Initial Review Process for COVID-19 Clinical Research Protocols Seeking Approval During the Pandemic

March 16, 2020

Dear Research Community Colleagues:

Thomas Flaig, MD, Vice Chancellor for Research and John Reilly, MD, Dean of the University of Colorado School of Medicine and Vice Chancellor for Health Affairs for the University of Colorado Anschutz Medical Campus have put together a COVID-19 Coordination and Prioritization Committee.  Given limited access to the hospital, this committee will evaluate COVID-19 clinical research protocols that are seeking approval during the coronavirus outbreak.

Research Administration is providing organizational support and expertise to the committee; however, they are not the ultimate decision makers.

Committee members will vary based upon service and availability of rotating faculty from the infectious diseases, pulmonary sciences division as well as bioethics.  With the current pandemic, these faculty are very aware of the changing hospital environment. Once the COVID-19 Coordination and Prioritization Committee recommends the protocol move forward, normal regulatory review is needed and then hospital approval.

The implications being considered by this committee in evaluating inpatient COVID-19 trials include:

  1. The impact on the clinical environment – research cannot impede clinical care especially in this time of increased clinical patient load during the pandemic.
  2. Use of PPE – PPE is an essential, limited resource thus the use for research purposes is difficult to justify without strong rationale.  This research must be done in conjunction with clinical care whenever possible.
  3. Risk to the study teams - being in the clinical environment during the pandemic period will put the research teams at risk – the hospitals have restricted access to these researchers.
  4. Strong preliminary data to support the project – the risk / benefit for each protocol must be significant to warrant the additional stress to the hospital system at this time.
  5. Avoidance of competing trials – considering the difficult clinical environment, the evaluation of an COVID-19 research involves setting scientific priority in the context of clinical care; therefore needing to select trials carefully so that patients aren’t approached by multiple research groups.

If you are interested in conducting COVID-19 research, complete the protocol summary template:

UCD COVID Protocol Synopsis Template 3.2020

If you have additional questions or concerns about this process contact or 303-724-1111.


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