Informed consent process
In a clinical study, the informed consent process is an ongoing process that provides a potential participant or current participant with explanations that will help him or her in making educated decisions about whether to begin or continue participating in a trial. Informed consent is an ongoing, interactive process rather than a one-time information session.
Under 21 CFR 50.20, no informed consent form may include any “language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.” In some cases, when the prospective subject is unable to provide legal consent, permission to participate may be obtained from a legally-authorized representative (such as parent or legal guardian).
NIH Clinical Research Trials and You The Basics: What is informed consent?
NCATS Toolkit for Patient-Focused Therapy Development: Consent Requirements
Rare Diseases Registry Program (RaDaR): Prtoect Human Research Participants