What is an Informed Consent Document?
Informed consent is a process that takes place before you join the study. It is a discussion of procedures, benefits, and risks of a clinical research study between clinical investigators and people interested in participating in the study. National Regulatory Authorities, such as the European Medicines Agency (EMEA) in Europe, require that volunteers sign an informed consent document that has been approved by an Ethics Review Board before entering a study. The Ethics Review Board is an independent review board that helps protect the rights of subjects participating in research. A doctor, nurse or other study staff will explain the purpose of the study and what you can expect. You can ask any questions you have about the study. You will be told about who will see your personal medical information, and how it will be kept confidential. You will also be given a consent document to read. You should ask questions about any part of the consent document you do not understand.
This is a document that ensures that your loved one has consented to participate in the clinical study. The Informed Consent process is a dialogue between your loved one and the study doctor and/or nurse about the study procedures, benefits, and risks. This discussion takes place before your loved one agrees to join the study. Your loved one will be given a consent document to read. He/she should ask questions about any part of the consent document he/she does not understand. If your loved one decides to take part in the study, he/she will be asked to sign the consent document. Even if these documents are signed, your loved one can change his/her mind and stop participating in the study at any time. Regulatory authorities, such as the Food and Drug Administration (FDA) in the United States, require that clinical trial volunteers sign an informed consent document that has been previously reviewed and approved by an Institutional Review Board (IRB) before entering a study. The IRB is an
(top) This is a document that provides you with a detailed description of the clinical study. Your signature on the informed consent document confirms your understanding of the risks and benefits of the study as well as your willingness to participate. Participation is entirely voluntary and you may withdraw at any time. Signing an informed consent document does not take away any of your legal rights.
This is a document that provides you with a detailed description of the clinical research study. Your signature on the informed consent document indicates that you have been provided with information about the study, that you understand the information related to risks and benefits of the study and that you are willing to participate in the study. Participation is entirely voluntary. You may stop participating in the study at any time.
Related Questions
- If a site enrolls a subject who cannot read and understand English, does the informed consent document need to be translated into the subject’s native language?
- Does RCRC IRB have specific requirements for the Informed Consent Document?
- Who must sign the informed consent or parental permission document?
