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This page is designed to help you to think through if you need to submit planned activities to the ORIC or the IRB because they are Human Subjects Research (HSR). This page presents simplified versions of questions and concepts addressed in more depth in the Not-HSR Self-Determination Form and HSR Determination Request Form. These forms are located on IRBNet, and can be found with all the other IRB/HSR forms by logging in to IRBNet, selecting “Forms and Templates” from the bottom of the left hand menu, and selecting the library titled “University of Alaska Anchorage IRB, Anchorage, AK – Documents for Researchers” from the drop-down menu.
Is Your Project Research?
OHRP defines “Research” this way:
- A systematic investigation … designed to develop or contribute to generalizable knowledge….
This can be difficult to discern for certain kinds of activities. Three helpful questions to ask:
- “Am I answering a question using scientific techniques?”
- “Am I going to publish or present on this work?”
- “Will the outcome be generalized for other places, programs, or organizations?”
If you need help answering this question, please consult with the HSR Determination
Does your Research Involve Human Subjects?
OHRP defines “Human Subject” this way:
- A living individual about whom an investigator conducting research obtains
- Data through intervention or interaction with the individual, or
- Identifiable private information.
NOTE: “obtains” can here include taking data you already possess as part of your normal duties, such as a professor having names and grades for their students, and using it for research purposes.
You can make a Not-HSR Self-Determination, or request for the IRB to make an HSR Determination, for your planned activities by filling out and submitting the appropriate form on IRBNet.
Some student research activities may qualify as Classroom Projects. For more information about Classroom Projects, see the UAA Course Instructor Certification Form on IRBNet.
Research Compliance oversight of HSR activities is all done on UAA’s electronic record-keeping system: IRBNet.
If you have concluded your activities with people or data about people are not research, you must document this by submitting a Not-HSR Self-Determination form on IRBNet.
- Document your Not-HSR Self-Determinations
If you are unable to make the determination or would like assistance making it, you must submit an HSR Determination Request form on IRBNet.
- Request an HSR Determination
If your activities are Human Subjects Research, please ensure it is UAA engaged research by contacting the ORIC or reviewing the Engagement SOP available on on IRBNet. Then, if your activities are UAA engaged Human Subjects Research, you must do one of the following:
- Submit a proposal for Exemption from IRB Review on IRBNet.
- Submit a Proposal for IRB Review (Either Limited, Expedited, or Full IRB review) on IRBNet.