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Informed consent in health Research: Challenges and barriers in low-and middle-income countries with specific reference to Nepal

Regmi, Pramod R.; Aryal, Nirmal; Kurmi, Om; Pant, Puspa Raj; van Teijlingen, Edwin; Wasti, Sharada P.

Authors

Pramod R. Regmi

Nirmal Aryal

Om Kurmi

Edwin van Teijlingen

Sharada P. Wasti



Abstract

Obtaining ‘informed consent’ from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require ‘informed consent form’ as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low-and middle-income countries (LMICs) in recent years, only limited work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent.

Journal Article Type Article
Acceptance Date Jul 13, 2016
Online Publication Date Aug 12, 2016
Publication Date Aug 31, 2017
Deposit Date Jan 23, 2024
Journal Developing World Bioethics
Print ISSN 1471-8731
Electronic ISSN 1471-8847
Publisher Wiley
Peer Reviewed Peer Reviewed
Volume 17
Issue 2
Pages 84-89
DOI https://doi.org/10.1111/dewb.12123
Public URL https://uwe-repository.worktribe.com/output/11396908