The sample consent form supplied by my clinical trial sponsor includes HIPAA language. Do I still need to use the HIPAA authorization form?
Yes. Do not include information about HIPAA in the informed consent form. Other than referencing the HIPAA Research Authorization form, the consent form should not cover the same topics covered in the HIPAA Authorization form. This means you will need to revise the language in the sample consent form.
Related Questions
- Must the IRB approve the separate authorization form or is the new HIPAA language included in the new consent form template?
- Does the OSMA have a model HIPAA authorization form or model consent to release information form?
- What is the HIPAA Waiver Authorization form for and when does it need to be submitted?
