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.