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Research Transition Provisions

This page addresses the documentation requirements that must be met in order for research involving health information that is active before 4/14/2003 to proceed on and after the HIPAA Privacy regulations compliance date of 4/14/2003.

For research begun before 4/14/2003

bulletIf an informed consent was signed by the research subject before 4/14/2003, it may be used to continue to use and collect individually identifiable health information about that subject after 4/14/2003 unless the research subject requests that their individually identifiable health information not be made available to researchers.  If re-consent is required, i.e., the subject must sign a new consent form after 4/14/2003 for that study, this grandfathering is no longer possible and you must follow one of the HIPAA appropriate mechanisms for obtaining further identifiable health information from the subject (see 'For research begun after 4/14/2003').
bulletIf a waiver of informed consent is issued by the IRB before 4/14/2003, you may continue to use that waiver to collect individually identifiable health information after 4/14/2003.  The IRB has reviewed 'exempted' studies and will be automatically issuing a waiver of informed consent to PIs where appropriate in order to meet this specific HIPAA transition provision.

For research begun after 4/14/2003

bulletHIPAA appropriate mechanism for use or acquisition of individually identifiable health information is required in addition to standard IRB documentation (informed consent, waiver of informed consent, etc.)
bulletHIPAA Authorization (requires subject signature)
bulletDe-Identification of data - removes all identifying elements specified by the regulations
bulletLimited Dataset - also requires data use agreement
bulletWaiver of Authorization (requires IRB approval)
bulletReviews Preparatory to Research - may not remove individually identifiable health information from where it is housed
bulletResearch on Decedents

This material is designed for internal University at Buffalo use only and is copyrighted.  Information and documents available on this site may be freely copied and used with appropriate attribution to the University at Buffalo.  None of the information on these pages should be construed as legal advice or expert opinion with respect to how any particular function or entity engages in work to come into compliance with HIPAA.
Last updated: July 28, 2009.  Privacy Policy
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