Online research in philosophy

How should medical services be distributed within society? Who should pay for them? Is it right that large amounts should be spent on sophisticated new technology and expensive operations, or would the resources be better employed in, for instance, less costly preventive measures? These and others are the questions addreses in this book. Norman Daniels examines some of the dilemmas thrown up by conflicting demands for medical attention, and goes on to advance a theory of justice in the distribution (...) of health care. The central argument is that health care, both preventive and acute, has a crucial effect on equality of opportunity, and that a principle guaranteeing equality of opportunity must underly the distribution of health-care services. Access to care, preventive measures, treatment of the elderly, and the obligations of doctors and medical administrations are fully discussed, and the theory is shown to underwrite various practical policies in the area. (shrink)

The context of international health research involving human subjects, and this should appear obvious, is the human community. As such, basic questions of how human beings should be treated by other human beings, particularly in situations of unequal power – e.g., in the form of control, choice, or opportunity – lay at the foundations of related ethical discourse when ethics are discussed at all. I trace a narrative that follows upon a recent revision process of international guidelines for (...) biomedical research involving human subjects. I focus in particular upon the issue of a standard of care. In the second section, I draw upon philosophers John Rawls, Claudia Card, and Allen Buchanan to discuss concerns regarding the 'least advantaged members of society' in the context of global inequality. The paper includes reflections upon pedagogy in courses focused upon international health research involving human subjects. (shrink)

How international research might contribute to justice in global health has not been substantively addressed by bioethics. Theories of justice from political philosophy establish obligations for parties from high-income countries owed to parties from low and middle-income countries. We have developed a new framework that is based on Jennifer Ruger's health capability paradigm to strengthen the link between international clinical research and justice in global health. The ‘research for health justice’ framework provides direction (...) on three aspects of international clinical research: the research target, research capacity strengthening, and post-trial benefits. It identifies the obligations of justice owed by national governments, research funders, research sponsors, and investigators to trial participants and host communities. These obligations vary from those currently articulated in international research ethics guidelines. Ethical requirements of a different kind are needed if international clinical research is to advance global health equity. (shrink)

Health research has been identified as a vehicle for advancing global justice in health. However, in bioethics, issues of global justice are mainly discussed within an ongoing debate on the conditions under which international clinical research is permissible. As a result, current ethical guidance predominantly links one type of international research (biomedical) to advancing one aspect of health equity (access to new treatments). International guidelines largely fail to connect international research to promoting broader (...) aspects of health equity – namely, healthier social environments and stronger health systems. Bioethical frameworks such as the human development approach do consider how international clinical research is connected to the social determinants of health but, again, do so to address the question of when international clinical research is permissible. It is suggested that the narrow focus of this debate is shaped by high-income countries' economic strategies. The article further argues that the debate's focus obscures a stronger imperative to consider how other types of international research might advance justice in global health. Bioethics should consider the need for non-clinical health research and its contribution to advancing global justice. (shrink)

Executive Summary There is a general perception that biomedical research has not given the same attention to the health problems of women that it has given ...

With increasing calls for global health research there is growing concern regarding the ethical challenges encountered by researchers from high-income countries (HICs) working in low or middle-income countries (LMICs). There is a dearth of literature on how to address these challenges in practice. In this article, we conduct a critical analysis of three case studies of research conducted in LMICs. We apply emerging ethical guidelines and principles specific to global health research and offer practical strategies (...) that researchers ought to consider. We present case studies in which Canadian health professional students conducted a health promotion project in a community in Honduras; a research capacity-building program in South Africa, in which Canadian students also worked alongside LMIC partners; and a community-university partnered research capacity-building program in which Ecuadorean graduate students, some working alongside Canadian students, conducted community-based health research projects in Ecuadorean communities. We examine each case, identifying ethical issues that emerged and how new ethical paradigms being promoted could be concretely applied. We conclude that research ethics boards should focus not only on protecting individual integrity and human dignity in health studies but also on beneficence and non-maleficence at the community level, explicitly considering social justice issues and local capacity-building imperatives. We conclude that researchers from HICs interested in global health research must work with LMIC partners to implement collaborative processes for assuring ethical research that respects local knowledge, cultural factors, the social determination of health, community participation and partnership, and making social accountability a paramount concern. (shrink)

Millions of people undergo displacement in the world. Internally displaced people (IDP) are especially vulnerable as they are not protected by special legislation in contrast to other migrants. Research conducted among IDPs must be correspondingly sensitive in dealing with ethical issues that may arise. Muslim IDPs in Puttalam district in the North-Western province of Sri Lanka were initially displaced from Northern Sri Lanka due to the conflict in 1991. In the backdrop of a study exploring the prevalence of common (...) mental disorders among the IDPs, researchers encountered various ethical challenges. These included inter-related issues of autonomy, non-maleficence, beneficence, confidentiality and informed consent, and how these were tailored in a culture-specific way to a population that has increased vulnerability. This paper analyses how these ethical issues were perceived, detected and managed by the researchers, and the role of ethics review committees in mental health research concerning IDPs. The relevance of guidelines and methodologies in the context of an atypical study population and the benefit versus risk potential of research for IDPs are also discussed. The limitations that were encountered while dealing with ethical challenges during the study are discussed. The concept of post-research ethical conduct audit is suggested to be considered as a potential step to minimize the exploitation of vulnerable populations such as IDPs in mental health research. (shrink)

Machine generated contents note: Introduction. -- Acknowledgments. -- The Author. -- 1 Ethical Theories and Bioethics in a Global Perspective. -- Theories of Ethics. -- Are Theories of Ethics Global? -- Can Theories of Ethics Encourage People to Do the Right Thing? -- 2 Autonomy and Informed Consent in Global Perspective. -- Ethical Principles and Practical Issues of Informed Consent. -- Does Informed Consent Really Matter to Patients? -- Is Informed Consent a Universal Principle or a Cultural Value? -- 3 (...) Withholding or Withdrawing Treatment and Physician-Assisted Suicide. -- Withholding or Withdrawing Treatment at the End of Life. -- Assisting Patients in Committing Suicide. -- 4 Ethical Issues in Reproductive Health. -- Ethics of Abortion in Different Times, Places, and Cultures. -- Current Ethical Issues in Abortion. -- Assisted Reproductive Technology and Stem Cell Research. -- Emergency Contraception. -- Ethics of Imposing Conditions on Funding. -- 5 Ethical Issues of Female Genital Mutilation. -- The Facts About FGM. -- FGM as a Challenge to Ethical Relativism. -- Ethics of FGM for Adult Women. -- 6 Ethical Issues of Research with Human Subjects. -- Background Information and the Belmont Report. -- Autonomy and Voluntary Informed Consent. -- Beneficence and Cost-Benefit Analysis. -- Issues of Justice and Fairness for Human Subjects. -- 7 The Right to Health Care, and Ethical Obligations to Provide Care. -- Is There an Ethical Right to Health Care? -- Ethical Obligations of Health Care Professionals. -- Ethical Obligations of for-Profit Health Care Providers. -- 8 Ethical Issues in Rationing and Allocation of Limited Resources. -- Levels of Allocating Resources. -- Methods of Rationing Health Resources. -- Comparative Effectiveness Research and Cost-Effectiveness Analysis. -- 9 Ethical Issues of Health Insurance and Health System Reform. -- Ethical Issues in Financing Health Services and Designing Insurance Systems. -- Fundamental Values of Health Systems. -- 10 Ethical Issues in the Movement of Patients Across National Borders. -- Ethical Duties to Provide Health Care to Undocumented Aliens. -- Ethical Issues in Medical Tourism. -- 11 Ethical Issues in the Movement of Health Care Professionals Across National Borders. -- Ethical Issues in the Migration of Health Professionals. -- Proposed Solutions and Their Ethical Implications. -- Fair Treatment of Health Care Workers from Other Countries. -- 12 Corruption and Informal Payments in Health Systems. -- Payment of Informal Fees by Patients and Their Families. -- Is Corruption Bad for Your (and Other People's) Health? -- References. -- Index. (shrink)

This paper examines the philosophical substructure to the theoretical conflicts that permeate contemporary mental health care in the UK. Theoretical conflicts are treated here as those that arise among practitioners holding divergent theoretical orientations towards the phenomena being treated. Such conflicts, although steeped in history, have become revitalized by recent attempts at integrating mental health services that have forced diversely trained practitioners to work collaboratively together, often under one roof. Part I of this paper examines how the (...) history of these conflicts can be understood as a tension between, on the one hand, the medical model and its use by the dominant profession of psychiatry, and on the other, those alternative models and practitioners in some way differentiated from the medical model camp. Examples will be given from recent policy and research to highlight the prevalence of this tension in contemporary practice. Part II of this paper explores the deeper commonalities that lay beneath the theoretical conflict outlined in Part I. These commonalities will be shown to be apart of a captivating framework that has continued to grip the conflict since its inception. By exposing this underlying framework--and the motivations inherent therein--the topic of integration appears in wholly different light, allowing a renewed philosophical basis for integration to emerge. (shrink)

Background: Family members are often required to act as substitute decision-makers when health care or research participation decisions must be made for an incapacitated relative. Yet most families are unable to accurately predict older adult preferences regarding future health care and willingness to engage in research studies. Discussion and documentation of preferences could improve proxies' abilities to decide for their loved ones. This trial assesses the efficacy of an advance planning intervention in improving the accuracy of (...) substitute decision-making and increasing the frequency of documented preferences for health care and research. It also investigates the financial impact on the healthcare system of improving substitute decision-making.Methods/DesignDyads (n = 240) comprising an older adult and his/her self-selected proxy are randomly allocated to the experimental or control group, after stratification for type of designated proxy and self-report of prior documentation of healthcare preferences. At baseline, clinical and research vignettes are used to elicit older adult preferences and assess the ability of their proxy to predict those preferences. Responses are elicited under four health states, ranging from the subject's current health state to severe dementia. For each state, we estimated the public costs of the healthcare services that would typically be provided to a patient under these scenarios. Experimental dyads are visited at home, twice, by a specially trained facilitator who communicates the dyad-specific results of the concordance assessment, helps older adults convey their wishes to their proxies, and offers assistance in completing a guide entitled My Preferences that we designed specifically for that purpose. In between these meetings, experimental dyads attend a group information session about My Preferences. Control dyads attend three monthly workshops aimed at promoting healthy behaviors. Concordance assessments are repeated at the end of the intervention and 6 months later to assess improvement in predictive accuracy and cost savings, if any. Copies of completed guides are made at the time of these assessments.DiscussionThis study will determine whether the tested intervention guides proxies in making decisions that concur with those of older adults, motivates the latter to record their wishes in writing, and yields savings for the healthcare system.Trial RegistrationISRCTN89993391. (shrink)

This paper offers a different pragmatic and patent-based approach to concerns regarding the negative effects of genetic-based patenting on advancing scientific research and providing adequate and accessible health care services. At the basis of this approach lies an explication of a mandatory provisional patented paper procedure (PPPA), designed for genetic-based patents and administered by leading scientific journals in the field, while officially acknowledged by the USPTO, and subsequently by other patent offices as well. It is argued that (...) the uniqueness of PPPAs lies in subsequently mitigating the negative ramifications of genetic patents on scientific research and genetic-based health care services, while basing such mitigation on a patents’ advocate viewpoint that neither discards the patent system nor jeopardizes its integrity. (shrink)

Community-based participatory research (CBPR) focuses on specific community needs, and produces results that directly address those needs. Although conducting ethical CBPR is critical to its success, few academic programs include this training in their curricula. This article describes the development and evaluation of an online training course designed to increase the use of CBPR in mental health disciplines. Developed using a participatory approach involving a community of experts, this course challenges traditional research by introducing a collaborative process (...) meant to encourage increased participation by special populations and narrow the parity gap in effective mental health treatment and services delivery. (shrink)

Community-based participatory research (CBPR) focuses on specific community needs, and produces results that directly address those needs. Although conducting ethical CBPR is critical to its success, few academic programs include this training in their curricula. This article describes the development and evaluation of an online training course designed to increase the use of CBPR in mental health disciplines. Developed using a participatory approach involving a community of experts, this course challenges traditional research by introducing a collaborative process (...) meant to encourage increased participation by special populations and narrow the parity gap in effective mental health treatment and services delivery. (shrink)

This article examines the responsibilities of researchers who conduct exploratory research to provide a service to vulnerable respondents. The term “service” is used to denote the provision of a tangible benefit in relation to the research question that is apart from the altruistic research benefits. This article explores what this “service” could look like, who might be responsible for providing it, and the challenges associated with such a service. The article argues that not providing a tangible benefit (...) to vulnerable research participants is inconsistent with the principle of social justice that undergirds much of the rationale for conducting health disparities research. (shrink)

Background: This article describes the types of community-wide benefits provided by investigators conducting public health research in South Asia as well as their self-reported reasons for providing such benefits. Methods: We conducted 52 in-depth interviews to explore how public health investigators in low-resource settings make decisions about the delivery of ancillary care to research subjects. In 39 of the interviews respondents described providing benefits to members of the community in which they conducted their study. We returned (...) to our narrative dataset to find answers to two questions: What types of community-wide benefits do researchers provide when conducting public health intervention studies in the community setting, and what reasons do researchers give when asked why they provided community-wide benefits? Findings: The types of community-wide benefits delivered were directed to the health and well-being of the population. The most common types of benefits delivered were the facilitation of access to health care for individuals in acute medical need and emergency response to natural disasters. Respondents' self-reported reasons when asked why they provided such benefits fell into 2 general categories: intrinsic importance and instrumental importance. (shrink)

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. (shrink)

This paper analyses the role chaplaincy plays in providing religious and spiritual care in the UK’s National Health Service. The approach considers both the current practice of chaplains and also the wider changes in society around beliefs and public service provision. Amid a small but growing literature about spirituality, health and illness, I shall argue that the role of the chaplain is changing and that such change is creating pressures on the identity and performance of the chaplain as (...) a religiously authorised health worker. I shall question whether either orthodox belief or religious belonging have any significant bearing on the patients’ demand for chaplaincy services. Utilising an example of chaplaincy work I shall argue that patient need constitutes the strongest platform for both practice development and an articulated understanding of what chaplains bring to health care. Drawing on a case study the definition and interpretation of spiritual need will be discussed in relation to chaplaincy practice. In conclusion, I shall set out the case for effective research to establish with greater precision the detail of the chaplain’s practice within a state-funded health system. (shrink)

The authors describe the ethical considerations underlying the inclusion of mental health services into a prioritizedhealth care system. The Oregon Health Plan is a process for defining and delivering basic health services to an entire state. As the plan was developed, the mental health community needed to decide whether or not to participate in the process and, if so, how. Lengthy discussions among mental health consumers, family members, and providers led to a strategy (...) that emphasized the integration of mental health and chemical dependency services into a comprehensive and universal health care program. This approach appears to have achieved relative parity for mental health. (shrink)

Asylum-seeking and refugee women (ASRW) are population groups characterized by diverse social, economic and legal backgrounds as well as diverse needs. Their backgrounds of forced migration have a profound impact on their overall health, including their sexual and reproductive health (SRH). In Europe, the SRH needs of ASRW are usually more pressing than those of the host country population. In the context of refugee health, it is important to distinguish between asylum seekers and statutory refugees, as asylum (...) seekers have distinct needs and often limited rights in their host country. Yet both groups face many barriers in accessing national health services. This article addresses the issue of entitlements to health services for asylum-seeking women in Europe, and highlights the wide range of difficulties of both asylum-seeking and refugee women in accessing (sexual and reproductive) health services. (shrink)

Chapter 1 Who this book is for and who it is not for1 There are already too many books offering solutions to the problems of the health service. ...

To identify motivational factors linked to child health status that affected the likelihood of parents’ allowing their child to participate in pediatric research.

While there has been significant discussion in the health sciences and ethics literatures about problems associated with publication practices (e.g., ghost- and gift-authorship, conflicts of interest), there has been relatively little practical guidance developed to help researchers determine how they should fairly allocate credit for multi-authored publications. Fair allocation of credit requires that participating authors be acknowledged for their contribution and responsibilities, but it is not obvious what contributions should warrant authorship, nor who should be responsible for the quality (...) and content of the scientific research findings presented in a publication. In this paper, we review arguments presented in the ethics and health science literatures, and the policies or guidelines proposed by learned societies and journals, in order to explore the link between author contribution and responsibility in multi-author multidisciplinary health science publications. We then critically examine the various procedures used in the field to help researchers fairly allocate authorship. (shrink)

BackgroundObtaining a research participant’s voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements.MethodsEmploying a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008–2011, which were purposively selected to reflect different types of research ethics (...) boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child’s assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child’s psychological and social perspective; (3) whether a child’s ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child’s perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed.ResultsThe review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study.ConclusionsThe analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics. (shrink)

Background: The formulation and implementation of national ethical regulations to protect research participants is fundamental to ethical conduct of research. Ethics education and capacity are inadequate in developing African countries. This study was designed to develop a module for online training in research ethics based on the Nigerian National Code of Health Research Ethics and assess its ease of use and reliability among biomedical researchers in Nigeria.MethodologyThis was a three-phased evaluation study. Phase one involved development (...) of an online training module based on the Nigerian Code of Health Research Ethics (NCHRE) and uploading it to the Collaborative Institutional Training Initiative (CITI) website while the second phase entailed the evaluation of the module for comprehensibility, readability and ease of use by 45 Nigerian biomedical researchers. The third phase involved modification and re-evaluation of the module by 30 Nigerian biomedical researchers and determination of test-retest reliability of the module using Cronbach’s alpha. Results: The online module was easily accessible and comprehensible to 95% of study participants. There were significant differences in the pretest and posttest scores of study participants during the evaluation of the online module (p = 0.001) with correlation coefficients of 0.9 and 0.8 for the pretest and posttest scores respectively. The module also demonstrated excellent test-retest reliability and internal consistency as shown by Cronbach’s alpha coefficients of 0.92 and 0.84 for the pretest and posttest respectively. Conclusion: The module based on the Nigerian Code was developed, tested and made available online as a valuable tool for training in cultural and societal relevant ethical principles to orient national and international biomedical researchers working in Nigeria. It would complement other general research ethics and Good Clinical Practice modules. Participants suggested that awareness of the online module should be increased through seminars, advertisement on government websites and portals used by Nigerian biomedical researchers, and incorporation of the Code into the undergraduate medical training curriculum. (shrink)

This paper offers a realist critique of socialresearch on health inequalities. A conspectus of thefield of health inequalities research identifies twomain research approaches: the positivist quantitativesurvey and the interpretivist qualitative `casestudy'. We argue that both approaches suffer fromserious philosophical limitations. We suggest that aturn to realism offers a productive `third way' bothfor the development of health inequality research inparticular and for the social scientific understandingof the complexities of the social world in general.

Making research data readily accessible during a public health emergency can have profound effects on our response capabilities. The moral milieu of this data sharing has not yet been adequately explored. This article explores the foundation and nature of a duty, if any, that researchers have to share data, specifically in the context of public health emergencies. There are three notable reasons that stand in opposition to a duty to share one’s data, relating to: (i) data property (...) and ownership, (ii) just distribution of benefits and burdens and (iii) the contemporary ethos of science. We argue each reason can be successfully met with corresponding rationale in favour of data sharing. Further support for data sharing has been echoed in policies of health agencies, funding bodies and academic institutions; in documents on the ethical conduct of biomedical research; and in discussions on the nature of public health. From this, we ascertain that sharing data is the morally sound default position. This article then highlights the key roles reciprocity and solidarity play in supporting the practice of data sharing. We conclude with recommendations to regard public health research data as a common-pool resource in order to build a framework for stable data sharing management. (shrink)

Finding an effective microbicide that could substantially lower women’s risk of acquiring HIV infection is an ethical imperative. Women and girls continue to be disproportionally affected by HIV in sub-Saharan Africa. Ethics guidelines for conducting preventive HIV microbicide trials call for steps that intertwine biomedical research and public health. Ethical considerations include adequate studies of the safety of microbicides, the use of placebo controls in future trials once a microbicide is shown to be effective, whether leftover microbicide from (...) a trial that demonstrated efficacy should be made available to the public or used in the control group of a future trial, what preventive measures and treatment should be provided for trial participants during and after the research, and what constitute ‘fair benefits’ to the community or country when a trial is completed. The Global Campaign for Microbicides conducted a study of the benefits being provided to participants in microbicide trials and others, and found substantial evidence that researchers and sponsors are meeting the obligations stated in ethical guidelines. A cautionary tale of an HIV prevention trial that was prematurely halted demonstrates the need for engagement with the community where trials are carried out. (shrink)

Medical Research Council, Capetown, South Africa Nasheen Naidoo Medical Research Council, Capetown, South Africa Shamagonam James Medical Research Council, Durban, South Africa Priscilla Reddy Medical Research Council, Capetown, South Africa * Corresponding author: 306 Arnold House, School of Public Health & Health Sciences, University of Massachusetts, Amherst, MA 01003, USA. Tel.: (413) 545 1005; Email: Buchanan{at}schoolph.umass.edu ' + u + '@' + d + ' '//--> . Abstract The analysis presented here lays out the (...) ethical warrants for requiring community oversight of health research conducted in international settings. It reviews the inadequacies with the current standards of individual informed consent and research ethics committee review, and then, shows how a broader population-based public health perspective raises new demands on justice involving due consideration of the rights, harms and benefits to the community as a whole. As developed here, an ethical standard that requires community oversight of health research is justified on three principled grounds: respect for community autonomy and their right to self-determination; due consideration of the consequences of the research for the community as a whole; and, a more complete understanding of human autonomy. The paper concludes with practical recommendations regarding the composition of Community Advisory Boards to ensure that they have legitimate decision-making authority in diverse socio-cultural contexts. CiteULike Connotea Del.icio.us What's this? (shrink)

Despite the international interest in priority setting as an important tool for health policy, there has been comparatively little interest in the setting of research priorities. One of the few places where there has been such an interest is at the National Institutes of Health (NIH) in the United States. Under pressure from Congress to explain its priority setting process, the NIH has tried to explain the criteria and process it uses. The NIH procedure is described, and (...) the problems created by the criteria it uses are analyzed. Although it uses the language of priority setting, it is uncertain whether it does have a real method of setting priorities. Nonetheless, despite the lack of a method, the results of its work are lauded. In the long run, however, NIH will need a more rigorous method of setting priorities. (shrink)

McGovern, Kevin This article explores statements from the National Health and Medical Research Council (NHMRC) about health research involving Aboriginal and Torres Strait Islander peoples.

Health researchers, research trainees, and ethics reviewers should be prepared for the special application of research ethics within complex humanitarian emergencies. This paper argues that as a precursor to published ethical guidelines for conducting research in complex emergencies, researchers and research ethics committees should observe the following primary ethical considerations: (1) the research is not at the expense of humanitarian action; (2) the research is justified in that it is needs-driven and relevant to (...) the affected populations; and (3) the research does not compromise the humanitarian principles of neutrality, impartiality and independence. These primary considerations are in harmony with the humanitarian goals of saving lives, alleviating suffering, and témoignage . Furthermore, there is an important role for research in supporting humanitarian action, and the extreme vulnerability of research participants in complex emergencies demands intense research ethics scrutiny. It is important to discern which ethical considerations are essential, and which are merely desirable, as excessive research ethics requirements may impede life-saving research. (shrink)

To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in early 1996 (...) led to a response from drug companies, especially Pfizer, as well as humanitarian workers from Médecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually – based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences. (shrink)

Social exclusion and legal marginalization are important determinants of health outcomes for people who use illicit drugs, sex workers, and persons who face criminal penalties because of homosexuality or transgenderism. Incarceration may add to the health risks associated with police repression and discrimination for these persons. Access to legal services may be essential to positive health outcomes in these populations. Through concrete examples, this paper explores types of legal problems and legal services linked to (...) class='Hi'>health outcomes for drug users, sex workers, and sexual minorities and makes recommendations for donors, legal service providers, and civil society organizations. (shrink)

In the field of bioethics, scholars have begun to consider carefully the impact of structural issues on global population health, including socioeconomic and political factors influencing the disproportionate burden of disease throughout the world. Human rights and social justice are key considerations for both population health and biomedical research. In this paper, I will briefly explore approaches to human rights in bioethics and review guidelines for ethical conduct in international health research, focusing specifically on (...) class='Hi'>health research conducted in resource-poor settings. I will demonstrate the potential for addressing human rights considerations in international health research with special attention to the importance of collaborative partnerships, capacity building, and respect for cultural traditions. Strengthening professional knowledge about international research ethics increases awareness of ethical concerns associated with study design and informed consent among researchers working in resource-poor settings. But this is not enough. Technological and financial resources are also necessary to build capacity for local communities to ensure that research results are integrated into existing health systems. Problematic issues surrounding the application of ethical guidelines in resource-poor settings are embedded in social history, cultural context, and the global political economy. Resolving the moral complexities requires a commitment to engaged dialogue and action among investigators, funding agencies, policy makers, governmental institutions, and private industry. (shrink)

Audit standards require auditors to conduct audits being independent in mental attitude from their clients. Regulators and financial statement users are concerned that auditors compromise their independence by allowing clients that contract for consulting services, i.e., non-audit services, more financial statement discretion relative to clients that demand relatively little non-audit services from their auditor. This paper begins by discussing the role of auditing in the capital markets and the various stakeholders that rely on audited financial information in (...) making their capital allocation decisions. The paper continues by explaining the ethical dilemma inherent in audit contracts in general, and more specifically, how the provision of non-audit services threatens auditor independence. The paper concludes by summarizing research studies that report conflicting evidence that there is a violation of auditor independence due to the provision of non-audit services to audit clients. (shrink)

With the recent expansion of child mental health research, more attention is being paid to the process of informed consent for research participation. For the consent to be truly informed, it is necessary that the relevant information be both disclosed and actually understood. Traditionally, much effort has gone to ensuring the comprehensiveness of consent/assent documents, which have progressively increased in length and complexity, whereas less attention has been paid to the comprehensibility of these documents. Available data indicate (...) that many parent and children have difficulties appreciating the research nature of treatment studies and that a higher level of formal education among the parents is associated with a greater degree of understanding. Promising approaches to achieving truly informed research participation have emerged, such as additional time for parents to meet with the researchers and using postexplanation questionnaires for identifying issues in need of further clarification. Research is needed to develop and test strategies for improving the effectiveness of the informed consent process in child mental health. (shrink)

Qualitative inquiry is increasingly used to foster change in health policy and practice. Research ethics committees often misunderstand qualitative inquiry, assuming its design can be judged by criteria of quantitative science. Traditional health research uses scientific realist standards as a means-to-an-end, answering the question “So what?” to support the advancement of practice and policy. In contrast, qualitative inquiry often draws on constructivist paradigms, generating knowledge either as an end-in-itself or as a means to (...) foster change. When reviewers inappropriately judge qualitative inquiry, it restricts the ways health phenomena can be understood. Qualitative inquiry is necessary because it enables an understanding not possible within scientific explanation. When such research illuminates, it can also shed light onto the “So what?” In order to ensure an appraisal of qualitative inquiry congruent with its paradigmatic premises, we suggest the “Illumination Test,” met when findings foster rich understanding of phenomena, resulting in a reflective “aha!”. (shrink)

Guidelines for health research focus on protecting individual research subjects. It is also vital to protect the communities involved in health research. In particular, a number of studies have been criticized on the grounds that they exploited host communities. The present paper attempts to address these concerns by providing an analysis of community exploitation and, based on this analysis, determining what safeguards are needed to protect communities in health research against exploitation. (edited).

This overview describes the breadth of topicscovered in this volume devoted to children inresearch. It summarizes how these articles areinterrelated and how they all respond to thechallenge proposed by the Children's Health Actof 2000: to consider what modifications, ifany, are necessary to current regulations ``toensure the adequate and appropriate protectionof children participating in research.''.

‘Researcher identity’ affects global health research in profound and complex ways. Anthropologists in particular have led the way in portraying the multiple, and sometimes tension-generating, identities that researchers ascribe to themselves, or have ascribed to them, in their places of research. However, the central importance of researcher identity in the ethical conduct of global health research has yet to be fully appreciated. The capacity of researchers to respond effectively to the ethical tensions surrounding their identities (...) is hampered by lack of conceptual clarity, as to the nature and scope of the issues involved. This paper strives to provide some clarification of these ethical tensions by considering researcher identity from the perspective of (1) Guillemin and Heggen's (2009) key distinction between procedural ethics and ethics in practice, and (2) our own distinction between perceptions of identity that are either symmetrical or asymmetrical, with the potential to shift research relationships toward greater or lesser ethical harmony. Discussion of these concepts is supported with ethnographic examples from relevant literature and from our own (United States (US) Government-funded) research in South Africa. A preliminary set of recommendations is provided in an effort to equip researchers with a greater sense of organization and control over the ethics of researcher identity. The paper concludes that the complex construction of researcher identity needs to be central among the ethical concerns of global health researchers, and that the conceptual tools discussed in the paper are a useful starting point for better organizing and acting on these ethical concerns. (shrink)

Funding agencies in Canada are attempting to break down the organizational boundaries between disciplines to promote interdisciplinary research and foster the integration of the social sciences into the health research field. This paper explores the extent to which biomedical and clinician scientists’ perceptions of social science research operate as a cultural boundary to the inclusion of social scientists into this field. Results indicated that cultural boundaries may impede social scientists’ entry into the health research (...) field through three modalities: (1) biomedical and clinician scientists’ unfavourable and ambivalent posture towards social science research; (2) their opposition to a resource increase for the social sciences; and (3) clinician scientists procedural assessment criteria for social science. The paper also discusses the merits and limitations of Tom Gieryn’s concept of boundary-work for studying social dynamics within the field of science. (shrink)

Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing (...) committees. Results Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity. (shrink)

The prevailing wisdom is that improving patient access to physician services is essential to promoting the public's health. This article suggests that, ironically, one effect of the 2010 federal health reform legislation may be to discourage physicians from serving the statute's intended beneficiaries, thereby exacerbating the access problem. The article examines several potential approaches to addressing this problem, comparing — from legal and policy perspectives — strategies based on legal conscription of physician services versus strategies that (...) instead would rely on incentivizing physician participation in serving otherwise access-impaired populations. The author argues in favor of the latter approach rather than one based on use of governmental force. (shrink)

BackgroundIncrease in global health research undertaken in resource poor settings in the last decade though a positive development has raised ethical concerns relating to potential for exploitation. Some of the suggested strategies to address these concerns include calls for providing universal standards of care, reasonable availability of proven interventions and more recently, promoting the overall social value of research especially in clinical research. Promoting the social value of research has been closely associated with providing fair (...) benefits to various stakeholders involved in research. The debate over what constitutes fair benefits; whether those that addresses micro level issues of justice or those focusing on the key determinants of health at the macro level has continued. This debate has however not benefited from empirical work on what stakeholders consider fair benefits. This study explores practical experiences of stakeholders involved in global health research in Kenya, over what benefits are fair within a developing world context.Methods and resultsWe conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups.The range of benefits articulated by stakeholders addresses both micro and macro level concerns for justice by for instance, seeking to engage with interests of those facilitating research, and the broader systemic issues that make resource poor settings vulnerable to exploitation. We interpret these views to suggest a need for global health research to engage with current crises that face people in these settings as well as the broader systemic issues that produce them.ConclusionGlobal health research should provide benefits that address both the micro and macro level issues of justice in order to forestall exploitation. Embracing the two is however challenging in terms of how the various competing interests/needs should be balanced ethically, especially in the absence of structures to guide the process. This challenge should point to the need for greater dialogue to facilitate value clarification among stakeholders. (shrink)

Ethical considerations are integral to the formulation and practice of biological and medical research. Every stage of the research process is (ostensibly) informed by principles and guidelines designed to ensure that research is conducted in an ethical manner. The difficulty inherent in defining what is "ethical" and in applying broad principles to novel situations means that increasing attention is being paid to ethics in research. In a field that appears to be constantly evolving as technologies and (...) societies change, it seems safe to assume that the practice of health research almost of necessity raises new ethical issues. This assumption is, however, worthy of critical attention, as it may have important .. (shrink)

When environmental health researchers study hazards in the home, they often discover information that may be relevant to protecting the health and safety of the research subjects and occupants. This article describes the ethical and legal basis for a duty to warn research subjects and occupants about hazards in the home and explores the extent of this duty. Investigators should inform research subjects and occupants about the results of tests conducted as part of the (...) class='Hi'>research protocol only if the information is likely to be accurate, reliable, and medically useful. Investigators should warn subjects and occupants about hazards they happen to discover while they are in the home, if a reasonable person would warn the subjects and occupants about those hazards. Investigators should not report illegal hazards discovered in the home to the authorities, unless those hazards constitute abuse or neglect of children or mentally disabled people living in the home. When investigators decide to warn research subjects and occupants about hazards in the home, they should take some steps to help them make effective use of this information, such as providing additional counselling or making a referral for remediation or medical treatment. Investigators should discuss these issues with research subjects during the informed consent process. (shrink)

Health industries attempt to influence the public through the news media and through their relationships with expert academics and opinion leaders. This study reports journalists' perceptions of their professional roles and responsibilities regarding the relationships between industry and academia and research results. Journalists believe that responsibility for the scientific validity of their reports rests with academics and systems of peer review. However, this approach fails to account for the extent of industry-academy interactions and the flaws of peer review. (...) Health journalists' retention of a critical stance regarding industry-academia relationships will include advocacy for and adoption of mandatory reporting of these relationships. (shrink)

Background Next Generation Sequencing (NGS) is expected to help find the elusive, causative genetic defects associated with Bipolar Disorder (BD). This article identifies the importance of NGS and further analyses the social and ethical implications of this approach when used in research projects studying BD, as well as other psychiatric ailments, with a view to ensuring the protection of research participants. Methods We performed a systematic review of studies through PubMed, followed by a manual search through the titles (...) and abstracts of original articles, including the reviews, commentaries and letters published in the last five years and dealing with the ethical and social issues raised by NGS technologies and genomics studies of mental disorders, especially BD. A total of 217 studies contributed to identify the themes discussed herein. Results The amount of information generated by NGS renders individuals suffering from BD particularly vulnerable, and increases the need for educational support throughout the consent process, and, subsequently, of genetic counselling, when communicating individual research results and incidental findings to them. Our results highlight the importance and difficulty of respecting participants’ autonomy while avoiding any therapeutic misconception. We also analysed the need for specific regulations on the use and communication of incidental findings, as well as the increasing influence of NGS in health care. Conclusions Shared efforts on the part of researchers and their institutions, Research Ethics Boards as well as participants’ representatives are needed to delineate a tailored consent process so as to better protect research participants. However, health care professionals involved in BD care and treatment need to first determine the scientific validity and clinical utility of NGS-generated findings, and thereafter their prevention and treatment significance. (shrink)

Background: Low rates of participation of adolescents and young adults (AYAs) in clinical oncology trials may contribute to poorer outcomes. Factors that influence the decision of AYAs to participate in health research and whether these factors are different from those that affect the participation of parents of children with cancer. Methods: This is a secondary analysis of data from validated questionnaires provided to adolescents (>12 years old) diagnosed with cancer and parents of children with cancer at 3 sites (...) in Canada (Halifax, Vancouver, and Montreal) and 2 in the United States (Atlanta, GA, and Memphis, TN). Respondents reported their own research participation and cited factors that would influence their own decision to participate in, or to provide parental authorization for their child to participate in health research. Results: Completed questionnaire rates for AYAs and parents were 86 (46.5%) of 185 and 409 (65.2%) of 627, respectively. AYAs (n = 86 [67%]) and parents (n = 409 [85%]) cited that they would participate in research because it would help others. AYAs perceived pressure by their family and friends (16%) and their physician (19%). Having too much to think about at the time of accrual was an impediment to both groups (36% AYAs and 47% parents). The main deterrent for AYAs was that research would take up too much time (45%). Nonwhite parents (7 of 56 [12.5%]) were more apt to decline than white parents (12 of 32 [3.7%]; P < .01). Conclusions: AYAs identified time commitment and having too much to think about as significant impediments to research participation. Addressing these barriers by minimizing time requirements and further supporting decision-making may improve informed consent and impact on enrollment in trials. (shrink)

Cross-border academic collaborations in conflict zones are vulnerable to escalated turbulence, liability concerns and flagging support. Multi-level stakeholder engagement at home and abroad is essential for securing the political and financial sustainability of such collaborations. This study examines the multilayered stakeholder arrangements within an international academic health science network contributing to peace-building in the Middle East. While organizational forms in this collaboration change to reflect the structural, epistemic and political expectations of various support groups operating locally and globally, the (...) legitimacy of the international research and its contribution to the peace-building process last as long as institutional norms of academic enterprise – integrity, impartiality and collegiality – are sustained. This paper analyzes the reconciliatory strategies used by the collaborating health scientists to mitigate organizational turbulence, reduce resource asymmetries and continually build and rebuild bridges across stakeholder communities. (shrink)

Our society has long sanctioned, at least tacitly, a degree of conflict of interest in medical practice and clinical research as an unavoidable consequence of the different interests of the physician or clinical investigator, the patient or clinical research subject, third party payers or research sponsors, the government, and society as a whole, to name a few. In the past, resolution of these conflicts has been left to the conscience of the individual physician or clinical investigator and (...) to professional organizations. The public is no longer willing to allow health care providers to wholly govern their own conflicts of interest for several reasons. These include: new forms of health care financing and delivery that provide innovative and lucrative opportunities for physician or insurer enrichment at patient expense; the increased importance of commercial research support as peer-reviewed governmental research support has decreased; evidence that physicians and clinical investigators too frequently resolve conflicts of interest in their own favor; and a general societal mistrust of authority. This volume represents a multidisciplinary effort, drawing from philosophy, medicine, law, economics and public policy to identify and categorize conflicts of interest in medical practice and clinical research, and, where possible, to offer a mechanism for resolving them. Part I addresses conflicts of interest from a theoretical perspective, offering basic concepts and analytical frameworks. The second part discusses two topics prominent in current health care policy debates--self-referral and financial incentives to limit care. Part III examines conflicts of interest generated by pharmaceutical industry involvement in clinical practice and research. The final section deals with conflicts of interest in clinical research in several contexts, including institutional reviews boards, clinical trials, Cooperative Research and Development Agreements between government and private researchers, brokerage of research subjects by Contract Research Organizations, and cost-effectiveness studies. (shrink)

Scientists, bioethicists, and policy makers are currently engaged in a contentious debate about the scientific prospects and morality of efforts to increase human longevity. Some demographers and geneticists suggest that there is little reason to think that it will be possible to significantly extend the human lifespan. Other biodemographers and geneticists argue that there might well be increases in both life expectancy and lifespan. Bioethicists and policy makers are currently addressing many of the ethical, social, and economic issues raised by (...) life extension research. However, the emphasis on philosophical argument supporting or condemning efforts to increase human longevity means that much less attention is currently being given to the factors that might play a role in generating interest in efforts to increase human longevity. This analysis considers three factors that might play a role in heightening public interest in efforts to develop biomedical technologies capable of retarding or reversing aging processes. While discussions of life extension research can seem quite futuristic and impractical, there are some powerful existential factors that might well generate considerable public support for life extension strategies if effective biomedical interventions emerge. Rather than providing philosophical justifications supporting or condemning efforts to increase human longevity, this essay seeks to promote a better understanding of the factors generating contemporary interest in prolonging life and postponing death. (shrink)

The first part of this article shows that oureffective means to know and modify directly thehuman genetic make-up generates singular anddifficult situations for the application offundamental medical categories. Specifically,we demonstrate that in dealing with thesesituations, some predominant views on health,such as descriptivism or that which reduces thestate of health to not having presentdisabilities, cannot provide adequate answerseither from the point of view of medicalscience or in terms of our ordinary intuitions.The second part of the article examines thereasons for (...) the failure of these views totackle the mentioned situations, proposessolutions to urgent problems and, finally,offers some foundations for an alternativetheoretical development, id est, for atheory of health able to satisfactorilyintegrate our genetic dimension. (shrink)

Community Engagement (CE) has been presented by bio-ethicists and scientists as a straightforward and unequivocal good which can minimize the risks of exploitation and ensure a fair distribution of research benefits in developing countries. By means of ethnographic fieldwork undertaken in Kenya between 2007 and 2009 we explored how CE is understood and enacted in paediatric vaccine trials conducted by the Kenyan Medical Research Institute and the US Centers for Disease Control (KEMRI/CDC). In this paper we focus on (...) the role of paid volunteers who act as an interface between villagers KEMRI/CDC. Village Reporters’ (VRs) position of being both with the community and with KEMRI/CDC is advantageous for the conduct of trials. However it is also problematic in terms of exercising trust, balancing allegiances and representing community views. VRs role is shaped by ambiguities related to their employment status and their dual accountability to researchers and their villages. VRs are understandably careful to stress their commitment to self-less community service since it augments their respectability at community level and opens up opportunities for financial gain and self-development. Simultaneously VRs association with KEMRI/CDC and proximity to trial participants requires them to negotiate implicit and explicit expectations for material and medical assistance in a cultural setting in which much importance is placed on sharing and mutuality. To ensure continuity of productive interactions between VRs, and similar community intermediaries, and researchers, open discussion is needed about the problematic aspects of relational ethics, issues concerning undue influence, power relations and negotiating expectations. (shrink)

Psychiatry is increasingly dominated by the reductionist claim that mental illness is caused by neurobiological abnormalities such as chemical imbalances in the brain. Critical psychiatry does not believe that this is the whole story and proposes a more ethical foundation for practice. This book describes an original framework for renewing mental health services in alliance with people with mental health problems. It is an advance over the polarization created by the "anti-psychiatry" of the past.

Does a kindly, charitable interest in others have health benefits for the agent, particularly when coupled with helping behaviours? Although the answer remains unclear, researchers have established that there is an association between generous emotions, helping behaviour, and longevity. Increasingly, emotional states and their related behaviours are being studied by mainstream scientists in relation to health promotion and disease prevention. If helping affect or behaviour can be linked with health and longevity, there are significant implications for how (...) we think about human nature and prosperity. Although studies show that those who are physically or psychologically overwhelmed by the needs of others do experience a stressful burden that can have significant negative health consequences, little attention has been given to whether there are health benefits from helping behaviour that is fulfilling, not overwhelming. In this book, Stephen Post brings together distinguished researchers from basic science to address this question in objective terms. The book provides heuristic models, from evolution and neuroscience, to explain the association between altruism and health, and examines potential public health and practical implications of the existing data. (shrink)

Inequities in health and health care are one of the greatest challenges facing the international community today. This problem raises serious questions for health care planners, politicians and ethicists alike. The major world religions can play an important role in this discussion. Therefore, interreligious dialogue on this topic between ethicists and health care professionals is of increasing relevance and urgency. This article gives an overview on the positions of Islam and Christianity on equity and the distribution (...) of resources in health care. It has been written in close collaboration and constant dialogue between the two authors coming from the two religions. Although there is no specific concept for the modern term equity in either of the two religions, several areas of agreement have been identified: All human beings share the same values and status, which constitutes the basis for an equitable distribution of rights and benefits. Special provisions need to be made for the most needy and disadvantaged. The obligation to provide equitable health services extends beyond national and religious boundaries. Several areas require intensified research and further dialogue: the relationship between the individual and the community interms of rights and responsibilities, how to operationalize the moral duty to decrease global inequalities in health, and the understanding and interpretation of human rights in regard to social services. (shrink)

Priority setting in health care means making distributional decisions, which inherently involves limiting access to some health services. Public health ethics involves many ethical principles like efficiency, equity and individual choice, which are frequently appealed to but rarely analysed. How these concepts are understood and applied impacts on healthcare planning and delivery policies. This article discusses findings of a research study undertaken in the context of the Iranian health system in which two main ethical (...) values appear to be operating: equity and personal choice. It asserts that the pro-market perspective, driven by individual choice appears to be dominant as it is influenced by the powerful medical profession. This is despite egalitarian intentions proclaimed in the Constitution and the majority of national laws. The study argues that the market influence in healthcare priority setting is unlikely to diminish because of weak implementation of existing laws. In conclusion, the article suggests that the private health sector could help to achieve the state’s proclaimed egalitarian goals only if new regulatory systems and new systems of governance are implemented. Such measures should be aimed at monitoring and controlling the performance of the private sector, to better manage and harness its capacities. (shrink)