Ethical issues of informed consent in malaria research proposals submitted to a research ethics committee in Thailand: a retrospective document review

Abstract

BackgroundThe informed-consent process should be one of meaningful information exchange between researchers and study participants. One of the responsibilities of research ethics committees is to oversee appropriate informed consent. The committee must consider various matters before deciding whether the process is appropriate, including the adequacy and completeness of the written information provided to study participants, and the process of obtaining informed consent.This study aimed to identify, quantitatively and qualitatively, consent-related issues in different types of malaria proposals submitted to the Faculty of Tropical Medicine, Ethics Committee.MethodsThis study reviewed proposal documentation submitted to two panels of the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, from 2011 to 2015. The documentation included proposals, notifications to researchers of review outcomes and ethical issues of concern to committee members. Each element of the informed-consent process was identified and analyzed by study classification, design, and specimen use, including whether the study involved a vulnerable population. Summative content analysis was used to analyze patterns of common issues raised in reviews.ResultsOf the 112 proposals reviewed, 63 required an informed consent process. All researchers proposed communicating with their study participants; however, about two-thirds needed to improve their explanations of study procedures (study activities and specimen/data-collection process) to participants. About 40% of the proposals attracted comments on informed-consent process elements--risk and discomfort, vulnerable status, and compensation. Studies that planned to collect or use new/linked specimens raised more issues around informed consent than studies using linked data/records. Studies that involved vulnerable populations raised more issues than those that did not. The committee usually asked researchers to clarify, elaborate, revise, or paraphrase the consent process elements that were considered to involve inadequate information exchange between researcher and study participant.ConclusionsThis study aimed to describe lessons for malaria researchers about common informed-consent process issues in different types of malaria proposals. The information and analysis of informed-consent elements should assist the preparation of malaria-research proposals.

Research Ethics Committees’ Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols

“…This article addressed a basic descriptive question-"what are the ethical issues raised by RECs reviewing biomedical research in South Africa?" The most frequent ethical issue identified in our study was informed consent-a finding comparable with similar studies in South Africa (Clarke, 2014;Cleaton-Jones, 2010;Tsoka-Gwegweni & Wassenaar, 2014), the United Kingdom (Angell, Bryman, Ashcroft, & Dixon-Woods, 2008;Boyce, 2002), the United States (Lidz et al, 2012), Thailand (Adams et al, 2017), the Netherlands (van Lent, Rongen & Out, 2014), France (Decullier, Lhéritier, & Chapuis, 2005), Brazil (Bueno et al, 2009), Spain (Dal-Ré, Morejón & Ortega, 2004; Martín-Arrabis, Rodríguez-Lozano, & Arias-Díaz, 2012), and Finland (Hemminki, Virtanen, & Regushevskaya, 2015). A German study reported that of 1,299 queries, 53% concerned the patient information and consent document (Russ, Busta, Riedel, Zollner, & Jost, 2009).…”

Use of Template Documents with Guidance to Improve the Quality of Human Subjects Research Protocol Submissions to a Thai Research Ethics Committee

“…At least 20% of the submitted ICFs during the postintervention period had deficient components for information about the research contact team, study duration, travel compensation, adequate description of research procedure, and use of technical terms. These findings were consistent with those reported in previous studies and likely reflect inadequate investigator knowledge of research methods and ethics considerations necessary for study protocols and ICF (Adams et al, 2017;Bergstraesser et al, 2020;Shah et al, 2016;Shetty et al, 2012;van Lent et al, 2014). Regular REC audits to periodically identify these deficiencies and tailored trainings for investigators with repeated resubmission requirements seem prudent.…”

Ética en la investigación clínica: desafíos del consentimiento informado

“…Hay que considerar entonces, que la cuestión basal en todos los códigos éticos, es el principio de una decisión libre e informada (Adams et al, 2017). Bajo esta consigna, en la investigación biomédica y en la experimentación clínica, se exige a los investigadores un comportamiento ético durante el proceso del estudio, que garantice un trato con justicia y beneficencia, no maleficencia y respeto, (T. L. Beauchamp & Childress, 2001) que evidencie el reconocimiento y ejercicio de la autonomía del participante.…”