A team of scientists led by TASO, Makerere University College of Health and Sciences and Uganda’s National Council for Science have developed ethical guidelines that will be used when engaging in community research.
The guidelines come at a time when researchers are becoming more involved in the community.
According to project leader 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 the ethical practice of CE in research, which promises better protection of the rights and well-being of research participants, as well as additional safeguards for vulnerable populations” , Mujimbi said.
Secondary motivations are to reduce the exploitation of communities of study and to provide community representatives, such as Community Advisory Boards (CABs), with assurances of independence in the functionality and performance of their roles.
The guidelines deal with the what, who/how and when. For this, we clearly define community engagement and community. What structures, strategies and approaches can contribute to community engagement? When and at what stage of research and clinical trials should communities be involved early and consistently?
Finally, the guidelines provide guidance on evaluating CE for process, output, outcome and impact – a very gray area in which researchers should exercise caution.
“We will now discuss penalties for non-compliance. These guidelines cover a wider range of topics, including animal research,” Dr Mujimba added.
Researchers developed a training program for community engagement in research in Uganda as part of the SCINE-U study: Strengthening Community Structures in Clinical Research to Improve the Oversight Role of National Research Regulatory Bodies Ethics in Uganda.
The has also developed an electronic system called e-CABSMIS to monitor the functionality and performance of Community Advisory Boards (CABs).
The study found that the majority of Community Advisory Board (CAC) members were aware that their role in clinical trials included 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 felt that developing and reviewing protocols was their role.
CABs were revealed to help the study team develop community engagement strategies, mobilize and recruit 10 trial participants, and provide community feedback to the study.
While investigators thought the CABs were effective and supportive, CAB members thought they were just a “shadow committee” that existed only in documents and had no contact with the communities that they represented.
The operation of the CABs was limited as they could not make independent decisions and had no power to call or cause a meeting, as this was the responsibility of the investigator.
Ethics training is still lacking among CAB members, and if it is provided, it is provided by investigators only concerned with their clinical trials.
People participate in clinical trials primarily to receive treatment. People do not participate in clinical trials for a variety of reasons including lack of time, stigma, myths, lies and misconceptions, study procedures, lack of study information, study fatigue, research and adverse events.
Going forward, the researchers recommend building the capacity of stakeholders in the research enterprise through the development of a training program and the use of multiple methods of engagement to ensure that the goals and effectiveness of community engagement are achieved.
Dr Richard Kabanda, Commissioner for Health Promotion at the Ministry of Health, commended the research team funded by European and Developing Clinical Trials Partnerships (EDCTP) 2 for developing national guidelines in collaboration with the National Council Ugandan for science and technology.
He reaffirmed the Ministry of Health’s commitment to research, adding that the ministry will implement guidelines and a community engagement program to encourage clinical research.