Table 3.
Results of quality of informed consent assessment: Recall section
| 1. I have been asked to attend the clinic today so that (n = 192): | |
| My baby can participate in a research study | 164 (85.4%) |
| My baby can receive expert treatment. | 14 (7.3%) |
| My baby can receive routine health care | 14 (7.3%) |
| 2. The purpose of the research study is to (n = 191): | |
| Test for protection against tuberculosis in my baby's blood. | 154 (80.6%) |
| Test for tuberculosis in my baby's blood | 35 (18.3%) |
| Test for HIV in my baby's blood | 2 (1.1%) |
| 3. Research staff wants to enroll my baby into the research study so that (n = 189): | |
| They can collect blood from my baby | 115 (60.9%) |
| They can inject my baby with BCG | 40 (21.1%) |
| They can test my baby for TB or HIV | 34 (18.0%) |
| 4. The total amount of time my baby will be expected to participate in the study is (n = 190): | |
| 1 day | 126 (66.3%) |
| 2 to 3 years | 45 (23.7%) |
| 8 to 14 weeks | 19 (10.0%) |
| 5. The most common risk involved when blood had been collected from my baby is (n = 192): | |
| My baby may suffer very slight scarring and some oozing | 152 (79.2%) |
| My baby can become infected with TB or HIV | 35 (18.2%) |
| My baby can loose too much blood | 5 (2.6%) |
| 6. The benefits available to me and my baby for participating in the study are (n = 191): | |
| My baby will be protected against TB | 98 (51.3%) |
| There are no immediate benefits | 70 (36.7%) |
| My baby and I will get better treatment at clinics | 23 (12.0%) |
| 7. If I didn't want to participate in this study, I could withdraw and (n = 189) | |
| My baby and I would suffer no loss at all | 123 (65.1%) |
| My baby and I will be treated differently by research and clinic staff | 47 (24.9%) |
| My baby and I would be denied access to health services at this clinic | 19 (10.0%) |
| 8. My baby's personal details will never be linked with her blood because (n = 191) | |
| Numbers with barcodes will be used to keep bloods anonymous | 140 (73.3%) |
| Highly trained research staff will keep information secret | 40 (20.9%) |
| Clinic staff will be sure not to give information to the research staff | 11 (11.8%) |
| 9. The blood of my baby that will be frozen and stored will be used (n = 187) | |
| For other tests concerning protection against TB | 155 (82.9%) |
| For all kinds of research in other countries | 29 (15.5%) |
| For HIV testing | 3 (1.6%) |
Correct answers based on information provided as part of the consent process in italics and listed first here, but in normal print and distributed randomly in the field questionnaire