Table 12. Elements in an informed consent document
Part 1: Information sheet
Introduction of the team leader/principal investigator and his/her institution.
Purpose of the research.
Type of research intervention.
Participant selection.
Voluntary participation.
Procedures (interview, focus group discussions (FGD), where interviews will take place, privacy and confidentiality issues).
Duration of the procedures/interview, the length of the intervention including follow-up.
Anticipated risks.
Benefits at different levels (individual, community or society).
Reimbursements (if necessary).
Confidentiality (note: FGDs present particular challenges to confidentiality, because once something is said in the group, it becomes common knowledge, and can be linked to a person).
Sharing of research results (process that will be used to share the research results) with all stakeholders.
Right to refuse or withdraw.
Who to contact (e.g. for any additional information or in case of complaints).
Part 2: Certificate of consent
This section must be written in the first person.
Should include a few brief statements about the research and be followed by a statement, indicating that the participant has read the information or the information has been read to him/her, they understand and are participating voluntarily.
If the participant is illiterate, but provides oral consent, a witness must sign and date the consent form.
The researcher or person going over the informed consent must sign and date each consent form.