Can I have one form for subjects to sign, one that combines consent and authorization?
A1: Yes, this will require IRB approval because it is a revised consent document. However, the IRB and Privacy Board do not recommend combining the consent and authorization because the medical providers (hospitals or doctors) are required to keep the original signed authorization form. The researcher no longer has the original signed consent document in this case. The IRB and Privacy Board recommend that you use separate authorization and consent documents.
Related Questions
- The sample consent form supplied by my clinical trial sponsor includes HIPAA language. Do I still need to use the HIPAA authorization form?
- Can I have one form for subjects to sign, one that combines consent and authorization?
- Do subjects receive a copy of the Authorization Form as they do a consent form?
