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Informed Consent Translation in Africa: A Guide for Sponsors

How to translate informed consent forms for African trial sites: language choice, plain language, back-translation, literacy and what guidelines say.

Quick Answer

Informed consent translation in Africa means giving each participant consent information in a language and form they understand, approved by the ethics committee. ICH E6(R3) asks for simple, clear language and an impartial witness when a participant cannot read. National guidelines in South Africa, Tanzania and Kenya add rules on preferred language, witnesses and verbal consent.

Why Does Informed Consent Translation in Africa Matter Now?

It matters because Africa carries a large share of disease but a small share of trials, and closing that gap means more sites in more languages. The Access to Medicine Foundation reported in September 2025 that Africa is home to 19% of the world’s population and one quarter of the global disease burden. Yet it hosted only 1.1% of all clinical trials in 2023, based on ClinicalTrials.gov data.

Language is part of the work at every new site. In South Africa’s Census 2022, isiZulu was the language most often spoken at home (24.4%), followed by isiXhosa (16.3%). English was the home language of 8.7%. In KwaZulu-Natal and the Eastern Cape, four in five people speak isiZulu and isiXhosa, respectively. In East Africa, the United Nations describes Kiswahili as having over 200 million speakers. One English ICF does not reach these participants.

What Do ICH E6(R3) and CIOMS Say About Consent Language?

Both ask for information that participants can understand, in simple language, approved by an ethics committee before use. ICH E6(R3), adopted on January 6, 2025, sets these points:

Consent information should be “clear and concise so as to be understandable by potential participants” (section 2.2).
It should “use simple language and avoid unnecessary volume and complexity” (section 2.8.1(b)).
Text, images, videos and other interactive methods may be used, taking the trial population into account (section 2.8.1(c)).
The IRB/IEC should approve consent materials before use, and revised materials need approval in advance (sections 2.8.1(a) and 2.8.2).
If a participant cannot read, an impartial witness should be present for the whole consent discussion (section 2.8.9).

The CIOMS International Ethical Guidelines (2016), Guideline 9, go further on language. Information must be in plain language the potential participant understands. Leaflet wording must be approved by the research ethics committee and should preferably not exceed two or three pages. CIOMS notes that local languages may help participants understand, and that many people do not readily understand concepts such as placebo or randomization. The protocol must describe how information will be communicated, and the project must include the resources needed for consent in different linguistic and cultural settings.

What Do African National Guidelines Add?

National guidelines turn these principles into specific rules on language, witnesses and verbal consent. Three examples:

Guideline	Language rule	Literacy and oral consent
South African GCP Guidelines, 3rd ed. (2020)	Consent document in the participant’s preferred written language, non-technical (5.9.7, 5.9.8)	If illiterate, verbal consent before an impartial witness; participant makes a mark, cross or fingerprint (5.9.12)
Tanzania NIMR Ethics Guidelines, 3rd ed. (2023)	Information in a language and form understandable to the participant	Witness for illiterate participants; thumbprint accepted; verbal consent script approved before use
Kenya NACOSTI Biomedical Research Guidelines (2020)	Information in a language that is simple and comprehensible	Not specified in the consent section (4.2.1)

Two details affect translation planning directly. South Africa’s guideline lists the informed consent form “including all applicable translations” among the trial’s essential documents. Tanzania’s guideline says the people named for participant questions must speak the participant’s language or be able to bring in an interpreter quickly.

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How Should you Choose the Language for Each Site?

Choose by site population, not by country. A national language may not be the language participants read best. Ask each site team which languages participants speak at home, which they read and which need audio support. South Africa’s census shows why: provinces differ sharply in their main home language.

Then check variants. Confirm that one Kiswahili version suits every Kiswahili-speaking site, or adapt terms per country. A site in northern Nigeria may need Hausa, while a site in the southwest may need Yoruba. In Ethiopia, Amharic may cover one site and Tigrinya another. Settle this list before translation starts, since each language adds a full review and ethics submission cycle.

What Does a Sound ICF Translation Workflow Look Like?

A sound workflow starts with a plain source text and ends with an approved, version-controlled translation for every language. Plain language matters at the source. A 2025 study in BMC Medical Ethics reviewed 266 English consent forms submitted to Tanzania’s national ethics committee and found 80.5% hard to read, requiring a US grade 10 reading level. Translation cannot fix a source that is too complex.

Simplify the English source. Shorten sentences and replace jargon before translation.
Map languages per site. Record language, script and whether an audio version is needed.
Build a glossary. Agree on terms for placebo, randomization, side effects and withdrawal with site staff.
Forward translate. Use native-speaking medical translators for each language.
Back-translate and reconcile. An independent translator renders the text back into English, and differences are resolved and logged.
Review with the community. Test comprehension with speakers from the participant population.
Submit to the ethics committee. File all translations with the protocol and keep approval letters.
Control versions. When the English ICF changes, update every language and get approval before use.

A DIA Global Forum article on West Africa (April 2025) describes back-translation as the step used there to check that translated content keeps its meaning. Requirements vary by country and committee, so confirm current expectations with the relevant ethics committee and national regulator before you submit. This article is informational only and is not legal or regulatory advice.

How Should you Handle Low Literacy and Oral Consent?

Plan for participants who cannot read by pairing the written ICF with a witnessed oral process and, where useful, audio. ICH E6(R3) section 2.8.9 says the ICF is read and explained, the participant consents orally and signs if able, and the impartial witness signs and dates the form. South Africa’s guideline accepts a cross or fingerprint as the participant’s mark.

Some languages have little written tradition. The DIA article notes that in Mali, Senegal and Côte d’Ivoire many local languages lack written forms. It describes ICFs being audio-recorded in the local language alongside the written translation. Tanzania’s guideline allows verbal consent in set situations, such as minimal-risk studies, with a script approved in advance and documentation through notes or recordings. Translate and record these scripts with the same care as the written form.

Frequently Asked Questions

Is Back-Translation Required for Consent Forms in Africa?

ICH E6(R3) and CIOMS do not name back-translation, but they require consent information participants understand and ethics committee approval. Back-translation gives the committee evidence that a translation keeps its meaning. Check each committee’s submission rules for what it expects.

Which Language Should Each ICF Use?

The language the participant understands best, at each site. South Africa’s guideline specifies the participant’s preferred written language. Confirm home and reading languages with every site team before translation.

What if a Participant Cannot Read?

ICH E6(R3) calls for an impartial witness throughout the consent discussion. The form is read and explained, the participant consents orally and signs if able, and the witness signs. South Africa also accepts a cross or fingerprint as the participant’s mark.

Do Translations Need Ethics Committee Approval?

Yes. ICH E6(R3) requires IRB/IEC approval of consent materials before use, and CIOMS requires the committee to approve leaflet wording. Revised translations also need approval before use.

How Afrasia Trans Can Help

Afrasia Trans translates informed consent forms, patient information sheets and recruitment materials into African languages, including Amharic, Tigrinya, Hausa and Somali. One team handles forward translation, back-translation and reconciliation, so every language follows the same steps. We also provide voice-over and transcription solutions for audio consent scripts in languages that are mainly spoken, and multilingual DTP for patient diaries and flyers. Explore our life sciences and clinical solutions or see the languages we cover. Planning sites in Africa? Contact us for a quote.

About the Author

Mohamed Salah

Mohamed Salah writes the Afrasia Trans industry guides on media, gaming, AI data, life sciences, legal and travel localization.

Sources

This article is for general information only. It is not legal, regulatory or medical advice.

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