1. Research vs Quality Assurance/Improvement

Generally, activities designed solely for internal purposes, with no external application or generalization, typically do not constitute human subject research and therefore do not require IRB review or exemption. Some Quality Assurance (QA) and Quality Improvement (QI) activities may also be research and thus need IRB approval.

• Helpful QA/QI Definitions
• Human Subject Regulations Decision Charts can help determine whether research activities involve human subjects and require IRB review. 

2. Data and Safety Monitoring Plan

Every therapeutic interventional trial ("clinical trial") conducted at the OSUCCC-James must include a plan for safety and data monitoring. Serious adverse events and responses will also be reviewed by the Data and Safety Monitoring Committee (DSMC). Read more here.

3. Clinical Scientific Review Committee (CSRC)

The committee plays a vital role in protocol review and monitoring to ensure that all trials are scientifically sound, maintain patient accrual goals, and show scientific progress.

Learn about the CSRC here and submit protocol proposals for review here.

4. OSU Cancer Institutional Review Board (IRB)

All activities that meet the definition of both research and human subjects must be approved by an IRB before being performed, unless the research has been determined to be exempt.

• Here is a list of Exempt Research Categories
• Protocol proposals are submitted in the Huron IRB system
• Resources for using Huron IRB (including step-by-step guides)
• Read more about the IRB review process

5. Office of Responsible Research Practices (ORRP)

The office supports faculty, staff, and student researchers with navigating research requirements through education and quality improvement initiatives designed to facilitate research, improve efficiencies, and ensure regulatory compliance.

Contact information for assistance is located here.