In their article, “The job of ‘ethics committees’”, Andrew Moore and Andrew Donnelly argue that current guidance documents provide that institutional research review committees ) perform two different and distinct functions, namely, a regulative review and an ethical review. They argue for separating those functions and for eliminating the ethics review role from IRBs. Instead, they want IRBs to focus exclusively on determining whether research proposals conform to governing regulations. In their argument, Moore and Donnelly correctly note that regulatory requirements (...) and ethical requirements can conflict. That point is correct, but hardly surprising. After all, regulations are general and the research proposals are specific, so an individual proposal may not conform to the general formulation of the rule and yet be consistent with ethics. Thus, a rule may generally be regarded as expressing a relevant moral consideration while providing a conclusion that does not appropriately reflect an ethical determination in the specific case. This inconsistency need not amount to what Moore and Donelly characterise as a ‘repellent’ or an ‘unconscionable’ review decision. Moore and Donnelly are also concerned that IRB decisions may differ from each other in their review of the same proposal. Again, they are correct in recognising that such inconsistent outcomes would be less likely if IRBs were to focus exclusively on whether proposals conformed to the regulations. That said, I reach the opposite conclusion. As I see it, IRBs present us with a good example of when the possibility of inconsistency is a relatively small consideration in comparison to the important values that are served by IRBs considering their protocol reviews in light of ethics and conforming to regulations. Allow me to explain. The authors and endorsers of research ethics …. (shrink)

As we look to the future in a world with porous borders and boundaries transgressed by technologies, an inevitable question is:Can there be a single, global bioethics? Intimately intertwined with this question is a second one: How might a global bioethics account for profound - and constantly transforming - sources of cultural difference? Can a uniform, global bioethics be relevant cross-culturally? These are not simple questions, rather, a multi-dimensional answer is required. It is important to distinguish between two meanings of (...) bioethics: the academic discipline of bioethics as opposed to bioethics as a set of practices governing clinical care and scientific research. There is growing evidence to support the notion of a shared global understanding of bioethics as a field of inquiry focused on the moral dimensions of science and biomedicine. (shrink)

These CQ Sources were compiled by Bette Anton.

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 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)

In this essay the ethical issues related to the ‘standard of care’ are discussed together with the implications for the treatment of the control group in transnational clinical trials. It is argued that the human right to health and the duty of justice formulate the moral basis on which this case should be debated.

Despite broad agreement that the vulnerable have a claim to special protection, defining vulnerable persons or populations has proved more difficult than we would like. This is a theoretical as well as a practical problem, as it hinders both convincing justifications for this claim and the practical application of required protections. In this paper, I review consent-based, harm-based, and comprehensive definitions of vulnerability in healthcare and research with human subjects. Although current definitions are subject to critique, their underlying assumptions may (...) be complementary. I propose that we should define vulnerability in research and healthcare as an identifiably increased likelihood of incurring additional or greater wrong. In order to identify the vulnerable, as well as the type of protection that they need, this definition requires that we start from the sorts of wrongs likely to occur and from identifiable increments in the likelihood, or to the likely degree, that these wrongs will occur. It is limited but appropriately so, as it only applies to special protection, not to any protection to which we have a valid claim. Using this definition would clarify that the normative force of claims for special protection does not rest with vulnerability itself, but with pre-existing claims when these are more likely to be denied. Such a clarification could help those who carry responsibility for the protection of vulnerable populations, such as Institutional Review Boards, to define the sort of protection required in a more targeted and effective manner. (shrink)

The governance of pharmaceutical medicines entails complex ethical decisions that should, in theory, be the responsibility of democratically accountable government agencies. However, in many Low- and Middle-Income Countries (LMICs), regulatory and health systems constraints mean that many people still lack access to safe, appropriate and affordable medication, posing significant ethical challenges for those working on the “front line”. Drawing on 18 months of fieldwork in Ghana, we present three detailed case studies of individuals in this position: an urban retail pharmacist, (...) a rural over-the-counter medicine retailer, and a local inspector. Through these case studies, we consider the significant burden of “ethical labour” borne by those operating “on the ground”, who navigate complex moral, legal and business imperatives in real time and with very real consequences for those they serve. The paper ends with a reflection on the tensions between abstract, generalised ethical frameworks based on high-level principles, and a pragmatic, contingent ethics-in-practice that foregrounds immediate individual needs – a tension rooted in the gap between the theory and the reality of pharmaceutical governance that shifts the burden of ethical labour downwards and perpetuates long-term public health risks. (shrink)

If funding allocation is an indicator of a field’s priorities, then the priorities of the field of bioethics are misaligned because they perpetuate injustice. Social justice mandates priority for the factors that drive systematic disadvantage, which tend not to be the areas supported by funding within academic bioethics. Current funding priorities violate social justice by overemphasizing technologies that aim to enhance the human condition without addressing underlying structural inequalities grounded in racism, and by deemphasizing areas of inquiry most frequently pursued (...) by Scholars of Color. This lack of attention to upstream determinants of health in bioethics research perpetuates a gap in the resources needed to understand the experiences of communities disproportionately experiencing poor health, which is itself a form of epistemic injustice. Both social and epistemic injustices are apparent in the impact of these funding priorities on people of color, both in the public and in the bioethics community. (shrink)

This article critically examines current responses to multi-drug resistant tuberculosis and argues that bioethics needs to be willing to engage in a more radical critique of the problem than is currently offered. In particular, we need to focus not simply on market-driven models of innovation and anti-microbial solutions to emergent and re-emergent infections such as TB. The global community also needs to address poverty and the structural factors that entrench inequalities—thus moving beyond the orthodox medical/public health frame of reference.

Communicable diseases, especially those that are highly contagious, are on the rise and each of us, no matter who we are or where we live, is equally at risk of transmitting contagious diseases to others as we are of contracting such diseases from others. Because contagious diseases are as readily passed state-to-state as person-to-person, we all have a stake in every country's ability to enact effective infectious disease control policies, while policies grounded in shared values are more likely to gain (...) widespread acceptance and thereby prove most effective. This paper suggests that principlism proved invaluable as an ethical framework for resolving hard medical cases and setting health care policy because it nicely “fits” dilemmas that arise in the context of the special relationship between doctors and patients or within family units. It then argues that communitarianism provides the better foundation for crafting infectious diseases control policies because contagious diseases, which often pass between perfect strangers, raise questions about the moral obligations we owe to (or are entitled to demand of) people with whom we share no “special” relationship. Accordingly, a socially embedded framework such as communitarianism may be a better fit for the more socially embedded ethical dilemmas of communicable diseases. (shrink)

Communicable diseases, especially those that are readily contagious, are on the rise as evidenced by the emergence of viruses like severe acute respiratory syndrome, the global resurgence of resistant forms of ancient mycobacteria such as extensively drug resistant tuberculosis, and the 2009 swine flu outbreak in Mexico. Moreover, each of us, no matter who we are or where we live, is just as likely to transmit contagious diseases to others as we are to contract such diseases from others. As cogently (...) described in the title of a recent book by Margaret Battin et al., we are all potential “victims and vectors.”Just as contagious diseases are readily passed person to person, so too can they readily be passed across local and national boundaries. We therefore all have a stake in the development of effective infectious disease control policies on a national scale, with “effective” being the operative term: regulations and statutes that are neither enforceable nor likely to be complied with may do more harm than good. (shrink)

Humanitarian emergencies and natural disasters can overwhelm the capacity of local and national agencies to respond to the needs of affected populations. In such cases, international relief organizations are frequently involved in the provision of emergency assistance. Health care professionals play a key role in these interventions. This practice environment is significantly different from the context of health care delivery in the home countries of expatriate health care professionals. Clinicians who travel from a developed nation to a resource-poor setting where (...) a humanitarian crisis has occurred experience a shift of professional, social, cultural and regulatory environments. In this dissertation I examine the ethics of health care practice in humanitarian work. I evaluate the literature of global bioethics, global health ethics and the ethics of humanitarian assistance, and consider the contributions of various ethics frameworks and normative approaches. I also develop a set of questions to guide health care professionals as they address ethically complex issues arising in clinical practice during humanitarian crises. In the empirical component of this research program I use Interpretive Description methodology to examine the moral experience of health care professionals in humanitarian relief work, and clinician experiences of resources and constraints for addressing ethical issues in humanitarian settings. Building upon the inductively derived findings, I argue for strategies and approaches that humanitarian organizations, project teams, and health care professionals can adopt to respond to the ethics of this field of practice. I also provide a critical review of Interpretive Description methodology. The research presented in this dissertation makes an important contribution to the ethical analysis of health care practice in humanitarian work. (shrink)