The Research Determination Office (RDO) is ancillary to the Institutional Review Board (IRB) and is used to make determinations on projects that may not meet the definition of research involving human subjects for Kaiser Permanente Northern California. We rely on research determination officials to determine whether or not an activity constitutes research involving human subjects.
The RDO review process results in one of three outcomes:
- Not Research (e.g. common for quality improvement and evidence-based practice projects)
- Not Human Subjects Research (e.g. research that does not involve human subjects-identifiable data or biospecimens)
- Research (e.g. research that does need IRB review and must formally go through the IRB for a determination. While some human research activities are exempt from further oversight from the IRB under the Common Rule, the IRB must still formally review these activities and make an exempt determination prior to engaging in any Human Research – the RDO may not make these determinations.)
To initiate the process of obtaining a research determination outcome, complete this form and email it to KPNC-RDO@kp.org.
In general, oversight by the IRB is not required for projects:
- That do not meet the definition of research, or
- Are research but do not meet the definition of research involving human subjects, or
- In which it is determined that the investigator and the institution are not engaged in research, or
- That are clinical repositories, or
- That are determined to be quality improvement assessment activities.
This guidance and accompanying definitions are intended to provide additional information for determining if an activity is human subjects research. If so, the research requires IRB review and approval.
Note: Certain activities that do not require IRB review and approval may still be subject to HIPAA requirements. Contact kpnc.irb@kp.org for assistance with HIPAA-related concerns.
