Table 1 Distribution of questions asked during informed consent discussions*
Nature of question | n | % of participants (n = 590) | % of questions (n = 1,239) |
|---|---|---|---|
TB skin and sputum diagnostic tests | 140 | 23.7 | 11.3 |
Risks to child of being in study | 138 | 23.4 | 11.1 |
Benefits of being in study | 105 | 17.8 | 8.5 |
Questions and comments about TB symptoms and treatment | 102 | 17.3 | 8.2 |
What is the rationale for/purpose of the study | 99 | 16.8 | 8.0 |
Duration of study | 97 | 16.4 | 7.8 |
What are the study procedures | 88 | 14.9 | 7.1 |
Confidentiality of child's information | 62 | 10.5 | 5.0 |
Implications of participation for child's other health care needs | 56 | 9.5 | 4.5 |
Questions and comments about other diseases | 55 | 9.3 | 4.4 |
Who to contact with questions | 53 | 9.0 | 4.3 |
Sponsors responsibility if child hurt during the study | 52 | 8.8 | 4.2 |
Availability of treatment for child or family members | 49 | 8.3 | 4.0 |
Who is the sponsor of the study | 32 | 5.4 | 2.6 |
Eligibility for the study and who else participating | 31 | 5.3 | 2.5 |
Costs of being in the study | 25 | 4.2 | 2.0 |
Comments: Approval of the study or hospital | 24 | 4.1 | 1.9 |
Any other question or comment | 31 | 5.3 | 2.5 |
Total | 1239 | 100 | 100 |