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Covid-19 IRB Research Protocol

Current concerns about the COVID-19 virus outbreak, the risk of exposure to the virus, and the risk /benefit ratio of research participation, must be taken into careful consideration for each IRB research protocol at DePauw. Following the most recent guidelines issued by the Office for Human Research Protection) (OHRP), a division of the U.S. Department of Health and Human Services (HHS), the following protocol will be observed by the DePauw University Institutional Review Board until further notice:

Research activities that involve direct contact with, or being in the presence of participants, and which offer little or no benefit to the participant, should be delayed or paused as soon as the delay or pause can be reasonably implemented. This delay or pause protocol will remain in effect until official notice is issued to the DePauw research community.

The following questions and answers will help guide researchers as protocols are being prepared, or are currently active:

FAQs

If my protocol was previously approved by the IRB, but I am pausing research or delaying research, do I have to submit notification to the IRB?

According to federal regulations, a researcher can make changes to an existing, previously approved research protocol if the changes are implemented to eliminate hazards to research participants and researchers alike without first obtaining IRB approval for the changes. Therefore, any protocol may be delayed or paused due to COVID-19 concerns without submitting a modification to the IRB. However, if these pause or delay changes become permanent changes, a modification should be submitted prior to implementing the changes.

 What research may continue under these guidelines?

Procedures such as telephone contact, remote data collection or observation without direct contact and, without violation of recommended social distancing, may continue for studies as planned. If the research protocol does not involve human contact, then the study needs neither to be delayed nor paused.

 What research may not continue under these guidelines?

If your research protocol involves human contact, and is neither a medical nor a psychological treatment, then either delay or pause the study immediately.

 Exception

The only exception to this guideline is studies that receive grants from the HHS or NIH aimed at researching the effects of the COVID-19 virus, or that research vaccines and other medications related to the virus, and which require human contact, may continue to be approved under current federal regulations and guidelines.