Understanding Ethical Concerns Involving Vulnerable Human Participant Populations in Medical Research: Mixed-Method Analysis of Liberian Ebola Survivors' Experiences in PREVAIL I-VII.

Abstract

Background: As the number of large-scale outbreaks continues to rise worldwide, clinical trials are increasingly engaging disease-affected peoples within the Minority World (nations with over 80% poverty rates). Yet global health research inadequately addresses potential ethical issues of including impoverished, disease-affected populations and their contextual vulnerabilities in medical research. Objective: This paper presents a mixed-method analysis from our 2022 semi-structured survey capturing the experiences of Liberian Ebola Virus Disease (EVD) survivors serving as study participants in the Partnership for Research on Ebola Virus in Liberia (PREVAIL) clinical trials. Methods: Firstly, we conducted an extensive literature review of the scholarship related to biomedical research and ethical standards protecting study participants to inform our survey method and design. Applying a theoretical framework on vulnerability, we then qualitatively explored the survey responses of 19 EVD survivors' perceptions and experiences taking part in PREVAIL, including their expectations, treatment, delivered benefits, and quality of care. We further quantitatively codified their statements for underlying themes of reported negative experiences against standard ethical regulations in biomedical research, conducting a statistical analysis to inform generalizability. Most of the 19 survivors reported facing extreme ongoing vulnerabilities related to their disease status, including physical impairments, psychosocial stress, and socio-economic inequity. Results: Initially, the survivors tended to experience a sense of hope and pride in volunteering for PREVAIL. One in five participants reported benefiting from PREVAIL's regular medical diagnoses. However, most of their survey responses indicated prevalent negative shared experiences, including continually being confused or misinformed of their study participant rights, roles, and benefits; being burdened by heavy participation transaction costs; and repeated incidents of poor treatment and discrimination by PREVAIL staff after initial recruitment. PREVAIL participant satisfaction ranking is negatively correlated with receiving insufficient financial compensation (r = -0.51), extensive time requirements for each medical visit (-0.40), and being poorly treated by clinical staff (-0.67).