Background The globalization of clinical research in the last two decades has led to a significant increase in the volume of clinical research in developing countries. As of 2016, Uganda was the third largest destination for clinical trials in Africa. This requires adequate capacity and systems to facilitate ethical practice. Methods This was a retrospective study involving review of laws, guidelines, policies and records from 1896 to date. Results Modern medicine evolved from 1896 and by the time of Uganda's independence (...) in 1962, a 1500 bed national referral hospital was in place and a fully‐fledged medical school was established at the Makerere University. As the practice of medicine evolved in the country, so did medical research that addressed priority health issues. The growth in modern medicine was not matched with development of research infrastructure and regulatory systems. The first documented regulation of research activities was in 1970 while the first research ethics committee established in 1986 was to facilitate review of research related to the HIV/AIDs pandemic. In 1990 an Act of Parliament was passed to facilitate development and implementation of policies, hence the development of the national guidelines in 1997, training, establishment and accreditation of research ethics committees, conferences and research site monitoring. Conclusion Over the past 120 years, the implementation and structural aspects of research ethics in Uganda have evolved through 70 years of no regulation, followed by 30 years of rudimentary regulation while the last 20 years have shown significant growth in the regulatory system associated with supportive laws, institutionalization of regulatory and training processes. (shrink)

The amount of biomedical research being conducted around the world has greatly expanded over the past 15 years, with particularly large growth occurring in low- and middle-income countries. This increased focus on understanding and responding to disease burdens around the world has brought forth a desire to help LMIC institutions enhance their own capacity to conduct scientifically and ethically sound research. In support of these goals the Johns Hopkins-Fogarty African Bioethics Training Program has, for the past six years, partnered with (...) three research institutions in Africa to support research ethics capacity. Each partnership began with a baseline evaluation of institutional research ethics environments in order to properly tailor capacity strengthening activities and help direct limited institutional resources. Through the course of these partnerships we have learned several lessons regarding the evaluation process and the framework used to complete the assessments. We believe that these lessons are generalizable and will be useful for groups conducting such assessments in the future. (shrink)

ABSTRACT The amount of biomedical research being conducted around the world has greatly expanded over the past 15 years, with particularly large growth occurring in low- and middle-income countries (LMICs). This increased focus on understanding and responding to disease burdens around the world has brought forth a desire to help LMIC institutions enhance their own capacity to conduct scientifically and ethically sound research. In support of these goals the Johns Hopkins-Fogarty African Bioethics Training Program (FABTP) has, for the past six (...) years, partnered with three research institutions in Africa (University of Botswana, Makerere University in Uganda, and the University of Zambia) to support research ethics capacity. Each partnership began with a baseline evaluation of institutional research ethics environments in order to properly tailor capacity strengthening activities and help direct limited institutional resources. Through the course of these partnerships we have learned several lessons regarding the evaluation process and the framework used to complete the assessments (the Octagon Model). We believe that these lessons are generalizable and will be useful for groups conducting such assessments in the future. (shrink)

BackgroundHuman biological materials are usually stored for possible future use in research because they preserve valuable biological information, save time and resources, which would have been spent on collection of fresh samples. However, use of these materials may pose ethical challenges such as unauthorized disclosure of genetic information, which can result in dire consequences for individuals or communities including discrimination, stigma, and psychological harm; has biosecurity implications; and loss of control or ownership of samples or data. To understand these problems (...) better, we evaluated the extent to which tuberculosis (TB) clinical research protocols that were used to collect and store biological materials for future use conform to the requirements stated in the Uganda national guidelines for research involving humans as participants.MethodsThis was a retrospective review of TB clinical research projects approved by the Uganda National Council for Science and Technology (UNCST) from 2011 to 2015, to examine whether they fulfilled the requirements for ethical collection and use of human materials. Data were abstracted through review of the project protocols using a template developed based on the informed consent and the Materials Transfer Agreement (MTA) requirements in the national guidelines.ResultsOut of 55 research protocols reviewed, most of the protocols 83.6% had been used to collect the stored samples (sputum, blood and sometimes urine), 28% had a section on specimen collection and 24% mentioned ownership of the biological materials. With respect to review of the consent forms used in the studies that stored materials for future use, only 9% of the protocols had a separate consent form for storage of materials, 4.5% of the consent forms explained the risks, 11.4% explained the purpose of the study while 6.8% mentioned the place of storage for the collected materials.ConclusionMany of the studies reviewed did not meet the requirements for collection and storage of biological materials contained in the national guidelines, which indicates a need to additional training on this topic. (shrink)

Background: The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Methods: Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies (...) had been administered to each study participant. Results: Of the 600 participants interviewed, two thirds (64.2 %, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9 %, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7 %, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7 %, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50 % less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95 % CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Conclusions: Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care. (shrink)