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

Autor: Srisin Khusmith, Jaranit Kaewkungwal, Sukanya Prakobtham, Paul Adams, Pitchapa Vutikes, Polrat Wilairatana, Chanthima Limpattaracharoen, Pornpimon Adams, Sumeth Suebtrakul
Rok vydání: 2017
Předmět:
Adult
Male
Biomedical Research
Health (social science)
Adolescent
Informed consent process
0603 philosophy
ethics and religion
Young Adult
03 medical and health sciences
0302 clinical medicine
Documentation
Informed consent
Tropical Medicine
Research participant
Humans
Institutional review board (IRB)
Medicine
030212 general & internal medicine
Information exchange
Retrospective Studies
Ethics
lcsh:R723-726
Medical education
Research ethics
Informed Consent
Malaria research proposal
business.industry
Health Policy
06 humanities and the arts
Thailand
Research Personnel
Malaria
Issues
ethics and legal aspects
Summative assessment
Research Design
Content analysis
Philosophy of medicine
Female
Forms and Records Control
060301 applied ethics
lcsh:Medical philosophy. Medical ethics
business
Ethics Committees
Research
Research Article
Zdroj: BMC Medical Ethics, Vol 18, Iss 1, Pp 1-19 (2017)
BMC Medical Ethics
ISSN: 1472-6939
Popis: Background The 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. Methods This 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. Results Of 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. Conclusions This 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.
Databáze: OpenAIRE
Externí odkaz: