A cancer institute in an African country delivers specialized cancer treatment and care to more than 35 million people throughout the East African region. The institution’s focus on cancer research has significantly increased over the past six years, as collaborators and other organizations came on board to identify causes of increasing cancer incidence in the region.
Cancer research in resource limited settings has a myriad of unique ethical issues given patient vulnerability mainly due to the absence of efficient standard cancer treatment in the region. In addition, researchers implementing cancer trials in Africa experience numerous challenges in obtaining ethical approvals largely due to delays in Research Ethics Committee (REC) meetings, unfamiliarity of the RECs with cancer research and complexity of multi-site approvals. The institute's increase in collaborative research and the ethical issues inherent in conducting this research prompted the establishment of its own Research and Ethics Committee in 2013. The establishment was motivated by the need to conduct efficient and highly specialized ethical review to ensure oversight of cancer trials in East Africa.
The REC was created by the institute's staff and in regular consultation with collaborators at a cancer research center in the United States. Establishing the institute's REC included identifying a local expert/consultant to provide guidance in meeting Uganda National Council for Science and Technology (UNCST) national requirements for RECs. The main activities included: 1) developing a work plan and budget; 2) recruiting REC members; 3) conducting trainings with members; 4) developing Standard Operating Procedures; 5) training REC staff in REC administration; 6) registering the REC with the Office for Human Subjects Protection and obtaining a Federal wide Assurance number; and 7) obtaining accreditation of the REC by UNCST. It was anticipated that the whole process would take about 12 months, but it took more than 18 months.
Major challenges to setting up the institute's REC included: Limited funds/resources for equipment and facilitating trainings to accommodate new REC members at the institute; finding the time to train very busy and committed REC members; and regulatory bureaucracies at UNCST. Due to limited funding and time, there was inadequate training of REC members and staff on ethical issues surrounding oncology research. Some equipment, like the IRB administration software, could not be purchased. Time delays were mainly in obtaining accreditation from UNCST. Competition for shared resources at the institute (e.g., physical office space, computers, stationery, and internet connection) also contributed to delays.
Consultations with local and international collaborators provided an in-depth understanding of the REC establishment process and expectations from different stakeholders in cancer research. Sensitization of government officials about developing a REC is vital in ensuring adequate resource allocation for establishment/maintenance of RECs. The process and timelines of establishing a REC also need to be explicitly set out in national guidelines.