Last Updated: 03-18-2020 6:57 p.m.
NOTICE: The EVMS IRBs and Human Subjects’ Protections Program are operating under Phase 2 at this time.
EVMS has developed recommendations to advise the research community during the current coronavirus public health emergency.
These recommendations are being made to ensure the protection of EVMS researchers, subjects, as well as our larger Hampton Roads community from risk of infection with COVID-19. At the same time, EVMS recognizes that access to certain research activities is necessary to provide essential care to research participants.
With the exception of a screening process and disinfecting sites described below, all changes to research protocols must receive review and approval by the EVMS IRBs. Investigators are permitted to implement study changes to eliminate immediate risks to subject safety. Amendments should be submitted to the EVMS IRBs promptly, describing any changes, as appropriate, and justification for why changes were put into place prior to IRB review.
Phase 1: Business as usual with some enhanced safety precautions
1. Screening Process
Investigators need to develop a screening procedure prior to any in-person, protocol-mandated interaction. The use of this screening procedure DOES NOT require IRB approval prior to implementation. For any sponsored study, investigators should consult with the sponsor for specific guidance or requirements. Suggestions include:
- Have you traveled out of the United States in the past 14 days?
- Have you had any of the following symptoms in the past 14 days without confirmation as something other than COVID-19 (such as a positive flu test, chronic medical condition, etc.)?
- Fever greater than 100.4 degrees Fahrenheit
- Difficulty breathing
- Sore throat
- In the last 14 days, have you lived with or been in contact with someone who has visited, cared for, or been in a room for a prolonged period of time with someone who is under investigation or has been confirmed for COVID-19?
If a participant says ‘yes’ to any of the above questions, it is recommended that study staff identify a resource to which a participant can be directed.
Develop intensive disinfecting protocols for your research site for the safety of research subjects and research team members. IRB approval is not required.
Prepare now to ramp down all clinical research studies
We know this is inconvenient and may affect research agreements and finances, but there is a new national standard emerging from this health crisis and we have taken relevant information from multiple, high-volume research sites to help set policy. That includes giving consideration to pausing certain aspects of clinical studies for the safety of all involved.
Voluntary Remote Visits
In general, research visits for on-going research studies should be performed remotely whenever possible. Options for remote conduct of research visits may include phone, Skype, FaceTime, etc. Any changes to your protocol to allow such remote visits must be IRB approved prior to implementation. Please submit Amendments as early as possible to avoid delays.
Phase 2: Requires a pause in face-to-face interactions
At the Phase 2 stage, it is likely many operations may be affected at the Medical School. There are very few cases that will warrant direct interactions between subjects and research sites. Most cases allowing direct interactions will be those involving a life-threatening condition that requires intervention. Initiating Phase 2 means that school leaders consider the situation to have moved to a critical juncture and risks to subjects and employees should be minimized as much as possible.
Any study procedures or visits that requires in-person contact must be paused unless participation in the research study, such as a clinical trial, is essential to a subject’s health or well-being. The determination of whether or not participation in the research is essential to the health or well-being of the subject is to be made by the principal investigator however, if the decision is to continue, the PI must notify the IRB in writing and receive confirmation from the IRB that it is acceptable to continue.
Research visits that cannot be performed remotely as described above and that are not essential to the safety and well-being of a subject must be postponed until such time as these measures are no longer necessary. The determination of whether a research visit is essential will be made by the principal investigator and based on which tier the study fits.
New enrollment and follow-up visits for non-interventional qualitative studies are to be considered ‘non-essential.’