Informed Consent in a Community Based Tuberculosis Prevention Study in the Western Cape, South Africa Prof Keymanthri Moodley, Prof Nulda Beyers,, Dr Sharon Kling, Ms Kathy Lawrence, Prof Landon Myer BIOETHICS UNIT –TYGERBERG DIVISION & DESMOND TUTU TB CENTRE FACULTY OF HEALTH SCIENCES UNIVERSITY OF STELLENBOSCH Copyright 2008 All rights reserved on this presentation

Zamstar TB Prevention Study Prevalence, Incidence Prevalence, Incidence Community randomisation for intervention trials Community randomisation for intervention trials

Khayelitsha-Cape Town, South Africa Fieldworkers – communities – IC – verbal & written, sputum collections Fieldworkers – communities – IC – verbal & written, sputum collections Population of Khayelitsha – 1million Site B Study pop

Objectives 1. To develop an appropriate tool to measure understanding of consent material. 2. To evaluate the IC process in the Zamstar TB prevalence study. 3. To make changes ( if necessary) to improve understanding of consent information. 4. To develop capacity of the research team in obtaining IC for the continued phases of the study.

Methodology IC document & process of TB prevalence study discussed with Zamstar team IC document & process of TB prevalence study discussed with Zamstar team Test of understanding: Quality of IC (QuIC) questionnaire based on Common Rule Test of understanding: Quality of IC (QuIC) questionnaire based on Common Rule TB prevalence IC doc compared with Common Rule req for IC TB prevalence IC doc compared with Common Rule req for IC

Elements of IC – Common Rule 1. Explanation of research and its purpose 2. Risks 3. Benefits 4. Alternative treatments 5. Confidentiality 6. Injury due to participation 7. Contact personnel 8. Voluntariness

Methodology Semi-structured questionnaire developed to test understanding Semi-structured questionnaire developed to test understanding 15 field workers trained 15 field workers trained Written IC Written IC Xhosa Xhosa Khayelitsha – home based Khayelitsha – home based

Results – Informed Consent Study 445/515 responses = 86% 445/515 responses = 86% Gender: Female = 69% Gender: Female = 69% Mean age 36 years (Range 14-81) Mean age 36 years (Range 14-81) 98.8% Xhosa speakers – all could read the newspaper in Xhosa &/or English 98.8% Xhosa speakers – all could read the newspaper in Xhosa &/or English

Results Original IC form - TB Prevalence Study: Flesch Reading Level = grade 9. Original IC form - TB Prevalence Study: Flesch Reading Level = grade 9. < Grade 9 : 180/445 (40%) < Grade 9 : 180/445 (40%) 16/445 (3.6%) – no schooling

Results – Informed Consent Study Trial Specific Questions: Trial Specific Questions:RESEARCH? 391/445 (87,9%) understood the reason for the study 391/445 (87,9%) understood the reason for the study

Results – Informed Consent Study CHOICE/VOLUNTARINESS CHOICE/VOLUNTARINESS 435/445 (97,8 %) - Yes 435/445 (97,8 %) - Yes 9/445 (2,0%) - No 9/445 (2,0%) - No 1/445 (0,2%) - Unsure 1/445 (0,2%) - Unsure

Results – Informed Consent Study IC PROCESS Verbal explanation – 95,5% Verbal explanation – 95,5% Clarity of explanation – 94% Clarity of explanation – 94%

Results – Informed Consent Study IC FORM 95,7% received a form 95,7% received a form

Results – Informed Consent Study IC FORM Understandable ? : Understandable ? : Yes 71,5% No 19,3% Missing data 9,2%

Results – Informed Consent Study IC FORM – NOT UNDERSTANDABLE - 19,3% Printing too small Printing too small Difficult Words Difficult Words Sentences too long Sentences too long Form too long Form too long Too much information Too much information Other – did not read form Other – did not read form

Results – Informed Consent Study BENEFITS 2/3 yes 2/3 yes Did not have to go to clinic Did not have to go to clinic Gained knowledge/information Gained knowledge/information Are sure they don’t have TB Are sure they don’t have TB Family benefit Family benefit

Results – Informed Consent Study BENEFITS 1/3 NO 1/3 NO “because they did not bring my results back”

Results – Informed Consent Study RISKS YES – 19/445 (4,3%) YES – 19/445 (4,3%) 1. Trust & suspicion 2. Stigma 3. Contamination of sputa

Results – Informed Consent Study CONFIDENTIALITY Most people (65,1%) had a median of 2 other family members present when fieldworkers visited. Most people (65,1%) had a median of 2 other family members present when fieldworkers visited.

Results – Informed Consent Study CONFIDENTIALITY Most (73,3%) did not mind having others around during visits & procedures Most (73,3%) did not mind having others around during visits & procedures

Discussion – IC Study Understanding of TB Prevalence study – good Understanding of TB Prevalence study – good Form –difficulties – 20% Form –difficulties – 20% Major problem – lack of return of results to participants – 1/3 Major problem – lack of return of results to participants – 1/3 Confidentiality ????? Confidentiality ?????

Recommendations IC forms – grade 6 level + style IC forms – grade 6 level + style Return of results + or – or clarify in IC process Return of results + or – or clarify in IC process Feedback data to field workers in all communities – SA & Zambia – for future training Feedback data to field workers in all communities – SA & Zambia – for future training

Conclusion Study objectives achieved Study objectives achieved IC process in TB prevalence study ethically acceptable IC process in TB prevalence study ethically acceptable Communities benefit from home based research Communities benefit from home based research Return of results important Return of results important