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VA IRB Chair Conference

November 15, 2006, Washington, DC

Talks:

* All files are in Power Point format.

• Human Subject Protection: Thoughts from OHRP, Bernard A. Schwetz
• Core IRB Responsibilities, Marisue Cody
• VA Central IRB, K. Lynn Cates
• Engagement in Human Research, Tom Puglisi
• Research Involving Sensitive Data & Databases, Brenda Cuccherini
• Conducting Exempt and Expedited Reviews, Julie Lowery and Joan Porter
• Emergency Use of Test Articles and Other Use Issues, Karen Jeans
• Review of Multi-site HSR&D Studies, Marisue Cody
• Cybersecurity, Privacy, & HIPAA, Brenda Cuccherini
• International Research & Research Involving Children, K. Lynn Cates

Handouts:

1. OPRR (now called OHRP) Letter on Engagement of Institutions in Research (January 26, 1999)
2. OHRP / HHS Guidance on Research Involving Coded Private Information or Biological Specimens (August 10, 2004)
3. VA Memorandum on Researcher Contacts with Veterans (104 KB, PDF) (July 10, 2006)
4. VA Memorandum on VA IT Directive 06-2, Safeguarding Confidential and Privacy Act-Protected Data at Alternative Work Locations (55 KB, PDF)(June 6, 2006)




VA Data Outside VA Facilities:

5. VA Directive 6504 Restrictions on Transmission, Transportation and Use of, and Access to, VA Data Outside VA Facilities (June 7, 2006)
6. OCR HIPAA Privacy, Research (December 3, 2002, Revised April 3, 2003)
7. Office of Health Data and Informatics, VHA Privacy Office, Privacy Fact Sheet, Volume 06, No. 3, (June 2006) http://vaww.vhaco.va.gov/privacy/Communications/FactSheetVol06No3.doc (VA Intranet Only)
8. Office of Health Data and Informatics, VHA Privacy Office, Privacy Fact Sheet, Volume 06, No. 4, (June 2006) http://vaww.vhaco.va.gov/privacy/Communications/FactSheetVol06No4.doc (VA Intranet Only)




International Research Involving Human Subjects:

9. VHA Directive 2005-050, Requirements for Conducting VA-Approved International Research Involving Human Subjects, Human Biological Specimens, or Human Data (November 4, 2005)
10. Instructions for Requesting Permission to Conduct International Research as required by VHA Directive 2005-050 "Requirements for Conducting VA Approved International Research Involving Human Subjects, Human Biological Specimens, or Human Data" (October 27, 2005)
11. VHA Directive 2001-028, Research Involving Children (April 27, 2001)

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