Tripping on the HIPAA Hurdle

Schilling expresses his disappointment when learning that submissions dealing with patient research would not be considered unless the research had been approved by the Human Subjects Committee of the author's institution. In July 2003, having received notification sent to all faculty about Health Insurance Portability and Accountability Act, he submitted an application to the Human Subjects Committee seeking approval of his project titled "Hereditary Spherocytosis: A Long Term Study of the Natural History." Final approval was granted on Aug 19, 2005, but several unexpected events transpired in the interval. He asked the appropriate university committee for a waiver because his data acquisition had been under way for at least 4 decades. The response from the committee denying his request contained the following advice for him: "Note that research activities conducted in the past without institutional review board approval cannot be approved by the Human Subjects Committee and would likely be considered a violation of regulations."