The Food and Drug Administration (FDA) does not dictate the specific language required for the informed consent document, but does require certain basic elements of consent be included.
INFORM DEFINITION TRIAL
Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work.Ī central part of the informed consent process is the informed consent document. This information is provided to potential participants through the informed consent process. Participation being a voluntary decision on their part. What risks or discomforts they may experience, How the protocol (plan of research) works, To make an informed decision about whether to participate or not in a clinical trial, people need to be informed about: While research subjects may get personal treatment benefit from participating in a clinical trial, they must understand that they:Īre entering into a study that may be very different from the standard medical practices that they currently know It is important for people who are considering participation in a clinical trial to understand their role, as a “subject of research” and not as a patient.
The main purpose of clinical trials is to “study” new medical products in people.
How effective is the medical product at relieving symptoms, treating or curing a condition. How should the product be used? (for example, the best dose, frequency, or any special precautions necessary to avoid problems), Clinical trials are used to answer questions such as:Īre new medical products safe enough to outweigh the risks related to the underlying condition?, (21 CFR 50.20.) What is Informed Consent?Īs new medical products are being developed, no one knows for sure how well they will work, or what risks they will find. This process must occur under circumstances that minimize the possibility of coercion or undue influence. The investigator (or other study staff who are conducting the informed consent interview) and the participant should exchange information and discuss the contents of the informed consent document. ( 21 CFR 50.20.) FDA considers this to include allowing sufficient time for participants to consider the information and providing time and opportunity for the participant to ask questions and have those questions answered. To be effective, the process must provide sufficient opportunity for the participant to consider whether to participate. Obtaining the potential participant's voluntary agreement to participate.Ĭontinuing to provide information as the clinical investigation progresses or as the subject or situation requires. Informed consent involves providing a potential participant with:Īdequate information to allow for an informed decision about participation in the clinical investigation.įacilitating the potential participant's understanding of the information.Īn appropriate amount of time to ask questions and to discuss with family and friends the research protocol and whether you should participate. FDA believes that obtaining a research participant's verbal or written informed consent is only part of the process. To many, the term informed consent is mistakenly viewed as the same as getting a research participant's signature on the consent form. Informed consent may not include language that When Appropriate, one or more of the following elements of information must also be provided in the informed consent documentĪ potential research subject must have an opportunity to On this page you will find information on:īefore enrolling in a clinical trial, the following information must be given to each potential research subject
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