The consent form must be written in clear, easily understandable and accessible language. The form must include no less than the following information:
1. Name, contact information and institutional affiliation of the researchers
- The form must state that the research participants can ask the researcher any question about any part of the research being conducted.
2. Title and purpose of the project
3. Description of participation, including:
- The general nature of the questions that will be asked, the tasks that must be accomplished and the observations or interventions that will be conducted;
- The length and frequency of the participant's participation;
- The location of the research work (add a description if the location is out of the ordinary);
- The discomfort and probable harms created by the research;
- The possible benefits that the investigator foresees;
- A declaration about possible conflicts of interest, where relevant.
4. Rights of the research participant, including:
- The right to withdraw from the project at any time;
- The right to refuse to answer questions without fear of reprisal or ill treatment;
- The right to be informed of how their identities will be protected in the publication of the data;
- The right to be informed of the limits of confidentiality.
5. Description of the compensation (where applicable)
6. Names of the funding agencies (where applicable)
7. Contact information for the Ethics Office and procedures for filing a complaint
8. Signature of the participant and researchers
- The signature of the participant does not mean that he or she has given up any right, but rather that the participants has been informed of the requirements of the proposed research and that he or she agrees to take part in the research project.
- Researchers should obtain this signature for their own protection, especially as evidence in the event of legal action in which the participant claims that informed consent was not obtained.