COVID-19 Guidance for the Vanderbilt Research Community

The IRB has established specific instructions on how a PI should respond to activities and concerns surrounding COVID-19 precautions. 

https://www.vumc.org/irb/covid-19-updates-research.

All changes to any research protocols still need to be reviewed and approved by the IRB except for the incorporation of the screening as described below as well as any measures needed to avoid an immediate apparent hazard to a patient/participant.

Research teams should take the following actions now:

Screening of Research Participants:

Research participants may be asked to complete a short screening for exposure COVID-19 before in-person interactions.

1. Have you traveled to China, Iran, Italy, Japan, or South Korea in the past 14 days? 
2. 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 deg F?
    • Cough?
    • Difficulty breathing?
    • Sore throat? 

3. In the last 14 days, have you lived with, 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/coronavirus infection?

If participants say “yes” to any of the questions, it is recommended that you reschedule testing for a later date and direct them to https://www.vanderbilt.edu/coronavirus/ for VU and a dedicated hotline, along with a dedicated website for VUMC.

The incorporation of this screening procedure does NOT require IRB approval.

Changes to Research to Avoid Immediate Hazard to Participants:

The PI is responsible for making the assessment that there is a need for immediate action to protect the safety and wellbeing of the participant. If there is a need, the PI may make the change without first obtaining IRB approval. Note this option is only available for changes that would impact participants already enrolled in the study. It is not appropriate to make such a change in order to enroll a new participant (for example exceptions to inclusion/exclusion criteria). 

Follow the steps below if a change is made to prevent immediate hazard without IRB approval:

• • • Submit to the IRB within 5 working days of the change.
    • The change and rationale for making it should be clearly documented in your research records (e.g. in a note to file.) 
    • This change may apply to one subject or a group/all subjects in the research study.

These changes do NOT require prior IRB approval.

Develop Contingency Plans:

Study teams should proactively prepare contingency plans for their active research protocols. Information regarding contingency plans for VUMC cores may be found here. Important considerations for contingency plans include:

1. Assess if the disruption of a research protocol might impact the safety of your research participants.  Consider the following:

1. 1. • Investigational Drugs– If research participants are on investigational drugs, work with the IDS to determine what the plan would be if the investigational drug could not be dispensed to your research participants. You might find a way to deliver investigational drugs to their home. If the investigational drugs cannot be dispensed to our research participants, you should make plans to transition research participants back onto their most appropriate clinically available medications. This transition should include consultations with the investigation drug service and the clinical team caring for the research participants.
      • Research Procedures– PIs need to assess whether any reduction in staff makes it unsafe to complete the planned research procedures.
      • Timely review of research data– If research team members are not available, integration of research care such as reviewing lab results in a timely manner might not be possible and will require special attention under the direction of the study PI. Study teams should consider the availability of appropriate back-ups to the PI to make safety assessments.
2. Utilization of alternate visit options including:

• • • Telephone or Vanderbilt Health On Call visits for participants who are unable or unwilling to come to on-site visits
    • Video conferencing – It would be wise to have up-to-date phone numbers for all of your research participants. You might also discuss videoconferencing.

Within the past week, VUMC has established a dedicated hotline where concerned individuals can be screened and, if needed, routed into our system at the appropriate point of care, along with a dedicated website where information for our employees and patients is centrally housed. We’ve also established designated assessment sites for screening patients who have respiratory symptoms and think they could be COVID-19 positive.

**Changes to the research protocol require approval by the IRB.**

Working with the IRB & OCM:

The IRB staff are available for consultation on contingency plans for active research studies. Please contact the IRB at 615-322-2918 or our list of contacts at: https://www.vumc.org/irb/staff-listing

Industry sponsors & other institutions with which VUMC is contracting, would need to be notified regarding any interruption in study activities. Office of Contract Management’s Contract Analyst can initiate this correspondence or would at least need to be notified of any such communication.

Yes.

Rationale: There is no increased risk to subjects relating to COVID-19

We continue to support research which can be conducted maintaining universal COVID-19 precautions. We ask that each PI consider the risk/benefit ratio, shorten visits, limit number of personnel on site, and avoid high risk studies that could result in an inpatient hospitalization.  Feel free to reach out for a case by case discussion for restarting your study.  We are following VUMC institutional policies for visitors, temperature checks, and mandatory masking.  Each participant and visitor will be expected to wear a mask during the entire duration of the visit unless they are alone in the room. We have a COVID-19 screening tool in place to be completed within 72 hours prior to the participant visit.  Email us at crcquoterequest@vumc.org if you need step by step instructions on completing this prior to your participant’s visit.  If a scheduled visit is directly impacted, we will notify those coordinators and investigators by email.  We appreciate your continued support as we work together to keep everyone safe.  

VUMC has a designated area for these individuals in the E pod which has been created to test and treat patients.  This area is located in the parking lot under the MCE.  For questions call (888) 312-0847.

See VUMC hospital guidance at: https://www.vumc.org/coronavirus/clinician-guidance

An example is tissue collection for research studies while a subject is undergoing standard of care surgery.

These should continue.

Rationale: There is no increased risk to the subjects relating to COVID-19.

For VUMC research sites in the greater Nashville area, this guidance applies, whether physically at VUMC, at a practice site, or elsewhere.

Rationale: The same rationale applies regarding the risks relating to COVID-19.

If the study does not require the subject to travel to a research site either before enrollment or after discharge, then it may continue.

Rationale: There is no increased risk relating to COVID-19.

You should inform the study sponsor and/or the overall PI of the study of the modified procedures and what documentation requirements will need to be modified (e.g., changes to CRFs, etc.).

Refer to the CDC guidance on discontinuation of isolation for persons with COVID-19  – In a Healthcare Setting / Not in a Healthcare Setting

Refer to the guidance from Clinical Research Fiscal Support Services (CRFSS) on StarBRITE: https://starbrite.app.vumc.org/research/crfss/covidtelemedicine.html?edit=true