How does the HIPAA Privacy Rule affect my research?
The Privacy Rule, which took effect on April 14, 2003, adds new privacy protections for subjects involved in research. The Rule specifies criteria that must be met for an IRB to approve waiver of the subject’s written authorization for use or disclosure of his or her protected health information (45 CFR 164.512(i)). The Rule also specifies several new requirements for information that must be in a valid authorization form for use or disclosure of protected health information (45 CFR 164.508). Additional information on these requirements is found in HIPAA Privacy Rule Requirements for Research, and in the WSIRB Research Application, Appendix I.
