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CGU IRB OPERATIONS DURING COVID-19 OUTBREAK AND IMPLICATIONS for human Subjects Research

If you are continuing with your study during the outbreak, we urge to pause and give consideration as to how these special circumstances impact the risk to human subjects in your study. The information here is intended to provide guidance for such considerations and for human subjects protections decisions specific to our current conditions. We will continue to update this page as circumstances change. 

Please note that stricter directives (e.g., lockdowns, campus closures, etc.) from CGU leadership, federal and state government, and/or local municipalities governing your research sites would supersede guidance provided here.

On April 9th, the U.S. Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) issued OHRP Guidance on COVID-19.

At this time, in accordance with guidance from the CDC, NIH, and CA Department of Public Health, human subject research involving direct interaction with study participants should be suspended to minimize risk of contracting or spreading COVID-19. Exceptions would be (1) studies in which interruption could create greater risks to human subjects, and (2) some studies with therapeutic benefits. You may also be able to avoid suspending your study by adapting procedures to replace in person interaction with online or phone interaction. If you are putting your research on hold during this period, you do not need to notify the IRB unless you think such an interruption might introduce risk to human subjects.

For all major study modifications or modifications that increase risk or introduce new risks, investigators must submit an amendment to the IRB. A restricted set of changes may be enacted even before the amendment is approved. (See below for more information.) All other changes may not be enacted until the amendment is approved. In addition, we have made modifications to the Amendments tab on protocol pages to streamline the process and allow us to prioritize amendments related to COVID-19 response.

 

Does my current (active) study require changes?

If you plan on pausing/suspending the research until after the crisis is resolved and CGU returns to normal operations, no changes are needed. Otherwise…

  • Does the study involve direct, in person interaction with research subjects (i.e., physical presence in lab; in person interviews, observations, or surveys)?
    • No—Your study probably does not require any changes.
    • Yes, but interrupting or adapting my study would create or increase risks to subjects—You should contact the IRB as soon as possible so that we can work together to consider what changes, if any, can/should be made to continue the study while minimizing new risks introduced by COVID-19. Examples of types of studies this might pertain to:
      • Suspending a study involving an intervention to treat depression or suicidal tendencies could result in greater risk to subjects than the risk of contracting COVID-19.
      • Likewise, risks might be increased by interrupting studies designed to help subjects use new procedures, devices, or apps to manage health conditions.
    • Yes—Your study requires changes to avoid the new risks introduced by COVID-19.

Does changing my current (active) study require an amendment?

Exempt studies

  • Will adapting the study to involve only online/phone interaction increase, or introduce new, risks?
    • No—No amendment is required.
    • Yes—Yes, please submit an amendment explaining how, and to what degree, the change impacts risk.

Non-exempt studies (Expedited or Full Board Review)

  • Changes to address risks posed by COVID-19 will require an amendment, however, if the changes consist solely in adapting the study to online and phone interaction and the changes do not increase, or introduce new, risk, investigators may proceed with the changes without waiting for approval.
  • Amendments must be submitted and approved for:
    • Protocol modifications that include changes that are not in response to the COVID-19 outbreak
    • Changes that negatively impact risk.
    • Changes in design, purpose, or methods, particularly if such changes might decrease the scientific benefit of the study.

Staging Enabled