Updated: August 24, 2020
NEW: VUMC Research Enterprise Plan for opening up.
NEW: VU Research Enterprise Plan for opening up.
Things to consider when ramping back up:
- If you made changes to your research to conduct remote sessions and/or interventions and you will continue the changes permanently, please submit an amendment to update your research materials;
- Please report any issues that may have occurred during your pause of the research such as safety issues, or issues that may impact your ability to safely begin your research, or that may impact the study's ability to meet its endpoints to the IRB as an amendment to update your research.
Biosafety Updates HERE
FDA Issues Emergency Use Authorization for Convalescent Plasma, dated August 23, 2020
FDA Guidance on the Conduct of Clinical Trials During a Pandemic dated July 6, 2020
FDA Guidance on requests for Expanded Access During COVID-19 dated June 2, 2020
OHRP Guidance on COVID-19 dated April 8, 2020
FDA Guidance on the Use of Convalescent Plasma dated April 2020
FDA Guidance on Ventilators and Accessories dated March 22, 2020
FDA Guidance on Clinical Trials During a Pandemic dated March 18, 2020
FDA Guidance on Remote Monitoring Devices dated March 20, 2020
FDA Guidance on Adverse Event Reporting dated March 20, 2020
NIH Guidance for Funded Clinical Trials dated March 16, 2020
All changes to any research protocols still need to be reviewed and approved by the IRB except for the incorporation of the screening for COVID-19 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.
If participants indicate active infection, 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 COVID-19 screening procedures do 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.
+Minor protocol deviations which do not have the potential to negatively impact participant safety or integrity of study data (ability to draw conclusions from the study data), or affect subject’s willingness to participate in the study.
Minor protocol deviations could include conducting a study visit virtually (by remote means) or outside of window, omitting a specific research procedure or collecting questionnaire/assessment data over the phone instead of in person. Minor protocol deviations are reported to the IRB at time of Continuing Review through submission of a Deviation Log.
These changes do NOT require prior IRB approval.
+Public Health Surveillance if authorized by a Public Health Authority, does NOT require IRB review and approval. These activities are not considered research.
Public health surveillance is the continuous, systematic collection, analysis and interpretation of health-related data needed for the planning, implementation, and evaluation of public health practice. Such surveillance can:
- serve as an early warning system for impending public health emergencies;
- document the impact of an intervention, or track progress towards specified goals; and
- monitor and clarify the epidemiology of health problems, to allow priorities to be set and to inform public health policy and strategies.
+Develop Contingency Plans:
Study teams should proactively prepare contingency plans for their active research protocols. Important considerations for contingency plans include:
- Assess if the disruption of a research protocol might impact the safety of your research participants. Consider the following:
- 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.
- Utilization of alternate visit options including:
- Telephone or Vanderbilt Health OnCall 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.
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:
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
For more information: