As of April 14, 2003, Georgetown University Researchers accessing protected health information maintained by MedStar must be trained in MedStar's responsibilities under HIPAA. MedStar is certifying all researchers, regardless of the researcher's affiliation.
All members of the research team are required to complete the HIPAA education module found on the MedStar Research Institute website set forth below in order to access PHI (Protected Health Information) in a MedStar facility, including Georgetown University Hospital.
All PIs must submit copies of the certificate of completion of HIPAA training to the IRB in order to obtain IRB approval of new studies, enroll in open studies, or access PHI for research on or after April 14, 2003. Access to PHI for subjects enrolled before April 14, 2003 does not require compliance with HIPAA regulations.
The HIPAA authorizations and requests for waiver/alteration of authorization require IRB approval, and should be sent to the IRB office. Sponsors should be directed to the template authorization on the website and encouraged to rely on the template form. If changes or additions are requested by the sponsor, they should be incorporated into the template and the competed form should be sent to the IRB for approval.
Requests for Review Preparatory to Research, Limited Date Sets, and Access to Decedent Information do not require IRB review and, at Georgetown University Hospital, should be submitted to the Vice President for Medical Affairs, Dr. Richard Goldberg.
HIPAA Authorizations and requests for waiver/alteration of HIPAA authorizations for open studies should be sent as soon as possible to the IRB in order to continue research on or after April 14, 2003. The legal criteria for waiver/alteration are set forth on the form.
Please note that researchers may only access, and the IRB and Covered Entity (MedStar) may only approve access, to the minimum PHI necessary to complete the research. Please tailor your requests accordingly. Also note the Statement of Assurance to accompany the authorization forms that are filed with the IRB in which the PI verifies the accuracy of the request.