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	July 8, 2008: Clarification of ORO's July 1, 2008, memo on PTSD research and Purpose and Plans for VHA's Research Administration Review (Sandi Isaacson, MSN, MBA, Director of Operations, Office of Research and Development)
	07/08/08 Agenda 07/08/08 Attachment: ORO memo on PTSD research (see clarification below) Clarification of ORO's July 1, 2008, memo on PTSD research: (1) ORO's request refers to all PTSD studies regardless of whether or not drugs are involved. "PTSD studies" means studies directed toward PTSD patients/subjects or studies in which PTSD patients/subjects are compared with others. (2) ORO's request covers only currently active, IRB-approved studies. (3) For record review studies, the special review panel should verify that the type of IRB review was appropriate, that informed consent and HIPAA authorization were properly obtained or waived, and that proper safeguards are in place to assure data security and privacy for the database oriented projects. (4) For ongoing exempt research, the special review panel should verify that the exemption is appropriate and valid. 07/08/08 Presentation: Plans for VHA's Research Administration Review
	May 13, 2008: ORO Memo on Compliance Oversight Procedures for Use and Storage of VA Sensitive Research Information & Discussion on Early Results of Questionnaire on Suggested Topics for ORO Bimonthly Teleconferences
	05/13/08 Agenda 05/13/08 Attachment : ORO Memo on Compliance Oversight Procedures for Use and Storage of VA Sensitive Research Information 05/31/08 Presentation : Results of ORO Bi-monthly Teleconference Questionnaire 05/31/08 Attachment : ORO Bi-monthly Teleconference Questionnaire (Note: If you have not submitted a response to our questionnaire, it is not too late. Please refer to the attachment for submission instructions.)
	January 9, 2008: Summary of Findings from ORO's 2007 On-site Reviews
	01/09/08 Agenda 01/08/08 Presentation
	November 14, 2007: New ORO VHA Handbooks
	11/14/07 Agenda 11/14/07 Presentation #1 : VHA Handbook 1058.03 11/14/07 Presentation #2: VHA Handbook 1058.04
	September 12, 2007: FDA Guidance for Industry -- Protecting the Rights, Safety, and Welfare of Study Subjects -- Supervisory Responsibilities of Investigators
	09/12/07 Agenda 09/12/07 Presentation 09/12/07 Attachment : May 2007 Draft Guidance on Investigator Responsibilities 09/12/07 Attachment : Drug vs. Device Investigator Responsibilities FDA Only
	May 9, 2007: Information/Data Security in Research AND OI&T Presentation on Field Security Operations
	05/09/07 Agenda 05/09/07 Presentation Updated presentation
	March 7, 2007: ORO Update on Information/Data Security in Research AND Annual Facility Director Certification of Research Oversight
	03/07/07 Agenda
	January 10, 2007: Current ORD Policy on Tissue Banking
	01/10/07 Agenda 01/10/07 Attachment: FAQ on Tissue Banking 01/10/07 Attachment: Information on Consent for Tissue Banking
	November 8, 2006: ORO Quality Reviews
	11/08/06 Agenda 11/08/06 Attachment: IRB Minutes 11/08/06 Attachment: International Research
	September 13, 2006:Vulnerability, Decisional Impairment, and Research Protection
	09/13/06 Agenda 09/13/06 Presentation Contact Dr. Strauss: He is willing to answer any questions or provide samples of his SOPs on IRB assessment of vulnerability, etc.
	July 12, 2006:Ethical Issues in Subject Enrollment
	07/12/06 Agenda 07/12/06 Presentation
	May 10, 2006: Research Involving Recombinant DNA Molecules
	05/10/06 Announcement with web links 05/10/06 Agenda 05/10/06 Presentation
	March 8, 2006: Compliance Strategies from the Field
	03/08/06 Agenda 03/08/06 Presentation #1 03/08/06 Presentation #2 03/08/06 Tool
	January 11, 2006: Compliance Issues from the Field
	01/11/06 Agenda 01/11/06 Presentation 21 CFR 11 Compliance Letter FDA Draft Guidance on 21 CFR 11 (pdf) FDA Draft Guidance on 21 CFR 11 (htm) Reporting of All Study Site-Monitoring Visit Results Memo from ORD (10/14/04)
	November 9, 2005: Privacy Issues in Research
	11/09/05 Agenda 11/09/05 Presentation VHA Handbook 1605.1, Privacy and Release of Information VHA Privacy Office
	September 14, 2005: What to Report to ORO
	09/14/05 Agenda 09/14/05 Presentation
	July 13, 2005: How to Interpret and Use VHA Handbook 1058.2 in Handling Allegations of Research Misconduct
	07/13/05 Agenda 07/13/05 Presentation 07/13/05 Hand-out
	May 11, 2005: Points to Consider in Ethically Conducting Medical Device Clinical Trials
	05/11/05 Agenda 05/11/05 Hand-out
	March 9, 2005: Protecting Older Research Subjects
	03/09/05 Agenda 03/09/05 Hand-out
	January 11, 2005 (Note: November teleconference was cancelled): What to Report to ORO
	01/11/05 Agenda Hand-out: What to Report to ORO Hand-out: VHA Handbook 1058.1, Reporting Adverse Events in Research to the Office of Research Oversight
	September 8, 2004: Compliance in Behavioral/Social Research: Issues in Research, Design, Review, and Monitoring
	09/08/04 Agenda 09/08/04 Hand-out
	July 14, 2004 Minutes (Note: this is the last teleconference for which minutes were recorded. Agenda and hand-outs only will be posted for all future teleconferences.): Enhancing Responsible Conduct of Research
	07/14/04 Agenda 07/14/04 Hand-out
	May 12, 2004 Minutes: Regulatory and Policy Requirements in Recording Human Subjects Protection Activities/Determinations
	05/12/04 Agenda 05/12/04 Hand-out
	March 10, 2004 Minutes: Common OHRP Findings of Noncompliance with Initial and Continuing Review
	03/10/04 Agenda 03/10/04 Hand-out
	January 14, 2004 Minutes: Dietary Supplements Compliance Issues
	01/14/04 Agenda 01/14/04 Presentation 01/14/04 Hand-out 1 01/14/04 Hand-out 2
	November 13, 2003 Minutes: Device Compliance Issues
	11/13/03 Attachment
	September 10, 2003 Minutes: ORO's first teleconference: ORO's Mission and Responsibilities
	09/10/03 Attachment

Reviewed/Updated Date: July 10, 2008