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A Continuous Process


Informed consent is an educational process between the investigator and the participant. The process begins with the initial presentation of a research activity to a prospective human subject by the investigator (or a member of the study/research team) and continues through the end of the research activity and the closing of the research study.

Yes, that’s right. The informed consent process is not a one-time thing that ends when a research subject agrees to participate and signs a consent form or choose “Yes” on an online survey. Instead, it is an active and ongoing process between the research subject and research personnel at all times throughout the course of the research.

Therefore, investigators are ethically obligated to keep subjects apprised of issues related to their participation in the study as appropriate. Any new information or changes in procedures that affect the participants should be presented to them in writing; in most cases this will involve the signing of a new consent form or a revision of the original form.