Temporary Halt to Human Subjects Research During COVID-19 Outbreak

All non-essential human subjects research that is conducted in-person must be suspended until further notice. In the context of the COVID-19 epidemic, this temporary policy is being implemented to protect our participants, researchers, students, and the larger community from risk of infection from COVID- 19.

This guidance does not apply to IRB-approved study activities that do not involve direct subject contact (e.g., chart review, Qualtrics surveys, remote interviews) or research that has already transitioned in-person visits over to virtual visits (e.g. interviews, surveys, questionnaires).

Participant research visits must be performed remotely (e.g., by phone, Zoom, or other secure means) whenever possible. Researchers may want to consider using telephone, web conferencing, and electronic communication to conduct data collection procedures normally done in-person. These methods may be added when possible and practical for mitigating research risks to human subjects or others related to COVID-19. Please refer to Pacific’s online instruction resources for communication resources.

Any deviation from a previously approved IRB protocol must first be approved by the IRB unless such change is necessary to eliminate an apparent immediate hazard. Please monitor Pacific’s IRB website for forthcoming resources and templates to assist with this process.

Enrollment of new patients on a clinical trial or other human subject-related research should occur only if the enrollment and participant interactions and interventions can be conducted remotely for the duration of the COVID-19 outbreak.

Principal investigators of clinical studies who determine that research visits cannot be performed remotely and are essential to a participant’s health and/or well-being are directed to contact the Institutional Review Board at irb@pacificu.edu.

While it is difficult to predict the future, you should have a plan for cessation of in-person, non-essential human subjects research for several months. Students should work with their faculty advisor regarding modifications to their human subjects research methods and IRB protocols.

If there are questions about any changes to participant risk, please contact the IRB at irb@pacificu.edu.

This policy will be updated when appropriate based on new information and circulated to the Pacific research community.