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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) |
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- 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.
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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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November 14, 2007: New ORO VHA Handbooks |
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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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May 9, 2007: Information/Data Security in Research AND OI&T Presentation on Field Security Operations |
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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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January 10, 2007: Current ORD Policy on Tissue Banking |
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November 8, 2006: ORO Quality Reviews |
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September 13, 2006:Vulnerability, Decisional Impairment, and Research Protection |
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July 12, 2006:Ethical Issues in Subject Enrollment |
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May 10, 2006: Research Involving Recombinant DNA Molecules |
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March 8, 2006: Compliance Strategies from the Field |
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January 11, 2006: Compliance Issues from the Field |
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November 9, 2005: Privacy Issues in Research |
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September 14, 2005: What to Report to ORO |
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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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May 11, 2005: Points to Consider in Ethically Conducting Medical Device Clinical Trials |
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March 9, 2005: Protecting Older Research Subjects |
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January 11, 2005 (Note: November teleconference was cancelled): What to Report to ORO |
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September 8, 2004: Compliance in Behavioral/Social Research: Issues in Research, Design, Review, and Monitoring |
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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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May 12, 2004 Minutes: Regulatory and Policy Requirements in Recording Human Subjects Protection Activities/Determinations |
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March 10, 2004 Minutes: Common OHRP Findings of Noncompliance with Initial and Continuing Review |
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January 14, 2004 Minutes: Dietary Supplements Compliance Issues |
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November 13, 2003 Minutes: Device Compliance Issues |
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September 10, 2003 Minutes: ORO's first teleconference: ORO's Mission and Responsibilities |
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