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September 9, 2008: VHA Handbook 1200.1, Research and Development Committee Handbook |
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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
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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
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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
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01/09/08 Agenda
01/08/08 Presentation
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November 14, 2007: New ORO VHA Handbooks
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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
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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
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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
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03/07/07 Agenda
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January 10, 2007: Current ORD Policy on Tissue Banking
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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
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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
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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
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07/12/06 Agenda
07/12/06 Presentation
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May 10, 2006: Research Involving Recombinant DNA Molecules
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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
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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
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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
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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
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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
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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
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05/11/05 Agenda
05/11/05 Hand-out
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March 9, 2005: Protecting Older Research Subjects
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03/09/05 Agenda
03/09/05 Hand-out
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January 11, 2005 : What to Report to ORO
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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
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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
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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
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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
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03/10/04 Agenda
03/10/04 Hand-out
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January 14, 2004 Minutes : Dietary Supplements Compliance Issues
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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
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11/13/03 Attachment
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September 10, 2003 Minutes: ORO's first teleconference: ORO's Mission and Responsibilities
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09/10/03 Attachment
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