An attempt to obtain retrospective approval of research unethically undermines the legitimacy of the Institutional Review Board (IRB) and the review process. Whatever the context, the need for the regulation of research during a health emergency is imperative.
In Liberia, the Ebola Virus Disease (EVD) ended in May 2016 with a death toll of 4,810 and 10,678 infected. In 2014, some researchers conducted EVD studies without obtaining approval by the relevant IRBs. During this period, the University of Liberia-Pacific Institute for Research and Evaluation (UL-PIRE) IRB in Monrovia, Liberia denied a researcher employed with an international UN public health agency retrospective ethical approval due to a failure to abide by the existing ethics regulations.
Methods of Identifying Ethical Dilemma
Our IRB convened and expedited the review process, given the importance of conducting research during the health emergency. However, the IRB was not aware that the research had already been completed when the application was submitted for review. The researcher had left Liberia and was not present at the meeting, but was represented by a less experienced research assistant. The Chair immediately adjourned the meeting due to the unethical conduct of the researcher.
Retrospective IRB approval of a research project where participants have already been exposed to unnecessary risks and undue inducement and influence is unethical. Conducting a research study without IRB oversight violates both ethical principles and IRB procedures. In this context, our decision took a stance on public policy that aims at increasing compliance with IRB requirements. In this case, the consent process conducted at the discretion of the researcher and the study team was unethical. We argued that providing so-called consent processes to participants in the frenzy of an epidemic can lead to misconceptions on their part. Risk mitigation measures were not fully assessed because guidance from an ethical institution was not explored or sought prior to the conduct of the study. The fundamental pillar of respect for persons was also ignored. Without IRB approval, it is highly unlikely that results of a study will be accepted by any reputable journal. We assumed that this was why the researcher tried to obtain retrospective approval. While our decision reached was emphatic, it was preceded by a short discussion on whether granting approval retrospectively, and allowing publication of the research results, may contribute to the public good. We decided otherwise, partly because the research had been undertaken on a highly vulnerable group of illiterate and uneducated subjects who had little or no knowledge of the research and consent process.
Retrospective approval may be acquired during emergencies where the vulnerability of the population is reasonably considerate in lieu of the disease outbreak. There are instances where this can be accommodated by IRBs. However, where the epidemic has a fatal and psychological impact on the population, researchers have to exercise due diligence and adhere to local IRB guidelines as was discovered in this study. Researchers must understand that circumventing ethical review under the pretext of the emergency and collected data from human participants is unethical. Researchers should always explore local resources prior to interventions.
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Jemee K. Tegli, MSc
University of Liberia-Pacific Institute for Research and Evaluation (UL-PIRE)
The author acknowledges UL-PIRE Africa Center, an infectious disease and social science research institution, and its Institutional Review Board.
This Case Study is condensed from Chapter 14: Seeking Retrospective Approval for a Study in Resource-Constrained Liberia in Schroeder et al. (2017) Ethics Dumping: Case Studies from North-South Research Collaborations, available open-access.