Step 4. Is Your Research Considered to be “ 91探花Research”?

Why this matters

  • If your research is considered 91探花research, you must obtain approval from the 91探花Institutional Review Board (IRB) or from another IRB which HSD has agreed to allow you to use instead of the 91探花IRB.
  • If your research is not 91探花research, you do not qualify for the use of the 91探花IRB.

Concept of engagement

Your research is considered to be 91探花research if it meets the criteria for 鈥渆ngagement鈥�. 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 ( 91探花research)

Your research is considered to be 91探花research if it meets either of these criteria:

  1. The 91探花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 91探花IRB will conduct a “dual review” with the local IRB or Ethics Review Committee (ERC). Review the聽International Research Guidance for more information.
    • 鈥淒irectly鈥� does not include a subcontract, pass-through, or flow-through funds from an organization that is the prime recipient of the federal research support.
  2. 91探花students or paid employees are involved in the research by doing any of the following:
    • 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 91探花agents are only involved by providing identifiable 91探花records or specimens to researchers at another organization or are obtaining coded information or specimens from another institution.

Special cases for identifying 91探花research

91探花faculty who are not 91探花paid employees. Research conducted by these individuals is not considered to be 91探花research unless funding for the research is coming to the UW.聽For example, many physicians at healthcare organizations that are not part of 91探花Medicine have 91探花Clinical Faculty appointments. Those appointments do not entitle them to use the 91探花IRB unless there is research funding coming to the UW.

Fulbright scholars. It is not considered to be 91探花research when 91探花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 91探花research when they perform research in order to fulfill a 91探花degree or 91探花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 91探花IRB.

WWAMI faculty. Research conducted by WWAMI faculty who are not UW-paid employees is not considered to be 91探花research.

91探花alumni. Research conducted by former 91探花students is not considered to be 91探花research.

Request a determination (optional)

Use the Engagement Worksheet to document your self-determination that the 91探花is not engaged in human subjects research activities. Or, if you need a formal determination about whether the 91探花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 91探花IRB review.

  1. Complete the questions marked “determination” on the standard IRB Protocol form or on the No Contact version of the form.
  2. 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.
  3. HSD will assess your application and issue a formal determination

Next step, if you believe your research is 91探花research

91探花research that is industry sponsored, cancer-related, or engages other institutions may need to be reviewed by a non- 91探花IRB. Visit this webpage to determine whether you should apply for IRB review using a non- 91探花IRB.
For studies that will be reviewed by the 91探花IRB, proceed to Step 5 to determine whether your research can be reviewed by the expedited process.

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