Diego S. Silva

Animal Study Registries: Results from a Stakeholder Analysis on Potential Strengths, Weaknesses, Facilitators, and Barriers.

Publication bias in animal research, its extent, its predictors, and its potential countermeasures are increasingly discussed. Recent reports and conferences highlight the potential strengths of animal study registries (ASRs) in this regard. Others have warned that prospective registration of animal studies could diminish creativity, add administrative burdens, and complicate intellectual property issues in translational research. A literature review and 21 international key-informant interviews were conducted and thematically analyzed to develop a comprehensive matrix of main- and subcategories for potential ASR-related strengths, weaknesses, facilitators, and barriers (SWFBs). We identified 130 potential SWFBs. All stakeholder groups agreed that ASRs could in various ways improve the quality and refinement of animal studies while allowing their number to be reduced, as well as supporting meta-research on animal studies. However, all stakeholder groups also highlighted the potential for theft of ideas, higher administrative burdens, and reduced creativity and serendipity in animal studies. Much more detailed reasoning was captured in the interviews than is currently found in the literature, providing a comprehensive account of the issues and arguments around ASRs. All stakeholder groups highlighted compelling potential strengths of ASRs. Although substantial weaknesses and implementation barriers were highlighted as well, different governance measures might help to minimize or even eliminate their impact. Such measures might include confidentiality time frames for accessing prospectively registered protocols, harmonized reporting requirements across ASRs, ethics reviews, lab notebooks, and journal submissions. The comprehensive information gathered in this study could help to guide a more evidence-based debate and to design pilot tests for ASRs.

Ethics for pandemics beyond influenza: Ebola, drug-resistant tuberculosis, and anticipating future ethical challenges in pandemic preparedness and response.

The unprecedented outbreak of Ebola virus disease (EVD) in West Africa has raised several novel ethical issues for global outbreak preparedness. It has also illustrated that familiar ethical issues in infectious disease management endure despite considerable efforts to understand and mitigate such issues in the wake of past outbreaks. To improve future global outbreak preparedness and response, we must examine these shortcomings and reflect upon the current state of ethical preparedness. To this end, we focus our efforts in this article on the examination of one substantial area: ethical guidance in pandemic plans. We argue that, due in part to their focus on considerations arising specifically in relation to pandemics of influenza origin, pandemic plans and their existing ethical guidance are ill-equipped to anticipate and facilitate the navigation of unique ethical challenges that may arise in other infectious disease pandemics. We proceed by outlining three reasons why this is so, and situate our analysis in the context of the EVD outbreak and the threat posed by drug-resistant tuberculosis: (1) different infectious diseases have distinct characteristics that challenge anticipated or existing modes of pandemic prevention, preparedness, response, and recovery, (2) clear, transparent, context-specific ethical reasoning and justification within current influenza pandemic plans are lacking, and (3) current plans neglect the context of how other significant pandemics may manifest. We conclude the article with several options for reflecting upon and ultimately addressing ethical issues that may emerge with different infectious disease pandemics.

Ethical issues in public health surveillance: a systematic qualitative review

BackgroundPublic health surveillance is not ethically neutral and yet, ethics guidance and training for surveillance programmes is sparse. Development of ethics guidance should be based on comprehensive and transparently derived overviews of ethical issues and arguments. However, existing overviews on surveillance ethics are limited in scope and in how transparently they derived their results. Our objective was accordingly to provide an overview of ethical issues in public health surveillance; in addition, to list the arguments put forward with regards to arguably the most contested issue in surveillance, that is whether to obtain informed consent.MethodsEthical issues were defined based on principlism. We assumed an ethical issue to arise in surveillance when a relevant normative principle is not adequately considered or two principles come into conflict. We searched Pubmed and Google Books for relevant publications. We analysed and synthesized the data using qualitative content analysis.ResultsOur search strategy retrieved 525 references of which 83 were included in the analysis. We identified 86 distinct ethical issues arising in the different phases of the surveillance life-cycle. We further identified 20 distinct conditions that make it more or less justifiable to forego informed consent procedures.ConclusionsThis is the first systematic qualitative review of ethical issues in public health surveillance resulting in a comprehensive ethics matrix that can inform guidelines, reports, strategy papers, and educational material and raise awareness among practitioners.

Reciprocity and Ethical Tuberculosis Treatment and Control.

This paper explores the notion of reciprocity in the context of active pulmonary and laryngeal tuberculosis (TB) treatment and related control policies and practices. We seek to do three things: First, we sketch the background to contemporary global TB care and suggest that poverty is a key feature when considering the treatment of TB patients. We use two examples from TB care to explore the role of reciprocity: isolation and the use of novel TB drugs. Second, we explore alternative means of justifying the use of reciprocity through appeal to different moral and political theoretical traditions (i.e., virtue ethics, deontology, and consequentialism). We suggest that each theory can be used to provide reasons to take reciprocity seriously as an independent moral concept, despite any other differences. Third, we explore general meanings and uses of the concept of reciprocity, with the primary intention of demonstrating that it cannot be simply reduced to other more frequently invoked moral concepts such as beneficence or justice. We argue that reciprocity can function as a mid-level principle in public health, and generally, captures a core social obligation arising once an individual or group is burdened as a result of acting for the benefit of others (even if they derive a benefit themselves). We conclude that while more needs to be explored in relation to the theoretical justification and application of reciprocity, sufficient arguments can be made for it to be taken more seriously as a key principle within public health ethics and bioethics more generally.

Using a Delphi process to define priorities for prison health research in Canada

Objectives A large number of Canadians spend time in correctional facilities each year, and they are likely to have poor health compared to the general population. Relatively little health research has been conducted in Canada with a focus on people who experience detention or incarceration. We aimed to conduct a Delphi process with key stakeholders to define priorities for research in prison health in Canada for the next 10 years. Setting We conducted a Delphi process using an online survey with two rounds in 2014 and 2015. Participants We invited key stakeholders in prison health research in Canada to participate, which we defined as persons who had published research on prison health in Canada since 1994 and persons in the investigators’ professional networks. We invited 143 persons to participate in the first round and 59 participated. We invited 137 persons to participate in the second round and 67 participated. Primary and secondary outcome measures Participants suggested topics in the first round, and these topics were collated by investigators. We measured the level of agreement among participants that each collated topic was a priority for prison health research in Canada for the next 10 years, and defined priorities based on the level of agreement. Results In the first round, participants suggested 71 topics. In the second round, consensus was achieved that a large number of suggested topics were research priorities. Top priorities were diversion and alternatives to incarceration, social and community re-integration, creating healthy environments in prisons, healthcare in custody, continuity of healthcare, substance use disorders and the health of Aboriginal persons in custody. Conclusions Generated in an inclusive and systematic process, these findings should inform future research efforts to improve the health and healthcare of people who experience detention and incarceration in Canada.

Ethics of health research with prisoners in Canada

BackgroundDespite the growing recognition for the need to improve the health of prisoners in Canada and the need for health research, there has been little discussion of the ethical issues with regards to health research with prisoners in Canada. The purpose of this paper is to encourage a national conversation about what it means to conduct ethically sound health research with prisoners given the current realities of the Canadian system. Lessons from the Canadian system could presumably apply in other jurisdictions.Main textAny discussion regarding research ethics with Canadian prisoners must begin by first taking into account the disproportionate number of Indigenous prisoners (e.g., 22–25% of prisoners are Indigenous, while representing approximately 3% of the general Canadian population) and the high proportion of prisoners suffering from mental illnesses (e.g., 45% of males and 69% of female inmates required mental health interventions while in custody). The main ethical challenges that researchers must navigate are (a) the power imbalances between them, the correctional services staff, and the prisoners, and the effects this has on obtaining voluntary consent to research; and (b), the various challenges associated to protecting the privacy and confidentiality of study participants who are prisoners. In order to solve these challenges, a first step would be to develop clear and transparent processes for ethical health research, which ought to be informed by multiple stakeholders, including prisoners, the correctional services staff, and researchers themselves.ConclusionStakeholder and community engagement ought to occur in Canada with regards to ethical health research with prisoners that should also include consultation with various parties, including prisoners, correctional services staff, and researchers. It is important that national and provincial research ethics organizations examine the sufficiency of existing research ethics guidance and, where there are gaps, to develop guidelines and help craft policy.

Systems thinking and ethics in public health: a necessary and mutually beneficial partnership

Systems thinking has emerged as a means of conceptualizing and addressing complex public health problems, thereby challenging more commonplace understanding of problems and corresponding solutions as straightforward explanations of cause and effect. Systems thinking tries to address the complexity of problems through qualitative and quantitative modeling based on a variety of systems theories, each with their own assumptions and, more importantly, implicit and unexamined values. To date, however, there has been little engagement between systems scientists and those working in bioethics and public health ethics. The goal of this paper is to begin to consider what it might mean to combine systems thinking with public health ethics to solve public health challenges. We argue that there is a role for ethics in systems thinking in public health as a means of elucidating implicit assumptions and facilitating ethics debate and dialogue with key stakeholders.

Attending to scalar ethical issues in emerging approaches to environmental health research and practice

Accelerated changes to the planet have created novel spaces to re-imagine the boundaries and foci of environmental health research. Climate change, mass species extinction, ocean acidification, biogeochemical disturbance, and other emergent environmental issues have precipitated new population health perspectives, including, but not limited to, one health, ecohealth, and planetary health. These perspectives, while nuanced, all attempt to reconcile broad global challenges with localized health impacts by attending to the reciprocal relationships between the health of ecosystems, animals, and humans. While such innovation is to be encouraged, we argue that a more comprehensive engagement with the ethics of these emerging fields of inquiry will add value in terms of the significance and impact of associated interventions. In this contribution, we highlight how the concept of spatial and temporal scale can be usefully deployed to shed light on a variety of ethical issues common to emerging environmental health perspectives, and that the potential of scalar analysis implicit to van Potter’s conceptualization of bioethics has yet to be fully appreciated. Specifically, we identify how scale interacts with key ethical issues that require consideration and clarification by one health, ecohealth, and planetary health researchers and practitioners to enhance the effectiveness of research and practice, including justice and governance.