Consent for Participating in Clinical Trials - Is It Really Informed?

Overview

Journal Dev World Bioeth

Specialty Medical Ethics

Date 2018 Jun 23

PMID 29933502

Citations 11

Authors

Teodora Alexa-Stratulat

Marius Neagu

Anca-Iulia Neagu

Ioana Dana Alexa

Beatrice Gabriela Ioan

Affiliations

Soon will be listed here.

Abstract

The article explores the challenges of ensuring voluntary and informed consent which is obtained from potential research subjects in the north-eastern part of Romania. This study is one of the first empirical papers of this nature in Romania. The study used a quantitative survey design using the adapted Quality of Informed Consent (QuIC) questionnaire. The target population consisted of 100 adult persons who voluntarily enrolled in clinical trials. The informed consent form must contain details regarding the potential risks and benefits, the aim of the clinical trial, study design, confidentiality, insurance and contact details in case of additional questions. Our study confirmed that although all required information was included in the ICF, few clinical trial participants truly understood it. We also found that the most important predictive factor for a good subjective and objective understanding of the clinical trial was the level of education. Our study suggests that researchers should consider putting more effort in order to help clinical trials participants achieve a better understanding of the informed consent. In this way they will ensure that participants' decision-making is meaningful and that their interests are protected.

Citing Articles

Researchers experience and views on participants' comprehension of informed consent in clinical trials in Malawi: a descriptive qualitative study.

Kazembe D, Woldeamanuel Y, Abay S BMC Med Ethics. 2024; 25(1):101.

PMID: 39334067 PMC: 11438391. DOI: 10.1186/s12910-024-01100-5.

Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study.

Iseselo M, Tarimo E BMC Med Ethics. 2024; 25(1):29.

PMID: 38481301 PMC: 10935914. DOI: 10.1186/s12910-024-01033-z.

Participants' understanding of informed consent in clinical trials: A systematic review and updated meta-analysis.

Wu C, Wang N, Wang Q, Wang C, Wei Z, Wu Z PLoS One. 2024; 19(1):e0295784.

PMID: 38166097 PMC: 10760836. DOI: 10.1371/journal.pone.0295784.

The significance of immune microenvironment in patients with endometriosis.

Pavaleanu I, Balan R, Grigoras A, Balan T, Amalinei C Rom J Morphol Embryol. 2023; 64(3):343-354.

PMID: 37867352 PMC: 10720939. DOI: 10.47162/RJME.64.3.06.

Factors Associated with Burnout in Medical Staff: A Look Back at the Role of the COVID-19 Pandemic.

Taranu S, Stefaniu R, Rotaru T, Turcu A, Pislaru A, Sandu I Healthcare (Basel). 2023; 11(18).

PMID: 37761730 PMC: 10530693. DOI: 10.3390/healthcare11182533.

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