Amending Protocols in Response to the Easing and Lifting of COVID-19 Restrictions

This page provides updated guidance previously posted on our Amending Protocols in Response to the COVID-19 Pandemic page.

In response to the coronavirus, many researchers transitioned their data collection methods to remote processes or added components to their studies to include questions about social and behavioral responses to the pandemic.

While in-person restrictions continue to be eased or lifted, Duke currently expects all research activities that can be carried out remotely to remain remote.

Researchers wanting to resume in-person activities suspended during the pandemic may not need to submit an amendment if those activities are still accurately described in the approved protocol.

Researchers wanting to add in-person activities to a protocol describing only remote activities must submit an amendment.

Researchers do not need to submit an amendment to discontinue remote portions of research activities. If an approved protocol includes pandemic-related components that are no longer in use, a simple annotation within the protocol indicating these activities have been discontinued will suffice. The Campus IRB does not encourage researchers to remove aspects of a research study described in an approved protocol.

For more information, please read our policy on Amending an Approved Protocol.

Please contact the Campus IRB if you have any questions about navigating proposed changes to your protocol.