Once a protocol is approved and the research has begun, the process of informed consent continues. New information regarding a study’s risks or potential benefits that may affect the subject’s willingness to continue participating must be disclosed, as should changes in the study’s procedures or other terms of the initial consent agreement. Some subjects may voluntarily withdraw themselves from the study, and in other cases, the investigator may remove a subject for safety or other reasons (e.g., exclusion criteria). An investigator must fulfill all of the commitments made to these subjects during the consent process.