title: Voluntary participation and comprehension of informed consent in a genetic epidemiological study of breast cancer in Nigeria.
abstract: BACKGROUND
  Studies 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.
  
  
  METHODS
  Surveys 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.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Department of Bioethics, School of Medicine, Room TA 227Case Western Reserve University10900 Euclid Avenue Cleveland, Ohio 44106-4976 Cleveland, USA. pam20@case.edu.
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Marshall
authors.forename: Clement A
authors.initials: CA
authors.lastname: Adebamowo
authors.forename: Adebowale A
authors.initials: AA
authors.lastname: Adeyemo
authors.forename: Temidayo O
authors.initials: TO
authors.lastname: Ogundiran
authors.forename: Teri
authors.initials: T
authors.lastname: Strenski
authors.forename: Jie
authors.initials: J
authors.lastname: Zhou
authors.forename: Charles N
authors.initials: CN
authors.lastname: Rotimi
mesh_terms: D000328:Adult; D044383:Black People; D001943:Breast Neoplasms / Q000453:epidemiology* / Q000235:genetics* / Q000523:psychology; D032882:Comprehension; D005260:Female; D020022:Genetic Predisposition to Disease; D036281:Genetic Research / Q000941:ethics; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D008297:Male; D017720:Molecular Epidemiology; D009549:Nigeria / Q000453:epidemiology / Q000208:ethnology; D018579:Patient Selection; D045808:Refusal to Participate / Q000208:ethnology; D011795:Surveys and Questionnaires; D020458:Third-Party Consent / Q000941:ethics / Q000706:statistics & numerical data*