Posts Tagged ‘Francis Masiye’


“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.

FABTP alumni reunite at 2016 World Congress of Bioethics

Thursday, November 3rd, 2016

The International Association of Bioethics (IAB) hosted the 13th World Congress of Bioethics in Edinburgh, Scotland in June 2016. The 2016 theme was: Individuals, Public Interests and Public Goods: What is the Contribution of Bioethics? Nine Fogarty alumni and affiliates attended the biennial conference and a number of them presented their research during the three-day event. The Fogarty alumni and coordinators who attended include: Joe Ali, Nicola Barsdorf, Mary Kasule, Paulina Tindana, Chris Mweemba, Dimpho Ralefala, Aminu Yakubu, Godfrey Tangwa, and Francis Masiye. The 2016 themes for the IAB’s World Congress were: Art and Ethics; Individuals, Public Interests and Public Goods; Public Health, Ethics and Law; and, of particular interest to Fogarty alumni, Global Bioethics. The next meeting of the IAB World Congress will be in 2018 in New Delhi, India.

 

Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi

Friday, April 22nd, 2016

BACKGROUND:

This paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi.

DISCUSSION:

The current research ethics regulations and guidelines in Malawi do not allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes. In conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi.

 

Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents

Friday, April 22nd, 2016

BACKGROUND:

The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium.

METHODS:

A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of test results.

RESULTS:

Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results.

CONCLUSION:

H3Africa research makes use of three consent models-specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa.

Book chapter: Toward an African Ubuntuology/uMunthuology bioethics in Malawi in the context of globalization

Friday, October 11th, 2013

Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi

Friday, October 11th, 2013

HIV/AIDS reduces the relevance of the principle of individual medical confidentiality among the Bantu people of Southern Africa

Wednesday, September 8th, 2010

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Therapeutic Misconception: New evidence from a qualitative study in Blantyre Malawi

Wednesday, September 8th, 2010

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Disseminating research results to research participants and their communities

Wednesday, September 8th, 2010

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