Impact on Goodwyn IRB procedures as a result of the HIPAA privacy rule:

. Goodwyn IRB application forms reflect HIPAA privacy regulation and include questions that allow us to assess whether investigators have what they need to meet the HIPAA regulation requirements triggered by their proposed research activity (including patient recruitment).

. Goodwyn IRB will review applications for alteration or waiver of authorization by full board or expedited procedures, granting and documenting such alteration or waiver in the prescribed manner.

. For all studies beginning on or after April 14, 2003:

When HIPAA authorization language is combined with the informed consent document, Goodwyn IRB will review the authorization language for compliance with the privacy rule requirements.

  When HIPAA authorizations are separate from the informed consent document, Goodwyn IRB does not require submission and IRB approval of these separate authorizations.

. For ongoing studies:

If enrollment period for the study is closed prior to April 14, 2003, the current consent form is "grand-fathered" and no additional HIPAA authorization is required.

If the enrollment period is continuing beyond April 14, 2003 and/or the study's informed consent document requires a change after that date, HIPAA authorization must supplement the informed consent for new enrollees and/or subjects being re-consented. This authorization is the research site's responsibility. However, Goodwyn IRB can provide a suggested template upon request to facilitate the transition effort.

HIPAA and Research - Quick Reference Guide