Step 4. Is Your Research Considered to be “UW Research”?
Why this matters
- If your research is considered UW research, you must obtain approval from the UW Institutional Review Board (IRB) or from another IRB which HSD has agreed to allow you to use instead of the UW IRB.
- If your research is not UW research, you do not qualify for the use of the UW IRB.
Concept of engagement
Your research is considered to be UW research if it meets the criteria for “engagement”. Engagement is a federal regulatory concept that means an institution is (or is not) conducting human subjects research activities. It has nothing to do with the physical location of the research procedures.
Definition of engagement (UW research)
Your research is considered to be UW research if it meets either of these criteria:
- The UW is receiving funding for the research (including any funding for salary support) through a grant, contract or cooperative agreement directly from a federal agency.
- It does not matter whether some or all of the human subjects activities will be carried out by another organization.
- When some or all of the activities occur at an international site, the UW IRB will conduct a “dual review” with the local IRB or Ethics Review Committee (ERC). Review the International Research Guidance for more information.
- “Directly” does not include a subcontract, pass-through, or flow-through funds from an organization that is the prime recipient of the federal research support.
- Performing research procedures with subjects
- Manipulating the environment of subjects for research purposes
- Interacting with subjects for any research purpose
- Obtaining informed consent from the subjects
- Obtaining for research purposes any identifiable private information or biological specimens even if there is no direct interaction with the subjects.
Consult the Engagement Worksheet to review activities that do not engage an institution, such as when UW agents are only involved by providing identifiable UW records or specimens to researchers at another organization or are obtaining coded information or specimens from another institution.
Special cases for identifying UW research
UW faculty who are not UW paid employees. Research conducted by these individuals is not considered to be UW research unless funding for the research is coming to the UW. For example, many physicians at healthcare organizations that are not part of UW Medicine have UW Clinical Faculty appointments. Those appointments do not entitle them to use the UW IRB unless there is research funding coming to the UW.
Fulbright scholars. It is not considered to be UW research when UW alumni or individuals from other institutions obtain a Fulbright scholarship, even if they obtained the Fulbright through the UW.
WWAMI students and residents. WWAMI students and residents are conducting UW research when they perform research in order to fulfill a UW degree or UW program related requirement, even if they are taking courses at another institution. The research may be reviewed by either the other institution’s IRB (after the student communicates with HSD and HSD establishes a reliance agreement with the IRB) or by the UW IRB.
WWAMI faculty. Research conducted by WWAMI faculty who are not UW-paid employees is not considered to be UW research.
UW alumni. Research conducted by former UW students is not considered to be UW research.
Request a determination (optional)
Use the Engagement Worksheet to document your self-determination that the UW is not engaged in human subjects research activities. Or, if you need a formal determination about whether the UW engaged in your research, follow the steps below. An example situation for which an HSD determination might be appropriate: a collaborating institution has asked for a determination about whether you need UW IRB review.
- Complete the questions marked “determination” on the standard IRB Protocol form or on the No Contact version of the form.
- In Zipline, create a new application by clicking on the Create a New Study button and following the instructions. Attach your completed IRB Protocol form at the indicated place.
- HSD will assess your application and issue a formal determination
Next step, if you believe your research is UW research
UW research that is industry sponsored, cancer-related, or engages other institutions may need to be reviewed by a non-UW IRB. Visit this webpage to determine whether you should apply for IRB review using a non-UW IRB.
For studies that will be reviewed by the UW IRB, proceed to Step 5 to determine whether your research can be reviewed by the expedited process.