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Table 3 Results of quality of informed consent assessment: Recall section

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

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%)

  1. 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