Informed consent in health research: challenges and barriers in low-and middle-income countries with specific reference to Nepal (In press)

Abstract

Obtaining ‘informed consent’ from every individual participant involved in a
 health research
 is
 a mandatory
 ethical p
 ractice
 .
 Informed consent is a process
 where
 by
 potential participants are genuinely informed about their role, risk
 and rights
 before they are enrolled in the study
 .
 Thus, e
 thics committees in
 most countries
 require
 ‘informed consent form’
 as part of an et
 hics 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
 .
 M
 ost 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
 assurin
 g
 proper research governance.
 With several examples
 from Nepal, t
 his paper reflects on the steps required to obtain informed
 consents
 and
 highlights some of the major challenges and barriers to
 seeking
 inform
 ed
 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.