COVID-19 Emergency Preparedness - Clinical Research
Updated 4 pm, March 24, 2020
Participant Enrollment and Visits – The most important consideration is to ensure the safety of participants enrolled in clinical research studies.
At this time, we ask that clinical researchers stop new enrollment in research studies that involve in-person contact. Specifically, research studies that involve in-person contact with research participants at all UT Physician clinics, Memorial Hermann locations, and Harris Health System locations should cease new enrollment immediately. This decision is intended to minimize exposure of patients, participants, and research staff. Additionally, we want to be mindful of the availability of PPE and other clinic and hospital resources and prioritize patient care.
Exceptions: Suspension of new enrollment does not apply to critical research studies such as research related to COVID-19 or ARDS and other critical and essential research studies. Requests for consideration to proceed should with new enrollment should be submitted to the IRB as a new submission for new proposals and as a change request for ongoing studies. Requests for consideration should include a statement from the Department Chair (or department reviewers) designating the proposed research as critical or essential. Research studies that do not involve in-person contact with participants (such as research studies that only involve online surveys, telephone calls, or chart reviews etc.) may continue to enroll participants. Requests for emergency use/compassionate use/single patient use may continue to be submitted as usual.
Currently Enrolled Participants: For UTHealth investigator initiated clinical trials that have active participants, consider if it is possible to change in-person study visits to remote visits (such as telephone call, using telemedicine technology etc.). Consider if it is possible to reduce the number of in-person study visits without jeopardizing the subjects’ safety or well-being. For sponsor initiated clinical trials or multicenter clinical trials where the UTHealth PI is not the lead PI – contact the study sponsor/lead PI to develop a plan. Remember to submit a change request to the IRB via iRIS before implementing any such changes. FDA Guidance on Conduct of Clinical Trials During COVID-19 Pandemic.
If it is in the best interest of participants who are already enrolled, to come for an in person study visit, at least one day before their study visit, research staff should contact participants/caregivers to assess COVID-19 exposure risk by asking the following questions:
- Did they travel outside of the US in the past 14 days? If yes – determine whether it was to a destination listed as Level 2 or higher travel advisory related to COVID-19 by either the Centers for Disease Control and Prevention or the U.S. Department of State.
- Do they know if they had or may have had contact (within approximately 6 feet) with a person who is under investigation for or confirmed to have COVID-19? If so, when was the last contact made?
- Do they have fever, and/or cough, difficulty breathing, flu-like symptoms, etc.?
If the answer to any of these questions is “yes”, inform the Principal Investigator. Principal Investigator should assess whether it is in the best interest of the participant to attend the study visit and which specific precautions should be made to reduce the risk of the visit to the subject, study personnel, and/or others. The Principal Investigator may reach out to Dr. Luis Ostrosky or Dr. Susan Wootton for help making decisions about individual study participant visits.
If the answers to all the questions is “no”, the participant may come for the study visit. The research staff should inform them that they will have to go through a screening process at UT Physicians and will be given a green wristband.
If a research participant requests withdrawal from the study, the study investigators should discuss alternative measures and address any problems arising from treatment interruptions or temporary stopping treatment.
Changes to Protocol: If changes have to be made to research plans in order to eliminate apparent immediate hazards to research participants, study personnel, or the community, these changes should be made and then reported to the CPHS within 5 days, as per CPHS policy as an unanticipated problem. Eliminating immediate hazards may include actions to reduce potential exposure to COVID-19, or to continue to provide medically necessary study care (including study drug) to participants who have been placed in isolation or quarantine because of suspected or known exposures. CPHS encourages sponsors and investigators to take such steps as necessary to eliminate apparent immediate additional risks to participants.
We strongly recommend that you develop an action plan for your research study to mitigate disruption caused by COVID-19 containment and response efforts. An example of a comprehensive plan developed by Dr. Mary Kay Koenig, Department of Pediatrics, is provided here.
As recommended in the FDA guidance, do keep a log of any changes to protocol or alternate procedures for each clinical research study. Here is a template that can help you keep track. COVID-19 Alternate Procedure Log.
Study Team Contact Information: Make sure the study delegation log is updated and the contact information of all study team members is correct. Ensure that your emergency communication plan is up to date and that all study team members are familiar with the communication plan. Plan for study team members to be able to work remotely.
IRB Operations: The Committee for Protection of Human Subjects (CPHS) and the IRB Office remain fully functional and no operational changes are anticipated. The IRB Panels will continue to meet via videoconferencing technology for the immediate future. Researchers submitting proposals related to COVID-19 should submit their proposals as usual via iRIS – however, please email the IRB office at firstname.lastname@example.org to alert the IRB if the submission is urgent. Some projects may overlap with public health authority activities and IRB review and approval might not be needed for these. The IRB office stands ready to assist you with these determinations.
Emergency Use of Investigational Products – The procedure for emergency use for investigational products remains the same - Emergency Use . Contact email@example.com for expanded access of investigational products.
Routine Monitoring Visits by CRAs – UTHealth has suspended routine monitoring visits for clinical trials conducted at UTHealth/Memorial Hermann Health System/Harris Health until April 30, 2020, effective immediately. This restriction will be continually reassessed and updated based on the COVID-19 situation. If there are reasons for a monitoring visit to occur urgently, please reach out to firstname.lastname@example.org with the request for approval.
- Is remote access to regulatory data available for monitoring? Depends on the study. Some research teams are able to provide remote access for sections of the regulatory files.
- Is remote access to MHH clinical data available for monitoring? It is possible, but limited. Reach out to Sheila Ryan at CIRI, MHH, or Shibu John, Manager, Centralized Scanning, at 713-802-3908. MHH TMC IDS can grant remote access to Drug Accountability System and temperature monitoring system. Please email requests with CRA name and email address to email@example.com. The remote access will charged as one monitor visit. There will be a 5- business day lead time for remote access request.
- Is remote access to Harris Health clinical data available for monitoring? No, Harris Health policies require that the monitor may review data in the electronic medical record only under the direct supervision of Harris Health authorized research staff. Monitors or any other sponsor representatives shall not be granted direct access to the electronic health records. However, the Investigational Drug Service (IDS) can scan and email requested subject DARFs and temp logs when needed. The contact person for Harris Health IDS is Celia Fenceroy and she can be contacted at 713-873-4457
IDS Pharmacy at Memorial Hermann TMC - IDS services may be impacted by the hospital’s emergency plan in response to COVID-19. At this time IDS is operating in a limited capacity and requests that new study enrollments be put on hold temporarily to minimize treatment disruptions due to logistical challenges and limited resources. IDS pharmacy requests that study teams contact them prior to obtaining consent to confirm dispensing feasibility. IDS pharmacy requests that study teams coordinate and share with emergency plans for existing subjects with scheduled study drug treatment to minimize treatment disruptions. Effectively immediately, IDS will temporarily stop accepting patient’s return of study medication to IDS pharmacy IDS Contact information - firstname.lastname@example.org or pager (713) 704-7243 x 22701.
Study meetings - Travel Restrictions – UTHealth investigators and research staff are prohibited from international travel (including Canada and Mexico) at this time until further notice. While UTHealth is not currently prohibiting work-related domestic travel, approval from supervisor and the Office of Enterprise Risk Management via the Travel Registration Form is required for all business travel within the U.S., regardless of the mode of transportation. Domestic travel is limited to essential, mission-critical activities and, in lieu of travel to out-of-town meetings and conferences, UTHealth recommends the use of institutional Skype, WebEx, and other conferencing tools to participate remotely. More information on travel restrictions and other COVID-19 information is at the UTHealth COVID-19 website.