Abstract
BackgroundStudies on informed consent to medical research conducted in low or middle-income settings have increased, including empirical investigations of consent to genetic research. We investigated voluntary participation and comprehension of informed consent among women involved in a genetic epidemiological study on breast cancer in an urban setting of Nigeria comparing women in the case and control groups.MethodsSurveys were administered in face-to-face interviews with 215 participants following their enrollment in the genetic study (106 patients, 109 controls). Audio-taped in-depth interviews were conducted with a sub-sample of 17 (8%) women who completed the survey.ResultsThe majority of all participants reported being told that participation in the genetic study was voluntary (97%), that they did not feel pressured to participate in the study (99%), and that they could withdraw from the study (81%). The majority of the breast cancer patients (83%) compared to 58% of women in the control group reported that the study purpose was to learn about the genetic inheritance of breast cancer (OR 3.44; 95% CI =1.66, 7.14, p value = 0.001). Most participants reported being told about study procedures (95%) and study benefits (98%). Sixty-eight percent of the patients, compared to 47% of the control group reported being told about study risks (p-value <0.001). Of the 165 married women, 19% reported asking permission from their husbands to enroll in the breast cancer study; no one sought permission from local elders. In-depth interviews highlight the use of persuasion and negotiation between a wife and her husband regarding study participation.ConclusionsThe global expansion of genetic and genomic research highlights our need to understand informed consent practices for studies in ethnically diverse cultural environments such as Africa. Quantitative and qualitative empirical investigations of the informed consent process for genetic and genomic research will further our knowledge of complex issues associated with communication of information, comprehension, decisional authority and voluntary participation. In the future, the development and testing of innovative strategies to promote voluntary participation and comprehension of the goals of genomic research will contribute to our understanding of strategies that enhance the consent process.
Highlights
Studies on informed consent to medical research conducted in low or middle-income settings have increased, including empirical investigations of consent to genetic research
Empirical studies on informed consent practices for biomedical research in low or middle-income countries have increased in recent years [3-17] including studies of consent for genetic research in culturally diverse populations in African settings [18-27]
We report findings from a study examining factors associated with voluntary participation and comprehension of the study purpose among women involved in genetic epidemiological research on breast cancer in Ibadan, Nigeria, a large metropolitan city
Summary
Studies on informed consent to medical research conducted in low or middle-income settings have increased, including empirical investigations of consent to genetic research. Empirical studies on informed consent practices for biomedical research in low or middle-income countries have increased in recent years [3-17] including studies of consent for genetic research in culturally diverse populations in African settings [18-27]. Richards and colleagues examined issues surrounding consent in a genetic epidemiological study of women with breast cancer [23] Marsh and her associates studied community engagement and informed consent in a genetic project on severe childhood diseases in Kenya [24]. Bull, Amenga-Etego, de Vries and colleagues have explored the consent process for participation in the MalariaGEN project, a genomic research study, implemented in Ghana [25] In their discussion of ethical issues raised in human genomics research in developing countries, de Vries, Bull, Doumbo, Ibrahim and colleagues draw on experiences of the MalariaGEN Consortium in developing countries including African sites [26]. Rotimi and Marshall outline specific challenges for informed consent to genetic and genomic research in culturally diverse low-income settings [27]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
