience, them having children, and them having postgraduate education in psychiatric nursing. The nurses stated their desire to be part of the team that decided on ethical problems in psychiatry. (shrink)

The resurgence of tuberculosis in the United States is due, in part, to the dismantling of large-scale treatment systems that were a critical part of the disease control effort for the better part of the twentieth century. As the number of cases grows, clinicians, politicians, public health officials and community advocates have grappled with the difficult problem of building systems to care for infected people that are consonant with current knowledge and beliefs about quality care. As an example, the United (...) Hospital Fund’s 1992 report, The Tuberculosis Revival: Individual and Societal Obligations in a Time of AIDS, discussed policies to guarantee adequate treatment that protects patients’ civil rights, needs for special facilities for care of TB patients, and the special problems faced by infected prisoners. This thoughtful report highlighted many areas of social policy that require further examination. (shrink)

The resurgence of tuberculosis in the United States is due, in part, to the dismantling of large-scale treatment systems that were a critical part of the disease control effort for the better part of the twentieth century. As the number of cases grows, clinicians, politicians, public health officials and community advocates have grappled with the difficult problem of building systems to care for infected people that are consonant with current knowledge and beliefs about quality care. As an example, the United (...) Hospital Fund’s 1992 report, The Tuberculosis Revival: Individual and Societal Obligations in a Time of AIDS, discussed policies to guarantee adequate treatment that protects patients’ civil rights, needs for special facilities for care of TB patients, and the special problems faced by infected prisoners. This thoughtful report highlighted many areas of social policy that require further examination. (shrink)

In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable more (...) extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research. Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges. (shrink)

The claim that individuals legitimately differ with respect to their values seems to be uncontroversial among bioethicists, yet many bioethicists nevertheless oppose right-to-try laws. This seems to be due in part to a failure to recognize that such laws are intended primarily to be political, not legal, instruments. The right-to-try movement seeks to build political support for increasing access to newly developed drugs outside of clinical trials. Opponents of right-to-try laws claim that increasing access outside of clinical trials would undermine (...) evidence-based medicine. They seek to maximize overall gains to patients by protecting them from adverse drug reactions and ensuring that drugs are more effective on average. In contrast, right-to-try activists have a point that regulatory judgments of drug safety and effectiveness impose one set of trade-offs on all individuals, regardless of their different values. That might be acceptable if determinations of safety and effectiveness were black and white, but that does not seem to be the case. This article argues that judgments of safety and effectiveness are in an important respect normative and reflect the perceived value of those ends relative to others. Such judgments, when universally imposed, harm patients who would readily make do with less knowledge of drug safety and effectiveness in exchange for more time and self-determination. The relevant moral principle is that of respect for individual autonomy. Just as that principle should lead one to substitute collective decisions for individual ones to regulate a natural monopoly, the same principle should lead one to substitute individual decisions for collective ones to avoid a government monopoly on access to newly developed drugs. It is argued that reforms should increase the number of treatment options available to patients outside of clinical trials. The final section of the article discusses ways in which current regulations might be reformed so as to provide more treatment options outside of clinical trials, without undermining evidence-based medicine. (shrink)

Thirteen years ago, commenting on the treatment of the human body and its cell lines as patentable commodities, Mary Taylor Danforth wrote:Research with human cells that results in significant economic gain for the researcher and no gain for the patient offends the traditional mores of our society in a manner impossible to quantify Such research tends to treat the human body as a commodity — a means to a profitable end. The dignity and sanctity with which we regard the human (...) whole, body as well as mind and soul, are absent when we allow researchers to further their own interests without the patient's participation by using a patient's cells as the basis for a marketable product.In his insightful article, David Resnik would have us travel further down the path of allowing the patenting of DNA in order to advance scientific research and the welfare of humankind. Dr. Resnik suggests that that the acquisition of such proprietary rights in DNA research must proceed cautiously. (shrink)

Thirteen years ago, commenting on the treatment of the human body and its cell lines as patentable commodities, Mary Taylor Danforth wrote:Research with human cells that results in significant economic gain for the researcher and no gain for the patient offends the traditional mores of our society in a manner impossible to quantify Such research tends to treat the human body as a commodity — a means to a profitable end. The dignity and sanctity with which we regard the human (...) whole, body as well as mind and soul, are absent when we allow researchers to further their own interests without the patient's participation by using a patient's cells as the basis for a marketable product.In his insightful article, David Resnik would have us travel further down the path of allowing the patenting of DNA in order to advance scientific research and the welfare of humankind. Dr. Resnik suggests that that the acquisition of such proprietary rights in DNA research must proceed cautiously. (shrink)