Today, UCF announced its plans to restart Human Subject Research (HSR) amid the COVID-19 pandemic.
The Office of Research announced a phased approach to restarting research in May, but HSR was not allowed to restart then because this kind of research often requires close contact and presents additional risks.
The task force that came up with the overall research plan in May, continued its work in collaboration with the Institutional Review Board (IRB) staff, IRB staff and members, Environmental Health and Safety and others to create and an approved, tailored plan for restarting HSR.
Those who can continue to do their HSR remotely, should continue to do so until further notice. You should read the full plan to make sure you meet additional reporting requirements.
If you cannot perform your work remotely, you must meet all the Research Ramp Up requirements announced in May to reopen your research space and take one of two paths forward depending on the specifics of your study.
One path requires you to follow an HSR COVID-19 Standard Safety Plan, which does not require IRB approval. However, you will need the written approval of your associate dean of research and to meet the requirements of the Standard Safety Plan before getting started.
To qualify for the Standard Safety Plan you must be able to say “yes” to each of the following:
- My study participants are not part of a COVID-19 vulnerable population
- During study procedures, I will be able to maintain greater than 6 feet of distance from my subjects the entire time, or 10 feet for procedures involving heavy exertion. This includes when providing/affixing the participant’s equipment.
- My participants and researchers will be able to always wear a face covering
- I can sanitize surfaces touched by participants or researchers between participants.
- My participants will not be asked to ingest food, liquids, medications, supplements, etc. as part of the research
If your answer is “no” to any of the above, you will need to follow the other path, which requires investigators to develop an HSR COVID-19 Study Specific Safety Plan. It will then be reviewed by IRB staff and EH&S leadership to determine whether the study may move forward at this time.
All requirements for reopening labs, including a slide presentation with step-by-step instructions, can be found at corona.research.ucf.edu
The guide also includes:
- HSR COVID-19 Standard Safety Plan requirements
- HSR COVID-19 Study Specific Safety Plan requirements
- Guidelines for basic COVID-19 risk reduction
- Information to share with participants regarding COVID-19
- IRB modification requirements and the deadline to submit modifications
- Guidance on the use of personal protective equipment (PPE)
- Instructions for those planning a new study