09/09/08 Agenda

09/09/08 Presentation:  Brief Overview - Compliance with VHA Handbook 1200.1, "The Research and Development Committee Handbook", Paula Squire Waterman, MS, Program Analyst, Office of Research Oversight

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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 of Research and Development

07/08/08 Agenda

07/08/08 Attachment:  ORO's July 1, 2008, memo on PTSD  research (see clarification below)

Clarification :
(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 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

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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.)

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January 9, 2008 : Summary of Findings from ORO's 2007 On-site Reviews

01/09/08 Agenda

01/08/08 Presentation

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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

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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

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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

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March 7, 2007: ORO Update on Information/Data Security in Research AND Annual Facility Director Certification of Research Oversight

03/07/07 Agenda

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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

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November 8, 2006:   ORO Quality Reviews

11/08/06 Agenda

11/08/06 Attachment: IRB Minutes

11/08/06 Attachment: International Research

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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.  

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July 12, 2006:  Ethical Issues in Subject Enrollment

07/12/06 Agenda

07/12/06 Presentation

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May 10, 2006:   Research Involving Recombinant DNA Molecules

05/10/06 Announcement with web links 

05/10/06 Agenda 

05/10/06 Presentation  

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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

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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 )

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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

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September 14, 2005:   What to Report to ORO

09/14/05 Agenda

09/14/05 Presentation  

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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

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May 11, 2005:   Points to Consider in Ethically Conducting Medical Device Clinical  Trials

05/11/05 Agenda

05/11/05 Hand-out

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March 9, 2005: Protecting Older Research Subjects

03/09/05 Agenda

03/09/05 Hand-out

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January 11, 2005 :  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

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September 8, 2004: Compliance in Behavioral/Social Research: Issues in Research, Design, Review, and Monitoring

09/08/04 Agenda

09/08/04 Hand-out

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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

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May 12, 2004 Minutes:  Regulatory and Policy Requirements in Recording Human Subjects Protection Activities/Determinations

05/12/04 Agenda    

05/12/04 Hand-out

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March 10, 2004 Minutes:  Common OHRP Findings of Noncompliance with Initial and Continuing Review 

03/10/04 Agenda    

03/10/04 Hand-out

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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

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November 13, 2003 Minutes:  Device Compliance Issues

11/13/03 Attachment

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September 10, 2003  Minutes: ORO's first teleconference: ORO's Mission and Responsibilities

  09/10/03 Attachment