The ethics review of qualitative health research poses various challenges that are due to a mismatch between the current practice of ethics review and the nature of qualitative methodology. The process of obtaining ethics approval for a study by a research ethics committee before the start of a research study has been described as “procedural ethics” and the identification and handling of ethical issues by researchers during the research process as “ethics in practice.” While some authors dispute and other authors (...) defend the use of procedural ethics in relation to qualitative health research, there is general agreement that it needs to be supplemented with ethics in practice. This article aims to provide an illustration of research ethics in practice by reflecting on the ways in which we identified and addressed ethical and methodological issues that arose in the context of an interview study with mental health service users and relatives. We describe the challenges we faced and the solutions we found in relation to the potential vulnerability of research participants, the voluntariness of consent, the increase of participant access and the heterogeneity of the sample, the protection of privacy and internal confidentiality, and the consideration of personal and contextual factors. (shrink)

Background: There is a significant discourse in the literature that opines that people who use illicit opiates are unable to provide informed consent due to withdrawal symptoms and cognitive impairment as a result of opiate use. Aims: This paper discusses the issues related to informed consent for this population. Ethical considerations: Ethical approval was obtained from both the local REB and the university. Written informed consent was obtained from all participants. Method: This was a qualitative interpretive descriptive study. 22 participants (...) were interviewed, including 18 nurses, 2 social workers and 2 clinic support workers. The findings were analyzed using thematic analysis, which is a way of systematically reducing the complexity of the information to arrive at generalized explanations. Results: The staff at the clinic were overwhelming clear in their judgment that people who use opiates can and should be able to participate in research and that their drug use is not a barrier to informed consent. Conclusions: It is important to involve people who use opiates in research. Protectionist concerns about this population may be overstated. Such concerns do not promote the interests of research participants. People who use heroin need to be able to tell their story. (shrink)

Advance care planning is a process that encourages people to identify their values, to reflect upon the meanings and consequences of serious illness, to define goals and preferences for future medical treatment and care, and to discuss these goals with family and health-care providers. Advance care planning is especially important for those who are chronically ill, as patients and their families face a variety of complex healthcare decisions. Participating in advance care planning has been associated with improved outcomes; yet, despite (...) over 25 years of public awareness campaigns, research, and interventions developed to increase participation, advance care planning completion rates for people with chronic illnesses are no different than those in the general public (approximately 25%).Advance care planning has traditionally used an individualistic approach to autonomy, which puts forward an understanding of agents as independent, rational and self-interested persons. Because this individualistic approach has been largely unsuccessful in improving advance care planning uptake, a re-examination of the philosophical underpinnings of this practice and an exploration of alternative frameworks is warranted. In offering this exploration, we briefly outline two current perspectives on autonomy: the individualistic view and the relational view as articulated by feminist philosophers. Using a critical examination of the theoretical and empirical work on this topic, we argue that the individualistic view of autonomy does not sufficiently capture the relational and social complexities of the decision-making process of advance care planning. To offer a counterpoint, we examine the relational view of autonomy and suggest that this perspective is better aligned with the process of advance care planning. Specifically, we demonstrate that a relational model of autonomy is well suited to exploring advance care planning for four main reasons: (1) it recognizes the importance of relationships, (2) it reflects the fluctuating nature of autonomy in chronic illness, (3) it recognizes vulnerability, and (4) it is consonant with empirical work examining the advance care planning process. (shrink)

Research is an integral part of evidence-based practice in the emergency department and critical care unit that improves patient management. It is important to understand the need and major obstacles for conducting research in emergency settings. Herein, we review the literature for the obligations, ethics and major implications of emergency research and the associated limiting factors influencing research activities in critical care and emergency settings. We reviewed research engines such as PubMed, MEDLINE, and EMBASE for the last two decades using (...) the key words “emergency department”, “critical care”, “research”, “consent”, and “ethics” as the search terms. Research within emergency settings is slow or non-existent due to time and financial constraints as well as the lack of a research tradition. There are several barriers to conducting research studies in emergency situations such as who, what, when, and how to obtain patient consent. The emergency environment is highly pressurized, emotional, and overburdened. The time taken for research is a particular risk that could delay the desired immediate interventions. Ethical issues abound, particularly relating to informed consent. Research in emergency settings is still in its infancy. Thus, there is a strong need for extensive research in the emergency setting through community awareness, resource management, ethics, collaborations, capacity building, and the development of a research interest for the improvement of patient care and outcomes. We need to establish a well-structured plan to assess and track the decision-making capacity, consider a multistep enrolment and consent strategy, and develop an integrated approach for recruitment into studies. (shrink)

The U.S. National Institute of Allergies and Infectious Diseases and the National Institute of Mental Health have a new research priority: inclusion of terminally ill persons living with HIV in HIV cure-related research. For example, the Last Gift is a clinical research study at the University of California San Diego for PLWHIV who have a terminal illness, with a prognosis of less than 6 months. As end-of-life HIV cure research is relatively new, the scientific community has a timely opportunity to (...) examine the related ethical challenges. Following an extensive review of the EOL and HIV cure research ethics literature, combined with deliberation from various stakeholders and our experience with the Last Gift study to date, we outline considerations to ensure that such research with terminally ill PLWHIV remains ethical, focusing on five topics: 1) protecting autonomy through informed consent, 2) avoiding exploitation and fostering altruism, 3) maintaining a favorable benefits/risks balance, 4) safeguarding against vulnerability through patient-participant centeredness, and 5) ensuring the acceptance of next-of-kin/loved ones and community stakeholders. EOL HIV cure-related research can be performed ethically and effectively by anticipating key issues that may arise. While not unique to the fields of EOL or HIV cure-related research, the considerations highlighted can help us support a new research approach. We must honor the lives of PLWHIV whose involvement in research can provide the knowledge needed to achieve the dream of making HIV infection curable. (shrink)

Refugees and asylum seekers may experience challenges related to pre-arrival experiences, structural disadvantage after migration and during resettlement requiring the need for special protection when participating in research. The aim was to review if and how people with refugee and asylum seeker backgrounds have had their need for special protection addressed in national and international research ethics guidelines. A systematic search of grey literature was undertaken. The search yielded 2187 documents of which fourteen met the inclusion criteria. Few guidelines addressed (...) specific ethical considerations for vulnerable groups much less people with refugee and asylum seeker backgrounds. One guideline explicitly addressed vulnerability for refugees and asylums seekers. To ensure members of ethics committees and researchers consider the potential challenges of conducting research with these groups, guidelines may need to be supplemented with a refugee and asylum seeker specific research ethics framework. Such a framework may be necessary to optimally protect people with refugee and asylum seeker backgrounds in research. (shrink)