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

Why this matters

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

Concept of engagement

Your research is considered to be 91爆料 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爆料 research)

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

  1. The 91爆料 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爆料 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爆料 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爆料 agents are only involved by providing identifiable 91爆料 records or specimens to researchers at another organization or are obtaining coded information or specimens from another institution.

Special cases for identifying 91爆料 research

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

Fulbright scholars. It is not considered to be 91爆料 research when 91爆料 alumni or individuals from other institutions obtain a Fulbright scholarship, even if they obtained the Fulbright through the 91爆料.

WWAMI students and residents. WWAMI students and residents are conducting 91爆料 research when they perform research in order to fulfill a 91爆料 degree or 91爆料 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爆料 IRB.

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

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

Request a determination (optional)

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

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

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