Protecting Human Subjects Research

Federal guidelines require IRB approval prior to the conduct of any Human Subjects Research project. The UH Institutional Review Board (IRB) Administration Office facilitates the review of Human Subjects Research that involves UH patients, data, property, or systems. The IRB Administration Office will pre-review submissions before forwarding them to the IRB or an IRB Chairperson for review.

Each UH department is assigned a specific IRB Specialist to help streamline communication and submission. In general, IRB Specialists can provide assistance navigating the electronic submission system, and may offer guidance on modifying a research proposal to comply with federal and local regulations. The IRB Specialists work as liaisons between the research community and the IRB reviewers to process submissions efficiently. They can meet with you and guide you to the policies, templates, and resources necessary for a complete submission. The IRB Administration Office provides regularly scheduled education sessions and will provide targeted education sessions upon request. The UH IRB has three committees and holds at least 6 meetings per month in order to facilitate the efficient review of research.

Requests for a determination that a project does not meet criteria for Human Subjects Research are also processed through this office. Additionally, the IRB Administration office helps facilitate the reliant review process where, at the request of sponsors or research teams, the UH IRB agrees to rely on another IRB for review of the study. In these cases, the UH IRB maintains responsibility for local requirements (verifying department approval, coverage analysis, study personnel, and other policies specific to UH) and a submission to the UH IRB is still required. The UH IRB is also able to serve as the IRB of record for other institutions for multi-site projects.

For assistance, please call the IRB Administration helpline at 216-844-1529 or email UHIRB@UHhospitals.org.

UH Research Compliance is staffed by Research Compliance Specialists and HRPP Specialists. This group supports a culture of research excellence and compliance with all applicable regulations and policies. Research Compliance Specialists can provide study start up guidance, and conduct routine and for-cause audits of research across the system. HRPP Specialists provide support for Research Compliance audits, and connect the IRB Administration Office and Research Compliance processes.

Research Conflicts of Interests (COIs) and Clinicaltrials.gov records are also monitored and managed through this core.

The Clinical Research Center at University Hospitals is committed to promoting standards of excellence in the conduct of clinical and translational research. Research Compliance is focused on a variety of areas, including identifying best practices for the conduct of research, ensuring compliance with requirements and ethical standards, providing education and training for the research community, and promoting and supporting research activities across the University Hospitals system.

For assistance with any of the above, please email UHResearchCompliance@UHhospitals.org.

Research Credentialing Office provides and manages the process of obtaining research credentials. The UH Research Credentialing Process allows non-UH personnel proper access to UH patients’ Protected Health Information (UH PHI) under Institutional Review Board (IRB)-approved research studies.