Informed consent depends on five necessary criteria: the willingness
to participate, the capacity to make a decision, disclosure of
information, comprehension, and the decision to participate. Research
conducted in developing countries is often thought to have weaker
informed consent due to limited education and healthcare access in those
countries, but few studies have delved into this.
Making sure that participants of a clinical trial provide informed
consent - understanding their role, along with any risks and benefits of
voluntary participation - is a cornerstone of ethical trials. Now,
researchers reporting in PLOS Neglected Tropical Diseases
for the first time, directly compared the quality of the informed
consent process in a developed and a developing country in similar
clinical trials of the same hookworm vaccine.
‘There is need for educational interventions directed at clinical trial participants, both in developing and developed countries, in order to improve understanding of the informed consent document.’
In the new work, David Diemert, of the George Washington University
School of Medicine and Health Sciences, Flávia Gazzinelli of the Federal
University of Minas Gerais, and colleagues used a 32-question survey to
assess the quality of informed consent in Phase 1 trials of a hookworm
vaccine that were being conducted in two locations in Brazil - one rural
and one urban - as well as the United States. 105 participants completed
the questionnaire, which asked about their understanding of the study as
well as their reasons for participating.
Overall, there were few statistically significant differences
between participants in urban Belo Horizonte, Brazil and Washington, DC,
but more differences between people in those locations and in rural,
resource-limited Americaninhas, Brazil.
Knowledge about the trial was
poor in all places, with the mean number of correct answers about the
study being 45.6% in Americaninhas, 65.2% in Belo Horizonte, and 59.1%
in Washington, DC. And while around 40% of participants in Belo
Horizonte and Washington, DC, had doubts about participating, only 1.5%
has concerns in Americaninhas.
Moreover, most people in Washington, DC,
and Belo Horizonte cited helping others and benefiting the world as
major reasons to participate, while most in Americaninhas said it was a
personal decision, or they wanted to benefit their own health.
"Based on our results, we conclude that the use of the terms
"developed" and "developing" to describe countries is a reductionist
exercise to define participants as vulnerable, whereas a rigorous
consideration of the specific characteristics of each group of
individuals recruited as participants in a clinical trial is necessary,"
the researchers say. "These findings also demonstrate the need for
educational interventions directed at clinical trial participants, both
in developing and developed countries, in order to improve understanding
of the informed consent document."