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Conducting Approved Human Subject Research during the COVID-19 Pandemic

Version 3.24.2020

 

Effective immediately, the University will use the following guidelines when assessing whether specific human subject research projects may continue at UF.  These guidelines are for human subject research only, pertinent only during the current COVID-19 epidemic, and will be in place until removed by the UF Vice President for Research.  Since this crisis is fluid, these recommendations may change over time:

Tier

Potential Health Benefit to Participants

Activities

Enrollment

Alternatives

1

COVID-19 research

Activities may continue.   

May continue

NA

2

Direct health benefit, serious risk to subjects if study interventions stopped

Activities may continue. 

Paused/halted

May request exception to enroll new subjects, see below.

3

Low to no direct health benefit, no face to face interactions with study subjects or between study staff.

Activities may continue, however any on-campus research activities must have prior approval by your appropriate Dean and UF Vice President for Research (VPR).

May continue

NA

4

Low to no direct health benefit, with face to face interactions with study subjects or between study staff.

All activities that involve face to face interaction with subjects or between study staff must be halted.*

Paused/halted

*See COVID-19 Investigator Guideline

 

Based on the above table:

Tier 1 – COVID-19 Research

Activities may continue. As part of the submission, you must describe safeguards you are taking to protect human subjects and researchers engaged in research that may come into contact with known or unknown infected individuals or materials in the conduct of the research.

 

Tier 2 – Direct Health Benefit to Research Participants

All protocols in which serious or immediate harm could be caused to the research participants if research activities are stopped.

For example:

For FDA governed clinical trials, please refer to the FDA guidance at https://www.fda.gov/media/136238/download

Research in Tier 2 can continue if the PI ensures the research can be conducted in a safe manner that protects subjects, researchers and staff, and the community.

Enrollment of new subjects must be paused.

·       A compelling reason to continue enrollment must be a matter of potential life or limb saving over the next 2 months.

·       PIs may petition the IRB if they have a compelling reason for not following this pausing enrollment policy.

o   Requests are made via a miscellaneous reportable event submission within myIRB.  Please complete and upload this request form:  http://irb.ufl.edu/wp-content/uploads/tier2exception.docx​.

o   Requests will be reviewed by the IRB.  The IRB may involve appropriate senior level staff to assist in the determinations.

o   Requests will be reviewed in order of priority.

·       These guidelines must be followed for studies seeking an appeal until such time as an appeal is granted.

 

Tier 3 – Low to No Direct Health Benefit to Research Participants

Research that has no face to face interaction or intervention with subjects.

·       Chart review studies

·       Research interactions conducted online or over the phone

·       Analysis of previously collected data/tissue

 

Research activities in Tier 3 may continue conducting all activities and enrolling subjects provided there is never any face to face interaction with subjects. If this involves on-campus activities, this will also require prior review and approval by the appropriate Dean and the UF VPR.

Tier 4 – Low to no Direct Health Benefit to Research Participants

Research in these categories that include face to face interaction with subjects. 

Research activities in Tier 4 must not enroll new participants in studies requiring face to face interaction nor continue to conduct face to face visits. Activities that do not require participant interaction may continue. Researchers may also submit a revision to the IRB to conduct interactions online or via phone.

 

Items to consider:

Develop Contingency Plans:

Study teams should immediately prepare contingency plans for their active research protocols. These changes may require IRB approval prior to implementation (see: http://irb.ufl.edu/wp-content/uploads/Temporary-Guideline-COVID-19-Related-Protocol-Revisions.pdf). Consider whether disruption of a research protocol will impact the safety of your research participants, and how you can manage that disruption: