Office of Research Compliance

The Office of Research Compliance (ORC) is a subdivision of the Va Maryland Health Care System (VAMHCS) Research Service. Its mission is the protection of human research subjects and the promotion of standards of excellence within the clinical trials staff of the VAMHCS. The ORC is charged with the development, implementation and evaluation of policies and procedures for human studies research. Together, these policies and procedures comprise the Human Research Protection Plan (HRPP) (HRP 01.02).

The policies that the ORC develops are influenced by policies, regulations, guidances and correspondence from Office of Research Oversight (ORO), Office of Research and Development (ORD), Office of Human Research Protections (OHRP), the Food & Drug Administration (FDA), Association for the Accreditation of Human Research Protections Programs (AAHRPP), and other applicable external agencies as well as complaints and allegations of noncompliance from subjects and staff and audit findings. The ORC is also influenced by the policies and procedures of the University of Maryland, Baltimore (UMB) Institutional Review Board (IRB), which is the IRB of record for the VAMHCS.

Once policies are approved, education of VAMHCS investigators, coordinators and staff begins. This is achieved through meetings, presentations, emails, web-based training, manuals, and other methods coordinated through the ORC. Investigators are responsible for ensuring that they and their staff are aware of VAMHCS policies and procedures, and that the policies and procedures are then implemented in their research units or individual protocols.

The ORC also serves as a resource for investigators and their staff. It assists them in the development of their own internal policies and procedures, in self-assessments of their own programs, in the institution of Data Safety Monitoring Plans (DSMPs), and provides guidance and consultation.

The ORC performs routine compliance audits and for-cause audits according to the Research Service SOP, "Overview of Quality Assurance Activities" (HRP 02.01).

The Office of Research Compliance consists of the following staff:

The Office of Research Compliance can be reached at 410-605-7000 ext 6512. The ORC is happy to respond to requests for advice or assistance on issues involving human studies research. It is also the office to receive complaints from subjects or staff regarding problems, or reports of possible noncompliance with institutional policies on human subjects protections.

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