Institutional Review Board

**Temporary halt to human subjects research during COVID-19 outbreak effective March 17, 2020**

All non-essential human subjects research that is conducted in-person is 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 this 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.

_______________________________________

The Institutional Review Board (IRB) uses IRBNet, an online submission system for all new submissions and post-approval requests. Instructions for IRBNet are found throughout this website. If you have any questions about IRBNet, please reach out to your IRB Representative.

Mission of the IRB

The primary mission of the Pacific University Institutional Review Board (IRB) is to protect the rights and safety of individuals who participate in human subjects research studies conducted by students or employees of Pacific University. The IRB also serves as a resource for the Pacific University community, providing education and guidance to researchers regarding the ethical and responsible conduct of human subjects research.

In order to ensure that federal regulations governing human subjects research are satisfied, and to meet the institutions federally mandated responsibility to provide oversight for such research, all Pacific University faculty, staff and students must submit for IRB review any research activity that involves human subjects. IRB approval is required before any research activities—including, but not limited to, recruitment—may begin.

Please note that not all data gathering and analysis activities using information gleaned from humans fall under IRB jurisdiction. However, the determination as to whether your proposed activities fall under the federal regulations for research with human subjects must be made by the IRB.

IRBNet - Online Submission System

All IRB proposals are submitted through IRBNet. Each member of the research team will need to make an account on IRBNet. See IRBNet Registration and Training Resources for step-by-step instructions for registering on IRBNet by using the IRBNet training site listed below.

IRBNet Registration and Training Resources

To access these resources, you will need the following username and password:
Username: pacific
Password: training
To begin your IRBNet training visit IRBNet.

IRB Resources and Information

Please use the menu items on the left to navigate the IRB's website. Resources, pages, and forms are being regularly updated, so please check our website frequently.

IRB Forms and Templates

All IRB Forms and Templates are downloadable from IRBNet under the Forms and Templates tab. An IRBNet account is required to access these documents.