The Ongoing Process of Consent

Although the process of consent is ongoing for the duration of all research studies, the investigator should obtain new consent for a subject’s continuing participation during the course of a study in which the research procedures, risks and/or benefits, or other terms of agreement with the subject have changed. The investigator will need to prepare an amended consent form addressing the pertinent changes, and the IRB will need to approve the amended protocol and consent forms. Once the “new” consent forms are approved, the investigator may then discuss with the subject his or her continued participation. For long-term studies in which there are no changes in the research design or objectives, the informed consent should be renewed at predetermined intervals. Minor subjects participating in longitudinal research who reach the age of majority during the course of the research are now capable of independently agreeing to participate and documenting their own consent, should they wish to continue to participate. Therefore, the process of consent should take place with the individual subject for ongoing participation once he or she reaches 18 years of age.