COVID-19 Guidance for the Vanderbilt Research Community

COVID-19 Guidance for the
Vanderbilt Research Community

From the Offices of the Executive Vice Presidents for Research

Updated March 26, 2020; 11:00am

 

Vanderbilt University Medical Center (VUMC) continues to closely follow the COVID-19 outbreak. These FAQs contain information about COVID-19 as it relates to the conduct of clinical investigation, operations, and sponsored projects. This webpage will continue to be updated frequently as new information is received and responses are subject to change. In addition, VUMC has a new policy related to visitation and can be accessed here. 

https://www.vumc.org/coronavirus/latest-news/vumc-covid-19-hospital-and-clinic-patient-visitor-policy-now-effect

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? 
  1. 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:
      • 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.
  1. 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.

We are open for patients for whom benefit outweighs risk, i.e. receiving a potentially beneficial treatment). We are closed for “healthy” patient visits for whom no clear benefit is derived. We are following institutional Vanderbilt visitor policy that will be implemented in both the Adult CRC and Pediatric CRC.  Again, these are for the health and well-being of our patients, visitors, and staff that we all take these preventative measures. Visitors will be limited, and all visitors will be screened and asked to wear a Visitor Screened sticker while on the unit.  Please pass this information on to your research participants so that they are not surprised by these preventative measures.  We appreciate your support as we continue to stay safe and keep our research participants safe.  Please watch your email for updated information and changes to the plan, as this will be the primary tool of communication. If a scheduled visit is directly impacted, we will notify those coordinators and investigators. Please review additional COVID-19 Guidance FAQs for Clinical Research for processes and procedures related to pausing your research recruitment.

VUMC is immediately suspending on-site access to any of VUMC’s facilities by research monitors until further notice.

Please click here (log in required) to access the letter/agreement which can be shared with sponsors and monitors inquiring about study monitoring during this period of suspended access. To facilitate continued monitoring using the electronic medical record, we are expediting remote access through the Vanderbilt Health Connect feature in eStar, if Sponsors sign the agreement. Prior to releasing records for remote access by a research monitor, the agreement must be sent to the Office of Contracts Management for PEER submission. Upon execution of this agreement, remote access is granted throughout the conduct of the study identified.

Send the agreement to Office of Contracts Management, using the central email address – research.contracts@vumc.org and CC CRFSS at CRFSS@vumc.org.

Study coordinators are responsible for reminding monitors not to access records remotely if an agreement has not been signed for the study they are monitoring. It is recommended that records be released for the same amount of time a monitor would have had access if monitoring on-site (max 5 days). Please contact crfss@vumc.org if you have any questions regarding remote access for monitors or the suspension of on-site access by monitors to VUMC facilities.

Please contact crfss@vumc.org if you have any questions regarding remote access for monitors or the suspension of on-site access by monitors to VUMC facilities.

This should be decided on a study-by-study basis.

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. 

Rationale: The risk/benefit ratio for subjects may have changed from the time at which the protocol was reviewed and approved.

Research participants may be asked to complete a short screening for exposure COVID-19 before in-person interactions.  This may be done over the phone or via a REDCap survey and should include the following questions:

  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? 

  1. 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.

If using REDCap: Click here for a copy of the survey and the data dictionary which can be imported into a new REDCap project (log-in required)

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.

Yes, but all research activities will need to comply with Institutional guidance for precautions associated with COVID-19.

No, for purposes of the pause, it is assumed that trials with investigational treatments, including drugs and devices, provide the potential for benefit and should continue.

Participating sites of multicenter IITs should adhere to their individual site directives. VUMC staff that oversee the conduct of those sites participating in research related activities should be in contact with the participating site to understand the site’s plan. Protocol adherence and disruption to enrollment during this time should be discussed per protocol per site. Investigators should decide on a case by case basis how to handle the protocol disruption and communicate effectively to regulatory agencies as described above. Contact information for participating sites should be provided by the lead Investigative team.

Yes. The FDA will need to be notified. Contact Research Support Services (researchsupportservices@vumc.org ) for specific guidance and information on the notification process.

Yes.

Rationale: The presumption is that most PI analyses of risks and benefits will be accepted by the IRB. The IRB will review these case-by-case situations very rapidly.

This will be decided by the IRB on a trial-by-trial basis. The PI should provide a revised risk-benefit statement that explicitly takes the COVID-19 risks into account.

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.

If a study is deemed to have potential benefit to individual subjects, the study may continue, unless there is concern that the risks from COVID-19 outweigh the potential benefits to subjects. Study-by-study guidance should be obtained from the IRB. Studies that are determined to not provide direct potential benefit to subjects must be paused. Investigators may present a risk/benefit analysis to the IRB that takes into account the prevalence of COVID-19 in the areas where the study is being conducted.

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.).

Yes, as soon as feasible. The regulations allow implementation of a change to study procedures without prospective IRB approval when it is necessary to avoid imminent hazards to subjects. The IRB of Record will need to approve resumption of study procedures. Please call (615) 322-2918 for specific study related questions.

For programmatic issues affecting your study, we strongly recommend you speak with your agency Program Official or other sponsor contact.  If any issues should persist, they may need to be reported in future progress reports.  Please coordinate any such actions with your OSP administrator.

Yes. Pursuant to VUMC’s indirect cost rate agreement with the federal government, sick leave and other paid absences that are permitted under Medical Center policy may be charged to the grant. Please note, Federal agencies require notification if the PI or Key Personnel named in the award will be absent of the project for greater than 90 days. While this is not expected, be mindful of this prior approval requirement and notify OSP sponsoredprograms@vumc.org for guidance.

Most federal sponsors, including NIH, allow for a one-time no cost extension for 12 months at the end of the project. Please discuss your specific project with your Project Officer, and OSP administrator, who will provide guidance on the options available to you.

As noted above; 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.

When a Federal or Foundation study has been identified, please contact Office of Sponsored Programs (OSP) sponsoredprograms@vumc.org or your OSP administrator.  OSP will coordinate and communicate an official response/update to the Sponsor; for your industry-sponsored studies, please contact the Office of Contracts Management at research.contracts@vumc.org

Most federal agencies, including NIH and NSF, do not grant prior approval for late submissions; however, there are existing policies that address extenuating circumstances.  Current NIH guidance can be located at NOT-OD-15-039 and Special Exceptions to NSF’s Deadline Date Policy (PAPPG 19-1).  We strongly encourage you to discuss your specific situation with your agency Program Official and OSP administrator.