What is an informed consent process in research?

The informed consent process in research is fundamentally a dynamic conversation about the study that occurs between the researcher and the participant. This interaction is designed to provide participants with comprehensive information about the study, including its purpose, procedures, risks, benefits, and their rights as participants. It emphasizes the importance of ensuring that participants understand what they are agreeing to and allowing them the opportunity to ask questions and express any concerns they may have before consenting to participate.

This process recognizes that informed consent is not just a one-time event marked by a signature but a crucial element of ongoing dialogue throughout the study. Participants are encouraged to re-engage with the researcher as questions arise or as new information becomes available, which helps to foster an environment of transparency and mutual respect.

In contrast, a one-time agreement signed at the beginning of a study oversimplifies the informed consent process and neglects the need for continual communication. A standard document designed for all studies fails to account for the variability in research methods and participant circumstances, while stating that informed consent is a procedure only for medical research ignores its relevance across a broad range of disciplines and study types.