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VA Puget Sound Health Care System


Research Compliance Office

What is the Research Compliance Office (RCO)?
Operating under the Office of Research Oversight (ORO), the role of the RCO is to help preserve public trust in the integrity and quality of research carried out by VA investigators. The RCO performs routine audits to evaluate the VA’s research program. It works hand in hand with the oversight committees to assure that adequate protections for research participants are in place while supporting the investigators as they work to advance science. The RCO evaluates compliance with all applicable laws, regulations, and policies related to the conduct of research.

What audits does the RCO perform? 
The RCO conducts two kinds of audits: 
1. Consent audits: the RCO reviews all signed consents on a weekly basis and alerts the PI if there are any errors.

2. Triennial audits: The RCO conducts comprehensive review of studies approaching three years of being active, as well as research that closes without a previous audit. Audits may be conducted prior to the 3-year mark for new investigators and/or higher risk studies. No audits are conducted for studies overseen by R&D only.   
Findings from consent audits and triennial audits are reported to the oversight committee.
No findings are good findings! The majority of audits have no findings and this signifies a job well done to the research team.

How to ensure no findings: 
The RCO offers several suggestions to avoid audit findings/errors:
• Make quality checks a priority during all aspects of your study
o Double check consents before giving a copy to the subject
o Monitor regulatory binders
• Know what the reviewing committee expects and timeframes for submissions
• Assign these above responsibilities to study staff

More Resources: Useful tips, reminders and announcments for researchers 
   RCO TipSheet    July  2016  
   RCO TipSheet    Sept 2015
   RCO TipSheet    May  2015

Contact information
For general or specific questions, concerns, best practices, etc., contact the RCO at The Research Compliance Officers for VA Puget Sound can also be reached directly:
• Joanne Lindwall -  206-277-4616
• John Kelly -  206-716-5645




Research and Development