Developing World Bioethics
August 2016 Volume 16, Issue 2 Pages 61–120
http://onlinelibrary.wiley.com/doi/10.1111/dewb.2016.16.issue-2/issuetoc

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EDITORIAL
Zika virus, women and ethics (pages 62–63)
Debora Diniz
Version of Record online: 5 JUL 2016 | DOI: 10.1111/dewb.12119
[No abstract]

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ORIGINAL ARTICLES
The Challenges of Research Informed Consent in Socio-Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo (pages 64–69)
Marion Kalabuanga, Raffaella Ravinetto, Vivi Maketa, Hypolite Muhindo Mavoko, Blaise Fungula, Raquel Inocêncio da Luz, Jean-Pierre Van Geertruyden and Pascal Lutumba
Version of Record online: 7 SEP 2015 | DOI: 10.1111/dewb.12090
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’s protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children’s responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of ‘culturally acceptable representative’ under supervision of the local Ethics Committee may be more suitable.
To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low-literacy contexts, potential witnesses often don’t have any previous relationship with patient and there may be power-unbalance in their relationship, rather than genuine dialogue.
In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to ‘competition’ to access the research-related benefits, with a risk of disturbance at societal or household level.
Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees.

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ORIGINAL ARTICLES
Attitudes toward Post-Trial Access to Medical Interventions: A Review of Academic Literature, Legislation, and International Guidelines (pages 70–79)
Kori Cook, Jeremy Snyder and John Calvert
Version of Record online: 5 JUN 2015 | DOI: 10.1111/dewb.12087
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 towards post-trial access and participants and community members. Given that clinical trials conducted in low-income countries will likely continue, there is an urgent need for consideration of post-trial benefits for participants, communities, and citizens of host countries. While this issue may not be as pressing in countries where participants have access to healthcare and medicines through public schemes, it is particularly important in regions where this may not be available.