Informed Consent was obtained from participants in my study prior to April 14, 2003. Are these participants required to sign a HIPAA Research Authorization?
Consent, authorization or other legal permission obtained prior to the mandatory compliance date (April 14, 2003) allows the PHI to be used after April 14, 2003 for the research. If, after April 14, 2003, a revised informed consent is required for prior enrollees, then a HIPAA RAF should be obtained from the prior enrollees.
Related Questions
- I am conducting a study using medical records under an IRB approved waiver of consent obtained prior to April 14, 2003. Do I need to do anything with respect to the Privacy Rule?
- Informed Consent was obtained from participants in my study prior to April 14, 2003. Are these participants required to sign a HIPAA Research Authorization?
- Is it always necessary to furnish an informed consent document to participants in a study?
