Announcement - UMB IRB and HRPO Research Guidance Regarding COVID19
UMB Institutional Review Board (IRB) and Human Research Protections Office (HRPO)
Preventing Spread of COVID-19 in Research and Scholarship*
(Adapted from UMSON Office of Research and Scholarship)
University of Maryland, Baltimore (UMB) Researchers (Including Faculty, Students/Trainees, and Staff) Participating in UMB/University of Maryland Medical Center (UMMC)/University of Maryland Medical System (UMMS) Research
Researchers with active protocols that include human subjects are directed to follow UMB’s Recommendations and Policies Regarding COVID-19 generally and more specifically UMB’s Clinical Guidance prior to any in-person contact (screening or scheduled research visit) with potential or actual participants. If possible, screening for COVID-19 symptoms should occur prior to any in-person interaction or visit.
If participants or potential participants are exhibiting symptoms of COVID-19, refer them to seek medical care immediately and reschedule their research visits. Capture each rescheduling event on the protocol deviation log present in the study-specific regulatory binder.
The UMB Human Research Protections Office and Institutional Review Board do not consider screening for COVID-19 and rescheduling visits based on any such COVID-19 screenings to be a major deviation unless the action places research participants at increased risk of harm.
It is the responsibility of the investigator to properly document deviations for their respective applicable research studies. If the deviation places the participant at increased risk, report the deviation immediately (within 5 (five) business days) to the Institutional Research Board (IRB). If the deviation does not place the participant at increased risk, present the rescheduling events in summary to the IRB at annual review and/or include in annual Data Safety Monitoring.
University of Maryland, Baltimore (UMB) Researchers (Including Faculty, Students/Trainees, and Staff) Participating in Non-UMB/UMMC/UMMS Research
UMB Personnel, including faculty, staff, and students/trainees, who are included on active protocols (human and non-human research) at non-UMB institutions, engaging in-person with potential or active participants are responsible for obtaining and following the non-UMB research/project site’s guidelines on engaging with participants during the COVID-19 outbreak.
Doctoral students and trainees conducting human subjects research should consult with their School’s faculty mentors and/or the Human Research Protections Office to discuss how best to proceed.
University of Maryland, Baltimore (UMB) Researchers (Including Faculty, Students/Trainees, and Staff) Participating in Non-Human Subjects Research
UMB Personnel, including faculty, students/trainees, and staff, who are members of project teams are responsible for obtaining and following the UMB's clinical guidance or, if
required, the non-UMB project site’s guidelines, on engaging with participants during the COVID-19 outbreak.
If the project site’s guidelines impact Doctoral students and trainees conducting research, they should consult with their School’s faculty mentors and/or the Human Research Protections Office to discuss how best to proceed.
Please note that this guidance does not pertain to chart reviews or studies/projects that no longer include in-person contact with potential or active participants (follow-up or phone call/email only).
*Faculty, staff, students, and trainees are expected to follow Centers for Disease Control and Prevention guidance for preventing the spread of COVID-19, including staying home except to get medical care if you are sick with COVID-19 or suspect you are infected with the virus that causes COVID-19.