For website questions or issues, contact rebecca.polito@va.gov.

©2019 by Research - VA Northeast Ohio Healthcare System. Proudly created with Wix.com

RESEARCH COMPLIANCE

 

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, and laboratory staff, and to promote standards of excellence within the VA Northeast Ohio Healthcare System research community.

 

The 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 annually (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 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, VA Northeast Ohio Healthcare System policies & procedures, and your approved protocols and grants.

 

Compliance Guidance:

Research Regulatory Binder Essential Documents

Audit Tools:

     Animal Welfare Audit Tool

     Human Research Protection Program (HRPP) Audit Tool

     ICD Audit Template (Annual)

     Pharmacy Audit Tool

     Safety 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

ORO Guidance for RCO Research Audit and Training Requirements

Commonly Used Documents:

Note to File (NTF)

Signature and Delegate Authority Log

For additional information, contact:

Research Compliance Officer Arlette Coulter*

* This link uses regular email and is not secure. Do not send personal or medical information unprotected over the Internet.