1 hipaa, researchers and the irb: session four alan homans, irb chair, nancy stalnaker, irb...
Post on 21-Dec-2015
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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
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HIPAA: DAY 2HIPAA: DAY 2
LiftoffLiftoff
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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
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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”
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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 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