Research on ethics in two large Human Biomonitoring projects ECNIS and NewGeneris: a bottom up approach

Assessment of ethical aspects and authorization by ethics committees have become a major constraint for health research including human subjects. Ethical reference values often are extrapolated from clinical settings, where emphasis lies on decisional autonomy and protection of individual's privacy. The question rises if this set of values used in clinical research can be considered as relevant references for HBM research, which is at the basis of public health surveillance. Current and future research activities using human biomarkers are facing new challenges and expectancies on sensitive socio-ethical issues. Reflection is needed on the necessity to balance individual rights against public interest. In addition, many HBM research programs require international collaboration. Domestic legislation is not always easily applicable in international projects. Also, there seem to be considerable inconsistencies in ethical assessments of similar research activities between different countries and even within one country. All this is causing delay and putting the researcher in situations in which it is unclear how to act in accordance with necessary legal requirements. Therefore, analysis of ethical practices and their consequences for HBM research is needed.This analysis will be performed by a bottom-up approach, based on a methodology for comparative analysis of determinants in ethical reasoning, allowing taking into account different social, cultural, political and historical traditions, in view of safeguarding common EU values. Based on information collected in real life complexity, paradigm cases and virtual case scenarios will be developed and discussed with relevant stakeholders to openly discuss possible obstacles and to identify options for improvement in regulation. The material collected will allow developing an ethical framework which may constitute the basis for a more harmonized and consistent socio-ethical and legal approach. This will not only increase the possibilities for comparison between data generated but may also allow for more equality in the protection of the rights of European citizens and establish trustful relationships between science and society, based on firmly rooted ethical values within the EU legislative framework.These considerations outline part of the research on legal, socio-ethical and communication aspects of HBM within the scope of ECNIS (NoE) and NewGeneris (IP).     

Ethics and data protection in human biomarker studies in environmental health

Human biomarker studies in environmental health are essential tools to study the relationship between health and environment. They should ultimately contribute to a better understanding of environmentally induced adverse health effects and to appropriate preventive actions. To ensure the protection of the rights and dignity of study participants a complex legal and ethical framework is applied, consisting of several international directives, conventions, and guidelines, whether or not translated in domestic laws. Main characteristics of ethics and data protection in studies using biomarkers in the field of environmental health are summarized and current discussions on related questions and bottlenecks highlighted. In the current regulatory context, dominated by the protection of the individual study participant, difficulties are reported due to the different interpretation and implementation of the regulations of concern within and across borders. Advancement of consistency and compatibility is recommended and efforts are ongoing. An increasing demand for secondary use of data and samples poses additional challenges in finding a right balance between the individual rights of the study participants on the one hand and the common interest of, and potential benefit for the public or community at large on the other. Ethics committees could play a key role in assessing problems originating from the sometimes competing needs at individual and societal level. Building trust in science amongst (potential) study participants and within the community allows the inclusion of arguments from the societal perspective. This requires increased attention for respectful communication efforts. Striving for public participation in decision making processes may promote policy relevant research and the related translation of study results into action.     

Clinical trials on medical products for human use in the case of acutely incapacitated patients within the fields of neurology and neurosurgery; implications of the new European legislation

To comply with the European directive on clinical trials on medical products for human use, an amendment to the Dutch Medical Research Involving Human Beings Act was formally submitted in the Netherlands on the 27th February 2003. The objective is harmonisation of legislation and the protection of patients participating in clinical trials within the European Union. An important element of the directive is additional protection for incapacitated patients. In the fields of neurology and neurosurgery much research, mainly phase III, is conducted into the safety and efficacy of pharmaceutical products in emergency situations such as traumatic skull-brain injury or an acute cerebral infarct. Future emergency research in patients with acute cerebral disorders will be hindered by the (shortly legal) requirement that prior proxy consent is mandatory and the fact that individual patients must directly benefit as a result of their participation. This unintended negative effect may be considered contrary to the ethical principals for conducting good scientific research to improve treatment results. Also, it may lead to a scientific backlog compared to countries outside of the European Union. In the case of emergency phase-III research among acutely incapacitated patients we recommend that the Central Committee on Research Involving Human Subjects [Dutch acronym: CCMO] tests the research, that trials have an independent committee to monitor the data and safety, that an independent physician may grant consent for the patient to participate and that the consent of the patient's representative(s) is obtained within 24 hours of the patient being included in the trial.     

Gesundheitsschutz als normatives Kriterium der Medizinethik

Illness and health are terms open to interpretation. Their meaning depends on cultural backgrounds, societal designations and historical change. During the modern era, having been shaped by natural sciences, knowledge in medicine has grown exponentially. However, critical voices warn of a medicalization of the image of humanity or an "absolutization" of health. They emphasize that limits must be set to medical progress. In return it has to be highlighted that contemporary medicine has opened up new chances of therapy, prevention and palliative treatment (pain relief), which could not be applied previously. As a result, it is the responsibility of medicine to make available the highest possible measure of progress to patients. The medical profession is confronted with the task of supporting patients in their right to self-determination and their decision competence. For the individual human being, health is a fundamental good. Therefore, each human individual has the right to health protection and medical care which correspond to the latest medical knowledge available. By now, this right has been acknowledged by human rights conventions and numerous legal documents. From an ethical point of view, health protection has to be interpreted as 1) the right to defense, 2) the right to claim and 3) the patient's right to participate. It falls to medical ethics to substantiate the meaning of health protection for the different spheres of medical activity.     

A Brief Talk on How to Promote China Health and Quarantine at Points of Entry in the Framework of Global Health

Global health concerns about the health of the global population and the concepts of global health are gradually being accepted by all of the countries in the world.China health and quarantine at points of entry(POEs) is an integral part of global health,and its duty of prevention and control of the communicable diseases in POEs is consistent with the duty of global health to promote the health of global population.Under the principle of "prevention first",health and quarantine organ carries out the work of disease prevention and control and international travel health care,the reinforcement of core capacity at POEs,and focuses on human rights protection.All the same,there are some gaps with the requirements of global health,such as the inadequate of health promotion planning capacity,ethics awareness and legal protection.The future work of health and quarantine should change ideas on communicable diseases prevention at POEs,focus more on ethical consideration,and should optimize system architecture and human resources,strengthen cooperation,maintain core capacity at POEs,thus to build points of entry public health system with Chinese characteristics,meanwhile to apply the concepts of global health deeply into every aspects of health and quarantine at POEs.     

Before the storm: informing and involving stakeholder groups in workplace biomarker monitoring

The social, legal and ethical implications of advances in biomarker indentification have been discussed by scholars and environmental researchers, but not by the "everyday" professionals and workers who may eventually make and be affected by decisions about their workplace applications. Through the use of a hypothetical scenario, this study introduced members of various professional and occupational groups to the potential uses of biomarkers research on biological monitoring in the workplace. The purpose was to obtain opinions about how events would proceed based on the scenario, leading to a broad discussion of potential uses and abuses of biomarker-based health monitoring. Six professionally homogeneous focus groups, comprised of 1) company health professionals, 2) third-party payers, 3) attorneys, 4) human resource managers, 5) non-unionized workers, and 6) unionized workers, participated in focus groups presented as "think-tank" discussions in Greenville and Charleston, S.C. Participants were given a fictitious "newspaper article" about the use of biomarker-based monitoring at a chemical plant and were asked to comment on what they thought would happen next. The discussion expanded to a general consideration of biological monitoring and its legal, social and ethical ramifications. Data was analyzed through the "immersion/crystallization" method. Few participants reported any knowledge of biological monitoring prior to the focus group session. Some had initial difficulty understanding the concept and how it differs from other means of measuring environmental risk. Although biological monitoring was previously unknown to many participants, occupational groups were relatively consistent in the issues they raised about its use in the workplace. In all groups, questions about potential discrimination against employees were raised. The general consensus was that the use of biomarker-based monitoring would result in conflict and litigation without regulations to protect employees from discrimination. Although most participants saw potential health benefits resulting from the preventive advantages associated with this technology, their concerns about its misuses were paramount. Perceptions varied as a function of occupation. Non-unionized workers expressed the most concern about discriminatory uses of biological monitoring. Unionized workers, who said they believed the union would support their interests, expressed much less concern. Health professionals (company physicians and nurse practitioners) were most alarmed about the "extra work" a monitoring program would create for them. Human resource managers concentrated on the company's "damage control" efforts. Attorneys emphasized that the reliable use of such tests would establish a causal relationship between exposure and personal injury. The results of this project illustrate that people who are most likely to be affected by biomarker-based biological monitoring in the workplace readily understand and are alarmed by its legal and ethical implications. It is unlikely that this technology will be fully accepted as an environmental risk assessment tool or as a prevention strategy without stringent protection of workers' rights. This study demonstrated the value of focus groups in obtaining opinion data about an environmental risk issue that it not yet well known to the general public.     

Setting the scene for the future: implications of key legal regulations for the development of e‐health interoperability in the EU

E‐health has experienced a dynamic development across the European Union in the recent years and enjoys support from the European Commission that seeks to achieve interoperability of national healthcare systems in order to facilitate free movement. Differences that can be observed between the member states in legal regulations, cultural approaches and technological solutions may hinder this process. This study compares the legal standing of e‐health in Denmark, Poland, Spain and the UK, along with key legal acts and their implications. The academic literature review along with an analysis of materials found through the desk study research (reports, legal acts, press articles, governmental web pages and so on) was performed in order to identify aspects relevant to e‐health interoperability. The approach to legal regulation of e‐health substantially differs by country. So do the procedures that they have developed regarding the requirement for patient's consent for the processing of their data, their rights to access to the medical data, to change the data, data confidentiality and types of electronic health records. The principles governing the assignment of responsibility for data protection are also different. These legal and technological differences must be reconciled if interoperability of European national e‐health systems is to be achieved. Copyright © 2016 John Wiley & Sons, Ltd.     

Dual loyalties and the ethical and human rights obligations of occupational health professionals

BACKGROUND: Underlying most ethical dilemmas in occupational health practice is the problem of Dual Loyalties where health professionals have simultaneous obligations, explicit or implicit, to a third party, usually a private employer. METHODS: A literature review was undertaken of case studies of workplace occupational health conflicts, international human rights and ethical codes and strategies for managing dual loyalties, complemented by iterative discussions in an international working group convened to address the problem of Dual Loyalties. RESULTS: Violations of the worker-patient's human rights may arise from: (1) the incompatibility of simultaneous obligations; (2) pressure on the professional from the third party; and (3) separation of the health professional's clinical role from that of a social agent. The practitioner's contractual relationship with the third party is often the underlying problem, being far more explicit than their moral obligation to patients, and encouraging a social identification at the expense of a practitioner's professional identity. CONCLUSIONS: Because existing ethical guidelines lack specificity on managing Dual Loyalties in occupational health, guidelines that draw on human rights standards have been developed by the working group. These guidelines propose standards for individual professional conduct and complementary institutional mechanisms to address the problem.     

Advancing sexual health through human rights: The role of the law

Since the International Conference on Population and Development, definitions of sexuality and sexual health have been greatly elaborated alongside widely accepted recognition that sexual health requires respect, protection and fulfilment of human rights. Considerable progress has also been made in enacting or changing laws that affect sexuality and sexual health, in line with human rights standards. These measures include legal guarantees against non-discrimination and violence, decriminalisation of consensual sexual conduct and guaranteeing availability, accessibility, acceptability and quality of sexual health information and services to all. Such legal actions have had positive effects on health and specifically on sexual health, particularly for marginalised populations. Yet in all regions of the world, laws still exist which jeopardise health, including sexual health, and violate human rights. In order to ensure accountability for the rights and health of their populations, states have an obligation to bring their laws into line with international, regional and national human rights standards. These rights-based legal guarantees, while insufficient alone, are essential for effective systems of accountability, achieving positive sexual health outcomes and the respect and protection of human rights.     

Preparing dossiers: strength of the evidence and problems of proof

In Europe, for authorisation of a health claim, applicants must follow the procedures in the legislation and in the guidelines for submission of a dossier set out by the European Food Safety Authority. The Functional Foods in Europe (FUFOSE) and Process for the Assessment of Scientific Support for Claims on Foods (PASSCLAIM) projects underpinned the laws and provided criteria against which the quality of the totality of the available data could be judged. Whereas the regulations and PASSCLAIM require an assessment of the extent to which cause and effect can be demonstrated between a food category, a food or constituent and a health benefit, the European Food Safety Authority requires conclusive evidence of cause and effect. This latter standard of proof and a focus on randomised controlled trials done on isolated components and using validated physiological biomarkers may not always be appropriate to assess nutrition science. The aims of this paper are to address the strengths and weaknesses of different sources of evidence that contribute to the totality of the available data, to undertake a critical examination of the application of a drug-like assessment model in evidence-based nutrition and to encourage research on new biomarkers of health and homeostatic adaptability. There is a need for (a) a robust and pragmatic scientific framework for assessing the strength, consistency and biological plausibility of the evidence, and (b) consumer understanding research on claims that use qualifying language and/or graphics to reflect the weight of evidence. Such scientific, policy and communication approaches are proportionate and could help stimulate academic research, promote fair trade and product innovation and contribute to consumer education about food and health.     

Pathologies of power: rethinking health and human rights.

The field of health and human rights has grown quickly, but its boundaries have yet to be traced. Fifty-one years after the Universal Declaration of Human Rights, consensus regarding the most promising directions for the future is lacking; however, outcome-oriented assessments lead us to question approaches that rely solely on recourse to formal legal and civil rights. Similarly unpromising are approaches that rely overmuch on appeals to governments: careful study reveals that state power has been responsible for most human rights violations and that most violations are embedded in "structural violence"--social and economic inequities that determine who will be at risk for assaults and who will be shielded. This article advances an agenda for research and action grounded in the struggle for social and economic rights, an agenda suited to public health and medicine, whose central contributions to future progress in human rights will be linked to the equitable distribution of the fruits of scientific advancement. Such an approach is in keeping with the Universal Declaration but runs counter to several of the reigning ideologies of public health, including those favoring efficacy over equity.     

Ethics in health policy and public health

The author explains and illustrates by historical references terms such as health policy, public health, health. Next he deals with ethical principles of the health policy in the following sections: a) respecting people and their rights, b) maximalization of benefit and minimalization of damage, c) legal aspects.     

The evolution of human rights in World Health Organization policy and the future of human rights through global health governance

The World Health Organization (WHO) was intended to serve at the forefront of efforts to realize human rights to advance global health, and yet this promise of a rights-based approach to health has long been threatened by political constraints in international relations, organizational resistance to legal discourses, and medical ambivalence toward human rights. Through legal research on international treaty obligations, historical research in the WHO organizational archives, and interview research with global health stakeholders, this research examines WHO's contributions to (and, in many cases, negligence of) the rights-based approach to health. Based upon such research, this article analyzes the evolving role of WHO in the development and implementation of human rights for global health, reviews the current state of human rights leadership in the WHO Secretariat, and looks to future institutions to reclaim the mantle of human rights as a normative framework for global health governance.     

Patient privacy and conflicting legal and ethical obligations in El Salvador: reporting of unlawful abortions

Postabortion care providers who breach patient confidentiality endanger women's health and violate ethics. A 1998 abortion ban in El Salvador likely spurred an increase in the number of women investigated, because many women were reported to legal authorities by health care providers. Having analyzed safeguards of confidentiality in laws and ethical guidelines, we obtained information from legal records on women prosecuted from 1998 to 2003 and identified factors that may lead to reporting through a survey of obstetrician-gynecologists (n=110). Although ethical and human rights standards oblige providers to respect patients' privacy, 80% of obstetrician-gynecologists mistakenly believed reporting was required. Most respondents (86%) knew that women delay seeking care because of fear of prosecution, yet a majority (56%) participated in notification of legal authorities.     

试论医疗机构及其医务人员的伦理困境与法律对策——以法定医疗伦理损害责任为背景

在医疗伦理损害责任背景下,医疗机构及其医务人员在具体履行医疗告知义务、患者（特定情况下其近亲属）知情不同意以及面临具体法之局限性时,常常陷于对患者的知情权、生命健康权、自主决定权、乃至自身的法律责任风险进行个人抉择的伦理困境。尽管导致伦理困境的原因是多方面的,但从法律视角来看,制定明确、规范的医疗伦理行为指引,建立解决医疗伦理困境的常设机构,健全医疗风险规避和医疗伦理督察制度,应是现实可行的应对之策。     

Third-party rights and risks: a forum on informed consent of persons affected by the study of human subjects--conditions, experiences, and concerns in a Nordic country.

In Denmark, health research using personal information can be conducted only with permission from a regional scientific ethical committee and the national Data Protection Office. There are no rules applying to the rights and risks of third parties. In this article, the implications for third-party rights and risks of the type and level of involvement of the subjects are discussed from a Danish point of view. Particular emphasis is put on the current conditions, experiences, and concerns with regard to use of already registered personal information, which in the Nordic countries offers unique opportunities for large-scale, longitudinal, population-based studies also involving third parties. These opportunities have recently been challenged by a European Community Directive, with which all member states must comply, requiring informed consent on every transaction of personal data, but through a political process, it was possible to obtain a series of amendments allowing the special register-based research to continue. Crucial arguments favoring the amendments were that no damage has been observed so far and that such research has no interest in the individual data, only in the statistical distributions and associations. Finally, the article suggests that the rights and risks of third parties might be considered on the basis of use: third-party information provided by the subject only as a source of such information distinct from use of the information as an integral part of the subjects' information about themselves and their lives.     

Genetics research and third parties: implications for education in the health professions.

Research that seeks information about the families of participants raises several questions regarding policy and the education of health professionals, including curriculum planning. The limits of individualism in health care and research, the moral grounding of informed consent and privacy and the moral and legal obligations of professionals in respecting them, the scientific promise and ethical perils of "geneticization," and responsible conduct in research are all topics to be included in the education of health professionals.     

Some implications of genetic biomarkers in occupational epidemiology and practice

This paper addresses the use of genetic biomarkers in occupational epidemiology and some of the scientific, ethical, and social implications for epidemiologists and practitioners to consider, including issues involving individual risk estimation, the communication of epidemiologic results, and the translation of epidemiologic data into clinical or occupational health practice. Three scenarios from the occupational setting illustrate some of these issues and implications. The scenarios involve glutathione-S-transferase theta 1 (GSTT1) and hematopoietic cancer in hospital workers, human leukocyte antigen coding for glutamic acid in the 69th position (HLA DPB1(E69)) and chronic beryllium disease in beryllium workers, and peripheral myelin protein 22 (PMP22) deletion and carpal tunnel syndrome in railroad track workers. Epidemiologic research involving genetic biomarkers requires the application of genetic tests and can be considered on a continuum between basic sciences and clinical and occupational and public health practice for which questions of test relevance, validity, and utility become important.     

Family consent and the pursuit of better medicines through genetic research.

Rapid changes in the science and technology related to genetic research are challenging scientists, health care providers, ethicists, regulators, patient groups, and the pharmaceutical industry to keep pace with ethically grounded, workable guidelines for both the research and clinical applications of human genetics. We describe the genetic research being conducted by one pharmaceutical company (GlaxoSmithKline) and how the company is addressing the ethical, legal, and social issues surrounding this research; discuss an industry working group's attempt to advance pharmacogenetic research by openly addressing and disseminating information on related ethical, legal, and regulatory issues; identify scientific and ethical differences among various types of genetic research; discuss potential implications of family consent on subject privacy and autonomy, data collection, and study conduct; and suggest points to consider when study sponsors, investigators, and ethics committees evaluate research proposals. Public and expert opinion regarding informed consent in genetic research is evolving as a result of increased education, discussion, and understanding of the relevant issues. Five years ago, there was strong support for anonymity in genetic research as a privacy safeguard. Now, an increasingly popular school of thought advocates against anonymity to preserve an individual's ability to withdraw and, if desired, access research results. It is important to recognize this evolution and address consent issues in a reasoned, practical, and consistent way, including input from patients and their families, health care providers, ethicists, scientists, regulatory bodies, research sponsors, and the lay community. Responsibility for assessing issues related to family consent for research should remain with local investigators, ethics boards, and study sponsors. A "one-size-fits-all" perspective in the form of new regulations, for example, would likely be a disservice to all.