In the context of the rapidly evolving COVID-19 outbreak, the Office of the Vice President for Research and the Human Subjects Office are providing guidance related to human subjects-related research visits. This policy is being implemented to protect research participants, researchers, and the larger UI community from risk of infection from COVID-19 as well as to ensure ongoing access to research which may provide essential support and care to participants.
As much as possible, we want to reduce exposure potential for study participants, researchers, research and clinical staff, and patients. For research studies occurring in or near University of Iowa Hospitals and Clinics, it is important to reduce foot traffic to UIHC facilities (including research buildings and off-site clinical buildings). For non-clinical studies, it is similarly important to reduce foot traffic to campus sites to reduce exposure potential.
This guidance does not apply to IRB-approved study activities that do not involve direct subject contact (e.g., chart review, Qualtrics surveys, and remote interviews) or research that has transitioned in person visits to virtual visits (e.g. interviews, surveys, questionnaires). Please refer to the OVPR COVID-19 Information for Researchers website and previous communication dated 3/13/13 for submission requirements regarding protocol deviations.
This policy will be updated when appropriate based on new information and circulated to the UI research community.
Temporary Policy Effective March 16, 2020
- Participant 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. Please see the OVPR COVID-19 Information for Researchers website for further guidance.
- Research visits that cannot be performed remotely and are not essential to a participant’s health and/or well-being should be postponed until further notice. Currently, the determination of whether a research visit is “essential to the health and/or well-being” of a participant is determined by the principal investigator of the research study, the participant, and the participant’s care provider (when applicable), and should be informed by current public health guidance regarding the COVID-19 outbreak.
- 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 prior to the study visit to determine whether the subject has fever or respiratory symptoms. If the participant does have respiratory symptoms, they should be directed to call 319-384-8442 (800-777-8442 toll free) or go onto MyChart to schedule screening for COVID testing. If the participant has no symptoms, the team should counsel the participant that the UI Health Care facilities have limited entry points to the facilities and are actively screening participants at the entrance. Participants should be provided with information regarding the current COVID-19 pandemic and how best to reduce their risk of infection. This information may be provided in multiple forms suited to the type of contact, including a website link, a telephone script and an in-person handout. If possible, this information should be shared before the research visit. See the following CDC COVID-19 guidance for reference and materials https://www.cdc.gov/coronavirus/2019-ncov/index.html
- Enrollment of new patients on a clinical trial or other human subject-related research should occur only if: 1) participation in the research is essential to a participant’s health and/or well-being, as determined as above; or 2) the enrollment and participant interactions and interventions can be conducted remotely for the duration of the COVID-19 outbreak.
In addition, University of Iowa researchers should follow all institutional requirements as posted on the Campus Coronavirus Updates website or guidance documents posted on UIHC The Loop https://medcom.uiowa.edu/theloop/2019-novel-coronavirus-covid-19#more-93131
Please address questions to the Office of the Vice President for Research at 319-335-2119 or firstname.lastname@example.org, the Human Subjects Office email@example.com or 319-335-6564, or visit the HSO website at hso.research.uiowa.edu.