Office of Research Compliance and Regulatory Affairs
Research Compliance

Research Compliance Program

The mission of the Research Compliance Program (RCP) at Cincinnati Children’s Hospital Medical Center is:

To protect all of our research participants
To educate our investigators in the conduct of research that is safe, effective and in compliance with federal, state and institutional requirements
To maintain a comprehensive and integrated compliance program that is facilitative and educational for the research community and provides Cincinnati Children’s assurance that research is being conducted ethically and in compliance with the above requirements

The RCP achieves this mission primarily through supporting the other program areas within ORCRA by providing the necessary and independent internal compliance auditing and investigation functions. The RCP also collaborates closely with ORCRA’s Research Education Program to identify and facilitate many of the institution’s research-related education and training needs.

The Research Compliance Program consists of auditing and QA oversight for the following functional areas:

Good Clinical Practice

Audits are performed on studies of research involving human participants. Audits serve two primary functions: (1) to provide support to investigators in the process of research and (2) to identify difficulties with the conduct of research at the earliest possible moment to proactively institute individual and system level changes to ensure that all human subjects research is conducted to the highest ethical standards and in compliance with all applicable federal, state and institutional requirements.

How are studies chosen for audit?

Randomly − based on a list of approved studies within the IRB
Directed − requested by the IRB or CCTST for oversight
Investigation − resulting from an allegation or concern of noncompliance
Educational / process improvement − investigators request ORCRA to perform an audit of their study

Regulations / Standards

21 CFR 50 Protection of Human Subjects
21 CFR 54 Financial Disclosure by Clinical Investigators
21 CFR 56 Institutional Review Boards
21 CFR 312 Investigational New Drug Application
21 CFR 812 Devices
45 CFR 46 Protection of Human Subjects (HHS)
AAHRPP
ICH E6: Good Clinical Practices

Good Manufacturing Practice / Good Tissue Practice

Quality assurance oversight is provided for the areas of Cincinnati Children’s that are obligated to comply with these regulations including the Cancer and Blood Diseases Institute’s Translational Core laboratories: Cellular Manipulations Laboratory (CML), Vector Production Facility (VPF) and Translational Trials Development and Support Laboratory (TTDSL).

Regulations / Standards

21 CFR 210 and 211 Good Manufacturing Practice
21 CFR 1270 and 1271 Good Tissue Practice

Good Laboratory Practice

Quality oversight is provided for the areas of Cincinnati Children’s that are subject to these additional standards, including the following three laboratories: Laboratory for Specialized Clinical Studies (Division of Infectious Diseases), Central Laboratory (Division of Pathology and Laboratory Medicine) and Laboratory for Applied Pharmacokinetics and Therapeutic Drug Management (LAPTDM).

Regulations / Standards

21 CFR 58 Good Laboratory Practice for Non-clinical Laboratory Studies

For additional information regarding the Cincinnati Children’s Research Compliance Program, including consultation regarding compliance planning or determining how to handle / manage compliance concerns, contact the ORCRA and ask to speak with the research compliance program director.

Educational Resources

ORCRA delivers, hosts or otherwise supports numerous educational opportunities related to the conduct of research, including online and classroom training for both an internal Cincinnati Children’s audience as well as more broad local or regional audiences. Learn more about educational resources.

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Research Compliance Program

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Office of Research Compliance and Regulatory Affairs
Research Compliance