This paper argues that international development research should be submitted to the oversight of research ethics committees from the countries where data will be collected. This includes research conducted by individuals who may fall outside the jurisdictions of most ethics guidelines or policies, such as individuals contracted by non-governmental organizations. The argument is grounded in an understanding of social justice that recognizes that not seeking local ethics approval can be an affront to the decolonization movement, and may lead to significant (...) direct harms to participants. Local ethics oversight can help ensure projects appropriately take into consideration local laws, regulations, priorities and context. For example, a local research ethics committee may be in a better position than a foreign one to assess whether any given proposed project carries context-specific risks. In addition, submitting to a local research ethics committee is to acknowledge the legitimacy of local authorities, thereby taking a stance against the history of colonizing disempowerment. Local oversight is a mechanism to increase the accountability of researchers working abroad: if respect for local authority and tailoring to local context are to be upheld, there must be mechanisms to ensure that research that does not meet these requirements does not proceed. Objections based on the limited oversight capacity in some countries and on concerns related to the politicization of the review process are discussed. Finally, the roles and responsibilities of the various stakeholders in the implementation of greater local ethics oversight are laid out. (shrink)

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. (shrink)

ObjectiveTo identify the ethical challenges associated with the development and implementation of new tuberculosis drugs and diagnostics.MethodsTwenty-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.ResultsDivergent 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.ConclusionsThis 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 implicationsEfforts 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. (shrink)

Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises – particularly in resource-poor settings – is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees. Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster research and argue that ethical disaster research (...) requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like – how it might be conceptualized and utilized – using the concept of real-time responsiveness. The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained. (shrink)

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. We aim to answer the following questions: 1) what do research ethics committee members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries 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. 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. 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. (shrink)

Imagine that you are part of the editorial board of a young bioethics journal committed to publishing open access (OA) and to ensuring accessibility to high quality and innovative scholarship. To support junior and interna- tional scholars who might not otherwise find places for their work in the leading Western bioethics journals, you do not charge author fees. Imagine also that you have no financial resources to pay for a professional website, auto- mated submissions manager, or even a part-time coordina- (...) tor: Your government has cut all grants for journals, you cannot go to industry for private funding because of the evident risk of apparent conflicts of interest, and your strapped-for-cash institution cannot afford to offer you any support. If one of the major publishers were to approach you to sign a deal, the temptation would be strong to accept. However, this would likely mean putting aside your ideals: It would be impossible to stay a “Green OA” publication (i.e., free of author publication charges) or supportive of junior and international scholars (because of pressures to “increase credibility” through artificially high rejection rates, for example). (shrink)

Developing Global Health Programming: A Guidebook for Medical and Professional Schools , edited by Jessica Evert, Paul Drain, and Thomas Hall, is reviewed. In spite of some editorial shortcomings, the book is a terrific aggregation of resources and reflections on the state of global health education that leaves readers with a multitude of useful and diverse tools, as well as directions about where to find additional ones.

The American Journal of Bioethics, Volume 11, Issue 10, Page 24-26, October 2011.