The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting.

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

Emotional support animals are not like prosthetics: a response to Sara Kolmes.

Sara Kolmes has argued that the human 'handlers' of emotional support animals (ESAs) should have the sorts of body-like rights to those animals that people with prosthetics have to their prosthetics. In support of this conclusion, she argues that ESAs both function and feel like prosthetics, and that the disanalogies between ESAs and prosthetics are irrelevant to whether humans can have body-like rights to their ESAs. In response, we argue that Ms Kolmes has failed to show that ESAs are body-like in the ways that paradigmatic prostheses are and that, even if they were, these similarities would be outweighed by a crucial dissimilarity that she underestimates.

In the name of science: animal appellations and best practice.

BACKGROUND: The practice of giving animal research subjects proper names is frowned on by the academic scientific community. While researchers provide a number of reasons for desisting from giving their animal subjects proper names, the most common are that (1) naming leads to anthropomorphising which, in turn, leads to data and results that are unobjective and invalid; and (2) while naming does not necessarily entail some mistake on the researcher's part, some feature of the research enterprise renders the practice impossible or ill-advised. OBJECTIVES: My aim is to assess whether the scientific community's attitude towards naming animal research subjects is justified. That is, I wish to consider whether the practice of naming animal research subjects is good or bad for the purposes of scientific research. METHOD: After reviewing the extant literature, I constructed a list of the main arguments researchers provide for desisting from naming their animal research subjects. I then analysed these arguments, with a view to determining whether they in fact provide good reasons to avoid naming animal research subjects. CONCLUSION: I argue that none of the aforementioned reasons usually provide good grounds for not naming animal research subjects. Moreover, there are usually powerful reasons in favour of researchers giving their research animals proper names. This is because the practice usually leads to greater empathy and so to improved animal well-being. This, in turn, leads to better animal science. Thus, the scientific community's attitude towards naming animal research subjects is not justified.

Are Indirect Benefits Relevant to Health Care Allocation Decisions?

When allocating scarce healthcare resources, the expected benefits of alternative allocations matter. But, there are different kinds of benefits. Some are direct benefits to the recipient of the resource such as the health improvements of receiving treatment. Others are indirect benefits to third parties such as the economic gains from having a healthier workforce. This article considers whether only the direct benefits of alternative healthcare resource allocations are relevant to allocation decisions, or whether indirect benefits are relevant too. First, we distinguish different conceptions of direct and indirect benefits and argue that only a recipient conception could be morally relevant. We analyze four arguments for thinking that indirect benefits should not count and argue that none is successful in showing that the indirectness of a benefit is a good reason not to count it. We conclude that direct and indirect benefits should be evaluated in the same way.

The Ethics of Continued Life-Sustaining Treatment for those Diagnosed as Brain-dead.

Given the long-standing controversy about whether the brain-dead should be considered alive in an irreversible coma or dead despite displaying apparent signs of life, the ethical and policy issues posed when family members insist on continued treatment are not as simple as commentators have claimed. In this article, we consider the kind of policy that should be adopted to manage a family's insistence that their brain-dead loved one continues to receive supportive care. We argue that while it would be ethically inappropriate to continue to devote scarce acute care resources to such patients in a hospital setting, it may not be ethically inappropriate for patients to receive these resources in certain other settings. Thus, if a family insists on continuing to care for their brain-dead loved at their home, we should not, from a policy perspective, interfere with the family's wishes. We also argue that healthcare professionals should make some effort to facilitate the transfer of brain-dead patients to these other settings when families insist on continued treatment despite being informed about the lack of any potential for recovery of consciousness. Our arguments are strengthened by the fact that patients in a persistent vegetative state, who, when correctly diagnosed, also have no potential for recovery of consciousness, are routinely transferred from hospitals to nursing homes or long-term care facilities where they continue to be ventilated, tube fed and to receive other supportive care. We also briefly explore the question of who should be responsible for the costs of such treatment at the long-term care facility.