Clinical trial informed consent quality similar in developed, developing countries

February 6, 2017, Public Library of Science
Physician inoculates patient, hopefully after receiving informed consent. Credit: blakespot, Flickr

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 have, 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.

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 due to limited education and healthcare access in those countries, but few studies have delved into this.

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 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."

Explore further: Shorter patient consent forms, video formats improve comprehension

More information: David J. Diemert et al, A Comparison of the Quality of Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and Developing Countries, PLOS Neglected Tropical Diseases (2017). DOI: 10.1371/journal.pntd.0005327

Related Stories

Shorter patient consent forms, video formats improve comprehension

June 6, 2016
When patients participate in a clinical trial, they are required—for legal and ethical reasons—to complete consent forms that are typically long, complicated and filled with technical language. Some experts fear these ...

Clinical trials for first-ever human hookworm vaccine advance

November 5, 2012
The Sabin Vaccine Institute (Sabin) today announced the start of Part II of its Phase I clinical trial of the Na-GST-1 vaccine candidate, marking another major milestone in the progress toward developing a human hookworm ...

Multisensory education enhances patient understanding of orthopaedic conditions

October 6, 2016
Patient education involving the use of multiple senses (sight, hearing and touch) during a physician-patient conversation about treatment, also known as "informed consent," improves understanding of anticipated care and possible ...

Support for research without prior consent in cases involving critically ill children

October 23, 2015
Public health experts at the University of Liverpool have shown that parents and medics support research without prior consent in the emergency treatment of critically ill children.

Clinical trials for childhood cancer drugs are critical, but parents don't always understand them

February 25, 2016
Each week in the United States, about 300 children are diagnosed with cancer. Many of them will be offered treatment as part of a clinical trial that tests different drugs or different ways to give standard drugs.

Recommended for you

Yelp reviews reveal strengths and weaknesses of emergency departments and urgent care

November 9, 2018
Yelp reviews reveal that emergency departments are viewed as being higher quality but lacking in service as compared to urgent care centers, which patients rate the opposite, according to a new study from researchers in the ...

A look at how colds and chronic disease affect DNA expression

November 8, 2018
We're all born with a DNA sequence that encodes (in the form of genes) the very traits that make us, us—eye color, height, and even personality. We think of those genes as unchanging, but in reality, the way they are expressed, ...

Patients with untreated hearing loss incur higher health care costs over time

November 8, 2018
Older adults with untreated hearing loss incur substantially higher total health care costs compared to those who don't have hearing loss—an average of 46 percent, totaling $22,434 per person over a decade, according to ...

Lifespan is increasing in people who live to 65

November 7, 2018
Stanford biologist Shripad Tuljapurkar had assumed humans were approaching the limit to their longevity – that's what previous research had suggested – but what he observed in 50 years of lifespan data was more optimistic ...

Researchers report connection between intestinal bacteria and development of diabetes

November 7, 2018
Researchers at Örebro University have, together with a well-known research team in Denmark, developed a method for studying how metabolism in gut bacteria influences health. Their method will now be published in its entirety ...

Patients' experiences with misdiagnosis inform patient safety improvement efforts

November 6, 2018
Diagnostic errors affect an estimated 12 million U.S. adult outpatients annually; however, patients' experiences of these errors are underexplored. To gain insight into the patient perspective, researchers from Baylor College ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.