Informed consent in Ghana: what do participants really understand? 2008

Z Hill, and C Tawiah-Agyemang, and S Odei-Danso, and B Kirkwood
Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK. Zelee.hill@lshtm.ac.uk

OBJECTIVE To explore how subjects in a placebo-controlled vitamin A supplementation trial among Ghanaian women aged 15-45 years perceive the trial and whether they know that not all trial capsules are the same, and to identify factors associated with this knowledge. METHODS 60 semistructured interviews and 12 focus groups were conducted to explore subjects' perceptions of the trial. Steps were taken to address areas of low comprehension, including retraining fieldworkers. 1971 trial subjects were randomly selected for a survey measuring their knowledge that not all trial capsules are the same. The subjects' fieldworkers were also interviewed about their characteristics and trial knowledge. Factors associated with knowledge were explored using multi-level modeling. RESULTS Although subjects knew they were taking part in research, most thought they were receiving an active and beneficial medication. Variables associated with knowledge were education and district of residence. Radio broadcasts benefited those with some schooling. Fieldworkers' characteristics were not associated with subjects' knowledge. CONCLUSIONS Research and debate on new or improved consent procedures are urgently required, particularly for subjects with little education.

UI MeSH Term Description Entries
D007258 Informed Consent Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment. Consent, Informed
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010353 Patient Education as Topic The teaching or training of patients concerning their own health needs. Education of Patients,Education, Patient,Patient Education
D010358 Patient Participation Patient involvement in the decision-making process in matters pertaining to health. Patient Activation,Patient Empowerment,Patient Engagement,Patient Involvement,Patient Participation Rates,Activation, Patient,Empowerment, Patient,Engagement, Patient,Involvement, Patient,Participation Rate, Patient,Participation Rates, Patient,Participation, Patient,Patient Participation Rate
D005260 Female Females
D005869 Ghana A republic in western Africa, south of BURKINA FASO and west of TOGO. Its capital is Accra. Gold Coast,Republic of Ghana
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D015999 Multivariate Analysis A set of techniques used when variation in several variables are studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables. Analysis, Multivariate,Multivariate Analyses

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