Policies & Procedures
- Research Standard Operating Procedures
Standard operating procedures (SOPs) are standardized processes developed for clinical research functions conducted at University Hospitals. Each SOP is reviewed regularly for possible revisions due to updates or changes in regulations, local policies or procedures, and to maintain compliance with applicable regulations, policies and/or laws.
- IRB Policies
University Hospitals Cleveland Medical Center’s Institutional Review Board (IRB) reviews its policies for adherence to current FDA and Institutional regulations every three years to ensure compliance. This policy review process is conducted to ensure appropriate maintenance of our AAHRPP accreditation as part of UH Cleveland Medical Center’s commitment to the highest Human Research Protection standards. The FDA regulations pertinent to IRBs include 21 CFR 50, Part 56, Part 312, and Part 812.
- UH Research Policies (UH employees and credentialed non-employees only)
Research policies in the UH System Policy Manual apply to all workforce members throughout UH who are engaged in research in any capacity. Much of the training and education provided by the Clinical Research Center reference these policies to ensure that compliance standards set by University Hospitals are met.
- Research Grants, Contracts, and Accounting Policies
Here you will find a comprehensive list of policies in the UH System Policy Manual specifically related to research grants, contracts, and grants accounting.
- Research Regulations
OHRP makes available the full text of the HHS regulations for the protection of human subjects in research (45 CFR 46), the Common Rule (45 CFR 46 Subpart A), and FDA human subject protection regulations.