Important notice from the Institutional Review Board about research activities

  • March 19, 2020
  • COVID-19 Students

Dear Colleagues:

In collaboration with IRB Chair Dr. Erika Nelson-Wong, University Compliance Coordinator Mr. Alan Stark, and Associate Legal Counsel Ms. Shannon Pipes, Regis University’s Institutional Official Dr. Janna Oakes, has determined that research activities involving face-to-face interactions or interventions with human subjects must cease until further notice. This decision has been made to protect research participants, investigators, research assistants, and lab personnel. This guidance does not apply to IRB-approved study activities that do not involve face-to-face subject contact or research that has transitioned in person visits to virtual visits.

  • Exceptions may be made only if canceling or postponing the activities would either

  1. increase the risk to the subject’s safety and/or wellbeing, or

  2. deprive the subject of a potential direct benefit. 

For Ongoing Research with Enrolled Subjects:

Research activities that do not involve face-to-face interactions with human subjects may continue. Research visits must be performed remotely (e.g. by phone, Zoom, or other means) whenever possible. Any deviation from an approved IRB protocol must be approved by the IRB unless such change is necessary to eliminate an apparent immediate hazard.  Research activities that involve face-to-face interaction with subjects, cannot be performed remotely and are not essential to a participant’s health and/or well-being must be postponed effective immediately until further notice.  

Exceptions may be made only if:

  1. The research holds the potential for direct benefit to the subject (e.g., investigational drug, devices or surgical procedure) and the interaction is required to deliver that potential direct benefit as determined by the principal investigator of the research study, the participant and the participant’s care provided (when applicable) and should be informed by current public health guidance regarding the COVID-19 outbreak; or

  2. Need for participant safety or coincident with clinical care (based on clinical judgment of the importance of the visit to detect potential adverse events)

  • Research visits that cannot be performed remotely and are essential to a participant’s health and/or well-being may be performed in person, with the following additional guidance: Study teams should attempt to contact the participants 24 hours prior to the study visit to ask the following questions.

1.      In the past 14 days, have you traveled outside the United States to a location with large numbers of COVID-19 patients (China, Iran, Italy, Japan, South Korea, France, Spain, Germany and any other countries included on CDC Guidance)?

2.      In the past 14 days, have you traveled within the United States to a state with larger numbers of COVID-19 patients (Washington, California, New York, Massachusetts and any other state included on CDC Guidance) or traveled on a cruise ship that had a confirmed COVID-19 passenger?

3.      In the past 14 days, have you had any of the following symptoms (without confirmation as something other than COVID-19 such as a positive flue test, chronic medical condition, etc.)?

·         Fever greater than 100.4 degrees Fahrenheit

·         Cough

·         Difficulty breathing

·         Sore throat

4.      In the past 14 days, have you lived with, visited, cared for, or been in a room for a prolonged period of time with someone who is under investigation for or has been firmed positive for COVID-19?

  • If the answers to any question is “yes”, the coordinator should reschedule the visit. Document your conversation with the subject and direct them to contact their care provider.

  • If the answer to all questions is “no”, inform the subject that we are restricting entrance of unnecessary visitors, and they can only be accompanied by those individuals essential to the visit. This would include legal guardians or an agent who must be present with the participant for health care/research related decisions. 

  • When the participant presents for a visit, questions about symptoms and exposure that might have occurred since the pre-screening conversation should be repeated (symptoms and lived with, visited, cared for or been in a room for a prolonged period of time with a presumptive positive or positive COVID-19 patient). 

New Enrollment into Existing Studies:

Enrollment of new subjects should occur only if: 1) participation in the research is essential to a participant’s health and/or well-being, as determined above; or 2) the enrollment and participant interactions and interventions can be conducted remotely for the duration of the COVID-19 outbreak.

Pending IRB Applications for Human Subjects Research:

Regis University’s IRB will continue to review and approve submissions. For studies that are approvable, but do not meet the above New Enrollment exception, the IRB will approve the study but explicitly note that enrollment cannot start until the pause in clinical research activities is lifted. 

If you have questions or need additional guidance, please contact irb@regis.edu.