Authors: Joseph Mukasa (Project Coordinator), Alice Sumbatala (Data Processing Officer) and Luz Azlor del Valle (Senior Research Officer).
At EDI Global, we are committed to the work we do and especially to the communities with whom we work. All researchers are required to complete a human research protection training when joining the company and then after every two years. Our team recently completed the refresher training and was reminded of the ethical responsibilities linked with conducting the work that we do. Oftentimes, we find that certain activities that safeguard the wellbeing of the respondents, such as writing an informative and transparent consent note or compiling all the documentation to submit to the relevant Institutional Review Board (IRB) is viewed as a bureaucratic step instead of a duty of the researchers. IRBs, also known as ethics review committees, review research proposals involving human subjects to make sure that they comply with the current regulations, and adequately protect the rights of research participants. Complying with IRB regulations and being approved by their boards is a requisite for research projects with human subjects and is usually also required by funding institutions.
In most of the research projects we conduct, EDI Global takes the lead or a supporting role in acquiring approval from the institutions of the country where the project is taking place through local IRBs. Having research projects reviewed by a local institution ensures that the study complies with local regulations and is fit for purpose. In this blog we share our experience in working with partners and local institutions to facilitate an effective research clearance process.
An Example: Local IRBs in Uganda – Any research involving human subjects that will be conducted in Uganda needs to be registered and approved and such research approval process consists of a two stage process.. The first stage is the application to a Research Ethics Committee (REC) which provides an initial approval that is subsequently submitted at a second stage to the Uganda National Council of Science and Technology (UNCST) for the final approval.
There are several RECs which are accredited by UNCST, and the researcher should choose a REC depending on the field of the research, as there are RECs specialised in particular areas, e.g., some only review clinical trials, others agricultural research, etc. EDI Global has experience using different institutions depending on the nature of the project and has built a strong professional rapport with the REC administrations which facilitates the easier following up on the application process. Follow-up needs to be made by email or phone as a reminder because there are a number of research approvals to be processed by an REC at any one time. EDI Global submits the research application in-person and monitors the process on behalf of our clients to ensure a smooth process. Based on our experience, REC approval is usually obtained three weeks after submission.
The UNCST oversees research conduct in Uganda and regulates the function of RECs in the country. An application can now be done through UNCST’s online portal and must be completed by the Principal Investigator (PI). Any foreign PI will be required to be affiliated to a local institution appropriate for the type of research proposed and the local institution will need to issue a letter of recommendation to be submitted to UNCST. The REC approval letter must have been obtained prior to UNCST submission and attached to application. Administrative clearance letters are required from those areas where the research is to be conducted, and these letters must also be attached to the UNCST submission. UNCST usually reviews the applications within two weeks, on average, whilst any resubmission that needs to be made after addressing the UNCST comments are usually reviewed in a matter of days.
Our Recommendations – Research Clearance does not just ensure that your research is conducted to the highest ethical standards but also provides a highly professional review to your survey by the chosen IRB who usually respond positively with substantial review comments on your study objectives. In recent years, research clearance has also provided strategic ways of conducting efficient research during the pandemic hence protecting all parties involved in the survey. Embracing technology such as the use of online submissions and reviews has been quite effective, however, this comes with some challenges which may require a number of physical visits to specific offices as it is common that some posts that are relevant to the process have a high turnover of officials and the rapport previously gained needs to be rebuilt.
To finalise this blog, we share 7 tips based on our experience in acquiring IRB approval from local Ugandan institutions:
Think about the ethical implications of the research from the inception of the project, and have a flexible timeline until the research has been cleared;
Find a local partner that can advise you on the process and follow up with the local authorities;
Ensure your study documents are clear and precise with simplified concepts, have a concise but informative consent and check with the local partner whether verbal consent is permitted or the consent form needs to be physically signed;
Clearly state your research objectives and the rationale for the project and also state an appropriate compensation for the study participants;
Gather all the relevant information on sampled areas e.g. administrative contacts at district level, as the IRB may require the letter of approval from local authorities;
If the IRB comes back with comments on your proposal, respond to each of the questions and concerns raised by the IRB attentively and in a timely manner; and,
While awaiting the IRB approval, you can carry on with other preparation activities, like the planning of training, fieldwork logistics, reporting etc.
The practical experience shared in this blog can help you improve your research clearance experience with the REC and the UNCST. From our experience the review process keeps getting better and we believe that regular discussions between researchers and the review boards remains relevant and responsive to the process in any given context.