Archive for the ‘2017 FABTP Articles’ Category


“I passed the test!” Evidence of diagnostic misconception in the recruitment of population controls for an H3Africa genomic study in Cape Town, South Africa

Thursday, August 31st, 2017

Abstract:

Background

Advances in genetic and genomic research have introduced challenges in obtaining informed consent for research in low and middle-income settings. However, there are only few studies that have explored challenges in obtaining informed consent in genetic and genomic research in Africa and none in South Africa. To start filling this gap, we conducted an empirical study to investigate the efficacy of informed consent procedures for an H3Africa genomic study on Rheumatic Heart Disease (RHDGen) at the University of Cape Town in South Africa. The main aim of the study was to understand ethical challenges in obtaining informed consent in the RHDGen study.

Methods

We used a qualitative study methodology involving in-depth interviews and participant observations. Our study participants were RHDGen cases (patients), healthy controls and research staff involved in the recruitment of RHDGen cases and controls. In total, we conducted 32 in-depth interviews with RHDGen cases and controls, 2 in-depth interviews with research staff and 57 direct observations of the consent procedures of RHDGen cases and controls. The interviews were conducted in English, audio-recorded and transcribed verbatim. Data were analyzed using thematic content analysis. The study was conducted in 3 sites within Cape Town, South Africa.

Results

Most healthy controls joined the RHDGen study in order to be screened for rheumatic heart disease (diagnostic misconception). A majority of RHDGen cases decided to join the RHDGen study because of therapeutic misconception.

Conclusion

The ethical challenges that impacted on obtaining informed consent in the RHDGen study were complex. In this study, the main challenges were diagnostic misconception among RHDGen controls and therapeutic misconception among RHDGen cases.

 

Masiye, Francis, Bongani Mayosi, and Jantina de Vries. ““I passed the test!” Evidence of diagnostic misconception in the recruitment of population controls for an H3Africa genomic study in Cape Town, South Africa.” BMC Medical Ethics 18.1 (2017): 12.

Research Ethics Committees in Nigeria: A Survey of Operations, Functions, and Needs

Thursday, August 31st, 2017

Abstract: Heightened global commitment to research on diseases such as HIV/AIDS, tuberculosis, and malaria has led to increased research over the past decade in many African countries, including Nigeria. This increase in research has led to debates about the ethics of health research in resource-poor or developing countries and has drawn further attention to existing ethical review processes. This study was undertaken to describe and benchmark the operational and organizational structures as well as functions of research ethics committees (RECs) in Nigeria. The article explores the factors that contribute to REC conformity with the Nigerian National Ethics Code and World Health Organization (WHO) guidelines for RECs. Data were collected using a self-administered, semistructured questionnaire. A descriptive analysis was conducted, and Fisher’s exact tests performed to assess associations between selected REC characteristics and the degree of conformity to applicable national and international requirements. Eighty percent of RECs (20 out of 25) had standard operating procedures, while 68% (17 out of 25) met at least quarterly and provided final review determinations within three months. RECs with committee chairs who had prior bioethics training were more likely to have operations conforming to the WHO and the Nigerian ethics guidelines. Overall, this study suggests that there is variability in the degree to which operations and functions of RECs in Nigeria conform to the Nigerian National Code and WHO guidelines.

 

Research Ethics Committees in Nigeria: A Survey of Operations, Functions, and Needs,. Aminu A. Yakubu, Adnan A. Hyder, Joseph Ali, and Nancy Kass. IRB: Ethics & Human Research. 2017. May-June 2017 Volume: 39, Issue: 3