One of the provisions of HIPAA is that a waiver of subject authorization may be allowed if a biostatistician certifies that the data gathered in a study has a low risk of identifying the subject.

Our IRB, acting as the privacy board at UCHC, has received a request for such a certification, but the biostatisticians here are at a loss as to how to go about providing such a certification, i.e., they don't know what biostatistical principles/techniques to apply in order to justify such a certification.

Anyone run into this yet?  Any solutions to this yet that can be shared?  Any services available for hire?

Leonard P. Paplauskas
Associate Vice President for Research Administration
University of Connecticut Health Center
MC1920
Farmington, CT   06030-1920
xxxxxx@adp.uchc.edu (external e-mail)
xxxxxx@exchange.uchc.edu (internal e-mail)
860-679-3173 (phone)
860-679-1371 (fax)

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