Stakeholder perspectives on informed consent and ethics review of research involving human specimen resource repositories (biobanks) in South Africa: a quantitative study.

Master of Health Research Ethics. University of KwaZulu-Natal, Pietermaritzburg 2017.On-going research has made the use of human biological materials and genetic material/data for biomedical research an area of high interest to researchers, bioethicists, philosophers, lawyers and various regulatory bodies. In this era of globalization, there are profound ethical, legal and social implications for the evolving nature of biobank research; these have to be considered during the ethics review process. The main objective of this study was to explore stakeholders’ perspectives of informed consent and ethics review of biobank research in South Africa, with the aim of obtaining information that could contribute to the harmonization of ethical guidelines of the consent process and biobank governance. This was a descriptive cross-sectional study that employed a positivist approach involving qualitative data collection methods. The study was conducted at Stellenbosch University, the University of KwaZulu-Natal, and seven research ethics committees in the KwaZulu-Natal and Western Cape provinces in South Africa. A purposive sampling technique was used to recruit significant stakeholders in biobank research in South Africa. Data was collected using self-administered online survey instruments. Completion of the survey implied consent. Quantitative data were summarized using descriptive summary statistics. Conventional content analysis was used for data collected from open ended questions. The response rate was low; 19 research ethics committee members and 62 researchers and other stakeholders participated in the study. All stakeholders agreed that there is need for functional regulatory frameworks to govern biobank research, particularly the strengthening of research ethics committees, to ensure comprehensive ethics review of biobank-based research. There were several areas of agreement and divergence in respondents’ perspectives on the collection, storage and future use of human biological materials. There was no consensus on the issue of re-consent and the likelihood of donor identification and harm during the use of human biological materials for secondary research. Stakeholders also identified a number of challenges in the ethics review process and the sharing of human biological materials. Generally, the attitude of research ethics committee members, researchers and other stakeholders on informed consent, ethics review of biobank research, and the export and sharing of de-identified HBM is positive and ethically informed. Stakeholders believe that there is need for robust regulatory frameworks to govern the collection, storage, sharing and future use of HBM both within South Africa and across borders. Several recommendations are proposed that could contribute to the harmonization of ethical guidelines on the relevant consent process and biobank governance

Musculoskeletal disorders among nursing staff: a comparison of five hospitals in Uganda

Abstract Introduction: Low and middle income countries have severe nursing staff shortages which is associated with risk of poor quality of patient car

Developing digital contact tracing tailored to haulage in East Africa to support COVID-19 surveillance: a protocol

International audienceIntroduction At the peak of Uganda’s first wave of SARS-CoV-2 in May 2020, one in three COVID-19 cases was linked to the haulage sector. This triggered a mandatory requirement for a negative PCR test result at all ports of entry and exit, resulting in significant delays as haulage drivers had to wait for 24–48 hours for results, which severely crippled the regional supply chain. To support public health and economic recovery, we aim to develop and test a mobile phone-based digital contact tracing (DCT) tool that both augments conventional contact tracing and also increases its speed and efficiency. Methods and analysis To test the DCT tool, we will use a stratified sample of haulage driver journeys, stratified by route type (regional and local journeys). We will include at least 65% of the haulage driver journeys ~83 200 on the network through Uganda. This allows us to capture variations in user demographics and socioeconomic characteristics that could influence the use and adoption of the DCT tool. The developed DCT tool will include a mobile application and web interface to collate and intelligently process data, whose output will support decision-making, resource allocation and feed mathematical models that predict epidemic waves. The main expected result will be an open source-tested DCT tool tailored to haulage use in developing countries. This study will inform the safe deployment of DCT technologies needed for combatting pandemics in low-income countries. Ethics and dissemination This work has received ethics approval from the School of Public Health Higher Degrees, Research and Ethics Committee at Makerere University and The Uganda National Council for Science and Technology. This work will be disseminated through peer-reviewed publications, our websites https://project-thea.org/ and Github for the open source code https://github.com/project-thea/

Mycotic aneurysm of the femoral artery resulting from mismanagement of a pathological femur fracture due to chronic osteomyelitis: a case report

Abstract Introduction Mycotic aneurysms are rarely listed among the possible complications of osteomyelitis of the long bones. To the best of our knowledge this is the first case of chronic osteomyelitis associated with a pathological fracture of the femur and a mycotic aneurysm of the femoral artery. Case presentation We present the case of a 13-year-old Ugandan boy who was referred to our hospital with chronic osteomyelitis associated with a pathological fracture of the right femur and a mycotic aneurysm of the femoral artery. He underwent a successful above-knee amputation and is currently undergoing rehabilitation. Conclusions Aneurysms associated with chronic osteomyelitis of the long bones are very rare. However, in Africa, where people often still believe in crude traditional remedies, they should be considered among the possible diagnoses especially where acute injuries of the limbs are massaged and manipulated.</p

A qualitative study on informed consent decision-making at two tertiary hospitals in Uganda: Experiences of patients undergoing emergency surgery and their next of kin

Background: In emergency situations, patients and their next of kin must make complex medical and ethical decisions in a quick and timely way. Objectives: To describe the decision-making process during informed consent for emergency surgery among patients and the next of kin of patients who have undergone emergency surgery. Methods: Consecutive sampling of 39 participants and in-depth semi-structured interviews were conducted at two tertiary teaching hospitals in Uganda. There were 22 patients and 17 next of kin of patients who had undergone emergency surgery within 24–72 h. Responses about decision-making were coded into themes using the social constructivist theory and phenomenological approach Results: There were four emergent themes; decision-makers, people consulted, documentation of the consent and factors influencing decision-making. Most patients and next of kin made decisions on their own and documented the consent for themselves. Other family members and doctors were consulted during the decision-making process. Decision-making was influenced by reassurance of good outcomes of surgery and disclosure by the doctors. Conclusion: Decisions were made collaboratively with the patient at the center but with input of health personnel, the next of kin and other family members. A communitarian approach combined with shared decision-making between the doctor and the patient and next of kin with adequate discussion and disclosure of information in simple language would improve decision-making for patients and their next of kin

Demographic characteristics.

IntroductionWhile there have been several studies examining the understanding and quality of informed consent in clinical trials of cancer therapies, there is limited empirical research on health practitioners’ experiences on the informed consent process in cancer care, especially from low resource settings. This study explored health professionals’ perspectives on information disclosure during the consenting process in cancer care.MethodsA qualitative descriptive approach was used to collect data. Face to face interviews were conducted with 10 purposively selected healthcare professionals who were actively involved in soliciting informed consent at a cancer treatment centre in Uganda. A thematic approach was used to interpret the results.ResultsThere were five key themes, and these included information disclosure to patients; assessment of patients’ cancer awareness, treatment preferences and expectations; informed consent practices; barriers to optimal informed consent and information disclosure; and recommendations for improving the consenting process. All respondents appreciated the value of disclosing accurate information to patients to facilitate informed decision making. However, the informed consent process was deemed sub-optimal. Respondents asserted that patients should be the psychological wellbeing of patients should be protected by mentally preparing them before disclosing potentially distressing information. All healthcare professionals were appreciative of the central role the family plays in the consenting process.ConclusionOverall, informed consent practices were not ideal because of the several challenges. Inadequate time is devoted to information disclosure and patient education; there is lack of privacy; and informed consent documentation is poor. There is a need for significant improvement in informed consent practices and healthcare professional-patient communication.</div

Themes and key findings.

IntroductionWhile there have been several studies examining the understanding and quality of informed consent in clinical trials of cancer therapies, there is limited empirical research on health practitioners’ experiences on the informed consent process in cancer care, especially from low resource settings. This study explored health professionals’ perspectives on information disclosure during the consenting process in cancer care.MethodsA qualitative descriptive approach was used to collect data. Face to face interviews were conducted with 10 purposively selected healthcare professionals who were actively involved in soliciting informed consent at a cancer treatment centre in Uganda. A thematic approach was used to interpret the results.ResultsThere were five key themes, and these included information disclosure to patients; assessment of patients’ cancer awareness, treatment preferences and expectations; informed consent practices; barriers to optimal informed consent and information disclosure; and recommendations for improving the consenting process. All respondents appreciated the value of disclosing accurate information to patients to facilitate informed decision making. However, the informed consent process was deemed sub-optimal. Respondents asserted that patients should be the psychological wellbeing of patients should be protected by mentally preparing them before disclosing potentially distressing information. All healthcare professionals were appreciative of the central role the family plays in the consenting process.ConclusionOverall, informed consent practices were not ideal because of the several challenges. Inadequate time is devoted to information disclosure and patient education; there is lack of privacy; and informed consent documentation is poor. There is a need for significant improvement in informed consent practices and healthcare professional-patient communication.</div

COREQ checklist.

IntroductionWhile there have been several studies examining the understanding and quality of informed consent in clinical trials of cancer therapies, there is limited empirical research on health practitioners’ experiences on the informed consent process in cancer care, especially from low resource settings. This study explored health professionals’ perspectives on information disclosure during the consenting process in cancer care.MethodsA qualitative descriptive approach was used to collect data. Face to face interviews were conducted with 10 purposively selected healthcare professionals who were actively involved in soliciting informed consent at a cancer treatment centre in Uganda. A thematic approach was used to interpret the results.ResultsThere were five key themes, and these included information disclosure to patients; assessment of patients’ cancer awareness, treatment preferences and expectations; informed consent practices; barriers to optimal informed consent and information disclosure; and recommendations for improving the consenting process. All respondents appreciated the value of disclosing accurate information to patients to facilitate informed decision making. However, the informed consent process was deemed sub-optimal. Respondents asserted that patients should be the psychological wellbeing of patients should be protected by mentally preparing them before disclosing potentially distressing information. All healthcare professionals were appreciative of the central role the family plays in the consenting process.ConclusionOverall, informed consent practices were not ideal because of the several challenges. Inadequate time is devoted to information disclosure and patient education; there is lack of privacy; and informed consent documentation is poor. There is a need for significant improvement in informed consent practices and healthcare professional-patient communication.</div