Course Outline
Introduction
In developing this course, we conducted an in-depth literature review to understand the structure and operations of RECs and SGCs in sub-Saharan Africa (SSA) in respect of their management of conflicts of interest in research.
The review identified the following:
- The majority of African countries have no RECs in their institutions and organisations (Elmahdi et al, 2018) although most have a national REC.
- The RECs generally lack standard operating procedures including mechanisms to deal with potential conflicts of interest (Zielinski et al., 2014)
- Not only did RECs indicate the lack of training or inadequate training but also the need for continuous training to ensure that the research conducted adheres to the highest ethical standards (Kruger et al., 2014; Manyonyi et al., 2014)
- The review also revealed there is limited training capacity.
Consequently, many RECs relied on regional and international organizations for training (Manyonyi et al., 2014; Mokgatla et al., 2018).
- Due to a lack of funding for research ethics and research integrity training, many funders and international organisations that fund scientific research also fund capacity development in research ethics. (Ndebele et al 2014; Oyedeji KS, 2011).
- Most of the training that was available focused on principles of bioethics, bioethics guidelines and regulation, review of proposals, protection of vulnerable groups and providing trainees with skills for standard operating systems (Ndebele et al 2014). Conflict of interest (COI) was not specifically highlighted.
- The review identified a lack of training modules on identifying and managing COI (Ndebele et al 2014; Nyika et al, 2009).
This Conflict of Interest (COI) e-learning course therefore responds to this gap. It situates COI in the broader context of research integrity.
The course is intended to assist REC and SGC members to prevent, mitigate and manage actual and potential conflicts of interest that may arise in various parts of the research ecosystem. While all of these measures are equally important, the first step is to identify COI so that action can be taken.
This course seeks to provide the skills needed for all these tasks.
The research ecosystem is complex and the potential for COIs to arise is extensive. Funders, SGCs, RECs, regulators, researchers and research participants are all important stakeholders. Research integrity is fundamental to all scientific endeavours and critical to building trust in science.
COIs may generate bad publicity, lead to damage of individual or institutional reputation, undermine research integrity and interfere with the independence of science, which is a key requirement for ethical research. It is critical that researchers, funders, REC members and SGC members are able to prevent, mitigate and manage COI.
It is important to note that there is nothing intrinsically wrong with the existence of a potential COI and its presence does not necessarily prohibit an investigator from participating in or leading a clinical study, provided that appropriate steps are taken to avoid any potential bias or impairment that may result from any of the disclosed interests (Ghooi, 2015; Thompson, 1993).
The key is how potential COI could be prevented from transforming into real COI, and adversely impacting the integrity of health research (Ghooi, 2015).
The course comprises four modules that collectively provide an understanding of COI from multiple perspectives and relate to different stakeholders in the research ecosystem.
It presents the learner with definitions and examples of COI that could arise in the context of research. Strategies to manage potential or real COI are explored.