As discussed in the Informed Consent module, informed consent is a process as well as a legally required document. Throughout any study, researchers must continue to keep study participants informed about the study and, in particular, about any new developments or findings that may affect participants’ willingness to remain in the study.
Researchers must:
Tell participants, in language they understand, about emerging developments in the study that are significant to participant safety.
Offer participants the opportunity to ask questions about the information they have been given.
Ensure that participants understand they may withdraw from the study at any time and cannot be penalized for doing so.
Be satisfied that each participant understands what he or she has been told and is making a voluntary, informed decision to remain in the study.