The Challenges of Research Informed Consent in Socio ‐Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo
Abstract
In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio‐cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of socio‐economic vulnerability.
To ensure children...
Source: Developing World Bioethics - September 6, 2015 Category: Medical Ethics Authors: Marion Kalabuanga, Raffaella Ravinetto, Vivi Maketa, Hypolite Muhindo Mavoko, Blaise Fungula, Raquel Inoc êncio da Luz, Jean‐Pierre Van Geertruyden, Pascal Lutumba Tags: Articles Source Type: research
Post‐trial obligations in the Declaration of Helsinki 2013: classification, reconstruction and interpretation
Abstract
The general aim of this article is to give a critical interpretation of post‐trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post‐trial obligations, specifically, access to care after research and access to information after research. The agents entitled t...
Source: Developing World Bioethics - August 1, 2015 Category: Medical Ethics Authors: Ignacio Mastroleo Tags: Original Article Source Type: research
Maintaining Research Integrity While Balancing Cultural Sensitivity: A Case Study and Lessons From the Field
We describe an ethical breach in the conduct of global health research by a arising from the ad‐hoc participation of a community stakeholder external to the visiting research group. A framework for reflection is developed from a careful examination of underlying factors and presented with a discussion of consequences and mitigation measures. This framework aims to present lessons learned for researchers working abroad who might face similar situations in their work. (Source: Developing World Bioethics)
Source: Developing World Bioethics - August 1, 2015 Category: Medical Ethics Authors: Rebekah Sibbald, Bethina Loiseau, Benedict Darren, Salem A. Raman, Helen Dimaras, Lawrence C. Loh Tags: Original Article Source Type: research
The Challenges of Research Informed Consent in Socio‐Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo
Abstract
In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio‐cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of socio‐economic vulnerability.
To ensure children...
Source: Developing World Bioethics - August 1, 2015 Category: Medical Ethics Authors: Marion Kalabuanga, Raffaella Ravinetto, Vivi Maketa, Hypolite Muhindo Mavoko, Blaise Fungula, Raquel Inocêncio da Luz, Jean‐Pierre Van Geertruyden, Pascal Lutumba Tags: Original Article Source Type: research
Eugenics and Mandatory Informed Prenatal Genetic Testing: A Unique Perspective from China
Abstract
The application of genetic technologies in China, especially in the area of prenatal genetic testing, is rapidly increasing in China. In the wealthy regions of China, prenatal genetic testing is already very widely adopted. We argue that the government should actively promote prenatal genetic testing to the poor areas of the country. In fact, the government should prioritize resources first to make prenatal genetic testing a standard routine care with an opt‐out model in these area. Healthcare professions would be required to inform pregnant women about the availability of genetic testing and provide free testin...
Source: Developing World Bioethics - July 30, 2015 Category: Medical Ethics Authors: Di Zhang, Vincent H. Ng, Zhaochen Wang, Xiaomei Zhai, Reidar K. Lie Tags: Original Article Source Type: research
Prioritization of healthcare workers for experimental Ebola therapeutic would exacerbate existing inequalities
(Source: Developing World Bioethics)
Source: Developing World Bioethics - July 20, 2015 Category: Medical Ethics Authors: Morenike Oluwatoyin Folayan, Bridget Haire Tags: LETTER TO THE EDITOR Source Type: research
Are International Ethical Guidance Documents and Statements Lacking Legitimacy?
(Source: Developing World Bioethics)
Source: Developing World Bioethics - July 20, 2015 Category: Medical Ethics Authors: Udo Schuklenk Tags: EDITORIAL Source Type: research
Attitudes toward Post ‐Trial Access to Medical Interventions: A Review of Academic Literature, Legislation, and International Guidelines
Abstract
There is currently no international consensus around post‐trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post‐trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post‐trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes...
Source: Developing World Bioethics - June 4, 2015 Category: Medical Ethics Authors: Kori Cook, Jeremy Snyder, John Calvert Tags: Original Article Source Type: research
Anything to Stay Alive: The Challenges of a Campaign for an Experimental Drug
Abstract
Drug‐resistant tuberculosis (TB) has a high mortality rate. Most medicines used to treat it are poorly tested and have terrible side effects. Activists have campaigned for patients with drug‐resistant TB to have access to experimental drugs, particularly one called bedaquiline, before these have been approved by regulatory authorities such as the Food and Drug Administration (FDA) in the United States (US) and the Medicines Control Council (MCC) in South Africa. Some activists have also campaigned for bedaquiline to be approved by regulatory authorities before testing of the drug is completed. These campaigns ...
Source: Developing World Bioethics - May 15, 2015 Category: Medical Ethics Authors: Nathan Geffen Tags: Original Article Source Type: research
Attitudes toward Post‐Trial Access to Medical Interventions: A Review of Academic Literature, Legislation, and International Guidelines
Abstract
There is currently no international consensus around post‐trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post‐trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post‐trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes...
Source: Developing World Bioethics - April 1, 2015 Category: Medical Ethics Authors: Kori Cook, Jeremy Snyder, John Calvert Tags: Original Article Source Type: research
Uterine Transplantation: Ethical Considerations within Middle Eastern Perspectives
Abstract
The field of reproductive medicine witnessed a breakthrough in September 2014 with the first successful live birth post uterine transplantation. This success represents the culmination of decades' worth of research on infertility and reproductive medicine. This subject of infertility gathers special attention in the Middle East, as childbearing is given paramount importance in the family unit. And as with any new medical advancement, Middle Eastern people look to their religious authorities for guidance. This paper describes the various ethical quandaries related to uterine transplantation, from a perspective of t...
Source: Developing World Bioethics - April 1, 2015 Category: Medical Ethics Authors: Zaid Altawil, Thalia Arawi Tags: Original Article Source Type: research
African Bioethics vs. Healthcare Ethics in Africa: A Critique of Godfrey Tangwa
Abstract
It is nearly two decades now since the publication of Godfrey Tangwa's article, ‘Bioethics: African Perspective’, without a critical review. His article is important because sequel to its publication in Bioethics, the idea of ‘African bioethics’ started gaining some attention in the international bioethics literature. This paper breaks this relative silence by critically examining Tangwa's claim on the existence of African bioethics. Employing conceptual and critical methods, this paper argues that Tangwa's account of African bioethics has some conceptual, methodic and substantive difficulties, which altog...
Source: Developing World Bioethics - April 1, 2015 Category: Medical Ethics Authors: Ademola K. Fayemi Tags: Original Article Source Type: research
Pharmaceutical Research, Democracy and Conspiracy: International Clinical Trials in Local Medical Institutions by Edison Bicudo. Surrey, UK and Burlington, VT: Gower Publishing Limited and Ashgate Publishing Company, 2014. 175pp (including bibliography and index). US$94.96 & £54.00 (Hardcover). ISBN: 978‐1‐4724‐2357‐3 (hbk).
(Source: Developing World Bioethics)
Source: Developing World Bioethics - March 3, 2015 Category: Medical Ethics Authors: Collin O'neil Tags: BOOK REVIEW Source Type: research
Empirical Research and Bioethics
(Source: Developing World Bioethics)
Source: Developing World Bioethics - March 3, 2015 Category: Medical Ethics Authors: Debora Diniz Tags: EDITORIAL Source Type: research
Managing Human Tissue Transfer Across National Boundaries – An Approach from an Institution in South Africa
This article will examine three significantly important ethico‐legal concepts that were deliberated and carefully adapted by a South African Institution to suit the transfer of Human Biological Materials (HBMs) and associated data for biobank research, namely: informed consent; benefit sharing arrangements; and ownership together with intellectual property rights in human tissues. The discussion includes an analysis of current practice; the ethico‐legal challenges in the South African/African context; the decisions made with regard to how the related ethico‐legal challenges were addressed in the MTA; and justificatio...
Source: Developing World Bioethics - February 17, 2015 Category: Medical Ethics Authors: Safia Mahomed, Kevin Behrens, Melodie Slabbert, Ian Sanne Tags: Original Article Source Type: research
