Table 2 Summary of Modified Meta-ethnographic Analysis
From: A systematic literature review of the ethics of conducting research in the humanitarian setting
Original Concepts and Ideas Taken From Articles | Cross-cutting Themes | Tensions and Future Research | Major Theme |
|---|---|---|---|
Lacking or dysfunctional review boards in LMICs [21] Inability of traditional ethics review during an emergency [22, 23] Real time responsiveness (RTR) ethical review [24] Ethical review challenges in humanitarian setting [25] Challenge of timely, efficient and comprehensive ethical review [11, 26] Traditional ethics review is not suitable to practical realties [27, 28] MSFs ERB during Ebola outbreak [29, 30] Ethics review board specific for MSF [31] Recommendations for improving ethical review [32] Unique set of ethical priorities governing post-disaster research [33, 34] Ethical guidelines revealed two core themes: vulnerability and review process [35] Deviation from normal ethical oversight in disaster setting may be acceptable [36] Historical lack of oversight in humanitarian contexts [37] Uniqueness of ethical review during Ebola outbreak [38] | In-country, local review [21, 30] Timely ethics review during and emergency [11, 22, 23, 29, 31, 35, 38] Question as to whether or not ethics review in the humanitarian setting should have different standards compared with traditional review [27, 28, 31, 33, 35, 36, 38] Collaboration across institutions for ethical review [37, 39] | Tensions: Inherent vulnerability makes ethical review processes extremely important. However, the timely nature of humanitarian situations makes traditional ethics review impractical. Future research/initiatives: Outline the specifics of ethical review of research in the humanitarian setting, as this process should be unique from traditional ethics review. | Ethical Review |
Ensuring that communities enjoy maximum benefit of research [41] Case studies on ethical research [42] Engagement with local governments/health authorities [43] “Uncomfortable power dynamic” between researchers and communities [44] Low research output from researchers from LMIC [45] Community engagement to facilitate a clinical trial [46] Ethical entry” and compliance with local cultural norms [21] Utilizing gatekeepers may augment hierarchies of power [22] Thai Government as a gatekeeper via a permit system [47] Community involvement as benchmark for ethical research [48, 49] Risk of cooperating with nefarious authorities [49] Ambivalence about working with authority figures [50] Local stakeholders involvement in ethicial review [32] Ethics committee members view of community engagement [33] Community engagement to avoid “clinical trial exploitation” [30] | Will local populations benefit from the research? [21, 30, 41, 42, 46, 48] Community engagement enhances cultural understanding, which can help reduce harm amongst participants [22, 43, 44, 46, 48] Engagement with local authorities may be necessary, though it has potential unintended consequences on local power dynamics and perceived legitimacy of the researchers [47, 50] Limited capacity of locals to conduct their own research [21, 33, 45, 47, 49] | Tensions: There is a need to work with local authorities for both practical and ethical reasons, though there is concern that this cooperation can be seen as legitimizing this authority. This may be undesirable. Without local participation it is unlikely that they will reap the full benefits of the research product. However, including locals in research is inherently difficult. Future research/initiatives: Formal post hoc evaluations to help determine if the community did, in fact, benefit from the research product. Strategies to prepare locals for a participatory role in research are needed. | Community Engagement |
Argument for single arm design over RCT for Ebola clinical trials [46] Clinical equipoise as justification for Ebola Virus Disease RTCs [51] Clinical equipoise justifies research in the humanitarian setting [27] Proposal for adaptive (Bayesian, cluster or step wedge) research [52] An a priori exclusion of pregnant subjects would deprive them of potential benefits of the research [29] Community engagement to avoid “clinical trial exploitation” [30] The individual vs. the collective interest complicates clinical trial ethics [53] Lack of focus on positive obligations of researchers toward participants [54] Systematic review demonstrates deviation from normal ethical oversight during clinical trials [36] Study design has ethical implications [38, 55] Refutation of a priori right to unvalidated clinical interventions [56] | Clinical trials where there is no known treatment for a catastrophic disease [27, 29, 30, 46, 51, 52] | Tensions: It is unclear which type of clinical trial is most appropriate in the humanitarian setting. Future research/initiatives: Review or meta-analysis to evaluate the best methodology for clinical trials in the humanitarian setting. | Clinical Trials |
Collaboration between academics and practitioners [41] Conflict in between researcher’s objectivity, and humanitarian’s advocacy [57] Researchers simultaneously participating in relief efforts [58] Research should be both academically sound and action driven [11, 59] Research is justified insofar as it is not compromising relief efforts [60] MSF’s refusal to participate in research on treatment rationing [55] The evolution form pure researcher to researcher-practitioner [61] Justification for research in conflict setting [62] Explanation of MSFs ethics of studying HIV medication rationing [63] Generally limited resources in these settings [64] Effective research design might inhibit optimal treatment initiatives [53] | Research at the expense of intervention, as these two goals may come in conflict [53, 57, 58, 60, 62, 64] Collaboration between NGOs and academic institutions [41, 59, 61] Discussions on the ethics of researching policies, which may be in conflict with humanitarian principles [55, 63] | Tensions: Research should be both academically rigorous and practical. Given that humanitarian response is grounded in specific principles is it ethical to research policies that fall outside of these principles? Future research/initiatives: Strengthen the relationships between humanitarian aid groups and academic institutions. | Dual Imperative |
Reassessing a participant’s consent during the experiment [44] Informed consent in the setting of a particularly fatal disease [46] Use of a “gatekeeper” when seeking informed consent [21] A more nuanced view of consent might be more suitable for emergencies [21] More flexible approach to consent [22] “Humanitarian misconception” [27] Challenges of consenting children [65] Consent during disasters may be coercive [23] Exclusion of groups may undermined justice [38] Regional collaboration for ethical review [66] | Participants may find it difficult to separate consent for research from receiving aid [27, 38, 46] Use of gatekeepers for attaining consent [21] Acceptance of less rigid consent procedures in the humanitarian setting [21, 22] Forcing participants to relive trauma for the purpose of research raises ethical questions [44, 65] Unavoidable coercion [23] | Tensions: May be necessary, for both practical and cultural reasons, to obtain consent for participation through an intermediary, which is in conflict with principle of autonomy. Future research/initiatives: Outline the specifics of consent for participation in research in the humanitarian setting. | Informed consent |
Child participation in conflict with local norms [67] Use of gatekeepers for informed consent [21] Research teams with local knowledge [50, 57] Thai permit system vs. western funding regulations [47] Research teams with local knowledge [50] | Cultural relativism [67] | Tensions: Much of the literature puts a premium on respecting cultural norms. There is also an understanding that these norms may be in conflict with accepted ethical principles. Future research/initiatives: Identify core principles or universal research ethics, which supersede cultural norms in so far as these norms come in conflict with the former, and thus justify their disregard. | Cultural Considerations |
Discussing sensitive topics can put researchers at risk [21] Unethical to put a researcher in a dangerous position without clear adequate forethought [68, 69] Researchers may witness horrific events, and should consent to these risks [23, 49] | Need for formal protocols for responding to threatening situations [21, 68] | Tensions: Working in humanitarian contexts comes with risk, and minimizing this risk is an ethical imperative. Future research/initiatives: Formal protocols for minimizing the risk to researchers. | Risks to Researchers |
Consensus that children should be involved as research participants [67] Researchers must anticipate urgent issues [43, 70] Consenting children to relive trauma for the purpose of research [65] | Fundamental right that children be allowed to participate in research [43, 67, 70] | Tensions: Children are particularly vulnerable but systematically excluding them from research participation could be unethical. Future research/initiatives: Clear guidelines for determining when the risks of including children outweigh the benefits. | Child participants |
Concern around the extraction of knowledge from disaster stricken areas [57] Data sharing as ethical imperative [45] | Data ownership as it relates to who benefits from research [45, 57] | Tensions: Potential extractive relationship in which the data produced in low-income countries is circulated only in high-income countries. Future research/initiatives: Standardized policies for data ownership | Data Ownership |
Stigmatization makes conducting research on mental health in LMICs particularly difficult [21] Friction between procedural ethics and ethics in practice vis-à-vis mental health [22] | Local stigma towards mental health complicates research on these topics [21, 22] | Tensions: Given pervasive stigma, studying mental health might put the subjects as well as researchers at risk. Future research/initiatives: Develop strategies to dispel stigma and misconceptions about mental health. | Mental Health |