Lisa Eckenwiler

Hopes for Helsinki: reconsidering “vulnerability”

The Declaration of Helsinki is recognised worldwide as a cornerstone of research ethics. Working in the wake of the Nazi doctors’ trials at Nuremberg, drafters of the Declaration set out to codify the obligations of physician-researchers to research participants. Its significance cannot be overstated. Indeed, it is cited in most major guidelines on research involving humans and in the regulations of over a dozen countries. Although it has undergone five revisions,1 and most recently incorporated (albeit controversial) language aimed at addressing concerns over research carried out in resource-poor countries,2–5 the Declaration could go much farther in addressing the profoundly altered landscape of research with humans. Research involving humans is now a global enterprise and often involves participants from resource-poor countries. Rather than being carried out at single institutions by veteran researchers, many studies are now conducted at many locations—including sites that are not academic medical centres—by new and relatively inexperienced investigators. A growing number of projects involve novel agents, based on innovative work in genomics and proteomics. Increasingly, research is sponsored by the for-profit sector. National governments and professional organisations around the globe provide laws, regulations and standards for the conduct of research involving humans. Considerable scholarship also critiques and guides this endeavour. In light of the current effort of the World Medical Association (WMA) to revise the Declaration, we offer ideas on how to re-conceive the concept of “vulnerability” and its links with the principle of justice and, in turn, redirect the attention of researchers towards those who might be so designated. In the research context, “vulnerability” is associated with an inability partly or totally to protect one’s own interests. Typically, conceptions of vulnerability centre upon characteristics associated with particular groups (such as children, prisoners, indigenous people, those who are ill and the poor) that …

Dealing With the Long-Term Social Implications of Research

Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards (IRBs) responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from considering them in their decisions. Yet IRBs often do consider the social implications of research protocols and sometimes create significant delays in initiating or even prevent such research. The social implications of research are important topics for public scrutiny and professional discussion. This article examines the reasons that the federal regulations preclude IRBs from assessing the social risks of research, and examines alternative approaches that have been used with varying success by national advisory groups to provide such guidance. The article concludes with recommendations for characteristics of a national advisory group that could successfully fulfill this need, including sustainability, independence, diverse and relevant expertise, and public transparency.

The Declaration of Helsinki through a feminist lens

This commentary was submitted to the World Medical Association on behalf of the International Network on Feminist Approaches to Bioethics. Our submission included (1) a description of feminist research ethics, (2) suggestions for specific revisions to the Declaration, and (3) elements found in other international research ethics codes that are important from a feminist perspective. Our goals were to encourage the WMA to craft a declaration that: (1) conceptualizes issues of vulnerability in richer and more nuanced ways, (2) resists the influence of profit motives, and (3) extends the scope of responsibility for ethical research more broadly.1

Fresh thinking about the Declaration of Helsinki

A comprehensive approach to ethical research

Real‐Time Responsiveness for Ethics Oversight During Disaster Research

Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises--particularly in resource-poor settings--is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees (RECs). Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster research and argue that ethical disaster research requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like--how it might be conceptualized and utilized--using the concept of real-time responsiveness (RTR). The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained.

Counterterrorism, ethics, and global health.

The intersection of national security, foreign policy, and health has been explored in a number of arenas, but little attention has been devoted to the ethical issues surrounding the global health impact of current counterterrorism policy and practice. In this essay, we’ll review a range of harms to population health traceable to counterterrorism operations, identify concerns involving moral agency and responsibility—specifically of humanitarian health workers, military medical personnel, and national security officials and operatives—and highlight two interrelated policy issues: the need for a conception of national security that incorporates a cosmopolitan concern for health, and the need for shared health governance, including governance of activities affecting health.

Ethics of emergent information and communication technology applications in humanitarian medical assistance

New applications of information and communication technology (ICT) are shaping the way we understand and provide humanitarian medical assistance in situations of disaster, disease outbreak or conflict. Each new crisis appears to be accompanied by advancements in humanitarian technology, leading to significant improvements in the humanitarian aid sector. However, ICTs raise ethical questions that warrant attention. Focusing on the context of humanitarian medical assistance, we review key domains of ICT innovation. We then discuss ethical challenges and uncertainties associated with the development and application of new ICTs in humanitarian medical assistance, including avoiding harm, ensuring privacy and security, responding to inequalities, demonstrating respect, protecting relationships, and addressing expectations. In doing so, we emphasize the centrality of ethics in humanitarian ICT design, application and evaluation.

The Challenge of Timely, Responsive and Rigorous Ethics Review of Disaster Research: Views of Research Ethics Committee Members

Background Research conducted following natural disasters such as earthquakes, floods or hurricanes is crucial for improving relief interventions. Such research, however, poses ethical, methodological and logistical challenges for researchers. Oversight of disaster research also poses challenges for research ethics committees (RECs), in part due to the rapid turnaround needed to initiate research after a disaster. Currently, there is limited knowledge available about how RECs respond to and appraise disaster research. To address this knowledge gap, we investigated the experiences of REC members who had reviewed disaster research conducted in low- or middle-income countries. Methods We used interpretive description methodology and conducted in-depth interviews with 15 respondents. Respondents were chairs, members, advisors, or coordinators from 13 RECs, including RECs affiliated with universities, governments, international organizations, a for-profit REC, and an ad hoc committee established during a disaster. Interviews were analyzed inductively using constant comparative techniques. Results Through this process, three elements were identified as characterizing effective and high-quality review: timeliness, responsiveness and rigorousness. To ensure timeliness, many RECs rely on adaptations of review procedures for urgent protocols. Respondents emphasized that responsive review requires awareness of and sensitivity to the particularities of disaster settings and disaster research. Rigorous review was linked with providing careful assessment of ethical considerations related to the research, as well as ensuring independence of the review process. Conclusion Both the frequency of disasters and the conduct of disaster research are on the rise. Ensuring effective and high quality review of disaster research is crucial, yet challenges, including time pressures for urgent protocols, exist for achieving this goal. Adapting standard REC procedures may be necessary. However, steps should be taken to ensure that ethics review of disaster research remains diligent and thorough.

Counterterrorism policies and practices: health and values at stake

The United States Central Intelligence Agency (CIA) used a fake vaccination programme to obtain DNA (deoxyribonucleic acid) samples in the search for Osama Bin Laden, which caused distrust and hampered polio eradication and other public health efforts in Pakistan.1,2 The Obama administration’s vow that the CIA will never again exploit a vaccination programme in its counterterrorism efforts, therefore came as welcome news to global health and humanitarian communities.3 Distrust and suspicion that public health programmes are being used to advance foreign interests have contributed to the increase in murders and violent attacks on vaccination workers.2 There have been setbacks to polio eradication efforts and other public health objectives.2 Counterterrorism policies and practices can have unintended health impacts, especially where health programmes are co-opted or undermined, in countries where health systems are strained and population-health indicators are poor. The reach of counterterrorism laws is long and they have adversely affected humanitarian health activities in many countries where identified terrorist groups are active and health needs are increased.4 Humanitarian actions can be categorized as providing material support to terrorists. Material support has been interpreted to include the provision of medical care (but not medicines), which can render the very activities that are associated with the core ethical commitments of the medical and nursing professions illegal. Even where specific prohibitions are not in place, such policies have a range of more diffuse effects which can undermine population health. Humanitarian organizations have become more hesitant to rely on local contractors who once provided essential resources like transportation and equipment for fear of making them vulnerable to criminal prosecution or violence.4 Risks of violence have, indeed, increased for health providers where local populations and armed factions perceive them as neither neutral nor impartial, and ultimately untrustworthy.1 This situation contributes to rising security concerns for health providers and facilities.5 The greatest risks, alongside adverse impacts on population health, are incurred by local health workers who may be seen as betraying their own communities, or perceived by other groups to be enemies for having treated members of those communities. Local health workers are typically unable to leave their communities in the face of danger and have access to fewer protections, compared to expatriate humanitarian workers.6 Intelligence officials may attempt to use health organizations and workers to gather intelligence. The United States military has also used health care in the context of counterinsurgency operations.7 These counterterrorism policies and practices can threaten people’s health by creating the conditions for distrust and by deterring people from seeking care. For humanitarian health workers, the principles of impartiality and independence, which lie at the centre of humanitarian work, are undermined. This can lead to moral distress for health workers concerning accountability to intended beneficiaries of services and to funders, responsibility to patients and the law, complicity with perceived wrongs and compromise of professional and personal ethical commitments.6,8 Several ethical values and principles are at stake, including: trust, solidarity, proportionality and accountability. Trust is an essential aspect of all human social interaction, but is especially important in global health work, where health workers employed in a particular public health programme have not previously worked with the local population. Solidarity, although traditionally interpreted as a principle and practice embraced within the confines of community, is now global in scope. Solidarity involves cultivating bonds with others, trying to imagine their plight and standing with them in fighting injustice. In advancing their counterterrorism agenda, strategists and policy-makers should not threaten solidarity in global health action. Indeed, we have witnessed solidarity around the moral imperative to detach counterterrorism measures from health programmes and interventions.2,3 The principle of proportionality states that there should be a balance between the risks of harm and the potential benefits of a given intervention. In this context there is no evidence that population-health impacts are considered by security advisers, an oversight we find ethically unjustifiable given the potential for harm resulting from decisions on the methods used to combat terrorism. This omission also violates obligations to respect and protect health care, established under international humanitarian law9 and human rights law.10 Those focused on fighting terrorism have the responsibility of weighing the potential health consequences for people living in areas targeted by counterterrorism efforts. To the extent that counterterrorism operations, laws, and policies damage population health – especially where these effects are foreseeable and preventable – such responsibilities are clearly established in ethics and international law. New mechanisms to ensure that counterterrorism activities do not contravene international law or ethical values and principles will require careful design. Apart from the ethical and legal grounds, there are good practical reasons to design more effective counterterrorism measures. Preventable harms to population health contribute to mistrust and instability and undermine the stated objectives of the intelligence services.

Introduction: ethics, national security, and global health

ISSN: 1362-3699 (Print) 1743-9396 (Online) Journal homepage: http://www.tandfonline.com/loi/fmcs20 Introduction: ethics, national security, and global health Lisa Eckenwiler & Matthew Hunt To cite this article: Lisa Eckenwiler & Matthew Hunt (2017): Introduction: ethics, national security, and global health, Medicine, Conflict and Survival, DOI: 10.1080/13623699.2017.1327147 To link to this article: http://dx.doi.org/10.1080/13623699.2017.1327147