Background: Informed consent (IC) is a legally enforceable right in South Africa based on constitutionally protected rights to bodily integrity and well-being. In terms of the law, patients cannot be involved in medical treatment or research without IC. Healthcare providers must inform patients about diagnosis, risks, benefits, treatment options, and right of refusal in a language patients understand based their literacy level. This study reports an empirical study on patients' perceptions of IC as practiced by doctors and nurses in South Africa.
Materials and methods: A cross-sectional study, using a bilingual semi-structured questionnaire was conducted among patients attending randomly selected public hospitals in eThekwini Metropolitan Municipality (Durban), KwaZulu-Natal province. Competent patients or legal surrogates were eligible for inclusion. IC was obtained from all participants.
Results: Four hundred and four participants completed questionnaires of which 68% were female. The median age of participants was 35 years (range 11-91 years). Most respondents spoke IsiZulu (55%), were single (56%), unemployed (66%), and with secondary school education (69%). Patients were generally informed about the diagnosis (81%), risks (57%), and benefits of treatment (61%). Few were informed about treatment options (41%), recommended treatment (28%), and right of refusal (25%). IC was obtained verbally in 73% of cases. Patients favored disclosure of all material risks (78%) and few consulted surrogates before decision-making (76%). There was an association between participant's age and knowledge of the age of consent (P = 0.005). Most patients were satisfied with information disclosed (91%) and did not feel coerced. Some were afraid to ask questions for fear of losing free treatment (8%).
Conclusion: This study reveals that South African patients are aware of the right to IC, but many were vulnerable due to indigence. Barriers to IC include poverty, language, and low educational level. South African patients prefer disclosure of all material risks, better communication skills by healthcare workers, and a shift toward informed or shared healthcare decision-making.