What does a research subject need to be informed of during the consent process?
The informed consent checklist outlines the regulatory requirements of the informed consent form and the IRB sample consent forms covers these topics. If these documents are used as a guideline, you should address all required topics within your consent document. However, consent is more than a document. Consent must be a process in which the research subject has the right to read and discuss the form and to ask any questions regarding the study and have them answered in a satisfactory manner.
