4 questions to ask about electronic informed consent

What is electronic informed consent? Informed Consent is a voluntary agreement to participate in research.  Clinical research professionals know that the informed consent process is more than just a signature on a form; it is a process of information exchange that may include:  providing subject recruitment materials, verbal instructions, question/answer sessions, time for the patient to read the form individually or with family members, and measures of subject understanding.  This is all in addition to actually signing the informed consent document.   Traditionally, paper-based consent has been the method through which researchers conducted and documented the informed consent process. Electronic consent forms often use tablets or computers as the medium for communicating information and seeking consent from the patient. How do we ensure the electronic informed consent process is adequate? FDA’s requirements for electronic records/electronic signatures, informed consent, and IRBs are set forth in 21 CFR Parts 11, 50, and 56, respectively.  The Department of Health and Human Services (HHS) also has requirements regarding the protection of human subjects which are set forth in 45 CFR Part 46, often referred to as The Common Rule. The information presented to the subject, processes used for obtaining informed consent, and documentation of the electronic informed consent (eIC) must meet the requirements of these and any other applicable regulations.   If the study is co...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog IMARC Source Type: news