Office of Research Oversight (ORO)

ORO serves as the primaryVHA office in advising the Under Secretary for Health
on all matters of compliance and assurance regarding human subject protections,
animal welfare, research safety and security, research data security, and research misconduct.  
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WHAT'S NEW

Waiver of Full-Time RCO Requirement - Memo Signed  (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. 

Research Compliance Officer (RCO)
Education Webpage
This new ORO Webpage is now available!  Click on the link in the dark blue navigation bar on the left to go to this page.  There you will find information and documents relating to RCO functions and responsibilities.  Be sure to click on the additional links in the light blue navigation bar at the top of the page — only the link to "RCO Guidance & Toolkit" is functional for now.  Remember . . . this is a work in progress - more information will be added soon.  If you have comments or suggestions concerning this page, please contact Lynda Poore at Lynda.Poore@va.gov.

Regulatory Audits of Human Subjects Protocols   (12/16/2008)
VHA Directive 2008-064 requires annual audits of informed consent and triennial regulatory audits of all human subjects protocols.  To meet these requirements, ORO recommends that RCOs complete regulatory audits of approximately 33% of active protocols each year.  Any protocol that is completed in less than 3 years must be audited at closeout if it was not audited previously.  ORO has developed a worksheet for conducting the required Triennial Regulatory Audits of Human Subjects Protocols .   Although use of this worksheet is optional, regulatory audits of human research must include all the information in the worksheet. Audit Worksheet Directions are attached.  These worksheets should be retained in the facility for 5 years after completion of the study, or longer if required by VA-approved records retention schedules. Tools to assist in the audit are being developed and will be distributed soon.  NOTE:  The Annual Certification of Facility Audits of VHA Research , First Reporting Period, has been recently updated (12/16/2008/pm) and covers annual reporting of informed consent audits and regulatory audits for protocols of all types.  This certification must be submitted to ORO as required by the FY 2009 Executive Career Field (ECF) Performance Plan.      
Initial Annual Report:  This report is due July 1, 2009, and will cover all regulatory audits accomplished for a portion of studies active (open to enrollment or closed in enrollment but still with data collection or data analysis) during January 1, 2009, through May 31, 2009.        
Subsequent Annual Reports:  In subsequent years, annual reports will cover all regulatory audits for a portion (approximately 33%) of studies active from June 1 of the previous year to May 31 of the current year.        
RCOs are encouraged to plan thoughtfully in determining which protocols to audit during the reporting period.  For example, RCOs might plan that protocols are to be audited sooner if:  (i) they will expire and have not been previously audited; (ii) they involve greater than minimal risk; (iii) their investigators have a previous history of serious noncompliance; etc. 

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.      

RECENTLY ISSUED

Waiver of Full-Time RCO Requirement - Memo Signed    (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. 

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.

Clinical Trial Monitor Access Agreement Reached  (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, "VHA/OIT Clinical Trial Monitor Access Agreement ".

CLARIFICATION: Questions have been raised regarding the December 12, 2008, Memorandum from the Assistant Secretary for Information & Technology (005) regarding "Follow-up Response to Clinical Trial Monitor Access."  This Memorandum reiterates the requirement that if clinical trial monitors are given full access to VA data systems, background investigations and training are first required.  However, there are three alternatives for limited access to VA subjects' medical records that do not require a background investigation:  Option A ("Limited Read-Only Access to Selected Data"), Option B ("VA Employee Driver"), and Option C ("Stand-alone Download").  Of these three limited access options, Option A still involves access to the VA network.  Therefore, if Option A is employed, clinical trial monitors must take VA Information Security Awareness Training and sign the National Rules of Behavior.  [This is what the December 12 Memorandum means by "an exception to option a"].  Options B and C do not require that trial monitors take VA Information Security Awareness Training and sign the National Rules of Behavior. (12/17/08)

Interim Guidance Policies
Interim Guidance on Special Safeguards (10/10/2008)
Interim Guidance on Usual Care Research (10/10/2008)

Society of Research Administrators (SRA)Conference
SRA Presentations  (October 2008)

Research Compliance Officer (RCO) Information
Sample Facility Level RCO Position Description/Functional Statement (10/14/08)
Sample VISN Level RCO Position Description/Functional Statement  (12/5/2008)
VHA Directive 2008-064 - RCOs and Auditing Human Subjects Research (10/16/2008)
Informed Consent Reporting Requirements (11/3/2008)
Informed Consent Sample Audit Template (01/9/2009)
Informed Consent Audit Annual Certification (11/3/2008)
 

ANNOUNCEMENTS

ORO Vacancy Announcements
Pharmacist (Good Clinical Practice Research Compliance Specialist) - 2 positions, open to all grous of qualified individuals.  These positions are located in the ORO Central Office in Washington, DC.
ORO Health Science Specialist - 2 positions, open to VA employees and current and former competitive service Federal employees.  These positions are located in the ORO Southern Regional Office, Decatur, GA.
Program Specialist - open to VA employees and current and former competitive service Federal employees.  This position is ocated in the ORO Southern Regional Office, Decatur, GA.

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.
 

DON'T FORGET

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 Resea rch 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 Staff Directory

Click here for Regional Office locations and contact information.

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