Changes in the Declaration of Helsinki: economic fundamentalism, ethical imperialism and social control]

This study is a critical reflection on attempts to alter the Declaration of Helsinki, a key document of the democratic theses achieved in the latter half of the 20th century and thus a legacy for humanity because of its ethical guidelines for research involving human beings. Therefore, there must be worldwide social control over such a document, and any change in it demands ample debate with international participation to avoid any reversal in its humanitarian thrust. The study analyzes current aspects of research with human subjects in so-called "outlying" or "developing" countries. It also brings a social and political focus to the matter, highlighting that the economic fundamentalism exercised by wealthy countries inevitably leads to an ethical imperialism, exposing communities of poor countries to even greater vulnerability, discrimination, and social exclusion.     

Beyond informed consent

Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. The emphasis in most externally sponsored research projects in developing countries is on laborious documentation of several mechanical aspects of the research process rather than on assuring true comprehension and voluntary participation. The onus for the oversight of this process is often left to overworked and ill-equipped local ethics review committees. Current guidelines and processes for obtaining informed consent should be reviewed with the specific aim of developing culturally appropriate methods of sharing information about the research project and obtaining and documenting consent that is truly informed. Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings.     

Integrating public health programs and research after the malaria vaccine implementation program (MVIP): Recommendations for next steps

BackgroundIn February 2020, international controversy arose about the ethical acceptability of the WHO Malaria Vaccine Implementation Program (MVIP). Whereas some have argued that this program must be seen as research that is not in line with international ethical standards, notably regarding informed consent and local ethical review, some WHO representatives consider the MVIP as a public health implementation program that need not adhere to these standards.MethodsWe performed a case analysis in light of the 2016 CIOMS International Ethical Guidelines for Health-related Research involving Humans.FindingsWe argue that the MVIP has a substantial research component, and that it is prudent to therefore apply ethical norms for research involving humans, such as the CIOMS guidelines. Accordingly, we agree that the ethical requirements of informed consent and independent ethical review have not been met. In addition, we are concerned that the study might not meet CIOMS’s social value requirement.RecommendationsWe urge WHO to release more details about the process that led to the MVIP program and make the MVIP protocol publicly available. The full protocol should be assessed by the relevant ethics committees, new and already enrolled parents should be informed about the uncertainties under investigation and given a real opportunity to consent or refuse (continued) participation, communities should be engaged, and aspects of MVIP that require alteration in light of ethical review should be altered, if possible. Furthermore, in order to improve good ethical practices, it is necessary to engage in international debate regarding the integration of research and public health programs. Procedurally, vaccine implementation programs that combine both prevention and research should involve the wider international ethics community and ensure participation of the target populations in setting the proper conditions for launching such programs.     

Ethical oversight of public health research: can rules and IRBs make a difference in developing countries?

Controversies in the conduct of international research continue to pose challenges for the system of ethical review, particularly for developing countries. Although the concept of vulnerability is key to addressing these challenges, ethical review has typically ignored the agency of vulnerable participants and groups in determining what kind of review process is needed. Concurrent with developments shaping the new public health that seek to operationalize empowerment of communities by placing them as initiators and organizers of their own health, ethical review of public health research must find ways to recognize the agency of vulnerable individuals, groups, and communities in the review process if it is to address effectively the ethical dilemmas currently evident in collaborative international research.     

Ethical Review of Global Short-Term Medical Volunteerism

Global short-term medical volunteerism is growing, and properly conducted, is a tool in the fight for greater global health equity. It is intrinsically “ethical” (i.e., it involves ethics at every step) and depends upon ethical conduct for its success. At present, ethical guidelines remain in their infancy, which presents a unique opportunity. This paper presents a set of basic ethical principles, building on prior work in this area and previously developed guidelines for international clinical research. The content of these principles, and the benchmarks used to evaluate them, remain intentionally vague and can only be filled by collaboration with those on-the-ground in local communities where this work occurs. Ethical review must additionally take into consideration the different obligations arising from the type of institution, type of intervention, and type of relationship involved. This paper argues that frequent and formalized ethical review, conducted from the beginning with the local community (where this community helps define the terms of debate), remains the most important ethical safeguard for this work.     

An Ethical Framework for Automated,Wearable Cameras in Health Behavior Research

Technologic advances mean automated, wearable cameras are now feasible for investigating health behaviors in a public health context. This paper attempts to identify and discuss the ethical implications of such research, in relation to existing guidelines for ethical research in traditional visual methodologies. Research using automated, wearable cameras can be very intrusive, generating unprecedented levels of image data, some of it potentially unflattering or unwanted. Participants and third parties they encounter may feel uncomfortable or that their privacy has been affected negatively. This paper attempts to formalize the protection of all according to best ethical principles through the development of an ethical framework. Respect for autonomy, through appropriate approaches to informed consent and adequate privacy and confidentiality controls, allows for ethical research, which has the potential to confer substantial benefits on the field of health behavior research.     

Ethical considerations for disability-inclusive gender-based violence research: Reflections from a South African qualitative case study

Globally, women with disabilities experience heightened and unique forms of violence compared to men with disabilities and women without disabilities. Yet formalised guidelines for their inclusion in gender-based violence (GBV) research is lacking. This paper draws on ethical guidelines for researching violence against women, and studies on the ethicality of including people with disabilities in research, to advocate for women with disabilities’ inclusion and safety in GBV research. Reflecting on lessons from a qualitative study on violence against women living with disabilities in South Africa, the paper considers what could be of value for GBV researchers and ethics review committees in low-middle income countries (LMICs). It aims to stimulate debate around the integration of reasonable accommodation, accessibility, and equal participation of women with disabilities in planning and conducting ethical GBV research. The paper recommends that considerations are practically applied and tested in other LMICs, and thereafter critiqued in consultation with a range of stakeholders and women with disabilities, to enhance best practice and form a basis for developing guidelines for undertaking ethical and inclusive GBV research in LMICs.     

Richtig gute epidemiologische Praxis

Objective/methods

The need for public health ethics and ethics in epidemiology has recently become more obvious. In this article a methodological and normative framework for public health ethics is discussed.

Results

Some of the prevalent approaches of public health ethics and ethics in epidemiology are missing a systematic philosophical account and/or norms that are relevant and enlightening for the ethical discussion in public health. For an approach of public health ethics one can learn from bioethics and adopt methodologies that have been applied and elaborated in this field. However, there is a need for a set of principles in public health ethics that differs from the bioethical principles. Ethical codes and guidelines are already applied in the practice of epidemiology and public health without relating these to ethical principles. This is a deficit for goal-oriented ethical reasoning in public health and epidemiology.

Conclusion

An applied ethical discourse in public health can be helpful for public health and epidemiology. Ethical principles facilitate coherent reasoning that enriches the discussion of ethical problems as opposed to only relying on very specific moral rules as in codes and guidelines.     

Public views on health care rationing: a group discussion study

This small-scale study develops a new methodology for investigating which ethical principles of health care rationing the public support after discussion and deliberation. In ten groups of about six people, members of the public are asked to discuss a hypothetical rationing choice, concerning four identified patients who are described in general terms but without detailed information. It is explained to respondents that the purpose of the exercise is to find out what general ethical principles they support. Discussions are chaired by an academic specialising in health policy, whose role is to encourage debate but not actively to participate. On the basis of an innovative qualitative data analysis, which translates what people say into ethical principles identified in the theoretical literature, the public appear to support three main rationing principles: (1) a broad 'rule of rescue' that gives priority to those in immediate need, (2) health maximisation and (3) equalisation of lifetime health. To our knowledge, this pluralistic viewpoint on rationing has never been developed into a coherent theoretical position, nor into a quantifiable model that health care managers can use for guidance.     

Translating ethics: researching public health and medical practices in Nepal

Conducting anthropological research into situations where public health interventions are ongoing raises a number of complex ethical issues. This paper addresses this by focusing on recent debate around questions of informed consent in research situations into health care in the 'developing' world. Two issues are developed: firstly, that of anthropological engagement with medical research trials; and secondly, how medical ethics debates have impinged upon and influenced anthropological ideas of ethics. Drawing on personal anthropological research into the implementation of the WHO prescribed tuberculosis control programme (DOTS) in the context of Nepal, I outline a number of ethical dilemmas and issues that arose. This research context included other ongoing research into DOTS implementation, as well as the local culture of health care provision. It involved moving between a number of sites and subject positions while interacting with heath professionals and patients. In conclusion, rather than prescribing ethical norms for researchers in such situations, I argue that we need more ethnographic examples and case studies as a means of thinking through the issues. I suggest that we need to reflect on both the ethical issues that arise when undertaking research into multifaceted public health interventions and into the situations where ethical guidelines and stipulations are formulated. The best place for this may be the Internet, where we increasingly see the conditions emerging for open dialogue.     

Principles for the justification of public health intervention

OBJECTIVES: The objective of this paper is to discuss principles relevant to ethical deliberation in public health. METHODS: Conceptual analysis and literature review. RESULTS: Four principles are identified: The Harm Principle, The Principle of Least Restrictive Means, The Reciprocity Principle, and The Transparency Principle. Two examples of how the principles are applied in practice are provided. INTERPRETATION: The paper illustrates how clinical ethics is not an appropriate model for public health ethics and argues that the type of reasoning involved in public health ethics may be at potential variance from that of empirical science. Further research and debate on the appropriate ethics for public health are required.     

Ethical dilemmas in research on Internet communities

There has been a rapid growth in the number of articles using Internet data sources to illuminate health behavior. However, little has been written about the ethical considerations of online research, especially studies involving data from Internet discussion boards. Guidelines are needed to ensure ethical conduct. In this article, the authors examine how a youth-focused research program negotiated ethical practices in the creation of its comprehensive health site and online message board. They address three situations in which ethical predicaments arose: (a) enrolling research participants, (b) protecting participants from risk or harm, and (c) linking public and private data. Drawing on the ethical principles of autonomy, nonmaleficence, justice, and beneficence, the authors present practical guidelines for resolving ethical dilemmas in research on Internet communities.     

The impact of genomics on global health

Ensuring that advances in genomics are applied to the health improvement of people living in developing countries is an important contemporary challenge. In the near term, such advances are likely to alleviate infectious diseases, with longer-term benefits envisaged for chronic disorders. To ensure that benefits are shared by developing countries, attention must be paid to complex ethical, legal, social, and economic issues, as well as to public education and engagement. Creative and equitable international mechanisms and goodwill are needed to turn high hopes into reality and allow the use of genomics to reduce health inequities between rich and poor nations.     

State health agencies and the legislative policy process.

A new era of health care reform places increasing pressure on public health leaders and agencies to participate in the public policy arena. Public health professionals have long been comfortable in providing the scientific knowledge base required in policy development. What has been more recent in its evolution, however, is recognition that they must also play an active role in leading and shaping the debate over policy. A profile of effective State legislative policy "entrepreneurs" and their strategies has been developed to assist health agencies in developing such a leadership position. Based on the experiences of State legislative liaison officers, specific strategies for dealing with State legislatures have been identified and are organized into five key areas--agency organization, staff skills, communications, negotiation, and active ongoing involvement. A public health agency must be organized effectively to participate in the legislative policy process. Typically, effective agencies centralize responsibility for policy activities and promote broad and coordinated participation throughout the organization. Playing a key role in the agency''s political interventions, the legislative liaison office should be staffed with persons possessing excellent interpersonal skills and a high degree of technical competence. Of central importance to effective legislative policy entrepreneurship is the ability to communicate the agency''s position clearly. This includes setting forward a focused policy agenda, documenting policy issues in a meaningful manner, and reaching legislators with the proper information. Once a matter is on the legislative agenda, the agency must be prepared to negotiate and build broad support for the measure. Finally, public health agencies must be active policy players.(ABSTRACT TRUNCATED AT 250 WORDS)     

Dietary guidelines for cancer prevention: the etiology of a confused debate

Several organizations in different countries have issued dietary guidelines for the public in order to reduce cancer incidence. Meanwhile, proponents and opponents of dietary guidelines disagree about their justification. Unfortunately, the discussion is confined to the question of whether or not present evidence is a firm enough base for recommendations. However, in addition to health-related aspects, other arguments, such as economic, sociological, psychological, ethical, philosophical, and education aspects, also play a role in the decision about dietary guidelines. It is argued that the present debate has resulted in much confusion, because the latter arguments have rarely come up for consideration in the discussion. This paper addresses the various arguments that are involved in the decision-making process. Thus, insight is gained into the causes of the present controversy with regard to dietary guidelines.     

The contribution of quality assurance to national veterinary organizations in developing countries: the case of Africa

Food safety has, within a few years, become an essential concern for producers and consumers, especially in Western countries, but also in Africa. African countries are increasingly aware of the issues involved, and of the need to react and to implement appropriate strategies in order to avoid public health risks and obstacles to their export markets. Most countries recognise that the overall sanitary quality of foodstuffs produced and distributed in the region must be improved. The OIE (World organisation for animal health) recommends that Veterinary Services attempt to improve the safety of animal products by establishing a framework of risk management, throughout the food chain, which will reduce risks by eliminating or controlling hazards during the first stages of processing. The activities of Veterinary Services, from the organisational, technical, financial and human resource points of view, must be guided by quality assurance considerations, pursuant to the standards laid down in the Terrestrial Animal Health Code of the OIE. The quality of Veterinary Services depends therefore on a range of factors, including fundamental ethical, organisational and technical principles. It goes without saying that ethical principles cannot be effective unless the Veterinary Services have the resources necessary to reinforce them. The implementation of quality assurance by the Veterinary Services in developing countries, and particularly in Africa, will promote better organisation, effective use of limited resources, and professionalism in decision-making. It will also allow for better access to international markets thanks to certification recognised by the OIE and the international community.     

Navigating ‘ethics in practice’: An ethnographic case study with young women living with HIV in Zambia

ABSTRACT

While ‘procedural ethics’ provides essential frameworks for governing global health research, reflecting on ‘ethics in practice’ offers important insights into addressing ethically important moments that arise in everyday research. Particularly for ethnographic research, renowned for it’s fluid and spontaneous nature, engaging with ‘ethics in practice’ has the potential to enhance research practice within global health. We provide a case study for such reflexivity, exploring ‘ethics in practice’ of ethnographic research with middle-income young women living with HIV in Lusaka, Zambia. We explore the ethical issues arising from the layered interaction of the population (young women), the disease under investigation (HIV), the method of study (ethnographic), and the setting (Zambia, a lower middle income country). We describe how we navigated five key practical ethical tensions that arose, namely the psycho-emotional benefits of the research, the negotiated researcher-participant relationship, protecting participants’ HIV status, confidentiality and data ownership, and researcher obligations after the end of the research. We exemplify reflexive engagement with ‘ethics in practice’ and suggest that engaging with ethics in this way can make important contributions towards developing more adequate ethical guidelines and research practice in global public health.     

Doctor-cared dying instead of physician-assisted suicide: a perspective from Germany

The current article deals with the ethics and practice of physician-assisted suicide (PAS) and dying. The debate about PAS must take the important legal and ethical context of medical acts at the end of life into consideration, and cannot be examined independently from physicians’ duties with respect to care for the terminally ill and dying. The discussion in Germany about active euthanasia, limiting medical intervention at the end of life, patient autonomy, advanced directives, and PAS is not fundamentally different in content and arguments from discussions led in other European countries and the United States. This must be emphasized, since it is occasionally claimed that in Germany a thorough discussion could not be held with the same openness as in other countries due to Germany’s recent history. Still, it is worthwhile to portray the debate, which has been held intensively both among experts and the German public, from the German perspective. In general, it can be stated that in Germany debates about questions of medical ethics and bioethics are taking place with relatively large participation of an interested public, as shown, for instance, by the intense recent discussions about the legalisation of advanced directives on June 18 2009, the generation and use of embryonic stem cells in research or the highly difficult challenges for the prioritizing and rationing of scarce resources within the German health care system. Hence, the current article provides some insights into central medical and legal documents and the controversial public debate on the regulation of end-of-life medical care. In conclusion, euthanasia and PAS as practices of direct medical killing or medically assisted killing of vulnerable persons as “due care” is to be strictly rejected. Instead, we propose a more holistically-oriented palliative concept of a compassionate and virtuous doctor-cared dying that is embedded in an ethics of care.