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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
 | If 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'). |
| If 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
| HIPAA 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.)
 | HIPAA Authorization (requires subject signature) |
| De-Identification of data - removes all identifying elements specified
by the regulations |
| Limited Dataset - also requires data use agreement |
| Waiver of Authorization (requires IRB approval) |
| Reviews Preparatory to Research - may not remove individually
identifiable health information from where it is housed |
| Research on Decedents |
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