Abstract
BackgroundWithin the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups. In this study, we explored the consent practices and attitudes regarding essential information required for the consent process within hospital-based trial communities from four referral hospitals in Vietnam.MethodsWe collected surveys from and conducted semi-structured interviews with study physicians, study nurses, ethics committee members, and study participants and family members regarding their experiences of participating in research, their perspectives toward research, and their views about various elements of the consent process.ResultsIn our findings, we describe three interrelated themes related to the consent process: (1) words and regulation; (2) reimbursement, suspicions, and joining; and (3) responsibilities. In general, stakeholders had highly varied perspectives of nghiên cứu (Eng.: research) and researchers used varying levels of detail regarding all aspects of the study in the consent process to build trust with and/or promote potential research participants’ choices about taking part in research. Findings additionally highlight how researchers felt that offering financial reimbursements in a hospital setting, where payment for services was routine, would be unfamiliar to participants and could raise suspicions about the research. Participants, however, focused their discussions on reimbursement or alternative reasons for joining the study, such as health related benefits or altruism. Finally, participants often relied on their physician to help them decide about joining a study or not.ConclusionFurther research is needed to understand how researchers and participants make sense of and practice consent, and how that impacts participants’ decision-making about research participation. To promote valid consent within this context, it is important to engage with hospital-based trial communities as a whole. The data from this study will inform future research on consent, guide the revisions of consent related policies within our research sites and point to several larger issues surrounding researcher-participant expectations, communication, and trust.
Highlights
Within the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups
Background the research community generally accepts that the consent process for clinical research should be culturally appropriate and tailored to the context, researchers continue to grapple with what valid consent means for research within specific communities and stakeholder groups [1]
The Council for International Organizations of Medical Sciences (CIOMS) defines a valid consent process as providing “potential research participants with the information and the opportunity to give their free and informed consent to participate in research” emphasizing processes that protect free choice and respect individual autonomy [2]
Summary
It is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups. The research community generally accepts that the consent process for clinical research should be culturally appropriate and tailored to the context, researchers continue to grapple with what valid consent means for research within specific communities and stakeholder groups [1]. The amount of information that is considered sufficient is not defined, understanding varies amongst and within communities, and choices (individual and otherwise) are influenced by a variety of factors that may not be obvious. Developing a consent process with the right amount of information for sufficient understanding continues to be a challenge for researchers, especially with complex study designs. Gillies (2018) synthesized papers that focused on patient reported measures of consent in clinical trials and found that the majority of measures focused on understanding, not the myriad factors that influence participation, such as decision-making mechanisms [6]
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