If an IRB uses a standard “fill-in-the-blank” consent format, does the IRB need to review the filled out form for each study?
Yes. A fill-in-the-blank format provides only some standard wording and a framework for organizing the relevant study information. The IRB should review a completed sample form, individualized for each study, to ensure that the consent document, in its entirety, contains all the information required by 21 CFR 50.25 in language the subject can understand. The completed sample form should be typed to enhance its readability by the subjects. The form finally approved by the IRB should be an exact copy of the form that will be presented to the research subjects. The IRB should also review the “process” for conducting the consent interviews, i.e., the circumstances under which consent will be obtained, who will obtain consent, and so forth. 38. The informed consent regulations [21 CFR 50.25 (a)(5)] require the consent document to include a statement that notes the possibility that FDA may inspect the records. Is this statement a waiver of the subject’s legal right to privacy? No. FDA does n
Related Questions
- How do I make changes, requested by the IRB, to the protocol and/or consent form during the initial review process, i.e., before the study receives initial approval?
- If an IRB uses a standard "fill-in-the-blank" consent format, does the IRB need to review the filled out form for each study?
- Is the sponsor required to review the consent form approved by the IRB to make sure all FDA requirements are met?
