July 9, 2020
On Monday, July 6, 2020 two communications were distributed about resumption of all human subjects research. The Larner College of Medicine (LCOM) routed a notice with updates and requirements to proceed for all research. The Vice President for Research routed a notice specific to non-College of Medicine Departments.
Separate notices were necessary as the majority of LCOM studies are either hospital-based, where COVID-19 related requirements are driven by hospital policy, or where lab safety plans have already been approved by the Dean of Research. ̽̽ Researchers outside the College of Medicine conducting research in various locations across campus are required to develop specific safety plans approved by their chair/dean prior to modifying their protocols with the IRB.
IRB Steps to Resume for College of Medicine Protocols
If the COVID-19 requirements have resulted in changes in your protocol or processes you must submit a modification (MOD) related to these changes for IRB review and approval. Please identify within the modification if the changes are specific to COVID and whether the planned changes are temporary or permanent.
IRB Steps to Resume for Non-College of Medicine Protocols
1. Ensure that your department has obtained approval from ̽̽ to return to work. Ensure all staff have completed ̽̽ VOSHA training.
2. Develop protocol-specific plan to address COVID-19 federal and state requirements. This plan should be entitled “COVID Mitigation Plan for Resumption of Research” and must be appended to the end of your currently approved protocol.
Note: You do not need to revise text within your protocol, the appendix is sufficient and hopefully temporary.
3. Obtain chair/dean approval of this plan.
4. Submit a modification to the IRB with the protocol and the new mitigation appendix and documentation of chair/dean approval. The approval could be their signature on the plan or it can be an email from your chair/dean.
5. Once you receive IRB approval of this modification, you are ready to resume your research.
Protocol-Specific Plans
To develop a protocol-specific plan you should step through each study activity to describe how the interaction will proceed. The following list of considerations is from the July 7, ̽̽ Safe and Healthy Return to Campus based upon the .
1. Facial Coverings - Facial coverings are required on campus for participants and staff. Participants must be informed of this requirement prior to the visit and provided with a mask if they do not have one. Describe other personal protective equipment as deemed necessary and how it will be provided.
2. Health Screenings - How do you plan to determine and document the participant is healthy prior to coming to campus?
a. Participant must verify that he or she has no symptoms of COVID-19 (fever, cough, shortness of breath or difficulty breathing, chills, repeated shaking with chills, fatigue, muscle or body aches, headache, congestion or runny nose, sore throat, new loss of taste or smell, nausea or vomiting, diarrhea).
3. Contact Tracing Journal – Describe maintainance of a contact journal for tracing.
4. Hand Hygiene - Describe access to sink for handwashing or hand santizer access.
5. Cleaning and Disinfecting - Describe plans for santizing exam and testing rooms, etc.
6. Physical Distancing - How will you ensure physical distancing for participants/research staff when on campus? If you have determined certain procedures can be done remotely, describe how those will be completed.
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Please visit our COVID-19 Information for RPO website for FAQs and to review updates and notices. This page is updated often so check back on a regular basis.