COVID-19 UAB Guidance for Clinical Research: Participant and Sponsor Interactions
Origination (V1): March 13, 2020
Update (V2): March 17, 2020
Update (V3): March 18, 2020 (new information found in RED)
Background
The University of Alabama at Birmingham (UAB) aims to assure the safety of all persons both within the University as well as that of its patients, vendors, visitors, etc. during the COVID-19 outbreak and is taking steps to mitigate the risk of the virus’ spread throughout our area. The COVID-19 pandemic affects clinical research and this document provides guidance on measures to mitigate the impact on participants and to research studies. Additional information regarding Human Subjects Protections and contact with sponsors can be found here
NEW INFORMATION: Participant Study Visits and Study Team Preparedness Non-Essential Research Visits- Research visits that cannot be performed remotely and are not essential to the participants’ health and/or well-being should be postponed until further notice. Currently, the determination of whether or not a research visit is "essential to the health and/or well-being" of a participant should be evaluated by the principal investigator of the research study, the participant, the sponsor, and if relevant, the participant's care provider. PIs are strongly encouraged to consider the safety of the research personnel and subjects in making their decisions, keeping in mind that the risks posed by COVID-19 to participants may greatly outweigh in many cases the benefits of a particular study.
Essential Research Visits-Research visits that cannot be performed remotely and are essential to a participant's health and/or well-being may be performed in person, with the following additional guidance:
• Research participants should be contacted and screened for fever, cough and flu-like symptoms by research staff prior to the research visit. Screening should be an ongoing process with each subsequent encounter, and should include consideration of travel to a COVID-19 hot-spot, known or potential contact with infected individuals, and/or a positive COVID-19 test result. Those participants who screen positive but are asymptomatic must quarantine for at least 14 days following the positive screen before being seen. Those screen positive participants who have a cough, fever, or flu-like symptoms must be symptom free for at least 8 days and have a negative COVID-19 test result prior to returning to participation. The UAB OIRB does not need to approve the incorporation of mandatory screenings, unless you or the sponsor wishes to incorporate the data collected as part of a new research objective of the clinical study. If so, the protocol will need to be amended and approved by the IRB.
• Enrollment of new patients on a clinical study might be allowed only if: 1) participation in the trial is essential to a participant's health and/or well-being, as noted as above; or 2) the enrollment and longitudinal participant management can be conducted remotely for the duration of the COVID-19 outbreak.
As knowledge about COVID-19 pandemic continues to develop, investigators and study teams should prepare contingency plans for active clinical research projects. Issues for consideration include:
• Temporary holds on enrollment or other study activities for non-essential studies
• Necessary modifications to the approved research protocol and adverse event reporting
• Distribution of investigational products
• Ongoing review of research data, such as lab results or other testing
• Coordinating with collaborators and/or collaborating institutions
• Ongoing oversight on research activities
Changes to IRB-approved protocols
Except as noted above relative to COVID-19 screening procedures, changes to human subjects protocols must be approved in advance by the IRB except when necessary to eliminate apparent immediate hazards to the subject. If you have a COVID-19 related protocol change or an initial submission that is related to COVID-19 that should be prioritized for review by the IRB, please contact Adam McClintock, Director of the Office of the IRB (
Study Sponsor Visits to the University (e.g., monitoring visits, site initiation visits, supplier, etc.)
• UAB is deferring all in-person monitoring visits and site initiation visits (SIVs) with Sponsors as a precautionary measure. If there is an urgent need to maintain an in-person monitoring visit, please contact Mark Marchant, Director of the UAB Clinical Trials Administrative Office (205-934-2098;
• Remote monitoring and communications are required. This should be coordinated through the study’s point of contact (Principal Investigator/Coordinator) at the University.
Additional Resources: https://www.fda.gov/media/136238/download