COVID-19 IMPACTS TO HUMAN SUBJECTS RESEARCH

At this point, the University of Iowa (UI) remains open and research activities are not restricted. However, this could change swiftly, so we encourage you to check the FAQs on the UI Campus Coronavirus Updates website often. 

For now, Principal Investigators (PIs) should prioritize the health and safety of project personnel, collaborators, and human subjects when deciding how to move forward with research activities. In general, research involving vulnerable populations, individuals over age 70, or individuals with underlying health conditions should take special precautions when possible (CDC guidelines: https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/high-risk-complications.html). 

Other things to consider (though not currently mandated):

Establish Formal Contingency Plans: All investigators engaging in human subjects research should develop concrete and actionable plans for:

·       Continuing or halting data collection.

·       Regularly communicating with the following to ensure everyone is operating under the procedures recommended by the university: Your research team, study sites, participants, and their caregivers.

·       Identify research priorities in the event University of Iowa employees are not able to come to work.

·       Managing data in the event the UI or its health campuses are closed for research purposes.

·       Arranging for the possibility of remote access to research files.

Investigators and study teams conducting research activities that involve medications and/or medical devices should create plans for patients with new devices or recent procedures and/or who require close monitoring because of the nature of the medications. These plans should include contingency plans for providing medications, cross training of staff, and ensuring access to required care.

Review Data Collection Procedures: As part of planning, investigators and study teams should revisit data collection procedures as well as the extent to which or circumstances under which data collection should be brought to a halt, either temporarily or permanently. Suggestions for biomedical and social behavioral research are provided here.

Biomedical and Social Behavioral Studies:

o   Ensure that the research staff is healthy and check with study sites to determine whether there have been any identified cases or if anyone at the site is or has been quarantined when collecting data from populations at higher risk of suffering severe health consequences if they contract COVID-19 (e.g., older adults or those designated at higher risk by the CDC) or in settings that bring large groups of people together in contained spaces (e.g., K-12 schools, close proximity living spaces).

o   Avoid or minimize bringing groups of people together for data collection activities (e.g., focus groups, whole group interventions); consider moving face-to-face data collections (e.g., interviews, surveys administered in person, some forms of observation) to telephone or online (e.g., Zoom) formats; follow recommended guidelines for reducing exposure and, if prudent, pause study activities; determine whether it is necessary to completely suspend research activities and if so, pause recruitment until the situation changes.

o   Consider screening study participants or potential participants for their travel histories within the past 14 days and flu-like symptoms. (this specific screening activity would not require prior UI IRB approval)

o   Ensure remote access to study files in the event research activities could be completed at an alternate location (e.g. data entry, transcription, data or statistical analysis, coding data, etc.) with appropriate IT security and confidentiality measures consistent with UI ITS policies (e.g. encryption, use of VPN, etc.)

Research involving subjects at UI Hospitals & Clinics: Research that requires subjects to enter UI Hospitals & Clinics (UIHC) must adhere to UI Healthcare guidance for all visitors to the hospital: anyone who has recently traveled to affected countries or has respiratory symptoms should not enter the building.  UIHC requires 100% screening for subjects that may meet these criteria.  More information can be found at https://uihc.org/2019-novel-coronavirus-covid-19.  UIHC and non UIHC patients can call 1-319-384-9010 if they are experiencing symptoms.  For UIHC patients, they may also schedule a video visit via MyChart. 

In Person Research Visits: Consider decreasing the number of protocol-mandated in-person study visits to healthcare facilities; replacing protocol-mandated visits to healthcare facilities with home visits or telemedicine, allowing blood draws at remote or commercial laboratories; and shipping investigational products directly to research participants.

Research Subject questions: If research participants are calling but are well and have general questions regarding COVID-19, please direct them to the Iowa Department of Public Health Hotline: 2-1-1. If research participants have a fever, cough or shortness of breath, they should not come in for their visit. Please advise them to schedule a video visit through MyChart or call 319-384-9010 if they are a UIHC patient or seek medical guidance from their care provider. According to Iowa Department of Public Health, no additional or special precautions are recommended for Iowans beyond the simple daily precautions to combat the flu. This includes washing hands frequently, covering coughs and sneezes, and staying home when ill.

Amend Protocols if Necessary: For full board and expedited studies, if an investigator or study team needs to alter data collection activities by shifting to phone or online, or another change needs to be made to a study protocol in order to protect participants or study personnel, an amendment should be submitted with the language “COVID” in the free text field in the HawkIRB form. This field is available just prior to choosing the “submit to IRB.” This will allow the Human Subjects Office and the IRB to flag the amendment to help review and approve it as quickly as possible.

If a sponsor or investigator needs to make a change to research plans where there may pose an immediate hazard or risk to the research participant, and is unable to submit an amendment, these changes can be made and then reported to the IRB within 5 days, as a reportable event. Eliminating immediate hazards may include actions to continue to provide medically necessary care (including study drug) to participants who have been placed in isolation or quarantine because of suspected or known exposure to COVID-19. Consistent with FDA regulations, the UI IRB encourages sponsors and investigators to take such medical steps as necessary to eliminate apparent additional risks to participants.

At the current time, the UI IRBs will continue to review and approve research protocols that have been or will be submitted, including those submissions that require full board review. However, any research team that has not yet begun research activities should ensure that doing so will not jeopardize members of the research team or participants. In addition, should the COVID-19 landscape change significantly, there may come a point when research activities—including research with human subjects—will be restricted and application reviews might be paused in the interest of individual and public health.

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