Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting

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dc.contributor.authorMinnies, Deonen_ZA
dc.contributor.authorHawkridge, Tonyen_ZA
dc.contributor.authorHanekom, Willemen_ZA
dc.contributor.authorEhrlich, Rodneyen_ZA
dc.contributor.authorLondon, Leslieen_ZA
dc.contributor.authorHussey, Gregen_ZA
dc.date.accessioned2015-10-12T10:57:22Z
dc.date.available2015-10-12T10:57:22Z
dc.date.issued2008en_ZA
dc.description.abstractBACKGROUND:Informed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process, particularly in Africa.Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB) in South Africa. This study was in turn nested in a large TB vaccine efficacy trial.The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality of consent.Cross-sectional study conducted over a 4 month period. METHODS: Consent was obtained from parents of trial participants. These parents were asked to complete a questionnaire that contained questions about the key elements of informed consent (voluntary participation, confidentiality, the main risks and benefits, etc.). The recall (success in selecting the correct answers) and understanding (correctness of interpretation of statements presented) were measured. RESULTS: The majority of the 192 subjects interviewed obtained scores greater than 75% for both the recall and understanding sections. The median score for recall was 66%; interquartile range (IQR) = 55%-77% and for understanding 75% (IQR = 50%-87%). Most (79%) were aware of the risks and 64% knew that they participated voluntarily. Participants who had completed Grade 7 at school and higher were more likely (OR = 4.94; 95% CI = 1.57 - 15.55) to obtain scores greater than 75% for recall than those who did not. Participants who were consented by professional nurses who had worked for more than two years in research were also more likely (OR = 2.62; 95% CI = 1.35-5.07) to obtain such scores for recall than those who were not. CONCLUSION: Notwithstanding the constraints in a developing country, in a population with low levels of literacy and education, the quality of informed consent found in this study could be considered as building blocks for establishing acceptable standards for public health research. Education level of respondents and experience of research staff taking the consent were associated with good quality informed consent.en_ZA
dc.identifier.apacitationMinnies, D., Hawkridge, T., Hanekom, W., Ehrlich, R., London, L., & Hussey, G. (2008). Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting. <i>BMC Medical Ethics</i>, http://hdl.handle.net/11427/14189en_ZA
dc.identifier.chicagocitationMinnies, Deon, Tony Hawkridge, Willem Hanekom, Rodney Ehrlich, Leslie London, and Greg Hussey "Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting." <i>BMC Medical Ethics</i> (2008) http://hdl.handle.net/11427/14189en_ZA
dc.identifier.citationMinnies, D., Hawkridge, T., Hanekom, W., Ehrlich, R., London, L., & Hussey, G. (2008). Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting. BMC medical ethics, 9(1), 15.en_ZA
dc.identifier.ris TY - Journal Article AU - Minnies, Deon AU - Hawkridge, Tony AU - Hanekom, Willem AU - Ehrlich, Rodney AU - London, Leslie AU - Hussey, Greg AB - BACKGROUND:Informed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process, particularly in Africa.Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB) in South Africa. This study was in turn nested in a large TB vaccine efficacy trial.The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality of consent.Cross-sectional study conducted over a 4 month period. METHODS: Consent was obtained from parents of trial participants. These parents were asked to complete a questionnaire that contained questions about the key elements of informed consent (voluntary participation, confidentiality, the main risks and benefits, etc.). The recall (success in selecting the correct answers) and understanding (correctness of interpretation of statements presented) were measured. RESULTS: The majority of the 192 subjects interviewed obtained scores greater than 75% for both the recall and understanding sections. The median score for recall was 66%; interquartile range (IQR) = 55%-77% and for understanding 75% (IQR = 50%-87%). Most (79%) were aware of the risks and 64% knew that they participated voluntarily. Participants who had completed Grade 7 at school and higher were more likely (OR = 4.94; 95% CI = 1.57 - 15.55) to obtain scores greater than 75% for recall than those who did not. Participants who were consented by professional nurses who had worked for more than two years in research were also more likely (OR = 2.62; 95% CI = 1.35-5.07) to obtain such scores for recall than those who were not. CONCLUSION: Notwithstanding the constraints in a developing country, in a population with low levels of literacy and education, the quality of informed consent found in this study could be considered as building blocks for establishing acceptable standards for public health research. Education level of respondents and experience of research staff taking the consent were associated with good quality informed consent. DA - 2008 DB - OpenUCT DO - 10.1186/1472-6939-9-15 DP - University of Cape Town J1 - BMC Medical Ethics LK - https://open.uct.ac.za PB - University of Cape Town PY - 2008 T1 - Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting TI - Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting UR - http://hdl.handle.net/11427/14189 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/14189
dc.identifier.urihttp://dx.doi.org/10.1186/1472-6939-9-15
dc.identifier.vancouvercitationMinnies D, Hawkridge T, Hanekom W, Ehrlich R, London L, Hussey G. Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting. BMC Medical Ethics. 2008; http://hdl.handle.net/11427/14189.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentInstitute of Infectious Disease and Molecular Medicineen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceBMC Medical Ethicsen_ZA
dc.source.urihttp://www.biomedcentral.com/bmcmedethics/en_ZA
dc.subject.otherMedical Ethicsen_ZA
dc.subject.otherVaccine trialsen_ZA
dc.titleEvaluation of the quality of informed consent in a vaccine field trial in a developing country settingen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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