Addressing diversity and complexity in the community engagement literature: The rationale for a realist review.

In this research note we reflect on our failed attempt to synthesize the community engagement literature through a standard systematic review and explain our rationale for now embarking on a realist synthesis of community engagement in global health research. We believe this paper will be helpful for many who grapple with the lack of clarity about community engagement's core elements and mechanisms.

Developing and Implementing new TB Technologies: Key Informants' Perspectives on the Ethical Challenges.

OBJECTIVE: To identify the ethical challenges associated with the development and implementation of new tuberculosis (TB) drugs and diagnostics. METHODS: Twenty-three semi-structured qualitative interviews conducted between December 2015 and September 2016 with programme administrators, healthcare workers, advocates, policymakers, and funders based in the Americas, Europe, and Africa. Interviews were analysed using thematic analysis. RESULTS: Divergent interests and responsibilities, coupled with power imbalances, are a primary source of ethical challenges; the uncertain risk profiles of new drugs present an additional one. Although this challenge can be partially mitigated through stringent pharmacovigilance, respondents highlighted that high-burden countries tend to lack the resources to facilitate safe implementation. Increased advocacy and community engagement are considered an ethical imperative for future TB development and implementation. CONCLUSIONS: This project helps identify some of the ethical challenges of new TB technologies. It demonstrates that investigating ethical challenges through qualitative research is one way to apprehend the difficulty of implementing new TB technologies. Addressing this difficulty will require that those in positions of power reconsider their interests in relation to disempowered communities. POLICY IMPLICATIONS: Efforts to build consensus regarding what values should underpin the global governance of TB research, prevention, and care are essential to facilitate the ethical implementation of new TB technologies.

A failure in solidarity: Ethical challenges in the development and implementation of new tuberculosis technologies.

Prominent tuberculosis (TB) actors are invoking solidarity to motivate and justify collective action to address TB, including through intensified development and implementation (D&I) of technologies such as drugs and diagnostics. We characterize the ethical challenges associated with D&I of new TB technologies by drawing on stakeholder perspectives from 23 key informant interviews and we articulate the ethical implications of solidarity for TB technology D&I. The fundamental ethical issue facing TB technological D&I is a failure within and beyond the TB community to stand in solidarity with persons with TB in addressing the complex sociopolitical contexts of technological D&I. The failure in solidarity relates to two further ethical challenges raised by respondents: skewed power dynamics that hinder D&I and uncertainties around weighing risks and benefits associated with new technologies. Respondents identified advocacy and participatory research practices as necessary to address such challenges and to motivate sustained collective action to accelerate toward TB elimination. We present the first empirical examination of bioethical accounts of solidarity in public and global health. Our study suggests that solidarity allows us better to understand and address the ethical challenges that arrest the D&I of new TB technologies. Solidarity lends credence to policies and practices that address the relational nature of illness and health through collective action.

Familiar ethical issues amplified: how members of research ethics committees describe ethical distinctions between disaster and non-disaster research.

BACKGROUND: The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, since post-disaster research is essential to the improvement of the humanitarian response, it is important that adequate research ethics oversight be available. METHODS: We aim to answer the following questions: 1) what do research ethics committee (REC) members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries (LMICs) perceive as the key ethical concerns associated with disaster research?, and 2) in what ways do REC members understand these concerns to be distinct from those arising in research conducted in non-crisis situations? This qualitative study was developed using interpretative description methodology; 15 interviews were conducted with REC members. RESULTS: Four key ethical issues were identified as presenting distinctive considerations for disaster research to be implemented in LMICs, and were described by participants as familiar research ethics issues that were amplified in these contexts. First, REC members viewed disaster research as having strong social value due to its potential for improving disaster response, but also as requiring a higher level of justification compared to other research settings. Second, they identified vulnerability as an overarching concern for disaster research ethics, and a feature that required careful and critical appraisal when assessing protocols. They noted that research participants' vulnerabilities frequently change in the aftermath of a disaster and often in unpredictable ways. Third, they identified concerns related to promoting and maintaining safety, confidentiality and data security in insecure or austere environments. Lastly, though REC members endorsed the need and usefulness of community engagement, they noted that there are significant challenges in a disaster setting over and above those typically encountered in global health research to achieve meaningful community engagement. CONCLUSION: Disaster research presents distinctive ethical considerations that require attention to ensure that participants are protected. As RECs review disaster research protocols, they should address these concerns and consider how justification, vulnerability, security and confidentially, and community engagement are shaped by the realities of conducting research in a disaster.

The Challenge of Timely, Responsive and Rigorous Ethics Review of Disaster Research: Views of Research Ethics Committee Members.

BACKGROUND: Research conducted following natural disasters such as earthquakes, floods or hurricanes is crucial for improving relief interventions. Such research, however, poses ethical, methodological and logistical challenges for researchers. Oversight of disaster research also poses challenges for research ethics committees (RECs), in part due to the rapid turnaround needed to initiate research after a disaster. Currently, there is limited knowledge available about how RECs respond to and appraise disaster research. To address this knowledge gap, we investigated the experiences of REC members who had reviewed disaster research conducted in low- or middle-income countries. METHODS: We used interpretive description methodology and conducted in-depth interviews with 15 respondents. Respondents were chairs, members, advisors, or coordinators from 13 RECs, including RECs affiliated with universities, governments, international organizations, a for-profit REC, and an ad hoc committee established during a disaster. Interviews were analyzed inductively using constant comparative techniques. RESULTS: Through this process, three elements were identified as characterizing effective and high-quality review: timeliness, responsiveness and rigorousness. To ensure timeliness, many RECs rely on adaptations of review procedures for urgent protocols. Respondents emphasized that responsive review requires awareness of and sensitivity to the particularities of disaster settings and disaster research. Rigorous review was linked with providing careful assessment of ethical considerations related to the research, as well as ensuring independence of the review process. CONCLUSION: Both the frequency of disasters and the conduct of disaster research are on the rise. Ensuring effective and high quality review of disaster research is crucial, yet challenges, including time pressures for urgent protocols, exist for achieving this goal. Adapting standard REC procedures may be necessary. However, steps should be taken to ensure that ethics review of disaster research remains diligent and thorough.

Where Caring Is Sharing: Evolving Ethical Considerations in Tuberculosis Prevention Among Healthcare Workers.

In many settings, the dedication of healthcare workers (HCWs) to the treatment of tuberculosis exposes them to serious risks. Current ethical considerations related to tuberculosis prevention in HCWs involve the threat posed by comorbidities, issues of power and space, the implications of intersectoral collaborations, (de)professionalization, just remuneration, the duty to care, and involvement in research. Emerging ethical considerations include mandatory vaccination and the use of geolocalization services and information technologies. The following exploration of these various ethical considerations demonstrates that the language of ethics can fruitfully be deployed to shed new light on policies that have repercussions on the lives of HCWs in underresourced settings. The language of ethics can help responsible parties get a clearer sense of what they owe HCWs, particularly when these individuals are poorly compensated, and it shows that it is essential that HCWs' contribution be acknowledged through a shared commitment to alleviate ethically problematic aspects of the environments within which they provide care. For this reason, there is a strong case for the community of bioethicists to continue to take greater interest both in the micro-level (eg, patient-provider interactions) and macro-level (eg, injustices that occur as a result of the world order) issues that put HCWs working in areas with high tuberculosis prevalence in ethically untenable positions. Ultimately, appropriate responses to the various ethical considerations explored here must vary based on the setting, but, as this article shows, they require thoughtful reflection and courageous action on the part of governments, policy makers, and managers responsible for national responses to the tuberculosis epidemic.

A road map to building ethics capacity in the home and community care and support services sector.

There are unique ethical issues that arise in home and community care because of its locus and range of service. However, the academic literature on ethical issues in the sector of home and community care and support remains minimal. Opportunities for education, collaboration and exchange among professionals and care providers are also severely limited. Although the proposed solution of developing ethics capacity in the home care setting is over 20 years old, only modest progress had been made until recently. This article introduces the Community Ethics Network (CEN), a replicable network of home and community care agencies in the Greater Toronto Area. Its achievements can be attributed to a commitment to work toward a common approach to ethical decision-making and to a focus on education, case reviews and policy development. CEN has produced numerous positive outcomes; key among these is the development and delivery of standardized training on ethics to more than 2,000 front-line staff of diverse backgrounds/professions and representing over 40 different organizations.

Engaging communities in tuberculosis research.

According to a growing consensus among biomedical researchers, community engagement can improve the ethics and outcomes of clinical trials. Although successful efforts to develop community engagement practices in HIV/AIDS research have been reported, little attention has been given to engagement with the community in tuberculosis research. This article aims to draw attention to some existing community engagement initiatives in tuberculosis research and to resources that might help tuberculosis researchers to establish and implement community engagement programmes for their trials. One of these resources-the good participatory practice guidelines for tuberculosis drug trials-offers a conceptual framework and practical guidance for community engagement in tuberculosis research. To build momentum and to improve community engagement, lessons need to be shared, and formal assessment strategies for community engagement initiatives need to be developed. To build successfully on the promising activities described in this personal view, research funders and sponsors should show leadership in allocation of resources for the implementation and assessment of community engagement programmes in tuberculosis trials.

Ethical implications of diversity in disaster research.

Enhancing the effectiveness, efficiency, and fairness of interventions is an increasing source of concern in the field of disaster response. As a result, the expansion of the disaster relief evidence base has been identified as a pressing need. There has been a corresponding increase in discussions of ethical standards and procedures for disaster research. In general, these discussions have focused on elucidating how traditional research ethics concerns can be operationalized in disaster settings. Less attention has been given to the exploration of the ethical implications of heterogeneity within the field of disaster research. Hence, while current efforts to discuss the ethics of disaster research in low-resource settings are very encouraging, it is clear that further initiatives will be crucial to promote the ethical conduct of disaster research. In this article, we explore how the ethical review of disaster research conducted in low-resource settings should account for this diversity. More specifically, we consider how the nature of the project (what?), sociopolitical and physical environment of research sites (where?), temporal proximity to the disaster event (when?), objectives motivating the research (why?), and identity of the stakeholders involved in the research process (who?) all relate to the ethics of disaster research.

Aligning community engagement with traditional authority structures in global health research: a case study from northern Ghana.

Despite the recognition of its importance, guidance on community engagement practices for researchers remains underdeveloped, and there is little empirical evidence of what makes community engagement effective in biomedical research. We chose to study the Navrongo Health Research Centre in northern Ghana because of its well-established community engagement practices and because of the opportunity it afforded to examine community engagement in a traditional African setting. Our findings suggest that specific preexisting features of the community have greatly facilitated community engagement and that using traditional community engagement mechanisms limits the social disruption associated with research conducted by outsiders. Finally, even in seemingly ideal, small, and homogeneous communities, cultural issues exist, such as gender inequities, that may not be effectively addressed by traditional practices alone.