Translating the consent form is the tip of the iceberg: using cognitive interviews to assess the barriers to informed consent in South African health facilities.

ABSTRACT

The increasing digitisation of personal health data has led to an increase in the demand for onward health data. This study sought to develop local language scripts for use in public sector maternity clinics to capture informed consent for onward health data use. The script considered five possible health data uses 1. Sending of general health information content via mobile phones; 2. Delivery of personalised health information via mobile phones; 3. Use of women's anonymised health data; 4. Use of child's anonymised health data; and 5. Use of data for recontact. Qualitative interviews (n = 54) were conducted among women attending maternity services in three public health facilities in Gauteng and Western Cape, South Africa. Using cognitive interviewing techniques, interviews sought to(1) explore understanding of the consent script in five South African languages, (2) assess women's understanding of what they were consenting to, and (3) improve the consent script. Multiple rounds of interviews were conducted, each followed by revisions to the consent script, until saturation was reached, and no additional cognitive failures identified. Cognitive failures were a result of (1) words and phrases that did not translate easily in some languages, (2) cognitive mismatches that arose as a result of different world views and contexts, (3) linguistic gaps, and (4) asymmetrical power relations that influence how consent is understood and interpreted. Study activities resulted in the development of an informed consent script for onward health data use in five South African languages for use in maternity clinics.

In the wake of growing digitisation of personal health data, greater scrutiny is needed on the language of informed consent and the processes for soliciting consent in health care facilities. Qualitative interviews using cognitive interviewing techniques were used to develop and refine consent language in English, Sesotho, isiXhosa, isiZulu and Setswana for the onward use of health data among maternity clients in public sector primary health clinics in the Western Cape and Gauteng provinces of South Africa. We found that translation in local languages and addressing individual words and phrases was only one barrier to requesting informed consent. Other barriers were cognitive mismatches between the question intent and how women understood the question, linguistic gaps that were linked to language and identity, and power dynamics that affected how women understood the consent script. Emerging language scripts used "/" to present words in multiple languages; a reflection of the multi-linguistic nature of communities in this context.