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HIPAA, Researchers and the HIPAA, Researchers and the IRB: Session ThreeIRB: Session Three

Alan Homans, IRB Chair and

Nancy Stalnaker, IRB Administrator

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21 days and counting !21 days and counting !

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Where to Find HIPAA Research Where to Find HIPAA Research InformationInformation

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HIPAA Research InformationHIPAA Research Information

IRB Website:IRB Website:

www.osp.uvm.edu/www.osp.uvm.edu/ - - Select “Human Subjects”Select “Human Subjects”

IRB Website:IRB Website:

www.osp.uvm.edu/www.osp.uvm.edu/ - - Select “Human Subjects”Select “Human Subjects”

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HIPAA Research InformationHIPAA Research Information

UVM and FAHC HIPAA Research Website:UVM and FAHC HIPAA Research Website:

www.med.uvm.edu/hipaawww.med.uvm.edu/hipaa

UVM and FAHC HIPAA Research Website:UVM and FAHC HIPAA Research Website:

www.med.uvm.edu/hipaawww.med.uvm.edu/hipaa

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What’s New Since Session Two (2/18/03)

AUTHORIZATIONS FOR CURRENTLY APPROVED AUTHORIZATIONS FOR CURRENTLY APPROVED PROTOCOLS:PROTOCOLS:

• IRB emailed all PIs having protocols identified as needing an IRB emailed all PIs having protocols identified as needing an authorization with instructions, a cover form and the authorization with instructions, a cover form and the template. template.

• The template, cover form and instructions are also available The template, cover form and instructions are also available on the IRB website. on the IRB website.

• If you have not been contacted to complete an authorization If you have not been contacted to complete an authorization for a specific protocol which you believe has PHI, please for a specific protocol which you believe has PHI, please contact Donna Silver in the IRB office.contact Donna Silver in the IRB office.

AUTHORIZATIONS FOR CURRENTLY APPROVED AUTHORIZATIONS FOR CURRENTLY APPROVED PROTOCOLS:PROTOCOLS:

• IRB emailed all PIs having protocols identified as needing an IRB emailed all PIs having protocols identified as needing an authorization with instructions, a cover form and the authorization with instructions, a cover form and the template. template.

• The template, cover form and instructions are also available The template, cover form and instructions are also available on the IRB website. on the IRB website.

• If you have not been contacted to complete an authorization If you have not been contacted to complete an authorization for a specific protocol which you believe has PHI, please for a specific protocol which you believe has PHI, please contact Donna Silver in the IRB office.contact Donna Silver in the IRB office.

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What’s New Since Session Two (2/18/03)

• Authorizations must be submitted, along with the Authorizations must be submitted, along with the Authorization Cover Form, and approved by the Authorization Cover Form, and approved by the IRB. Requests for deviations from the template IRB. Requests for deviations from the template must be in writing and must include a rationale for must be in writing and must include a rationale for the deviation. The IRB will obtain FAHC approval the deviation. The IRB will obtain FAHC approval for any exception prior to approval.for any exception prior to approval.

• Effective 4/14/03, an authorization is required for Effective 4/14/03, an authorization is required for any subject being consented (even if this is a re-any subject being consented (even if this is a re-consent for a protocol change). consent for a protocol change).

• Authorizations must be submitted, along with the Authorizations must be submitted, along with the Authorization Cover Form, and approved by the Authorization Cover Form, and approved by the IRB. Requests for deviations from the template IRB. Requests for deviations from the template must be in writing and must include a rationale for must be in writing and must include a rationale for the deviation. The IRB will obtain FAHC approval the deviation. The IRB will obtain FAHC approval for any exception prior to approval.for any exception prior to approval.

• Effective 4/14/03, an authorization is required for Effective 4/14/03, an authorization is required for any subject being consented (even if this is a re-any subject being consented (even if this is a re-consent for a protocol change). consent for a protocol change).

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What’s In the Pipeline

AUTHORIZATIONS FOR NEW PROTOCOLS SUBMITTED AUTHORIZATIONS FOR NEW PROTOCOLS SUBMITTED AFTER APRIL 14, 2003:AFTER APRIL 14, 2003:

• The IRB protocol cover form is being revised to include The IRB protocol cover form is being revised to include a section on PHI and authorization. a section on PHI and authorization.

• The authorization, using the template, must be The authorization, using the template, must be submitted along with the authorization cover form.submitted along with the authorization cover form.

• All of these documents are (or will be) located on the All of these documents are (or will be) located on the IRB website.IRB website.

AUTHORIZATIONS FOR NEW PROTOCOLS SUBMITTED AUTHORIZATIONS FOR NEW PROTOCOLS SUBMITTED AFTER APRIL 14, 2003:AFTER APRIL 14, 2003:

• The IRB protocol cover form is being revised to include The IRB protocol cover form is being revised to include a section on PHI and authorization. a section on PHI and authorization.

• The authorization, using the template, must be The authorization, using the template, must be submitted along with the authorization cover form.submitted along with the authorization cover form.

• All of these documents are (or will be) located on the All of these documents are (or will be) located on the IRB website.IRB website.

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REQUESTS FOR WAIVER OF AUTHORIZATION:REQUESTS FOR WAIVER OF AUTHORIZATION:

• A form, A form, Request for Waiver of Informed Request for Waiver of Informed Consent/Authorization, Consent/Authorization, has been developed for this has been developed for this purpose. purpose.

• It will be available on the IRB website within the It will be available on the IRB website within the next week.next week.

REQUESTS FOR WAIVER OF AUTHORIZATION:REQUESTS FOR WAIVER OF AUTHORIZATION:

• A form, A form, Request for Waiver of Informed Request for Waiver of Informed Consent/Authorization, Consent/Authorization, has been developed for this has been developed for this purpose. purpose.

• It will be available on the IRB website within the It will be available on the IRB website within the next week.next week.

What’s In the Pipeline

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Other Anticipated Changes in the Near Future:Other Anticipated Changes in the Near Future:

• ““ACCESS TO PATIENT INFORMATIONACCESS TO PATIENT INFORMATION” form – to make ” form – to make procedures consistent with new HIPAA standardsprocedures consistent with new HIPAA standards

• Continuing Review Form – to collect new HIPAA related Continuing Review Form – to collect new HIPAA related informationinformation

Watch the IRB Website for Future ChangesWatch the IRB Website for Future Changes

Other Anticipated Changes in the Near Future:Other Anticipated Changes in the Near Future:

• ““ACCESS TO PATIENT INFORMATIONACCESS TO PATIENT INFORMATION” form – to make ” form – to make procedures consistent with new HIPAA standardsprocedures consistent with new HIPAA standards

• Continuing Review Form – to collect new HIPAA related Continuing Review Form – to collect new HIPAA related informationinformation

Watch the IRB Website for Future ChangesWatch the IRB Website for Future Changes

What’s In the Pipeline