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| Informed Consent Information |
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What is informed consent? Informed consent is a process by which people learn the important facts about a clinical trial to help them decide whether to participate. This information includes details about what is involved, such as the purpose of the study, the tests and other procedures used in the study, and the possible risks and benefits. In addition to talking with the doctor or nurse, people receive a written consent form explaining the study. People who agree to take part in the study are asked to sign the informed consent form. However, signing the form does not mean people must stay in the study. People can leave the study at any time—either before the study starts or at any time during the study or the follow-up period. The informed consent process continues throughout the study. If new benefits, risks, or side effects are discovered during the study, the researchers must inform the participants. They may be asked to sign new consent forms if they want to stay in the study. Following is list of links to resources related to the informed consent process: NCI Materials National Cancer Institute's (NCI)Guide to Understanding Informed Consent A guide to the process of informed consent, in which people considering participation in a trial learn about potential risks and benefits of the trial as well as their rights and responsibilities. Monitoring the Safety of Clinical Trials Information about the ways in which clinical trials participants are protected before and during the conduct of a study. Simplification of Informed Consent Documents Information on NCI's recommendations for simplifying informed consent documents, with guidance on how to develop them. Human Participant Protections Education for Research Teams A Web-based course developed at the National Institutes of Health (NIH) for physicians, nurses and other members of research teams. Regulations and governing documents from the U.S. Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP): General requirements for informed consent From the Code of Federal Regulations of the Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks Informed Consent - Protection of Human Subjects From the U.S. Food and Drug Administration (FDA) web site FDA Information Sheet on Informed Consent OHRP Tips on Informed Consent - OHRP Guidance on Documenting Informed Consent for non-English Speakers - OHRP Short Form - Spanish Translation |