摘要：Objectives. We compared voluntary participation and comprehension of informed consent among individuals of African ancestry enrolled in similarly designed genetic studies of hypertension in the United States and Nigeria. Methods. Survey questionnaires were used to evaluate factors associated with voluntariness (the number of people volunteering) and understanding of the study’s genetic purpose. A total of 655 individuals (United States: 348; Nigeria: 307) were interviewed after participation in the genetic studies. Results. Most US respondents (99%), compared with 72% of Nigerian respondents, reported being told the study purpose. Fewer than half of the respondents at both sites reported that the study purpose was to learn about genetic inheritance of hypertension. Most respondents indicated that their participation was voluntary. In the United States, 97% reported that they could withdraw, compared with 67% in Nigeria. In Nigeria, nearly half the married women reported asking permission from husbands to enroll in the hypertension study; no respondents sought permission from local elders to participate in the study. Conclusions. Our findings highlight the need for more effective approaches and interventions to improve comprehension of consent for genetic research among ethnically and linguistically diverse populations in all settings. Informed consent represents a key ethical concern in clinical and community-based epidemiological genetic research. 1 – 9 Voluntary informed consent is universally accepted as a precondition for scientific research involving human beings. National and international guidelines for ethical conduct in research outline specific requirements for obtaining informed consent. 10 – 13 Despite the promulgation of ethical guidelines for obtaining informed consent, the application of national and international guidelines can be difficult in practice. 14 – 17 Research participants may have difficulty understanding consent documents that include information about complex biomedical and genetic concepts. 18 – 28 Language barriers may hinder effective communication between researchers and participants invited to join a study. 29 Requirements for written consent can further exacerbate challenges to effective communication, particularly in areas with high illiteracy rates or low levels of trust in medical institutions, or where signatures are seldom used for conducting business. 30 In many non-Western settings, family members or community leaders may have an important role in determining participation in medical and genetic research. 31 – 37 In resource-poor settings, individuals and communities may be vulnerable to coercion because of their social status or poverty, and political conditions may complicate the ethical principle of voluntary participation in research. 38 – 40 There is a small but growing literature on informed consent to medical research conducted in low- or middle-income countries. 41 – 49 However, little is known about informed consent to genetic epidemiological research in culturally or socioeconomically diverse communities in resource-poor or industrialized nations. 50 – 52 The increasing global effort to use genetic epidemiological tools to understand the etiology of complex diseases such as HIV infection, malaria, diabetes, and hypertension requires more direct and intense collaborations between many disciplines and between wealthy and poor nations. 19 The rapid growth of genetic research initiatives worldwide heightens the urgency to understand more about informed consent practices for genetic studies with diverse populations. Participants may respond differently to informed consent for genetic research because the research may have serious implications for family relationships, personal and ethnic identity, and the emotionally charged notions of “race.” 53 Genetic research differs from other types of medical research because of culturally embedded beliefs about heredity. Inherited genetic traits cannot be changed. Moreover, results of genetic research may reinforce racist stereotypes or result in discriminatory practices against individuals or populations. These issues are relevant for populations everywhere. However, individuals involved in genetic research in industrialized settings with high rates of literacy might be expected to have greater understanding of the genetic purpose of such studies than their counterparts in low-income countries, particularly in areas of low literacy. 52 Differences in understanding the voluntary nature of participation might also be expected between participants in genetic research in these diverse environments. In order to examine these assumptions, we compared factors associated with voluntary participation and comprehension of the purpose of studies among individuals participating in genetic epidemiological research on hypertension in an urban setting in the United States and in a rural town in Nigeria. Although commentary (editorials and opinion pieces) is abundant, this study is unique because it is the first large-scale cross-cultural empirical investigation of voluntary participation and informed consent among individuals enrolled in similarly designed and implemented genetic studies conducted in an industrialized and a resource-poor country. Moreover, all participants were African American or Nigerian.
