1 hipaa, researchers and the irb: session four alan homans, irb chair, nancy stalnaker, irb...

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1 HIPAA, Researchers and the HIPAA, Researchers and the IRB: Session Four IRB: Session Four Alan Homans, IRB Chair, Nancy Stalnaker, IRB Administrator Michael Caputo, Director of Information Systems UVM/College of

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Page 1: 1 HIPAA, Researchers and the IRB: Session Four Alan Homans, IRB Chair, Nancy Stalnaker, IRB Administrator Michael Caputo, Director of Information Systems

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HIPAA, Researchers and the HIPAA, Researchers and the IRB: Session FourIRB: Session Four

Alan Homans, IRB Chair, Nancy Stalnaker, IRB AdministratorMichael Caputo, Director of Information Systems UVM/College of Medicine

Page 2: 1 HIPAA, Researchers and the IRB: Session Four Alan Homans, IRB Chair, Nancy Stalnaker, IRB Administrator Michael Caputo, Director of Information Systems

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HIPAA: DAY 2HIPAA: DAY 2

LiftoffLiftoff

Page 3: 1 HIPAA, Researchers and the IRB: Session Four Alan Homans, IRB Chair, Nancy Stalnaker, IRB Administrator Michael Caputo, Director of Information Systems

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Where We Are To Date:Where We Are To Date:

Authorizations Received: 241

Authorizations Approved: 184

Authorizations Reviewed & Pending Action from PI: 57

Anticipated Authorizations Not Yet Received: 98

Authorizations Received & Not Yet Reviewed: 0

Page 4: 1 HIPAA, Researchers and the IRB: Session Four Alan Homans, IRB Chair, Nancy Stalnaker, IRB Administrator Michael Caputo, Director of Information Systems

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What’s New Since Session Three

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

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

• The HIPAA training module for research was The HIPAA training module for research was posted on the FAHC Angel Website (completed by posted on the FAHC Angel Website (completed by 288 people to date). 288 people to date).

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

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

• The HIPAA training module for research was The HIPAA training module for research was posted on the FAHC Angel Website (completed by posted on the FAHC Angel Website (completed by 288 people to date). 288 people to date).

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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”

Page 6: 1 HIPAA, Researchers and the IRB: Session Four Alan Homans, IRB Chair, Nancy Stalnaker, IRB Administrator Michael Caputo, Director of Information Systems

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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

Page 7: 1 HIPAA, Researchers and the IRB: Session Four Alan Homans, IRB Chair, Nancy Stalnaker, IRB Administrator Michael Caputo, Director of Information Systems

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What’s Next?

Review of Databases and Review of Databases and Registries – HIPAA Registries – HIPAA Security RuleSecurity Rule

Review of Databases and Review of Databases and Registries – HIPAA Registries – HIPAA Security RuleSecurity Rule