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 involve research and therefore require 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 safety and data monitoring plan. Serious adverse events and responses atr reviewed by the Data and Safety Monitoring Committee (DSMC). Read more here.

3. Clinical Scientific Review Committee (CSRC)

The OSUCCC committee plays a vital role in protocol review and monitoring to ensure that all studies 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)

An IRB must approve all activities that meet the definition of both research and human subjects before being performed, unless the research has been determined to be exempt.

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

5. OSU Office of Responsible Research Practices (ORRP)

The office supports faculty, staff, and student researchers in navigating research requirements through education and quality improvement initiatives that facilitate research, improve efficiency, and ensure regulatory compliance.

Contact information for assistance is located here.