A Médecins Sans Frontières Ethics Framework for Humanitarian Innovation

Summary

Kiran Jobanputra and colleagues describe an ethics framework to support the ethics oversight of innovation projects in medical humanitarian contexts.

Background

Innovation is at the core of humanitarian action. Humanitarian contexts are often volatile, uncertain, complex, and ambiguous, requiring responders to take a flexible, learning approach. For a medical humanitarian organisation such as Médecins sans Frontières/Doctors Without Borders (MSF), the challenges of delivering assistance to people in need mean that innovation is an ethical obligation; we cannot rely on old solutions for new problems. For instance, the unprecedented scale of the West African Ebola outbreak presented challenges in patient and data management that required rapid adoption of new tools and methods of working [1,2]. For MSF, innovation involves the creation or implementation of new products or processes to improve quality of care and become more effective in pursuit of our goals of providing medical assistance and “témoignage” (witnessing) to populations in need [3]. Along with intended benefits, however, can come harms, either to the individuals or populations we seek to benefit; to our staff, processes, and reputation; or to the trust placed in us by those in need (Box 1). Well-established ethical guidance exists for medical research in humanitarian settings [4–10]. However, many innovations fall outside the purview of formal research ethics review, and there is a need for ethics guidance for innovations specific to humanitarian action. To address this issue in MSF, we have developed and piloted an ethics framework for innovation projects. Fig 1 outlines the relationship between innovation and research in MSF and clarifies when use of the framework would be appropriate. Research involving human participants, including use of their data, requires approval by the MSF Ethics Review Board (ERB) [6,7], and, similarly, innovation projects that constitute medical research (i.e., involving human participants or their data) should follow the research ethics review process.

The framework is intended for self-guided use by nonmedical innovators (or innovation project owners) with little or no knowledge of medical ethics. Our hope is that it will provide a useful tool to organisations undertaking innovative projects in humanitarian settings by enabling staff to identify and weigh the harms and benefits of such work and be attentive towards a plurality of ethical considerations.

The Need for a Framework

Why not just use existing research ERBs for innovation projects? Importantly, many humanitarian innovation projects do not directly involve human participants or their data, even if they may ultimately have an impact on patient care or services provided for communities. For such projects, the approach to ethics oversight should be proportionate to the reasonably foreseeable harms. In seeking innovative solutions, ethical judgements may need to be made that require potential benefits and harms to be identified and weighed. However, excessive or disproportionate regulation could stifle innovation such that potential benefits could be lost [11]. MSF, as an organization, wants to create an environment conducive to innovation without imposing excessive or disproportionate bureaucratic oversight. This tension between the imperative to innovate and the need to avoid or mitigate harm was key to the decision to develop our ethics framework. Furthermore, innovation is a dynamic process, seldom a one-off event. It involves identifying problems, developing and selecting possible solutions, preliminary implementation and testing, and, where merited, widespread adoption [12]. An ethics framework for innovation should therefore not be an initial hurdle to be jumped but a guide that promotes and informs reflection throughout the innovation cycle.

Deriving an Ethics Framework for Humanitarian Innovation

The framework was developed through an iterative discursive process between senior MSF medical and operations managers and bioethicists with experience in humanitarian medical programming and service delivery. The starting point was our core humanitarian values of neutrality and impartiality [3]. The emerging framework was reviewed in light of literature on biomedical and research ethics as well as ethics of humanitarian innovation [3,4,11,13–16]. Two resources were particularly important: firstly, the MSF Research Ethics Framework, which elaborates key concerns in planning and enacting research, some of which are translatable to innovation projects [4]; secondly, recent elaborations of high-level ethics principles in humanitarian innovation [14,15]. However, one issue that arises when using exclusively high-level principles is the absence of decision-guiding content in specific circumstances—they can leave moral judgment “undetermined” [16]. A major challenge with a principled approach is therefore stepping down from high-level principles to practical decision-making. We thus decided that our framework should capture the moral concerns of the innovation principles from an MSF vantage point that includes the foundation of the MSF Research Ethics Framework [4]. Our intention is to facilitate and focus MSF innovation and thus to be practically oriented in guiding action.

We give particular emphasis to promoting a participatory approach to innovation, as the relationship between humanitarian organisations and the populations they assist can be the source of ethical tensions and opportunities. This also informs the focus of the framework on the needs of particularly vulnerable groups—a central moral concern for MSF. Our framework is not intended to give simple binary outcomes. This is where the hard work of ethical judgment takes place. It involves specifying which of the principles are active in any given decision—that is to say, what the respect for any individual principle means in the context under discussion—and the strength of the claims arising from it. It may also involve weighing the claims arising from different principles and adjudicating between them where they conflict.

A Médecins Sans Frontières Ethics Framework for Humanitarian Innovation

This framework is intended to be used to guide work that does not directly involve human participants and does not lie within the purview of formal research ethics oversight.

• Clearly identify the problem you are seeking to address and what benefit you expect the innovation to have. This step may seem obvious, so what is its ethical significance? When identifying the problem, there should be consideration of upstream solutions that may address the problem in a holistic and sustainable way. For instance, rather than focusing on technocratic fixes, what are the sociopolitical determinants of the problem and the wider possibilities for solutions? Who has stakes in finding a solution and who may have interests in perpetuating the problem? Is the problem a moving target? Collaboration and cross-fertilization with other disciplines should be considered in order to help to see the problem from various perspectives. In short, do not underestimate the importance of fully identifying the problem.

• Ensure that the innovation shows respect for human dignity. While this is a broad concept, it has practical implications. The focus of concern is respect for human beings, reminding us that the simplest or most direct solutions may not be ethically appropriate. Innovators must show due respect for the multiple and overlapping interests of those affected by the innovation. It extends beyond a concern for physical wellbeing to include psychological and cultural integrity. It also incorporates a concern for individual privacy and a respect for the confidentiality of individual-, family-, and community-based data.

• Clarify how you will involve the end user from the start of the process. Innovation should be driven by the requirements of the user. The innovation cycle should be participatory, using methods to involve relevant individuals and communities. Innovators must be sensitive to power dynamics between and within cultures and power imbalances between aid workers and beneficiaries.

• Identify and weigh harms and benefits. When considering innovations, a critical first step is the identification, as far as is reasonably possible, of potential harms along with the anticipated benefits. The next step involves weighing these harms and benefits.

  • Where reasonably foreseeable harms outweigh the likely benefits, implementation will not be ethical. Potential harms include, but are not limited to, physical and psychological harms to individuals. There is also need to consider potential harm to communities.

  • Where innovation involves a favourable balance of benefits and harms, all reasonable steps must be taken to minimise (mitigate) the harms as far as possible. Unnecessary harms must be eliminated. Where harms are unavoidable, those affected should be informed of the nature and severity of the risks involved.

  • Conflicted partnerships or conflicts of interest may result in reputational harm to the organisation. If these are identified, then oversight by an existing ERB is recommended.

• Describe the distribution of harms and benefits, and ensure that the risk of harm is not borne by those who do not stand to benefit. Innovators need to give careful consideration to the distribution of benefits and harms associated with their projects. Do the risks or benefits fall unequally across groups? If so, is it appropriate to proceed, and how can these inequalities of distribution be addressed or mitigated? Equally, it is important that the innovation takes into account vulnerable groups; it may be ethically warranted to give particular attention to those who have particular needs. Just as we tend to give more health care to the unwell, so particular attention may need to be given to those who are vulnerable or who may not be able to protect their own interests. This is expressed in the humanitarian principle of impartiality. In addition, consider whether anyone is “wronged” by the innovation. A “wrong” is an infringement that is distinct from harm. For example, selecting one group for an innovation project over another may wrong the other group (as opposed to harming them).

• Plan (and carry out) an evaluation that delivers the information needed for subsequent decisions to implement or scale-up the innovation, and then ensure that the beneficiaries have access to the innovation. Innovation requires an acceptance of the risk of failure—not all innovation projects will achieve their desired outcome. But in all cases, we can learn and apply these lessons in the future. Given the time, energy, and resources that these projects require, rigorous evaluation and sharing of lessons is itself a moral obligation. Therefore, consideration should be given to dissemination of findings, since it may be important to avoid further exposure to potential harm by sharing findings, whether these are positive or negative. Likewise, there should be a willingness and strategy for wider implementation of the innovation if found to be successful and a commitment to ensure beneficiaries—at least in the communities where it was tested and ideally in similar communities affected by humanitarian crises—have access to the innovation subsequently.

Applying the Framework

The case studies presented in Tables 1–3 are based on analysis of abstracts and slides of conference presentations of MSF innovation projects [17–19]. Project leaders were contacted and gave permission for their project to be analysed and to provide clarification where necessary. Each case study contains a brief outline of the project, analysis of the project using the innovation ethics framework, and conclusions about the ethical considerations raised and what might have been done differently if the framework had been applied at the start of the project. Application of the framework identified ethical concerns in all three of the innovation projects. In addition, the conclusion is reached that many of these concerns could have been mitigated had the framework been applied initially. From discussions at fora such as the annual Humanitarian Innovation Conference [20], it is clear that these issues are not unique to MSF but are common across the humanitarian sector.

What Next?

The framework has been shared widely within MSF and made available on the submission site for the MSF Scientific Days conference in May 2016 [21]. All authors submitting an abstract on an innovation project were required to confirm either that the project had undergone formal ethics review (in the case of projects involving formal research with human participants or their data) or that the author had used the framework to critically appraise and oversee their own project together with the project sponsor. The framework as presented here represents a first attempt to generate a robust but user-friendly tool to support the ethics oversight of these innovation projects. We intend to evaluate its use and assess its utility through auditing innovation abstracts and surveying their authors as well as through sharing and conversing with other innovators within and outside MSF.

We believe that this framework will help to improve the quality and learning potential of innovation projects as well as the anticipation of potential harms and (where appropriate) their mitigation. Far from discouraging innovation, we hope that this framework will contribute towards a culture of responsible and informed medical humanitarian innovation.