Are Well-Informed Potential Trial Participants More Likely to Participate?

Abstract

Bearing in mind the importance of the informed consent, flaws in this process may be a barrier to participants' recruitment. Our objective was to determine the relationship between the degree of comprehension of the informed consent document plus the importance given to individual elements by potential participants of a hypothetical trial and their willingness to participate in such trials. We performed an Online Survey simulating an emergency department trial recruitment, posteriorly evaluating participants' ratings of importance and self-assessed comprehension of specific topics of the informed consent document. Only 10% of the sample read the entire document. Some specific topics were associated with willingness to participate in the hypothetical trial, but simple composite additive scores of comprehension and importance were not. We concluded that participants in general do not read the entire informed consent document and that importance given to specific topics may influence willingness to participate.

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Citation

Published Version (Please cite this version)

10.1177/1556264617737163

Publication Info

de Oliveira, Lucas Lentini Herling, Joao Ricardo Nickenig Vissoci, Wagner de Lara Machado, Clarissa G Rodrigues and Alexander T Limkakeng (2017). Are Well-Informed Potential Trial Participants More Likely to Participate?. Journal of empirical research on human research ethics : JERHRE, 12(5). 10.1177/1556264617737163 Retrieved from https://hdl.handle.net/10161/16696.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Vissoci

Joao Ricardo Nickenig Vissoci

Assistant Professor in Emergency Medicine

Joao Ricardo Nickenig Vissoci, MSc, PhD is an Assistant Professor of Emergency Medicine, Neurosurgery and Global Health. He is the Chief of the Division of Translational Health Sciences in the Department of Emergency Medicine, co-Director of the Global Emergency Medicine Innovation and Implementation (GEMINI) Research Center and a faculty member of the Research Design and Analysis Core (RDAC) in the Duke Global Health Institute. Dr. Vissoci has a background in social psychology and data science. Dr. Vissoci, a Brazilian native, earned a bachelor’s degree in Psychology from State University of Maringá/Brazil, a Masters in Physical Education, an MBA in Human Resources, and a PhD in Social Psychology. During his PhD, he completed a fellowship in Data Science at Duke University. After graduating his PhD in Social Psychology from the Pontificia Universidade Católica of São Paulo/Brazil, Dr. Vissoci completed a postdoctoral fellowship at the University of Sao Paulo (2015) in Design and Analysis for Mental Health research. He completed a second postdoctoral fellowship at the Duke Global Health Institute in Global Health and Data Science in 2016. Dr. Vissoci held a faculty position and taught Public Health and Health Sciences in Brazil from 2009 to 2015. After completing his fellowship at DGHI, he joined the Duke Department of Emergency Medicine as faculty in 2017. In his last 14 years as faculty (2009-current), he has mentored over 200 trainees at all levels of training from undergraduate, graduate, medical education, postdoctoral to faculty level. He has published over 200 manuscripts and collaborated on over 6 R-level NIH grants, multiple (K and D) NIH training grants, other federal grants UK/Brazil based, and foundational grants.


His research interests focus on leveraging data through analytics and technology to bridge the gap in access and equity in care in low resource settings, translating evidence into practice or policy impact. He uses data science and mixed-methods research to design and implement innovative data-driven solutions to address health care gaps.

Limkakeng

Alexander Tan Limkakeng

Professor of Emergency Medicine

Dr. Alexander T. Limkakeng, Jr., MD, MHSc, FACEP is a Professor of Emergency Medicine, Vice Chair of Clinical Research, Director of the Acute Care Research Team, and Director of the Resident Research Fellowship for the Department of Emergency Medicine in the Duke University School of Medicine in Durham, North Carolina.

Dr. Limkakeng has served as chair of the American College of Emergency Physicians (ACEP) Research Committee, and been the Course Director of the ACEP Research Forum from 2016-2018, the largest emergency medical research platform in the nation. He is also the Assistant Director of ACEP’s Emergency Medicine Basic Research Skills course. He was elected to the Nominating Committee of the Society of Academic Emergency Medicine.

As a researcher, Dr. Limkakeng has led multiple clinical trials and interdepartmental sponsored projects and is author on over 100 peer-reviewed manuscripts. These include studies in emergency conditions such as COVID-19, traumatic brain injury, hypertension, heart failure, thrombosis, stroke, envenomations, and septic shock. His research has been funded by grants and contracts totaling over $9 million dollars. He has lectured internationally on acute coronary syndrome, responsible conduct of research, design of clinical trials, and precision medicine in emergency care. He has led Duke’s involvement in NIH-funded research networks and in industry-funded work that led to FDA approval for multiple high-sensitivity cardiac troponin assays and point-of-care COVID-19 diagnostic tests. He has servesd as Co-PI for the Duke U24 Hub in the NIH Early Phase Pain Investigation Clinical Network (EPPIC-Net) (1U24NS114416) and now serves as a co-PI on the Duke U24 Hub award (1U24NS129498) in the NIH Strategies to Innovate Emergency Care Clinical Trials (SIREN) Network and in the NIH NINDS Strokenet network (1U24NS135250)

His personal research interest is finding new ways to diagnose acute coronary syndrome. In particular, he is interested in novel biomarkers and precision medicine approaches to this problem. The common element throughout this work is a focus on time-sensitive health conditions.

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