HRP-101 – HUMAN RESEARCH PROTECTION PROGRAM PLAN defines the activities that this institution considers to be “Human Research.” A decision tree for determining whether an activity is Human Research can be found in HRP-310 – WORKSHEET – Human Research Determination. Use this worksheet for guidance as to whether an activity meets either the DHHS or FDA definition of Human Research, keeping in mind that the IRB makes the ultimate determination in questionable cases as to whether an activity constitutes Human Research subject to IRB oversight.

You are responsible not to conduct Human Research without prior IRB review and approval (or an institutional review and determination of exempt Human Research). If you have questions about whether an activity is Human Research, contact the IRB Office who will assist you in determining whether an activity is Human Research. Additionally, you can use the Quality Improvement/Program Evaluation Tool to self-certify whether your project constitutes Human Research. See Quality Improvement Projects for more information.