The Scope of pharmacy ethics-an evaluation of the international research literature, 1990-2002

This paper attempts to provide a critical overview of international published discourse relating to ethical issues in pharmacy practice from 1990 to 2002. We found that there is little research literature specifically addressing ethics in pharmacy practice and almost none addressing fundamental philosophical issues or values for pharmacy ethics. There is no dedicated journal for pharmacy ethics. Most material relating to pharmacy ethics is articulated as codes or pronouncements from professional bodies, as opinion or reflection in textbooks and in debate such as letters and articles. However, this should not be taken to mean that pharmacy and ethics are strangers; simply that such matters are not frequently analysed in published pharmacy literature. The presumption is usually that most matters of pharmacy ethics are very familiar and require no exploration or explanation. Where the research literature does target ethical issues, the most common method is to employ "the scenario approach". This term describes the technique of using a vignette or scenario from actual pharmacy practice and then exploring a variety of possible options to identify one or more defensible solutions. The vast majority of scenarios related to the delivery of healthcare per se; rather fewer derived from delivery of healthcare in a commercial environment. One notable exception to this approach is the body of work by Latif and colleagues on moral reasoning and community pharmacy practice. Our review suggests there is a need for the knowledge base in pharmacy ethics to be systematised and integrated into the wider scheme of general healthcare ethics. The principal areas in which research is needed include, how best to teach and assess "ethical competence" before practice; how to develop and update this competence in practising pharmacists; and how the business environment, particularly where there are corporate values and reward systems in operation, affects ethical competence. In addition, general research in pharmacy practice may benefit from a greater awareness and enquiry as to the ethical issues raised by the projects being undertaken.     

Practicing research ethics: private-sector physicians & pharmaceutical clinical trials

This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first on historical studies of physicians as investigators and then on 12 months of qualitative fieldwork in the Southwestern US, this paper analyzes the shifting, contextualized ethics that shape physicians' relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities.     

When people matter: The ethics of qualitative research in the health and social sciences

When research involves people, ethics are fundamental. In the health and social sciences, when qualitative methodologies are used, in addition to ensuring an ethical process approved by the ethics review board, it is also necessary to guarantee an ethical practice capable of responding adequately to the complex questions and dilemmas which arise as the study progresses. This theoretical article analyses some of the most sensitive issues involved in qualitative research and discusses the following questions: (a) How should ethics be approached when working with vulnerable groups? (b) Is informed consent enough? (c) Should we rethink anonymity? (d) What is the difference between confidentiality and anonymity? (e) What exactly do we mean by relational ethics? (f) How can we avoid hurting people, yet remain honest? In the conclusions, we discuss some basic aspects for ensuring ethical studies. This paper, therefore, may be of interest to all health and social researchers concerned about ensuring that their studies comply with ethical principles which recognise, protect and respect participants’ rights.     

Ethics in research with human beings: some issues about psychology

This paper examines some ethical issues in research with human beings, especially addressing the area of Psychology, such as the use of ethical codes; minimum risk; informed consent; debriefing; confidentiality; and ethical committees. It suggests ways for researchers to increase understanding and the proper use of the ethical codes, to guarantee their own protection, and to avoid abuses of power. Special attention is given to methodological issues related to ethics.     

Using mystery clients to assess condom negotiation in Malawi: some ethical concerns

To halt the HIV/AIDS epidemic in Malawi, donors supported the government in promoting safer sex among women who solicit sex with men in and around bars. In 1996, a qualitative study explored the changing dynamics of concurrent sexual partnerships, using a variety of researchers and methods. Although most international ethical research codes prescribe the informed consent of research subjects, the present author, as principal investigator for that study, included the mystery-client method, which omits informants' consent. Five trained, pilot-tested, and closely supervised male researchers contacted 101 bar girls and "freelancing" women in trading and urban centers to assess the women's ability to negotiate condom use. The men posed as clients but were instructed not to have sex with their informants. This approach provided important contextualized information to improve HIV transmission-prevention programs, yet it raises ethical concerns. This article is intended to contribute to the dialogue and debate on ethical research involving mystery clients and to encourage other researchers to share their ethical dilemmas and show how they have addressed them.     

Qualitative research with small connected communities: generating new knowledge while upholding research ethics

Qualitative researchers have a dual mission: to generate knowledge through rigorous research and to uphold ethical standards and principles. Qualitative researchers often conduct studies with small connected communities in which relationships exist among community members. When engaging such communities, researchers might face ethical issues in upholding confidentiality standards while they work to achieve their dual mandate. Qualitative scholars have paid little attention to the ethical challenges that might arise in this context. Drawing on our experiences conducting studies with such communities, we expand the dialogue concerning qualitative research ethics by making explicit conceptual and practical tensions that emerge at various stages of the research process; articulating our respective reflective processes; and exploring issues associated with strategies for upholding confidentiality. We conclude with lessons learned to guide researchers who might face similar challenges.     

Evidence, ethics, and values: a framework for health promotion

We propose a new approach to guide health promotion practice. Health promotion should draw on 2 related systems of reasoning: an evidential system and an ethical system. Further, there are concepts, values, and procedures inherent in both health promotion evidence and ethics, and these should be made explicit. We illustrate our approach with the exemplar of intervention in weight, and use a specific mass-media campaign to show the real-world dangers of intervening with insufficient attention to ethics and evidence. Both researchers and health promotion practitioners should work to build the capacities required for evidential and ethical deliberation in the health promotion profession.     

The Convention on the Rights of Persons With Disabilities: A Foundation for Ethical Disability and Health Research in Developing Countries

The United Nations Convention on the Rights of Persons with Disabilities (CRPD) has foregrounded disability as a human rights and equity issue, elevating it to a priority global research area.Academics from Western universities are likely to play an increasing role in disability health research in developing countries. In such contexts, there is a need to bridge the gap between procedural ethics and the realities of disability research in cross-cultural contexts.We provide guidance on engaging in ethical disability health research that intersects with and upholds the CRPD. We highlight challenges and tensions in doing so, underscoring the need to be sensitive to the sociocultural and political context of disability that determines how ethical research should proceed. We conclude with 5 recommendations.Since entering into force in May 2008, the United Nations Convention on the Rights of Persons with Disabilities (CRPD) has been the first human rights Convention to expressly protect persons with disabilities.1 The Convention identifies persons with disabilities as people

who have long-term physical, mental, intellectual or sensory impairments which in interaction with various barriers may hinder their full and effective participation in society on an equal basis with others,2^(p4)

and is the definition we use in this article. The CRPD not only secures the right to health for persons with disabilities (Article 25), but also secures rights related to the underlying determinants of health, defined as, “the circumstances in which people are born, grow up, live, work and age” and the systems put in place to deal with those circumstances.3^(p26) This includes the social gradient of disability or recognition that people with disabilities in lower socioeconomic quintiles are likely to experience higher levels of functional impairment than those with disabilities in the quintiles above them.The CRPD affirms the large body of empirical evidence that shows that people with disabilities experience comparatively lower educational attainment, lower employment, worse standards of living, higher poverty, and poorer health outcomes than their nondisabled counterparts.4–8 Although limited, the available evidence on people with disabilities in low and middle income countries (LMICs) suggests that they experience similar or even greater socioeconomic challenges and worse health outcomes than their counterparts in more affluent nations.4,5 The lack of evidence makes redressing this situation with sustainable and equitable interventions problematic.1,4,5,9–12 Article 31 of the CRPD, however, insists that States Parties have a legal obligation to undertake research to implement appropriate policies.2 Article 31 implicitly extends data collection processes to include persons with disabilities in all stages of the research process.10The CRPD has foregrounded disability as a human rights and equity issue, and consistent with Article 32 (international cooperation), elevated it to a priority area of international research by increasing funding commitments.1,10,13–15 It is expected that, in light of the unique opportunity offered by the CRPD, more researchers from Western universities, including researchers with disabilities, will undertake disability research in different cultural settings. Undertaking research in different cultural contexts, however, can present particular challenges because researchers are often required to make ethical decisions in complex situations and in settings where they may have limited familiarity.16–18 These challenges relate to a range of factors, including different traditions of knowledge and ethical framings, sociocultural norms, and power hierarchies.16–20 Furthermore, people with disabilities are not a homogeneous group, and economic, cultural, political, and social factors influence factors such as stigma and discrimination. If not acknowledged, these different dynamics can lead to researchers inadvertently perpetuating existing power differentials, working against the inclusive principles contained in the CRPD.21–24Although there has been research on the ethical challenges of research with people with disabilities and research ethics committees,25–28 this has been primarily related to research in advanced economies.26,27,29 Similarly, there is an emerging body of literature on the tensions between procedural ethics in Western-based universities and research in different contexts,16,17,30–34 but this literature rarely includes research with persons with disabilities. Thus, there is limited guidance on how Western-based academics should collaborate in ethically, culturally responsive disability research partnerships that reflect the content of the CRPD. We highlight some of the potential issues researchers may face when commencing disability research in different cultural contexts. Our overall intent is to provide guidance on undertaking disability health research that upholds the CRPD. We hope that this article is particularly helpful for researchers commencing disability research in different cultural contexts and for the research ethics committees that will play a critical role in approving proposed research.25,26,35 We conclude the article with 5 recommendations, and we suggest that dialogue is fundamental in the pursuit of a just and ethical approach.     

The Principle-Based Method of Practical Ethics

This paper is about the methodology of doing practical ethics. There is a variety of methods employed in ethics. One of them is the principle-based approach, which has an established place in ethical reasoning. In everyday life, we often judge the rightness and wrongness of actions by their conformity to principles, and the appeal to principles plays a significant role in practical ethics, too. In this paper, I try to provide a better understanding of the nature of principle-based reasoning. To accomplish this, I show in the first section that these principles can be applied to cases in a meaningful and sufficiently precise way. The second section discusses the question how relevant applying principles is to the resolution of ethical issues. This depends on their nature. I argue that the principles under consideration in this paper should be interpreted as presumptive principles and I conclude that although they cannot be expected to bear the weight of definitely resolving ethical problems, these principles can nevertheless play a considerable role in ethical research.     

Person Centred Care and Shared Decision Making: Implications for Ethics, Public Health and Research

This paper presents a systematic account of ethical issues actualised in different areas, as well as at different levels and stages of health care, by introducing organisational and other procedures that embody a shift towards person centred care and shared decision-making (PCC/SDM). The analysis builds on general ethical theory and earlier work on aspects of PCC/SDM relevant from an ethics perspective. This account leads up to a number of theoretical as well as empirical and practice oriented issues that, in view of broad advancements towards PCC/SDM, need to be considered by health care ethics researchers. Given a PCC/SDM-based reorientation of health care practice, such ethics research is essential from a quality assurance perspective.     

Ethical Issues in Measuring Biomarkers in Children’s Environmental Health

Background

Studying the impact of environmental exposures is important in children because they are more vulnerable to adverse effects on growth, development, and health. Assessing exposure in children is difficult, and measuring biomarkers is potentially useful. Research measuring biomarkers in children raises a number of ethical issues, some of which relate to children as research subjects and some of which are specific to biomarker research.

Objective

As an international group with experience in pediatric research, biomarkers, and the ethics of research in children, we highlight the ethical issues of undertaking biomarker research in children in these environments.

Discussion

Significant issues include undertaking research in vulnerable communities, especially in developing countries; managing community expectations; obtaining appropriate consent to conduct the research; the potential conflicts of obtaining permission from an ethics review board in an economically developed country to perform research in a community that may have different cultural values; returning research results to participants and communities when the researchers are uncertain of how to interpret the results; and the conflicting ethical obligations of maintaining participant confidentiality when information about harm or illegal activities mandate reporting to authorities.

Conclusion

None of these challenges are insurmountable and all deserve discussion. Pediatric biomarker research is necessary for advancing child health.     

Fetal conditions and fatal decisions: ethical dilemmas in ultrasound screening in Vietnam

This paper situates discussion of the ethics of ethnographic research against the background of a theoretical and methodological debate about the relationship between ethics and method, and about the relationships between research methods and their objects. In particular, the paper investigates the implications of folding together the ethical and the empirical in research and argues that this requires the development of new ethico-ethnographic methods for the investigation of ethico-moral objects. The paper falls into three main parts. The first considers calls for what has come to be known as empirical ethics, that is, for a more empirically informed bioethics, by way of an exploration of the integration of ethnographic methods in bioethics, and concludes that approaches which see the ethical and the empirical as 'complementary' do not do justice to the methodological implications of enfolding the ethical and the ethnographic. The second part juxtaposes this with calls for the integration of ethics in ethnography and, similarly, argues that the enfolding of the ethical and the empirical in ethnography calls for the development of new methods. The paper goes on to problematise the 'negotiational' approaches to informed consent preferred by many ethnographers, arguing that the concept of negotiation, rather than offering a solution to the problem of consent, is itself ethically complex and in need of analysis. The paper argues that, in the context of ethnographic research, the possibility of negotiational forms of consent depends upon engagement between researchers and researched, with unavoidably 'ethical' concepts such as 'respect', 'recognition', 'dignity', 'justice' and so on, and that this poses methodological challenges to ethnography. The paper's third section explores the implications of these arguments for research practice, using The Genethics Club as an example.     

TOWARD CRITICAL RESEARCH ETHICS: TRANSFORMING ETHICAL CONDUCT IN QUALITATIVE HEALTH CARE RESEARCH

Based on research conducted with women injection drug users (WIDUs), I discuss the ethical conflicts that researchers and subcontractors face in gaining access to the life narratives of WIDUs. Foremost among these is the potentially exploitative nature of the study participant–researcher relationship. I suggest that federal and institutional guidelines for human subject research must incorporate additional safeguards to protect study populations such as WIDUs. Moreover, the ethical concerns related to health care research should be addressed in guidelines for ethical conduct with human subjects, research ethics seminars, and required training programs for researchers and subcontractors separately.     

Toward critical research ethics: transforming ethical conduct in qualitative health care research

Based on research conducted with women injection drug users (WIDUs), I discuss the ethical conflicts that researchers and sub-contractors face in gaining access to the life narratives of WIDUs. Foremost among these is the potentially exploitative nature of the study participant-researcher relationship. I suggest that federal and institutional guidelines for human subject research must incorporate additional safeguards to protect study populations such as WIDUs. Moreover, the ethical concerns related to health care research should be addressed in guidelines for ethical conduct with human subjects, research ethics seminars, and required training programs for researchers and subcontractors separately.     

Judging the ethics of qualitative research: considering the "ethics as process" model

Decision-making about the ethics of qualitative research is problematic where the research design is emergent, and the balance between risks and benefits for research subjects are difficult to ascertain prior to study implementation. The discourses of health/medical research ethics and those of social research are shown to be divergent and, furthermore, where ethics committees tie themselves to the health/medical model of ethical decision-making, qualitative research approaches can be disadvantaged. Having demonstrated the dual discourses and their relevance to qualitative research ethics, a critical review of current approaches to maximising the success of qualitative research proposals being considered for approval by ethics committees is undertaken. This leads to a call for a system of monitoring qualitative research so that the "benefit to risk" ratio is always on the side of benefit. This has implications for the ways in which ethics committees are organised and the ways in which they function.     

Neuroscientists’ everyday experiences of ethics: the interplay of regulatory,professional, personal and tangible ethical spheres

The ethical issues neuroscience raises are subject to increasing attention, exemplified in the emergence of the discipline neuroethics. While the moral implications of neurotechnological developments are often discussed, less is known about how ethics intersects with everyday work in neuroscience and how scientists themselves perceive the ethics of their research. Drawing on observation and interviews with members of one UK group conducting neuroscience research at both the laboratory bench and in the clinic, this article examines what ethics meant to these researchers and delineates four specific types of ethics that shaped their day‐to‐day work: regulatory, professional, personal and tangible. While the first three categories are similar to those identified elsewhere in sociological work on scientific and clinical ethics, the notion of ‘tangible ethics’ emerged by attending to everyday practice, in which these scientists’ discursive distinctions between right and wrong were sometimes challenged. The findings shed light on how ethical positions produce and are, in turn, produced by scientific practice. Informing sociological understandings of neuroscience, they also throw the category of neuroscience and its ethical specificity into question, given that members of this group did not experience their work as raising issues that were distinctly neuro‐ethical.     

Social responsibility and research ethics in community-driven studies of industrialized hog production

Environmental health research can document exposures and health effects that result from inequitable relationships between communities of low income or people of color and the institutions that derive benefits (profits, federal and state funding or services, avoidance of wastes) from activities and policies that burden these communities. Researchers, most of whom work in relatively privileged institutions, are placed in situations of conflicting loyalties if they conduct research in collaboration with, or on behalf of, communities burdened by environmental injustices. These conflicts can threaten the self-interest of researchers and may raise social and ethical issues that do not typically arise in research projects that respond to the agendas of institutions. This article describes how we addressed issues of research ethics and social responsibility in environmental health research on industrialized hog production in North Carolina. Researchers and institutional review boards are not well prepared to address ethical issues when interests of entire communities, as well as individual research participants, are involved. Community-driven research partnerships can help address problems in research ethics and can enhance the social responsibility of researchers and their institutions.     

When communities are really in control: ethical issues surrounding community mobilisation for dengue prevention in Mexico and Nicaragua

We discuss two ethical issues raised by Camino Verde, a 2011–2012 cluster-randomised controlled trial in Mexico and Nicaragua, that reduced dengue risk though community mobilisation. The issues arise from the approach adopted by the intervention, one called Socialisation of Evidence for Participatory Action. Community volunteer teams informed householders of evidence about dengue, its costs and the life-cycle of Aedes aegypti mosquitoes, while showing them the mosquito larvae in their own water receptacles, without prescribing solutions. Each community responded in an informed manner but on its own terms. The approach involves partnerships with communities, presenting evidence in a way that brings conflicting views and interests to the surface and encourages communities themselves to deal with the resulting tensions.One such tension is that between individual and community rights. This tension can be resolved creatively in concrete day-to-day circumstances provided those seeking to persuade their neighbours to join in efforts to benefit community health do so in an atmosphere of dialogue and with respect for personal autonomy.A second tension arises between researchers’ responsibilities for ethical conduct of research and community autonomy in the conduct of an intervention. An ethic of respect for individual and community autonomy must infuse community intervention research from its inception, because as researchers succeed in fostering community self-determination their direct influence in ethical matters diminishes. Trial registration: ISRCTN 27581154