In the first letter, OCR, in collaboration with FDA, takes the position that the Privacy Rule, FDA guidance, and the Common Rule do not require IRB review of standalone HIPAA authorizations. The letter concludes by stating that "in light of the urgent circumstances identified by [the IPPC letter], we encourage all entities concerned to avail themselves of this flexibility to permit continued enrollment of individuals in clinical trials." If you are having trouble with enrollment because of delays in IRB approval of authorizations, then the letter may be helpful to you. You can access the letter on OCR's website at http://www.hhs.gov/ocr/hipaa/privguideresearch.pdf or by clicking on the title above.
A second similar letter from the FDA expressing its support for this position can be accessed by clicking on the title above.
Both letters have been combined and can be accessed by clicking on the title above.