Informed consent for controlled human infection studies in low‐ and middle‐income countries: Ethical challenges and proposed solutions

Bioethics ◽  
2020 ◽  
Vol 34 (8) ◽  
pp. 809-818
Author(s):  
Vina Vaswani ◽  
Abha Saxena ◽  
Seema K. Shah ◽  
Ricardo Palacios ◽  
Annette Rid
2016 ◽  
Vol 17 (2) ◽  
pp. 84-89 ◽  
Author(s):  
Pramod R. Regmi ◽  
Nirmal Aryal ◽  
Om Kurmi ◽  
Puspa Raj Pant ◽  
Edwin van Teijlingen ◽  
...  

2021 ◽  
pp. 107780122110357
Author(s):  
Sanne Weber ◽  
Margaret Hardiman ◽  
Wangu Kanja ◽  
Siân Thomas ◽  
Nicole Robinson-Edwards ◽  
...  

Research with survivors of gender-based violence in low- and middle-income countries is important to improve understanding of experiences of violence and the policies that can help combat it. But this research also implies risks for survivors, such as re-traumatization, safety concerns, and feelings of exploitation. These risks are magnified if research is undertaken by researchers from high-income countries, whose positionality produces power inequalities affecting both participants and research partners. This article describes the ethical challenges of international gender-based violence research from the perspective of Kenyan researchers and organizations and identifies recommendations about how to prevent them.


2014 ◽  
Vol 20 (3) ◽  
pp. 6
Author(s):  
Jonathan K Burns

<p>With the publication of the <em>Diagnostic and Statistical Manual</em>, 5th edition, and the ongoing revision of the <em>International Classification of Diseases</em>, currently 10th edition, it is timely to consider the wider societal implications of evolving psychiatric classification, especially within low- and middle-income countries (LMICs). </p><p>The author reviewed developments in psychiatric classification, especially the move from categorical to dimensional approaches based on biobehavioural phenotypes. While research supports this move, there are several important associated ethical challenges. Dimensional classification runs the risk of ‘medicalising’ a range of normality; the broadening of some definitions and the introduction of new disorders means more people are likely to attract psychiatric diagnoses. Many LMICs do not have the political, social, legal and economic systems to protect individuals in society from the excesses of medicalisation, thus potentially rendering more citizens vulnerable to forms of stigma, exploitation and abuse, conducted in the name of medicine and psychiatry. Excessive medicalisation within such contexts is also likely to worsen existing disparities in healthcare and widen the treatment gap, as inappropriate diagnosis and treatment of mildly ill or essentially normal people has an impact on health budgets and resources, leading to relative neglect of those with genuine, severe psychiatric disorders.<strong> </strong></p><p>In an era of evolving psychiatric classification, those concerned for, and involved in, global mental health should be critically self-reflective of all aspects of the modern psychiatric paradigm, especially changes in classification systems, and should alert the global profession to the sociopolitical, economic and cultural implications of changing nosology for LMIC regions of the world.</p>


Author(s):  
Diego S. Silva ◽  
Michael Selgelid

Although tuberculosis (TB) affects people worldwide, particularly those of lower socioeconomic status, the vast majority of the burden is felt in low- and middle-income countries (LMICs). In turn, the ethical challenges posed by TB care and control are especially salient in LMICs faced with acute and chronic resource constraints. For some of these challenges, there is broad agreement about what ought to be done. TB prevention among close contacts of contagious patients, for example, is essential. Other challenges, however, are either new or refractory and require greater consideration. This chapter discusses three such key ethical challenges posed by TB care and control, particularly within the context of LMICs: isolation and involuntary isolation, third-party notification, and the introduction of new antitubercular drugs.


2021 ◽  
pp. 1-17
Author(s):  
Katherine Standish ◽  
Katherine McDaniel ◽  
Shirin Ahmed ◽  
Nikole H. Allen ◽  
Sohini Sircar ◽  
...  

2021 ◽  
Vol 6 (5) ◽  
pp. e005757
Author(s):  
Stuti Pant ◽  
Maya Annie Elias ◽  
Kerry Woolfall ◽  
Maria Moreno Morales ◽  
Bensitta Lincy ◽  
...  

IntroductionTime-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in India, Sri Lanka and Bangladesh.MethodsTerm infants with neonatal encephalopathy, aged less than 6 hours, were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed A-V records of the consent process using a 5-point Likert scale on three parameters—empathy, information and autonomy. In addition, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 healthcare professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.ResultsA total of 294 A-V records of the HELIX trial were analysed. Median (IQR) score for empathy, information and autonomy was 5 (0), 5 (1) and 5 (1), respectively. However, thematic analysis suggested that the consenting was a ceremonial process; and parental decision to participate was based on unreserved trust in the treating doctors, therapeutic misconception and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial nor the nature of the intervention. Professionals showed a strong bias towards cooling therapy and reported time constraints and explaining to multiple family members as key challenges.ConclusionDespite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context-appropriate strategies for informed trial participation.


2012 ◽  
Author(s):  
Joop de Jong ◽  
Mark Jordans ◽  
Ivan Komproe ◽  
Robert Macy ◽  
Aline & Herman Ndayisaba ◽  
...  

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