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?

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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?

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You should continue to protect the privacy of your subjects’ information but the Privacy Rule does not require that you re-apply to the IRB. Ongoing studies for which the IRB approved a waiver of informed consent before April 14, 2003 are grandfathered under the Privacy Rule. HHS specifically rejected the need for an IRB to reconsider these studies, given the undue burden it would impose. But although a new waiver is not required it is important to note that the individual rights provided by the Privacy Rule go into effect on April 14, 2003. As a result, for example, any disclosure of PHI made pursuant to a waiver of authorization must be tracked by the covered entity.

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