Human Subjects Research

In the College of Health and Human Development, the process to request approval to initiate in-person human subjects research will run in parallel with our current Return to Research process. These processes can be initiated at the same time, but the college will not forward support for approval for in-person human subjects research to the University until the researcher has received college approval for the Return to Research.

An important component of the request to conduct in-person human subjects research is a solid and compelling rationale for carrying out the research now, in the middle of a global pandemic, with increasing cases.  Stating that the research cannot be done remotely will not be accepted as a sufficient justification.

The process, workflow, and form for requesting approval for in-person human subjects research are available at Procedures: Request to Conduct In-person Human Subjects Research During COVID-19 Pandemic. Please continue to check the Revised Standards and the IRB website for additional information.

NOTE: The process for approval of initiating in-person human subjects research is separate from IRB approval, although IRB approval is first required for all human subjects research.

Process Overview for Initiating In-Person Human Subjects Research

1. Researcher submits FORM: Request to Conduct In-person Human Subjects Research During COVID-19 Pandemic via InfoReady.

   When completing the required information, researchers are encouraged to keep the following in mind:

   • A detailed rationale for conducting in-person human subjects research at this time is required
   • Information on all the activities of the participants and the research staff is required, including a time flow of activities, specifying any instances where social distancing cannot be maintained, and the duration of such activities
   • If known, information on the relative risk of COVID-19 for the particular population of participants should be included
   • If researchers will also be requesting use of a shared research facility (e.g., Clinical Research Center [CRC] or the Social, Life, and Engineering Sciences Center [SLEIC], they are encouraged to reach out to these entities for information on their availability and other requirements; key points about safety precautions, cleaning procedures, etc. should be described in the application (i.e., it is not sufficient to state that CRC procedures will be followed)
2. The deans and the campus chancellors will review the requests in InfoReady; they can approve or reject the research proceeding. InfoReady will send an email when a request is ready for review.
3. If approved by the dean or chancellor, requests will then be forwarded to the Office of the Senior Vice President for Research (OSVPR) for approval.
4. The College Dean's office will also need to complete or update the Return-to-Work/Return-to-Research Authorization with HR and Space Re-Occupancy Registration following the approval of the request to conduct in-person human subjects research.
5. Once confirmed by OSVPR in InfoReady and prior to initiating research, studies must have approval from the appropriate compliance committees (i.e., IRB, IBC, etc.).

Approval Process Timeline

Please be aware that the approval process will be rigorous and will start slowly. It is imperative that we maintain the health and safety of our community. A strong and compelling rationale for bringing participants onto campus during the global pandemic is imperative, and only a small number of in-person studies will be approved.

Qualifying Activities

Please also note that requests to return to campus related exclusively to the completion of research-related activities do not need to follow the college Return to Work process. However, any individual or group returning to campus for tasks related to both research and other activities, will need to follow the Return to Research process as well as the Return to Work process.