The scheduled in person HIPAA training presentations formerly scheduled once a month have been cancelled indefinitely. Investigators needing to complete the "HIPAA for Research" training can do so via the internet at:

http://privacy.health.ufl.edu/

or you may request a group training for new research faculty, staff, or students by emailing Kenneth Kepler, IRB Education Coordinator at kepler@vpha.health.ufl.edu or telephoning (352) 392-7875.

The IRB is pleased to announce that Linda Kephart Fallon, former IRB Editor, has accepted a promotion to be the IRB HIPAA Coordinator. You may direct all HIPAA inquiries to Ms. Fallon at 352-846-1710 or lfallon@ufl.edu.

Our former HIPAA Coordinator, Michael Scian, has accepted a promotion with DSR. Please direct all HIPAA questions to Michael Mahoney or Kenneth Kepler in the IRB office until a new HIPAA Coordinator is hired. Thank you!

As part of the University's continuing HIPAA training all Principal Investigators, sub-Investigators, coordinators, and study related staff must re-take the required HIPAA training for researchers every 2 years. The training can be done on-line or at one of the live training sessions. If you initially took the training before 4/14/2003 you must take it again by 4/14/2005. If you initially took the training on or after 4/14/2003 you must take it again by your two year anniversary date.

Click here for the link to UF's Privacy Office web page in order to complete the training on-line (http://privacy.health.ufl.edu/training/research/)

or

Click here to see when you can attend one of the live training sessions.

PLEASE NOTE: this training is research specific, and is in addition to any training that Shands, UF, or the VA requires you to complete for your clinical duties.

HIPAA Covered Studies

Subjects enrolled in studies after April 13, 2003 are required to sign an appropriate HIPAA authorization. If the IRB-01 office discovers that subjects were enrolled without signing a HIPAA authorization we will refer the issue to the UF Privacy Office. Until the UF Privacy Office has resolved the situation the IRB will be unable to process any accompanying submissions. This may affect protocol revisions or the timeliness of a continuing renewal.

Current UF Privacy Office policy allows PIs 30 days to obtain a signed authorization from previously enrolled study subjects. If the authorization is not or cannot be obtained within the time limit then the PI may be required to destroy any data collected without authorization. PIs should be aware that the UF Privacy Office may take more severe actions in egregious cases. Please contact the UF Privacy Office directly for more information.

Principal Investigators are reminded that they are ultimately responsible for the proper conduct of their study. This responsibility cannot be delegated to staff.

When research requires a Waiver of Authorization, researchers are no longer required to submit a separate Waiver application for research conducted at the VA. A single Waiver will now cover research conducted both at UF and/or the VA.

NOTE: May 9th, 2003 - VA PRIVACY BOARD
All research being conducted at the VA must also be approved by the VA SubCommittee for Clinical Investigation (SCI) if your study involves the collection, creation, use OR disclosure of PHI at the VA and you need to receive separate VA approval for any (1) Waivers of Authorization, (2) Certificates for Preparatory Research, and/or (3) Certificates for Research Involving Decedents Information. As a result you must use the new VA versions of these forms located on our HIPAA Forms page. HIPAA Authorizations and Informed Consents with HIPAA Language will continue to be approved only by IRB-01.

Thus, if your research requires a Waiver of Authorization for enrolling subjects and you are conducting your research at UF/Shands and the VA, you will need to submit two different Waiver of Authorization forms: the UF version to IRB-01 and the VA version to the SCI/VA Privacy Board.

HIPAA is now in effect!
(as of 4/14/03)

When consenting potential subjects to participate in your research projects you must use either:
(1) an Informed Consent form with HIPAA Authorization elements which has been approved by the IRB and has not expired, or (2) an IRB approved Informed Consent form which is not expired AND a separate IRB approved HIPAA Authorization form. As always, make sure you keep original copies of all signed documents for your research records as well as give a copy of all documents to the subject.