|
ORO Communications
VISN Network Oversight of Research Compliance (02/26/09)
Joint memo issued by ORO and the Deputy Under Secretary for Health to Network Directors.
Communications with ORO (9/17/2008)
Joint memo issued by ORO and the Deputy Under Secretary for Health to Network Directors.
Secretary Directs ORO to Coordinate Review of Studies with PTSD Subjects (07/01/2008)
ORO will conduct a comprehensive review of all VHA research studies involve individuals with Post-Traumatic Stress Disorder (PTSD). Copies of all review panel reports and all relevant IRB meeting minutes must be received in ORO Central Office by August 15, 2008. Points of Clarification.
Studies Seeking Information from Medical Centers (07/11/2008)
This memo, co-signed by the Deputy Under Secretary for Health for Operations and Management (10N) and the Chief Research Oversight Officer (10R), was distributed to the field on July 15, 2008.
Secretary Directs ORO to Coordinate Review of Studies with PTSD Subjects (07/01/2008)
ORO will conduct a comprehensive review of all VHA research studies involve individuals with Post-Traumatic Stress Disorder (PTSD). Copies of all review panel reports and all relevant IRB meeting minutes must be received in ORO Central Office by August 15, 2008. Points of Clarification.(ADD)
2008 Facility Director’s Certification of Research Oversight (06/13/2008)
Effective February 21, 2007, VHA policy requires Medical Center Directors to annually certify oversight of their facilities research programs. The attached checklist and remedial Action Plan to address identified deficiencies are due no later than July 15, 2008.
Biosafety Level (BSL) 3 Research Laboratory Physical Security Inspections (03/23/2007)
Memo from ORO to Facility Directors requiring annual self inspections in years when ORO does not perform inspections. Attachment: ORO BSL-3 Research Laboratory Security Checklist.
Reporting Unanticipated Problems and Adverse Events in Researc (12/06/2006) Memo detailing ORO’s interpretation of regulatory requirements for reporting unanticipated problems and adverse events to the responsible Institutional Review Board (IRB).
What to Report to ORO (09/08/2005)
ORO memo to Institutional Officials clarifies current requirements for reporting research-related issued to ORO.
Interim Instructions for Filing Federalwide Assurances (FWAs) and Institutional Review Board (IRB) Registration (02/1/2005)
ORO manages the FWA program in VA and is the contact for OHRP. With the new electronic filing with OHRP , VA facilities can follow one of the two following options outlined in these instructions.
Quality Assurance Project to Promote Research Compliance (02/01/2005)
Memo to Facility Directors concerning ORO’s quality assurance project directed at evaluating the elements contained in the IRB minutes and certain procedural aspects of the IRB review of VHA facilities that rely on affiliate IRBs as their IRB or record.
Checklist for the Development of a Memorandum of Understanding (MOU) (01/11/2005)
Memo issued by ORO and the Office of Research and Development (ORD) providing a checklist for the MOU, a required supplement to the VA Federalwide Assurance issued by ORO and the Office of Human Research Protections. Attachment 1: Checklist. Attachment 2: Additional Info.
Announcement of Initiation of Routine Reviews (11/02/2004)
Memo to Directors of VA Facilities conducting research announcing ORO’s Routine Review program to prospectively and systematically review regulatory compliance at facilities conducting research.
ORD Communications
Research Administrative Review Report (12/15/08)
This report focuses on the findings and recommendations that emerged from the Office of Research and Development's (ORD) recent Research Administrative Review that was conducted to develop recommendations to respond to the challenge of effective management and to strengthen research activities occurring with VA field research centers.
Interim Guidance on Special Safeguards (10/10/2008)
Individuals with a variety of physical or mental conditions may deserve special safeguards, depending upon the particular circumstances of a proposed research study. IRBs should consider the attached guidance in reviewing research that may warrant special safeguards to protect human subjects.
Interim Guidance on Usual Care Research (10/10/2008)
IRBs should consider the attached guidance in evaluating the risks and benefits of "usual care" studies.
VA/VHA Communications
Research Compliance Officer and Compliance and Business Integrity Officer Positions (03/03/09)
This memo details the key functions of the Research Compliance Officer and the Business Integrity Officer positions
Waiver of Full-Time RCO Requirement (01/09/09)
This memo details the Under Secretary for Health's requirements for waiver of the full-time RCO requirement at facilities conducting human subjects research. Please read full memo for details of the request procedure.
RCO Waiver Clarification Memo and Designation of Full-Time "Acting" RCO (01/12/09)
The Deputy Under Secretary for Health for Operations
and Management (10N) and the Chief Officer, Office of Research Oversight (10R) hav issued a clarification memo concerning the RCO waiver and the designation of a
full-time "acting" RCO.
Clinical Trial Monitor Access Agreement Reached with OIT (12/12/2008)
VHA and the Office of Information Technology has reached an agreement on providing clinical trial monitors with access to pertinent medical records of study subjects. Details of this agreement are in the attached memo .
Clinical Trail Monitor Access Memoranda (USH request: 04/28/2008 & OIT response: 06/26/2008)
The Under Secretary for Health requested to use alternative methods of providing clinical trail monitors with access to pertinent medical records. The comments are suggestions for the manner of implementation of the approved alternative access methods. Note: Please read both these memos to obtain the full meaning of the documents. See updated memo above dated December 12, 2008.
Directors Certification of Oversight of VHA Research (02/21/2007)
Memo from the Under Secretary of Health requiring yearly certification of facility research program by the Director due July 1 each year. Note: the original checklist attached has been modified; be sure to obtain the correct copy prior to submitting.
Researcher Contacts with Veterans (07/10/2006)
To ensure the privacy and data security of research subjects, the Principal Deputy Under Secretary for Health (10A) issued the attached memorandum.
Search Educational Opportunities Glossary of Terms
Staff Directory Web Links Archives Products
|
