Motivations, Understanding, and Voluntariness in International Randomized Trials

Research on informed consent conducted in wealthy countries has found that subjects' understanding of research often is incomplete or, at times, inaccurate. 1 Other studies reveal a subtler clouding of the distinction between treatment and research, whereby patient/subjects know they are in research, but view research as treatment for their disease. 2Such a misunderstanding may compromise meaningful decision-making about participation in clinical trials. 3e minimal empirical research on informed consent that exists from developing countries suggests that trial subjects in the developing world encounter similar challenges.Research participants in resource poor regions may face additional barriers in informed consent related to language, education, culture, beliefs, and/or decision-making styles. 4For example, in a study in Haiti on HIV transmission, only three of 15 potential participants scored well enough on a true-false comprehension test to be enrolled, 5 and investigators in The Gambia found that 90% of participants in a vaccine trial knew the purpose of the vaccine, but only 10% understood placebos. 6tonomous decision-making, a standard goal of existing national and international research ethics guidelines, may be especially challenging for research conducted in international settings.It is expected that autonomous decision-makers voluntarily agree to participate in clinical trials.Yet voluntariness can be compromised by a variety of factors, including poverty, limited access to medical care, and patterns of decision-making related to gender, socioeconomic status, or culture. 7 The political and human rights context of studies can also compromise voluntariness. 8Moreover, in some contexts, potential participants may feel they cannot say no to a professional's recommendation that they enroll in a study. 9It has been well documented in both U.S. and international research that trust in researchers contributes significantly to participation in research, regardless of whether participants understand the study. 10Finally, concerns have been raised that financial or medical incentives may create undue influence to participate in research, 11 although the degree to which inducements are problematic remains a matter of debate. 12Given the limited empirical data documenting understanding and voluntariness in international research, we conducted a qualitative pilot study to learn how participants in international clinical trials define research and why they enroll.We interviewed participants in three developing countries who were participants in six different randomized, controlled