You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
Informed consent checklists, just like the informed consent, are more than just a document, but rather can be a process. To begin, what is an informed consent checklist and how do you use one?
Topics: Informed Consent, 21 CFR 50.20, Protection of Human Subjects
Informed consent must be obtained from research subjects prior to having any study-related testing or procedures completed for clinical trials. For the requirements of informed consent, we refer to the Code of Federal Regulations (CFR), Title 21, Part 50: Protection of Human Subjects. 21 CFR 50.20 states, “The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.” And 21 CFR 50.25 describes elements which have to be included in the Informed Consent. But what does this mean exactly?
Topics: Informed Consent, 21 CFR 50.20, Non-English Speaking Subjects