Is the sponsor required to review the consent form approved by the IRB to make sure all FDA requirements are met?
For investigational devices, the informed consent is a required part of the IDE submission. It is, therefore, approved by FDA as part of the IDE application. When an IRB makes substantive changes in the document, FDA reapproval is required and the sponsor is necessarily involved in this process. FDA regulations for other products do not specifically require the sponsor to review IRB approved consent documents. However, most sponsors do conduct such reviews to assure the wording is acceptable to the sponsor.
Related Questions
- Our initial/continuing review/modification has been approved. Where do we find the approved documents such as the consent form?
- Is the sponsor required to review the consent form approved by the IRB to make sure all FDA requirements are met?
- How do I know which version of the IRB approved consent/assent form to use?
