1. 1 HIPAA, Researchers and the IRB: Session Three Alan Homans, IRB Chair and Nancy Stalnaker, IRB Administrator

2. 2 21 days and counting !

3. 3 Where to Find HIPAA Research Information

4. 4 HIPAA Research Information IRB Website: www.osp.uvm.edu/www.osp.uvm.edu/ - Select “Human Subjects” www.osp.uvm.edu/

5. 5 HIPAA Research Information UVM and FAHC HIPAA Research Website: www.med.uvm.edu/hipaa

6. 6 What’s New Since Session Two (2/18/03) AUTHORIZATIONS FOR CURRENTLY APPROVED PROTOCOLS: IRB emailed all PIs having protocols identified as needing an authorization with instructions, a cover form and the template.IRB emailed all PIs having protocols identified as needing an authorization with instructions, a cover form and the template. The template, cover form and instructions are also available on the IRB website.The template, cover form and instructions are also available on the IRB website. If you have not been contacted to complete an authorization for a specific protocol which you believe has PHI, please contact Donna Silver in the IRB office.If you have not been contacted to complete an authorization for a specific protocol which you believe has PHI, please contact Donna Silver in the IRB office.

7. 7 What’s New Since Session Two (2/18/03) Authorizations must be submitted, along with the Authorization Cover Form, and approved by the IRB. Requests for deviations from the template must be in writing and must include a rationale for the deviation. The IRB will obtain FAHC approval for any exception prior to approval.Authorizations must be submitted, along with the Authorization Cover Form, and approved by the IRB. Requests for deviations from the template must be in writing and must include a rationale for the deviation. The IRB will obtain FAHC approval for any exception prior to approval. Effective 4/14/03, an authorization is required for any subject being consented (even if this is a re- consent for a protocol change).Effective 4/14/03, an authorization is required for any subject being consented (even if this is a re- consent for a protocol change).

8. 8 What’s In the Pipeline AUTHORIZATIONS FOR NEW PROTOCOLS SUBMITTED AFTER APRIL 14, 2003: The IRB protocol cover form is being revised to include a section on PHI and authorization.The IRB protocol cover form is being revised to include a section on PHI and authorization. The authorization, using the template, must be submitted along with the authorization cover form.The authorization, using the template, must be submitted along with the authorization cover form. All of these documents are (or will be) located on the IRB website.All of these documents are (or will be) located on the IRB website.

9. 9 REQUESTS FOR WAIVER OF AUTHORIZATION: A form, Request for Waiver of Informed Consent/Authorization, has been developed for this purpose.A form, Request for Waiver of Informed Consent/Authorization, has been developed for this purpose. It will be available on the IRB website within the next week.It will be available on the IRB website within the next week. What’s In the Pipeline

10. 10 Other Anticipated Changes in the Near Future: “ ACCESS TO PATIENT INFORMATION ” form – to make procedures consistent with new HIPAA standards“ ACCESS TO PATIENT INFORMATION ” form – to make procedures consistent with new HIPAA standards Continuing Review Form – to collect new HIPAA related informationContinuing Review Form – to collect new HIPAA related information Watch the IRB Website for Future Changes What’s In the Pipeline