Table 5.
Reference (year) | Study description | Study location | Major findings |
Kamuya et al 15 (2015) | Qualitative—Focus groups and interviews conducted with participants of RSV and malaria studies | Kenya | Authors describe the phenomenon of silent refusal. Possible causes include avoiding conflict within households, maintaining a good relationship with the research team and retaining study benefits. For women and young adults, it might be a way to exert agency within the patriarchal system. Authors discuss negotiations that take place during the consent process, and how ethical principles are interpreted and negotiated in a context-specific way. |
Sarkar et al 29 (2009) | Mixed methods research—Comprehension and recall of informed consent process in a paediatric diarrhoea study | India | Findings showed low recall of study purposes 4 years after enrolment. Most respondents were mothers and mentioned spousal approval and free medical care for their children as main motivations to consent and remain in the study. Educational level was significantly associated with recall of study purpose. Few respondents knew they could leave the study at any time. Authors point out the need for continuous reinforcement of the consent process. |
Minnies et al 12 (2008) | Mixed methods—Recall of the consent process for a study of immune protection against TB | South Africa | Mothers who had consented for the study then completed a questionnaire about key elements of informed consent, recall and understanding. Most obtained scores greater than 75% for recall and understanding. Seventy-nine per cent were aware of the risks and 64% knew participation was voluntary. A higher level of education and being consented by professional nurses were associated with higher recall. Authors suggest monitoring the quality of consent procedures periodically. |
RSV, respiratory syncytial virus; TB, tuberculosis.