Tufts Medical Center and Tufts University view informed consent as a dynamic, ongoing, interactive and multifaceted process, not just “signing a form.”A subject’s consent must always be given freely, without coercion, and must be based on a clear comprehension of what participation involves.
The informed consent process begins during initial contact with a potential subject and continues for the duration of the subject’s participation. The informed consent form (ICF) provides a summary of the study (including its purpose, the duration, the procedures and schedule, potential risks and benefits, alternatives to participation, etc.), explains the subject’s rights as a participant, and documents the subject’s willingness to be in the study. Federal regulations outline the required elements of informed consent, specifically 21 CFR 50 and 45 CFR 46.
The ICF and all materials given to subjects (including advertisements, contact letters, questionnaires, telephone scripts, and study summary sheets) should be written in “lay language” at an 8th grade reading level or lower, and should not contain technical and medical terminology or jargon.The institutions have developed template ICFs for adults and a template ICF for minors that investigators are strongly encouraged to use.
The Office for Human Research Protections (OHRP) has also created an ICF checklistto help investigators. IRB Reviewers also use this document when evaluating an ICF. Both OHRP and the Food and Drug Administration have created guidance documents about consent that investigators are encouraged to review.
The consent discussion and ICF should be presented to a potential subject sufficiently in advance of the start of study-related procedures to ensure that a subject has adequate time to voluntarily decide whether or not to participate in a research study.The institutions strongly recommend that subjects be encouraged to discuss participation with family, friends, etc., and be encouraged to take as much time as needed to decide whether or not to participate.
Consent must be given by a subject before any study-related procedures, including screening procedures, may take place.Once the ICF has been signed, subjects are considered enrolled.