What are the two primary methods for documenting informed consent?

The two primary methods for documenting informed consent are written and orally. Written documentation provides a formal record that captures the subject's agreement to participate in a study, often including details about the study, risks, and benefits, as well as the participant's comprehension of this information. This method not only safeguards the rights of the participants but also serves as a legal document if needed.

Oral consent, while less formal than written consent, can also be appropriate in certain situations, particularly when working with populations that may have difficulty reading or writing. In these cases, documentation might involve having a witness present to verify that the participant understood the information provided and consented to participate. This oral method emphasizes the importance of clear communication and understanding between the researcher and the participant.

Informed consent is a crucial ethical obligation in research involving human subjects, and both methods serve to ensure that participants are fully informed and voluntarily agreeing to participate.