Office of Research Oversight (ORO)

ORO serves as the primaryVHA office in advising the Under Secretary for Health
and exercising oversight concerning all matters of research compliance and assurance, including human
subject protections, laboratory animal welfare, research safety, research laboratory security, research
information security, research misconduct, debarment for research impropriety, and other matters that the 
Under Secretary for Health may assign.  ORO is also responsible for developing and conducting research compliance officer education programs as directed by the Under Secretary for Health.  
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WHAT'S NEW

ORO Comments During VHA Director's Call (05/01/09)
In response to the many questions concerning the new requirments for RCOs and mandatory compliance audits, Dr. Tom Puglisi, ORO Chief Officer, read this attached statement, "Compliance Officer and Research Audit Requirements".

Technical Correction to VHA Handbook 1200.01 (05/01/09)
The Chief Research and Development Officer,
Dr. Joel Kupersmith, issued a memorandum concerning a technical reference to Handbook 1200.01, Paragraph 4.d.  Please read the attached memorandum for more information.

Technical Correction to VHA Handbook 1200.05   (04/24/09)
A technical correct to Handbook 1200.05   “Protection of Human Subjects in Research” has been made.   The change is in Paragraph 7j and this paragraph now reads:
j.  Record Retention.  The required records, including the investigator’s research records, must be retained until disposition instructions are approved by the National Archives and Records Administration and are published in VHA's Records Control Schedule (RCS 10-1). 
      (1)  All records must be accessible for inspection and copying by authorized representatives of VA, OHRP, FDA and other authorized entities at reasonable times and in a reasonable manner.
      (2)  Records are the property and the responsibility of the local research office.  The medical center must designate where the records will be maintained and/or stored.
      (3)  Complete (non-redacted) minutes, whether from the VA or affiliate IRB reviewing VA research, must be submitted to the R&D Committee and maintained in the facility research office.  The R&D Committee must review and act upon all IRB minutes regardless whether the IRB is established at the medical center or at the affiliate university.
Until a schedule for local research records is published, ALL records including identifiers must be retained. Consent forms and HIPAA authorization forms should not include a timeframe for destruction. If there is language in the consent or authorization about destruction, it must only say “in accordance with the record control schedule.”  ORO is working with the Privacy Office and ORD to get this situation resolved as soon as possible.

VHA Handbook 1200.01 Issued (04/24/09)
This handbook, "Research and Development Committee" is a major revision to the current VHA procedures governing Research and Development (R&D) Committees' responsibilities and operations.  The major change is that the R&D Committee may focus on oversight of the local research program rather than individual protocols.  Changes enable the R&D Committee to prioritize their deliberations around broad areas of program development, risk management, and quality and performance activities.

New Handbook Released (04/20/09)
VHA Handbook 1605.03, Privacy Compliance Assurance Program and Privacy Compliance Monitoring, has been released.  Be sure to review Appendix A which specifically addresses research.
 
RCO Reporting of Noncompliance in VA Human Research (03/25/09)
Be sure to check out this decision chart  that has been prepared to help Research Compliance Officers (RCO) determine when/if a VA research project or VA researcher fails to comply with the laws, regulations, or policies governing VA research or with IRB requirements or determinations. Also the  RCO Reporting of Serious Adverse Events and Problems Involving Risk to Subjects or Others in VA Research Decision Chart is now available (04/13/09). 

VHA Handbook 1200.12 Has Been Issued  (03/09/09)
VHA Handbook 1200.12, Use of Data and Data Repositories in VHA Research has finally been published.  The Office of Research and Development hopes to be developing guidance on implementation of the handbook in the near future.  It will have an impact on both new as well as pre-existing research data respositories.

VHA Handbook 1058.01 Has Been Signed! (03/03/09)
VHA Handbook 1058.01 contains many revisions for reporting research events within VHA facilities and to ORO.  We encourage everyone to read it carefully and contact ORO if there are any questions.  You may also want to review ORO's Chief Officer, Tom Puglisi's PowerPoint Presentation  on these revisions.

VHA Directive 2008-079 Research Participant Outreach Progam    (02/13/09)
This Directive is now available and requires the Director of each VA research facility establish and implement a Research Participant Outreach Program.   Paragraph 4a of the Directive requires that the Outreach Program include "(2) Making available the informational brochure, Volunteering in research - Here are some things you need to know, to potential research participants in settings where participants may be recruited (e.g., clinical waiting areas), and to each prospective participant when that individual is approached to take part in a project".  Note: Specific IRB review of the brochure as part if the application package is not necessary:  The brochure contains General information about research participation and must be presented to each individual asked to participate in a research program; the brochure contains no specific data about an individual research project.

ANNOUNCEMENTS  

Health Science Specialist (GS0601-14)  - This position in located in ORO's Midwestern Regional Office, Hines, IL and is open to all United States Citizens.  Closing date is May 11, 2009.

DON'T FORGET

Reporting Serious or Continuing Noncompliance to ORO
Serious or continuing noncompliance identified during a Research Compliance Officer’s audit (or otherwise) must be reported as described in VHA Handbook 1058.01(Requirements for Reporting Research Events to Facility Oversight Committees and the Office of Research Oversight) to be issued soon.  The Handbook specifies the nature of serious and continuing research noncompliance that must be reported to ORO as well as time intervals for such reporting.

Privacy and Information Security Training Due Dates    (12/16/2008)
The Office of Information and Technology has issued a memo establishing deadlines for Mandatory Privacy and Information Security training for FY 2009 as June 30, 2009.  For details of the required training courses, please refer to the attached memo, Official FY09 Privacy and Information Security Awareness Training Announcement.

Storing Research Information
ORO Compliance Oversight Procedures for Use and Storage of VA Sensitive Research Information (05/29/2008) - ORO has adopted these procedures for oversight of compliance with VA policies.  Note:  This memorandum reflects ONLY ORO's procedures and does not address policies issued by other VA or VHA offices.

Reporting Requirements
Reporting Unanticpated Problems and Adverse Events to Institutional Review Boards  (12/6/2006)
What to Report to ORO Memo (09/8/2005)  

Remember —
VHA Policy Is More Restrictive than the National Institutes of Health's (NIH) guidance regarding recruitment of study subjects under the HIPAA Privacy Rule.   Click here to view the revised clarification. (09/05/2007)

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Office of Research Oversight (10R)
Mailing Address:  810 Vermont Avene, NW, Washington, DC  20420
Physical Location:  1717 H Street NW, Fifth Floor, Washington, DC  20006
Phone: (202)266 4577

ORO Regional Office Locations

ORO Staff Directory

Click here for Regional Office locations and contact information.

Development of this site was sponsored in part by a grant from the "Bataan-Corregidor Memorial Fund."

American Defenders of Bataan and Corregidor

Bringing together WWII Veterans who were POWs of the Japanese and assisting the families of those men killed in action or who died in captivity.