Updated Guidance for Research Studies

March 16, 2020 @ 11:51 a.m.

Dear Clinical Research Colleagues,

The goal of this communication is to provide guidance related to clinical research studies at the CU Denver | Anschutz campuses and associated CU faculty. In this rapidly changing environment, please recognize that the situation and guidance may be updated based on new information. Please go to the CU Anschutz and the CU Denver COVID-19 info sites for the most up to date information.

General guidance on clinical research

Clinical research Principal Investigators (PIs) should evaluate each of their studies to determine if changes are needed in response to COVID-19. The guiding principle in this consideration should be based on study participant benefit and safety. For each current and upcoming study, the PI should consider the options of discontinuing in-person study activities, modifying clinical study activities, or temporarily suspending enrollment of new participants. The study PI should also determine the optimal staffing of their research team, allowing CU employees not designated as “critical” to work remotely whenever possible. The PI should also take into consideration COVID-19 risk factors that may be present in study personnel in staffing determination.

Of note, federal regulations do allow researchers to make changes to clinical research to eliminate apparent immediate hazard to participants without IRB approval. This could include cancelling non-essential study visits or conducting phone visits in place of in-person visits, for example.

COMIRB has provided additional information and details on this topic.

For clinical studies providing potential immediate clinical benefit or patient safety assurance

  • These studies should generally continue when possible for any active participants. Consideration of new enrollment should depend on the degree of potential health benefit to patients and available alternatives.  

For clinical studies with limited potential patient benefit or patient safety assurance  

  • Consider completing the trial for current participants, although discontinuation of in-person study procedures is strongly encouraged in most cases. New enrollment should be suspended, unless significant extenuating circumstances.  

For clinical studies without patient benefit or safety assurance (e.g. studies of health volunteers)

  • In-person study visits and future enrollment should be suspended in almost all cases. Alternatives such as phone visits should be considered. 

For clinical research involving COVID-19 directly

  • Some clinical studies of COVID-19 may need to take place during the active phase of the disease. Key considerations include addressing the safety of the research team and minimizing any impact to the care of the involved patients.  

We will have follow up communications about any planned ongoing clinical research.  

Study binder security

Do not store electronic research data on unsecure devices in order to work remotely. Use University-approved cloud services and VPN access while working at home instead of storing data directly on your devices.

If making copies of physical research records or data (paper consent forms, case report forms, questionnaires/surveys, etc), secure all paper locally following HIPAA principles and return to the IRB-approved location as soon as is practical.

Clinical studies being performed at CHCO and UCHealth

Both Children’s Hospital Colorado and UCHealth have developed guidance for clinical research performed at their clinical sites and the use of data when working from home. Please refer to this guidance in determining the best course for research studies conducted at these partner institutions, applying the principles reviewed here for Children's Hospital Colorado and here for UCHealth. Login may be required so please contact your clinical supervisor with any issues.

Clinical studies being performed in University-managed sites

Please see our previous guidance on participant screening for COVID-19. This screening should be completed prior to any study visit or procedures. After the study PI has identified any protocol changes that should occur in a clinical study, they should contact the clinical site manager/medical director to discuss and confirm the availability of adequate support staff at the study location for any ongoing research activities.  
If a PI does revise or suspend a clinic research protocol, they should also notify the sponsor and/or the overall PI. For federally-sponsored projects, contact the grant office. Additional NIH guidance is available here.

If the University of Colorado holds the IND/IDE, please contact us with any changes at clinicalresearchsupportcenter@ucdenver.edu.

Thank you for your understanding and cooperation with this updated guidance.

 

Sincerely, 

Thomas Flaig, MD
Vice Chancellor for Research
University of Colorado Denver | Anschutz Medical Campus

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