Active Health Research Monitoring in Tanzania: Perspectives from Members of Institutional Review Boards

Abstract

Background Ethical approval for research involving human subjects began in Europe due to gross abuse and unethical practices that occurred during the Second World War. In Africa, the ethical approval and active research monitoring of human research arose due to concern of possible ethical misconducts and exploitation on vulnerable population. In Tanzania, the National Health Research Ethics Committee (NatHREC) was established in 2002 to oversee all health research activities. To widen its scope, NatHREC accredited institutional review boards (IRBs) to review, approve and actively monitor research conducted by local investigators with non-foreign collaboration at institution level. However, available evidence indicates that active research monitoring is scarce. Lack of available guidelines, competent personal and funds has been mentioned as factors that constrain or enable the conduct of active research monitoring in other countries. A knowledge gap remains on understanding the conduct of active research monitoring with perspectives from members of IRBs in Tanzania. Objective The main objective of this research was to explore active health research monitoring in Tanzania with perspectives from members of institutional review boards. Methodology A mixed method research that employed quantitative and qualitative research techniques for data collection and analysis was carried out between June-July in 2017. IRB documents such as annual report, proposals, active monitoring SOPs and were reviewed and analysed manually. In-depth interviews were conducted among 11 key informants purposively selected from four IRBs in Dar es Salaam, Tanzania. Interviews were recorded, transcribed and translated before being analysed using content analysis technique with NVivo software version 10 software. Results Active research monitoring was preserved to be an important obligation for IRB members, however it was not being conducted regularly. Some of the IRB members felt that they were less involved in the decision-making on the conduct of active monitoring. Factors noted to constrain active monitoring included; financial resources, training, members‟ availability, lack of guidelines and tools, lack of prioritization and difficult to monitor research in remote areas. Factors that had enabled active monitoring included; institutional support and sense of obligation, alarming reports from passive monitoring, available SOPs and tools, proposal submission fees and the use of heads of departments. Conclusion and recommendations The study findings revealed that active research monitoring at the IRBs was perceived to be inadequate. Inadequate financial support, training among IRB members, devoted time from members, lack of full time secretariat staff, lack of specific guidelines and tools for active monitoring as well as the lack of regular supervision and mentorship were described to hinder its implementation. Strategies considered to be important in addressing these challenges included; reinforcement of existing SOPs and guidelines from national level, IRB members to be more pro-active to prioritize its need during review meetings, consider IRB specific means in rising financial support for active monitoring e.g. through submission fee and subcontracting qualified individuals at regional, district and department level when required.