Background: Demand for organisational ethics capacity is growing in health organisations, particularly among managers. The role of clinical ethicists in, and perspective on, organisational ethics has not been well described or documented in the literature. Objective: To describe clinical ethicists’ perspectives on organisational ethics issues in their hospitals, their institutional role in relation to organisational ethics, and their perceived effectiveness in helping to address organisational ethics issues. Design and Setting: Qualitative case study involving semi-structured interviews with 18 clinical ethicists across (...) 13 health organisations in Toronto, Canada. Results: From the clinical ethicists’ perspective, the most pressing organisational ethics issues in their organisations are: resource allocation, staff moral distress linked to the organisation’s moral climate, conflicts of interest, and clinical issues with a significant organisational dimension. Clinical ethicists were consulted in particular on issues related to staff moral distress and clinical issues with an organisational dimension. Some ethicists described being increasingly consulted on resource allocation, conflicts of interest, and other corporate decisions. Many clinical ethicists felt they lacked sufficient knowledge and understanding of organisational decision-making processes, training in organisational ethics, and access to organisational ethics tools to deal effectively with the increasing demand for organisational ethics support. Conclusion: Growing demand for organisational ethics expertise in healthcare institutions is reshaping the role of clinical ethicists. Effectiveness in organisational ethics entails a re-evaluation of clinical ethics training to include capacity building in organisational ethics and organisational decision-making processes as a complement to traditional clinical ethics education. (shrink)

In their article “Ethical Issues in Fecal Microbiota Transplantation in Practice,” Ma and colleagues (2017) raise a number of questions related to the development of fecal microbiota transplants (F...

Fecal microbiota transplantation has demonstrated efficacy and is increasingly being used in the treatment of patients with recurrent Clostridium difficile infection. Despite a lack of high-quality trials to provide more information on the long-term effects of FMT, there has been great enthusiasm about the potential for expanding its applications. However, FMT presents many serious ethical and social challenges that must be addressed as part of a successful regulatory policy response. In this article, we draw on a sample of the scientific (...) and bioethics literatures to examine clusters of ethical and social issues arising in five main areas: informed consent and the vulnerability of patients; determining what a “suitable healthy donor” is; safety and risk; commercialization and potential exploitation of vulnerable patients; and public health implications. We find that these issues are complex and worthy of careful consideration by health care professionals. Desperation of a patient should not be the basis for selecting treatment with FMT, and the patient's interests should always be of paramount concern. Authorities must prioritize development of appropriate and effective regulation of FMT to safeguard patients and donors, promote further research into safety and efficacy, and avoid abuse of the treatment. (shrink)

In this article, the authors explore the impact of a potential future regulatory decision by FDA whether or not to continue its enforcement discretion policy allowing physicians to perform, and stool banks to sell, stool product for fecal microbiota transplantation as a treatment for recurrent Clostridium Difficile infection without an Investigative New Drug application. The paper looks at the Agency's regulatory options in light of the current gut microbiota based products that are in the FDA pipeline for drug approval and (...) the potential impact and repercussions of their approval on FDA action. In laying out FDA's options we consider the implications of market exclusivity and off-label use of newly approved drugs. Ultimately, we explore the potential impact of FDA's decision on patients, research, and innovation. (shrink)

Children and adults with dementia are vulnerable populations. Both groups are also relatively seldom included in biomedical research. However, including them in clinical trials is necessary, since both groups are in need of scientific innovation and new therapies. Their dependence and limited decision-making capacities increase their vulnerability, necessitating extra precautions when including them in clinical trials. Beside these similarities there are also many differences between the groups. The most obvious one is that children have an entire life ahead of them (...) and will become persons with certain ideals and preferences, while adults with dementia have lived a life in which they have expressed their ideals and preferences. Some of the available research guidelines recognize these differences, setting one list of specific requirements for groups of incapacitated adults and another list for children. Other documents, however, do not differentiate and only set requirements for subjects unable to consent as a single category of subjects. In this article we analyse to what extent the similarities and differences between the two groups are represented in legal documents and ethical guidelines. The article presents an overview and an analysis of the requirements for doing research with children and dementia patients. We conclude with suggestions about how to better incorporate the morally relevant aspects of these two groups in legislation and ethical guidelines. (shrink)

Children and adults with dementia are vulnerable populations. Both groups are also relatively seldom included in biomedical research. However, including them in clinical trials is necessary, since both groups are in need of scientific innovation and new therapies. Their dependence and limited decision‐making capacities increase their vulnerability, necessitating extra precautions when including them in clinical trials. Beside these similarities there are also many differences between the groups. The most obvious one is that children have an entire life ahead of them (...) and will become persons with certain ideals and preferences, while adults with dementia have lived a life in which they have expressed their ideals and preferences. Some of the available research guidelines recognize these differences, setting one list of specific requirements for groups of incapacitated adults and another list for children. Other documents, however, do not differentiate and only set requirements for subjects unable to consent as a single category of subjects.In this article we analyse to what extent the similarities and differences between the two groups are represented in legal documents and ethical guidelines. The article presents an overview and an analysis of the requirements for doing research with children and dementia patients. We conclude with suggestions about how to better incorporate the morally relevant aspects of these two groups in legislation and ethical guidelines. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

Ethical challenges that arise within healthcare delivery institutions are currently categorized as either clinical or organizational, based on the type of issue. Despite this common binary issue-based methodology, empirical study and increasing academic dialogue indicate that a clear line cannot easily be drawn between organizational and clinical ethics. Disagreement around end-of-life treatments, for example, often spawn value differences amongst parties at both organizational and clinical levels and requires a resolution to address both the case at hand and large-scale underlying system-level (...) confounders. I refer to issues that contain elements of both clinical and organizational issues as hybrids and propose a new taxonomy to characterize hybrid cases. I contend that salient contextual features of an ethical issue, such as where it is identified, who it impacts and where it is ideally resolved in relation to its scope of impact, should inform procedure. Implementation of a Hybrid taxonomy viewing ethical issues as existing on a continuum furthers that end. The primary goals are to 1) systematize thinking about ethical issues that arise within healthcare delivery institutions and 2) allow the content of the ethical challenge to drive the process, rather than continuing to rely on the traditional binary issue-based choice. Failure to capture the complexity of hybrid situations perpetuates incomplete information and ultimately an inchoate resolution that creates more questions than answers. (shrink)