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Michelle Farrington, Oxfam

Lessons from research to explore the incontinence needs of older people in Malawi and Ethiopia

By Amita Bhakta (Independent), Michelle Farrington (Oxfam), Diana Hiscock (HelpAge International) and Marion Staunton (HelpAge International)

As humanitarian practitioners, we are guided by sector and organisation-endorsed guidelines that aim to ensure our work is ethical and follows the principle of ‘do no harm’. However, when it comes to research in humanitarian settings, there is often a confusion between ethics and ethical approval.

There is an increasing interest amongst donors in requesting formal ethical approval for humanitarian research, but less clarity around where the distinction lies between formalised research and programmatic learning, and the timeframes needed to complete activities. In this blog, we reflect on lessons we learned while applying for ethical approvals for our project that explores the needs of older people with incontinence in humanitarian settings in Malawi and Ethiopia. It is funded by the Humanitarian Innovation Fund (HIF) and the Sanitation Learning Hub, and led by Oxfam and HelpAge International.

At the very start of our research process, there were several things we needed to consider: Why are we doing this research? What questions are we trying to address? Why does this research need to be done in a humanitarian context rather than a non-humanitarian context? How can we ensure that the local community is consulted and has an interest in engaging with this research?  What are we doing, and should we do as part of this research to protect more vulnerable participants? These questions shaped our approach to the research and its design. They helped us take stock of the policies, procedures and regulations our organisations had in place for protecting those who are vulnerable in humanitarian crises, and where we needed to strengthen both our own, and our field team’s understanding of these for the research to take place safely and ethically. Through this process, we felt that we had developed an ethically sound research protocol for what we planned to do. However, we also felt that having external approval from Internal Review Boards (IRBs) or Ethical Approval Committees would provide additional reassurance that we had considered the ethics of our research from all angles.

Why is ethical approval important for humanitarian research?

Ethical issues cannot be ignored in any type of research. All research should be conducted in a way that promotes respect for individuals and their communities, protects them from unnecessary harm, whilst providing evidence to address key issues which matter to them. Humanitarian research should also contribute to improvements in the way humanitarian work is conducted, the quality of service people in crisis receive and ultimately, in promoting social justice. Reviews of research protocols by ethical boards ensure that humanitarian research respects the same principles of research in other settings, particularly where it is focused on more vulnerable groups, and can be a required component for dissemination of the research findings through specific channels. However, formal ethical approval should not be a ‘tick-box’ exercise; but part of an ongoing process of reflection, discussion and application throughout the research that ensures it is being conducted ethically.

How to approach the ethical approval process

Ethical approvals can be sought through a range of different organisations such as academic institutions, regulatory bodies, government agencies, or government-level authorities such as a health ministry. A key piece of learning for our team has been that it’s not always straight-forward to find the right ethics review board for approval. For example, in Ethiopia, we approached review boards at academic institutions, and at both regional and national levels before finding an appropriate committee. This process took around four months in total. Our project required submission to three ethical approval boards – one in Ethiopia, one in Malawi and one in the UK – and we relied heavily on the knowledge of our local partners to help us find the most appropriate boards for our research. This was a challenge as the experience of applying for ethics approval was new for them as well. In some cases, applying for approval also meant forming partnership agreements with research institutions, as they did not accept applications to their IRB unless they were actively involved in the research. Since partnership arrangements take time, this caused delays. However, as a positive outcome, we forged more engaged research partnerships in each country.

Moreover, there are often specific requirements to be met when submitting ethical approval applications, and these can vary widely among ethics boards. Before preparing the application, we found it was important to read through the guidance as carefully and as early as possible, and we summarised the needs of each board in a table to ensure we covered all the requirements. All three boards for our project needed the research protocol presented in different ways, both the Malawian and Ethiopian boards required translation of participant information sheets, and one required translation of all the research tools into local languages. All required different sets of supporting documents and all had different schedules and deadlines for the next ethics board meetings. We also learnt that ethical approvals come with a cost, and this needs to be budgeted for up-front. This constitutes not only the submission fees – which vary from board to board – but also the cost of translation, and payments to local partners for their time and assistance. Our key piece of learning was that it was helpful to nominate a team lead with prior experience of ethical approval applications to organise and prioritise complex tasks to meet the required deadlines. However, in a research team where no member was budgeted full time to the project, this proved challenging and contributed to further delays in submissions.

The challenges for ethical approval in humanitarian research

The process of seeking ethical approvals presents some specific challenges for humanitarian research. Firstly, as described above, we encountered significant delays at each stage of the project. Many of these were related to our inexperience of submitting research to ethical approval boards, however we also found that the timeframes of ethical approval processes and humanitarian funding did not align. Some approval boards could take up to three months to make their decision, which may still be pending based on any changes required to the protocol. Of the three approval processes we undertook, one took two weeks, one took three months and one is still pending approval after three months. It took approximately six months to find the relevant research boards, adapt the applications, organise translations and make the submission. This, however, was heavily linked to the time availability of the research team. Ethical approvals can be challenging within the short time frames of humanitarian funding grants; if ethical approval is a requirement for the research, the associated funding needs longer grant periods or a more flexible approach to funding.

Another challenge lies in understanding why and when ethical approval may be necessary. As discussed above, working ethically is a process that is the responsibility of the research team, and is not guaranteed through formal ethical approval alone. Much of the research we undertake as humanitarian practitioners is action-based, i.e. it is self-reflective designed to improve our own practices, and the findings are largely disseminated through channels outside of those usually used by more traditional academic or medical research (i.e. peer-reviewed journals). We found that the subject of our research did not usually fit into the categories of research proposed by the ethical review boards. In some cases, the measures around consent, protection of data and the ‘do no harm’ guidelines we had compiled from our own organisations had more stringent requirements than those requested by the approval boards.

Moving Forward

Reflecting on our project team’s experience of applying for ethical approvals we have certainly learnt a great deal about identifying the right review boards for our research, being better prepared for the process and formulating research protocols and tools that support ethical research. However, we have encountered challenges along the way which, without a supportive and flexible donor, would have meant that the research would never have been completed within its original timeframe.

We needed to find both additional funding and additional time to be able to achieve the planned project outcomes – largely because of the unforeseen challenges associated with the ethical approval process. As a sector, we need to better understand the role of formalised ethical approval for humanitarian research and how it can support our pre-existing policies and procedures for protecting research participants. Further guidance from donors, perhaps in the form of a checklist of essential requirements, could minimise the need for formal ethical approval for action-based research, if funding timelines cannot accommodate a full application process. We need to consider possible alternatives to formal ethical approvals, for example peer-reviewed systems that can also support in monitoring ethical working throughout the research process.  Lastly, we need to continue the conversation around ethics approvals in our research to find ways forward that don’t compromise on participant safety and practitioner learning, which helps us to adapt quickly to key issues in humanitarian contexts and can ultimately result in better outcomes for those we serve.

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