A team of scientists led by TASO, Makerere University College of Health and Sciences, and the Uganda National Council for Science has developed ethical guidelines that will be used when conducting community engagement in research.
The guidelines come at a time when researchers are becoming more involved in the community.
According to the project's lead, Dr. Andrew Mujimbi of The AIDS Support Organization (TASO), his team was inspired to create the guidelines after discovering that there was little guidance on how to regulate ethical Community Engagement (CE) in clinical trials in Uganda.
"The ultimate goal of the guidelines is to regulate ethical CE practise in research, which promises better protection of research participants' rights and welfare, as well as additional safeguards for vulnerable populations," Mujimbi said.
Secondary motivations are to reduce exploitation of study communities and to provide community representatives, such as Community Advisory Boards (CABs), with assurances of independence in the functionality and performance of their roles.
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The guidelines address the What, Who/How, and When. To this, we clearly define Community engagement and Community. What structures, strategies, and approaches can help with community engagement? When and at what stage of research and clinical trials should communities be engaged early and consistently?
Finally, the guidelines provide guidance on evaluating CE for processes, outputs, outcomes, and impact - a very grey area in which researchers should exercise caution.
"We will now discuss the penalties for noncompliance. These guidelines cover a broader range of topics, including animal research," added Dr. Mujimba
Researchers developed a training curriculum for community engagement in research in Uganda as part of the SCINE-U: Strengthening Community Structures in Clinical Research to Improve Oversight Role of National Ethics Regulatory Bodies in Uganda study.
The also developed an electronic system called e-CABSMIS for monitoring the functionality and performance of Community Advisory Boards (CABs)
According to the findings of the study, the majority of Community Advisory Boards (CABs) members were aware that their roles in clinical trials include building trust with the local community, informing research priorities based on local needs, and advising researchers on community norms and expectations.
Only half of CAB members believed that developing and reviewing protocols was their role.
Additional findings
CABs were revealed to assist the study team in developing community engagement strategies, mobilising and recruiting 10 trial participants, and relaying community feedback to the study.
While investigators believed CABs were effective and supportive, CAB members believed they were merely a "ghost committee" that existed only in documents and had no contact with the communities they represented.
The CABs' operation was limited because they could not make independent decisions and had no authority to call or cause a meeting, as this was the responsibility of the investigator.
Training in ethics is still lacking among CAB members, and if it is provided, it is provided by investigators who are solely concerned with their clinical trials.
People take part in clinical trials primarily to receive treatment. People do not participate in clinical trials for a variety of reasons, including a lack of time, stigma, myths, lies, and misconceptions, study procedures, a lack of information about the study, research fatigue, and adverse events.
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Moving forward, the researchers recommend strengthening the capacity of stakeholders in the research enterprise through the development of a training curriculum and the use of multiple methods of engagement to ensure that the goals and effectiveness of community engagement are met.
Dr. Richard Kabanda, Commissioner in Charge of Health Promotion at the Health Ministry, congratulated the research team funded by European and Developing Clinical Trials Partnerships (EDCTP) 2 for developing national guidelines in collaboration with the Uganda National Council for Science and Technology.
He reaffirmed the Ministry of Health's commitment to research, adding that the ministry will implement community engagement guidelines and curriculum to encourage clinical research.
