Amending Protocols in Response to COVID-19

The IRB can provide one-on-one remote consultation for researchers navigating changes to their research protocols in light of COVID19. Many researchers have already transitioned their data collection methods to remote processes or added a component to their study to include questions about social and behavioral responses to the pandemic.

Please note, communication with participants to check on their welfare or ability to continue participation in your research is permissible and does not require an amendment to your protocol. As always, we encourage you to engage with participants with special sensitivity to their well-being.

If accommodations in a changing COVID19 environment will lessen the burden of participation to subjects, for example, relaxing deadlines or thresholds for compensation, an amendment will not be required but you must contact IRB staff for instructions on how to document accommodations.

If accommodations increase risk or burden to participants, for example moving a sensitive focus group activity to video conferencing, or disclosing information on one’s mental health or behavior under “stay-at-home” orders, you must submit an amendment to your protocol. If your changes need to be submitted as an amendment, please put “COVID-19 Amendment” in the subject line of your email as well as in the Request to Amend an Approved Protocol form. These amendments will be given priority for IRB review/approval.

Researchers considering possible alternatives in research design to accommodate this changing landscape should choose the option that best protects participant safety and well-being, or that provides some benefit to participants that may justify the imposition of possible risk.

We also recommend being in consultation with colleagues and administration about guarding the scientific integrity of projects in process, while upholding our shared commitment to the protection of human subjects.

Visit the Campus IRB COVID-19 updates page and Duke's research-related updates regarding the coronavirus for more information. These pages will be updated frequently.