Informed consent form
In a clinical study, the informed consent form is the document used during the informed consent process that is the basis for explaining to potential subjects the potential risks and benefits of a study and the rights and responsibilities of the parties involved. The informed consent document provides a summary of a clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains an individual’s rights as a subject. It is designed to begin the informed consent process, which consists of conversations between the subject and the research team. If the individual then decides to enter the trial, s/he gives her/his official consent by signing the document. The informed consent form in a clinical study requires Institutional Review Board (IRB) review and approval before the study begins.
In a registry, the informed consent is the document that describes the rights of a registry participants and provides details about the registry, such as its purpose, duration, key contacts, and how the registry data will be shared and used. An informed consent form is required if the registry data will be shared with researchers. Review by an IRB may be required if the registry data includes certain health or medical information or if the registry data will be used in therapy development process, even if that is in the distant future.
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