Guiding Priciples: Guidelines for Resuming Clinical Research Activities

Our goal is to resume clinical research activities on campus, to the extent that is possible during the COVID-19 pandemic. It is important to acknowledge recent modeling suggests the number of new infections will not peak until mid-August, and that may change depending on how many new infections occurred during the recent civil unrest. With this in mind, we are developing plans for resumption of clinical research activities with these guidelines:

Parameters

  • Safety remains our top priority.
  • This will be a staged sunrise based on patient and staff safety, resources, and investigator priorities.
  • Not every clinical study will be allowed to resume on campus in the first steps of the sunrise process. For example, if the patient population is at particular high risk for COVID-19, the study may not be allowed to resume at this time.
  • Any clinical research that is dedicated to COVID-19 will continue to do that work as a priority.
  • Every effort should be made to change protocols to do as much by virtual visit as possible. Most industry-sponsored studies and NIH clinical trials have been open to adaptation of the protocol to make it as safe as possible.
  • The OVPR/HRPP/IRB will need to sign off on any plan to resume a clinical trial or clinical research.

Employees

  • At this point in time, the return to work is voluntary. Some employees will remain uncomfortable returning to work, and this should be addressed on a case-by-case basis with supervisors.
  • If work can be done from home, it should continue to be done from home.
  • Those with medical conditions associated with increased risk of severe infection should not return to work until all restrictions are lifted and they feel safe returning to work.
  • Please see the Human Resources Toolkit for information on what to do if an employee has a known exposure to COVID-19 or a positive test.

Logistics

  • Social distancing must be maintained at all times. That means always maintaining a distance of 6 feet from colleagues and wearing a mask at all times in Medical School and OACA space. Work schedules should be staggered.
  • Any employee with symptoms of COVID-19 should get tested and remain home in quarantine until they can safely return to work.