VA Ann Arbor Healthcare System Research Services
The Reseach Compliance Office (RCO) serves as a consultant to the Research Service, Research Oversight Committees (RCD, IRB, IACUC, SRS) and Investigators. The RCO also completes audits of research. Audit results are issued to the ACOS/Research, R&D Committee, relevant R&D Subcommittees and Project and Protocol PIs. The RCO does not make Determination(s) of Research Non-Compliance or possible Required Corrective Actions. Non-Compliance and Corrective Actions are Determined by VAAAHS Research Oversight Committee (RDC) and RDC Subcommittees (IRB, SRS, IACUC).
The VA Research Process may differ in many respects from processed practiced at another institution. Whenever in doubt, please contact the VA Research Office or the Research Compliance Office for clarification and/or guidance.
|VAAAHS Research Compliance Officer (RCO)
Scott Sample, MS, T.M.
|VAAAHS Research Compliance Auditor (RCA)
The Research Compliance Office performs 4 types of audits:
- Informed consent - annually
- Regulatory binders - triennially
- Lab safety
- Animal welfare
The VA Office of Research Oversight (ORO) has mandated that all VA Human Research Studies initiated after January 1, 2008, undergo comprehensive regulatory review by the facility Research Compliance Office. The focus of these audits will be a review of your Study-Specific Regulatory Binder. Your binder should be assembled and maintained in a manner that produces a single-source repository of all required documentation. We understand that assembling, organizing and maintaining your required binder will require considerable time and effort. To help you prepare for these comprehensive audits, we are providing the attached set of documents to assist you in meeting this VA Office of Research Oversight requirement. You will be notified in advance of your audit date with as much lead time as possible but it is recommended that you begin the preparation of your binder as soon as possible.
Investigators: Please ensure that the attached documents are forwarded to your study team personnel responsible for assembling and maintaining your binder. The first page of the attachment provides more detail on assembling your binder.
Human Studies Research Regulatory Binder [12/23/14]
(New Instructions+Section Headings - Clarification on eBinders, Master List of Subjects (No Longer Required), and Obtaining Informed Consent PRIOR to First Research activity!)
Informed Consent CheckList [11/26/19]
(Recommended by RCO for each consented subject)
(Now includes check-box for HIPAA Authorization Form]