BackgroundClinical ethics consultations can be complex interventions, involving multiple methods, stakeholders, and competing ethical values. Despite longstanding calls for rigorous evaluation in the field, progress has been limited. The Medical Research Council proposed guidelines for evaluating the effectiveness of complex interventions. The evaluation of CEC may benefit from application of the MRC framework to advance the transparency and methodological rigor of this field. A first step is to understand the outcomes measured in evaluations of CEC in healthcare settings. ObjectiveThe primary (...) objective of this review was to identify and map the outcomes reported in primary studies of CEC. The secondary objective was to provide a comprehensive overview of CEC structures, processes, and roles to enhance understanding and to inform standardization.MethodsWe searched electronic databases to identify primary studies of CEC involving patients, substitute decision-makers and/or family members, clinicians, healthcare staff and leaders. Outcomes were mapped across five conceptual domains as identified a priori based on our clinical ethics experience and preliminary literature searches and revised based on our emerging interpretation of the data. These domains included personal factors, process factors, clinical factors, quality, and resource factors. ResultsForty-eight studies were included in the review. Studies were highly heterogeneous and varied considerably regarding format and process of ethical intervention, credentials of interventionist, population of study, outcomes reported, and measures employed. In addition, few studies used validated measurement tools. The top three outcome domains that studies reported on were quality, process factors, and clinical factors. The majority of studies examined multiple outcome domains. All five outcome domains were multidimensional and included a variety of subthemes.ConclusionsThis scoping review represents the initial phase of mapping the outcomes reported in primary studies of CEC and identifying gaps in the evidence. The confirmed lack of standardization represents a hindrance to the provision of high quality intervention and CEC scientific progress. Insights gained can inform the development of a core outcome set to standardize outcome measures in CEC evaluation research and enable scientifically rigorous efficacy trials of CEC. (shrink)

As scholars integrate empirical approaches to ethical questions in healthcare, relational autonomy theory must inform research design and change practice. Qualitative approaches are well suited to issues where patient values play a central role, and they can be combined with relational autonomy theory to investigate the factors influencing autonomy-rich experiences. This paper draws upon my experience conducting bioethics research related to clinical trial decision-making to develop a systematic method for applying relational autonomy as a theoretical lens to qualitative health research. (...) The resultant practical guide utilizes Susan Sherwin’s theory of relational autonomy and presents an empirical method responsive to autonomy-relevant questions. (shrink)

BackgroundThe boundaries between health-related research and practice have become blurred as initiatives traditionally considered to be practice increasingly use the same methodology as research. Further, the application of different ethical requirements based on this distinction raises concerns because many initiatives commonly labelled as “non-research” are associated with risks to patients, participants, and other stakeholders, yet may not be subject to any ethical oversight. Accordingly, we sought to develop a tool to facilitate the systematic identification of risks to human participants and (...) determination of risk level across a broad range of projects and health-related contexts. This paper describes the development of the Public Health Ontario Risk Screening Tool.MethodDevelopment of the PHO Risk Screening Tool included: preparation of a draft risk tool ; expert appraisal; internal stakeholder validation; external validation; pilot testing and evalution of the draft tool; and revision after 1 year of testing.ResultsA risk screening tool was generated consisting of 20 items organized into five risk domains: Sensitivity; Participant Selection, Recruitment and Consent; Data/Sample Collection; Identifiability and Privacy Risk; and Commercial Interests. The PHO Risk Screening Tool is an electronic tool, designed to identify potential project-associated risks to participants and communities and to determine what level of ethics review is required, if any. The tool features an easy to use checklist format that generates a risk score associated with a suggested level of ethics review once all items have been completed. The final score is based on a threshold approach to ensure that the final score represents the highest level of risk identified in any of the domains of the tool.ConclusionsThe PHO Risk Screening Tool offers a practical solution to the problem of how to maintain accountability and appropriate risk oversight that transcends the boundaries of research and practice. We hope that the PHO Risk Screening Tool will prove useful in minimizing the problems of over and under protection across a wide range of disciplines and jurisdictions. (shrink)

A recent article in this journal described practical and conceptual difficulties faced by public health researchers studying scabies outbreaks in British residential care facilities. Their study population was elderly, decisionally incapacitated residents, many of whom lacked a legally appropriate decision-maker for healthcare decisions. The researchers reported difficulties securing Research Ethics Committee approval. As practicing healthcare ethicists working in a large Canadian research hospital, we are familiar with this challenge and welcomed the authors’ invitation to join the discussion of the ‘outstanding (...) ambiguities and further questions’ that their experience uncovered. We propose a Power of Attorney for Research as one substantive solution to help address the problems they identified. Although we acknowledge the familiar shortcomings associated with Advance Directives in the clinical context, we believe that Powers of Attorney for Research Participation, accompanied by Advance Research Directives, may increase the likelihood of gaining deeper understandings of potential participant’s values and priorities and how they might apply to foreseeable research opportunities. (shrink)