Appendix C. Model Informed Consent Elements

A good consent process (adapt to local language, literacy, culture and the requirements of the ethics committee) covers:

Who is doing the research, and for whom; how to contact the researcher and the ethics committee.

The purpose of the study, in plain language.

What participation involves, how long it takes and where it happens.

Possible risks and discomforts and any benefits.

That participation is voluntary, and the person may refuse to answer or withdraw without penalty.

How information will be recorded, used, stored, shared and protected, and for how long.

Limits to confidentiality (for example, if there is a risk of serious harm).

Whether quotations may be used, and whether the person will be identified.

Any payment, reimbursement or gift.

How results will be shared with participants and communities.

Opportunity to ask questions, and a copy of the information.

Documentation of consent: signature, thumbprint, witnessed oral consent or recorded consent, as approved.