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Informed Consent in a Informed Consent in a Community Based Community Based
Tuberculosis Prevention Tuberculosis Prevention Study in the Western Cape, Study in the Western Cape,
South AfricaSouth Africa
Prof Keymanthri Moodley , Prof Nulda Beyers,, Dr Sharon Kling, Ms Kathy Lawrence, Prof Landon Myer
BIOETHICS UNIT –TYGERBERG DIVISION & DESMOND TUTU TB CENTREFACULTY OF HEALTH SCIENCESUNIVERSITY OF STELLENBOSCHCopyright 2008 All rights reserved on this presentation
Zamstar TB Prevention Study
Prevalence, Prevalence, Incidence Incidence
Community Community randomisatiorandomisation for n for intervention intervention trialstrials
Khayelitsha-Cape Town, Khayelitsha-Cape Town, South AfricaSouth Africa
Fieldworkers – Fieldworkers – communities – IC – communities – IC – verbal & written, verbal & written, sputum collections sputum collections
Population of Khayelitsha – 1million
Site B 255 000
Study pop 25 000
ObjectivesObjectives
1.1. To develop an appropriate tool to measure To develop an appropriate tool to measure understanding of consent material.understanding of consent material.
2.2. To evaluate the IC process in the Zamstar To evaluate the IC process in the Zamstar TB prevalence study.TB prevalence study.
3.3. To make changes ( if necessary) to improve To make changes ( if necessary) to improve understanding of consent information.understanding of consent information.
4.4. To develop capacity of the research team in To develop capacity of the research team in obtaining IC for the continued phases of obtaining IC for the continued phases of the study.the study.
MethodologyMethodology IC document & process of TB IC document & process of TB
prevalence study discussed prevalence study discussed with Zamstar teamwith Zamstar team
Test of understanding: Quality Test of understanding: Quality of IC (QuIC) questionnaire of IC (QuIC) questionnaire based on Common Rule based on Common Rule
TB prevalence IC doc TB prevalence IC doc compared with Common Rule compared with Common Rule req for ICreq for IC
Elements of IC – Common Elements of IC – Common RuleRule
1.1. Explanation of research and its purposeExplanation of research and its purpose
2.2. RisksRisks
3.3. BenefitsBenefits
4.4. Alternative treatmentsAlternative treatments
5.5. ConfidentialityConfidentiality
6.6. Injury due to participationInjury due to participation
7.7. Contact personnelContact personnel
8.8. VoluntarinessVoluntariness
MethodologyMethodology
Semi-structured questionnaire Semi-structured questionnaire developed to test developed to test understandingunderstanding
15 field workers trained15 field workers trained Written ICWritten IC XhosaXhosa Khayelitsha – home basedKhayelitsha – home based
Results – Results – Informed Informed
Consent StudyConsent Study
445/515 responses = 86%445/515 responses = 86%
Gender: Female = 69%Gender: Female = 69% Mean age 36 years (Range 14-Mean age 36 years (Range 14-81)81) 98.8% Xhosa speakers – all 98.8% Xhosa speakers – all could read the newspaper in could read the newspaper in Xhosa &/or EnglishXhosa &/or English
ResultsResults Original IC form - TB Original IC form - TB Prevalence Study: Flesch Prevalence Study: Flesch Reading Level = grade 9.Reading Level = grade 9.
< Grade 9 : 180/445 (40%) < Grade 9 : 180/445 (40%)
16/445 (3.6%) – no schooling16/445 (3.6%) – no schooling
Results – Results – Informed Informed
Consent StudyConsent Study
Trial Specific Questions:Trial Specific Questions:
RESEARCH?RESEARCH?
391/445 (87,9%) understood 391/445 (87,9%) understood the reason for the studythe reason for the study
Results – Results – Informed Informed
Consent StudyConsent Study
CHOICE/VOLUNTARINESSCHOICE/VOLUNTARINESS
435/445 (97,8 %) - Yes435/445 (97,8 %) - Yes 9/445 (2,0%) - No9/445 (2,0%) - No 1/445 (0,2%) - Unsure1/445 (0,2%) - Unsure
Results – Results – Informed Informed
Consent StudyConsent Study
IC PROCESSIC PROCESS
Verbal explanation – 95,5% Verbal explanation – 95,5%
Clarity of explanation – 94%Clarity of explanation – 94%
Results – Results – Informed Informed
Consent StudyConsent Study
IC FORMIC FORM
95,7% received a form95,7% received a form
Results – Results – Informed Informed
Consent StudyConsent Study
IC FORMIC FORM
Understandable ? :Understandable ? :
Yes 71,5%Yes 71,5%
No 19,3%No 19,3%
Missing data 9,2%Missing data 9,2%
Results – Results – Informed Informed
Consent StudyConsent Study
IC FORM – NOT UNDERSTANDABLE - IC FORM – NOT UNDERSTANDABLE - 19,3%19,3%
Printing too smallPrinting too small Difficult WordsDifficult Words Sentences too longSentences too long Form too longForm too long Too much informationToo much information
Other – did not read formOther – did not read form
Results – Results – Informed Informed
Consent StudyConsent Study
BENEFITS BENEFITS 2/3 yes2/3 yes Did not have to go to clinicDid not have to go to clinic Gained Gained knowledge/informationknowledge/information Are sure they don’t have TBAre sure they don’t have TB Family benefitFamily benefit
Results – Results – Informed Informed
Consent StudyConsent Study
BENEFITS BENEFITS
1/3 NO 1/3 NO
““because they did not bring because they did not bring my results back”my results back”
Results – Results – Informed Informed
Consent StudyConsent Study
RISKS RISKS
YES – 19/445 (4,3%)YES – 19/445 (4,3%)
1.1. Trust & suspicionTrust & suspicion
2.2. StigmaStigma
3.3. Contamination of sputaContamination of sputa
Results – Results – Informed Informed
Consent StudyConsent Study
CONFIDENTIALITY CONFIDENTIALITY
Most people (65,1%) Most people (65,1%) had a median of 2 had a median of 2 other family members other family members present when present when fieldworkers visited.fieldworkers visited.
Results – Results – Informed Informed
Consent StudyConsent Study
CONFIDENTIALITY CONFIDENTIALITY
Most (73,3%) did not Most (73,3%) did not mind having others mind having others around during visits & around during visits & proceduresprocedures
Discussion – IC Discussion – IC StudyStudy
Understanding of TB Understanding of TB Prevalence study – goodPrevalence study – good
Form –difficulties – 20%Form –difficulties – 20% Major problem – lack of Major problem – lack of
return of results to return of results to participants – 1/3participants – 1/3
Confidentiality ?????Confidentiality ?????
RecommendationsRecommendations
IC forms – grade 6 level + styleIC forms – grade 6 level + style Return of results + or – or clarify Return of results + or – or clarify
in IC processin IC process Feedback data to field workers in Feedback data to field workers in
all communities – SA & Zambia – all communities – SA & Zambia – for future trainingfor future training
ConclusionConclusion
Study objectives achievedStudy objectives achieved
IC process in TB prevalence study IC process in TB prevalence study ethically acceptableethically acceptable
Communities benefit from home Communities benefit from home based researchbased research
Return of results importantReturn of results important