What is informed consent?
Prior to participating in a clinical research study, you will be asked to provide informed consent.
The following are some important notes about informed consent.
Informed consent is a process, not just a form. Complete and understandable information must be presented to research subjects in order for them to voluntarily decide whether or not to take part in a study. The informed consent document will explain the purpose of the study, the length of the study, experimental procedures involved in the study, alternative therapies that are available, risks and benefits of the study article, and the confidentiality of your research record. The signed informed consent document provides the basis for consent and can be used by the subject for future reference. The informed consent document will be updated when additional information has been learned about the study article. Subjects will be asked to sign these revised informed consent documents.
While an informed consent document provides you with the information you need, one of the most vital parts of the informed consent process is the opportunity to discuss any questions or concerns that you may have with a knowledgeable member of the research team.
All research protocols and informed consent documents must be approved by an Institutional Review Committee or Board. This group's primary function is to ensure that the possible benefits of the research article being studied outweigh the risks, and that all known risks are stated in the informed consent document.