Research Compliance Office

In 2008, the VA Office of Research and Development (ORD) issued a national mandate that all VA research oversight be conducted by Research Compliance Officers (RCO).  The Research Compliance Office works independent of but cooperatively with the Research Service.  The RCO reports directly to the Medical Center Director.

The Research Compliance Office oversees the conduct of human, animal and laboratory studies.  Its mission is to protect human research participants, animals used in research, laboratory staff and to promote standards of excellence within the Louis Stokes Cleveland VAMC (LSCVAMC) research community.

VA Office of Research Oversight (ORO) has mandated that the key component of compliance must be auditing of the research program.

  • All studies initiated after 1/1/08 (human, animal, and laboratory) must be audited on a rotating basis every three years (regulatory requirements and study conduct).
  • 100% of research informed consent forms (human studies) must be audited (annual audits with a 12-month look-back period).
  • 33% of closed studies within the reporting period must be audited.
  • For-cause audits must be conducted as necessary (investigations of noncompliance, complaints, and allegations) or as requested by IRB, IACUC, SRS, VA Office of Research Oversight (ORO), or other oversight agencies.

If you conduct research in the VA or VA leased space, with VA funding, or using VA participants you are required to conduct those studies in accordance with VHA Handbooks and policies, LSCVAMC policies & procedures and your approved protocols and grants.

Compliance Guidance:

LSCVAMC Research Regulatory Binder Essential Documents

LSCVAMC Annual ICD Template

LSCVAMC Safety Audit Template

LSCVAMC Triennial Regulatory

LSCVAMC Animal Welfare Audit Tool

LSCVAMC Pharmacy Audit Tool

Decision chart for reporting noncompliance in VA Human Research

Decision chart for reporting SAEs and problem involving risks in VA Human Research

Federal Wide Assurance Number (FWA)

Laboratory Accreditations

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Commonly Used Documents:

aote to File (NTF)

Signature and Delegate Authority Log