A look at the establishment and impact of the research ethics committee at University Eduardo Mondlane and Maputo Central Hospital from 2013-2016
Imagine you're a patient seeking treatment at a hospital, and you're asked to participate in a medical study. How can you be confident the research won't harm you or misuse your personal information? This fundamental question lies at the heart of research ethics—a field dedicated to protecting people who volunteer for scientific studies.
In 2012, Mozambique took a significant step toward strengthening these protections by establishing a new research ethics committee at its premier medical institution. This is the story of how that committee launched, evolved, and managed the delicate balance between scientific progress and human protection in its first four years.
In the early 2000s, Mozambique was experiencing a remarkable growth in biomedical research, particularly in infectious disease studies 2 . With this expansion came an increasing responsibility to ensure all research conducted in the country met international ethical standards for protecting participants.
The new committee operated within established international and national ethical guidelines:
Between March 2013 and December 2016, the newly-formed committee embarked on an ambitious review process, evaluating 356 separate research protocols 2 . Of these, 309 were fully reviewed and approved—an impressive 87% approval rate that reflects both the quality of submissions and the committee's constructive approach to recommending improvements when needed 2 .
The overwhelming predominance of descriptive cross-sectional studies (61%) reflects a research environment focused on establishing baseline data about health conditions in Mozambique—a crucial first step in addressing public health challenges 2 .
The CIBS FM & MCH was composed of 15 members from diverse backgrounds 2 :
This multidisciplinary composition ensured that research protocols were examined from multiple perspectives 2 .
New committee members received comprehensive training in 2 :
Upon joining, each member signed a declaration of no conflict of interest—a crucial safeguard to ensure decisions were made purely to protect research participants 2 .
This disparity highlighted both the added complexity of reviewing higher-risk studies and potential bottlenecks at the national level—important information for ongoing efforts to optimize Mozambique's ethical review system 2 .
Based on the committee's experience, several elements emerged as crucial for conducting ethically sound research in any setting:
The foundation of any ethical review, detailing the study's purpose, methodology, and potential impacts on participants.
Clear, understandable forms that explain the research to potential participants in their own language, ensuring they can make truly voluntary decisions about involvement.
Specific protocols for collecting, storing, and protecting participant data, particularly important in studies involving sensitive health information.
A thorough analysis weighing potential risks to participants against possible benefits to science and society.
Additional protections for groups who may require special consideration, such as children, pregnant women, or marginalized communities.
The CIBS FM & MCH enhanced this toolkit with several innovative approaches, including investigator mentoring programs and an electronic protocol submission platform, which significantly improved both the efficiency of the review process and the quality of submitted protocols 2 .
The successful establishment and operation of the joint ethics committee at UEM and Maputo Central Hospital offers valuable insights for other institutions in low- and middle-income countries seeking to strengthen their research ethics infrastructure.
Over its first four years, the committee demonstrated that with proper training, clear procedures, and diverse expertise, local institutions can effectively manage ethical review processes 2 .
Perhaps the committee's most significant achievement was its role in building local capacity for ethical research oversight 2 .
By handling the majority of review needs at the institutional level, the committee allowed the national body to focus on more complex, higher-risk protocols 2 .
"Long-term investments in training and ethical capacity building for CIBS across the country continue to be needed, as Mozambique develops greater capacity for research and makes progress toward improving the health of all its citizens" 2 .
This story of Mozambique's research ethics journey reminds us that scientific progress and human protection must advance together. Behind every approved protocol lie countless research participants who can trust that their rights, safety, and dignity will be protected—the ultimate achievement of any research ethics committee.