Principal Investigator Plans for Human Subjects Research Staff for Reopening

 

June 12, 2020

 

Dear Colleagues:

The university is adopting a phased plan for re-opening human participant research in line with its overall plan for re-opening. In preparation for having research staff and appropriate trainees access their research workspaces, each principal investigator (or group of investigators who share staff) needs to complete a clinical research reopening staff form. This form is separate from the processes to submit your human participant protocols for review for reopening.

The form targets the plans for providing a safe work space for clinical research staff. This space plan only covers the space which is not formally managed clinical space, or “non-clinical space”. We are defining clinical space as space under the supervision of health system clinical operations in terms of patient safety, equipment and cleaning.

When completing the form, principal investigators should consider all research staff who report to them as well as trainees where “non-clinical” space is their primary work space. Principal investigators should report on all staff including those already designated as essential personnel and those working exclusively on COVID studies.

The form additionally asks for names of clinical research staff who work only in formally managed clinical space so that we may build a database of all clinical research staff in the SOM. However, we are not evaluating space plans for those staff.

Guiding Principles Consistent with JHU Guidelines:
    • Research activities that can be accomplished appropriately at home via telework should be continued at home.
    • Maintain low density in work spaces to minimize risk to staff while allowing human subjects research to restart per the phased plan.
    • Provide a safe environment for research staff to work including access to personal protective equipment, social distancing per guidelines and appropriate training.
    • Assure work environments meet regular cleaning standards and have plans for appropriate cleaning should a staff or participant be identified as COVID+.
    • Every individual returning to work on-site must conduct personal safety practices of daily reporting of symptoms, universal face coverings, social distancing, and hand washing.
    • Research staff in clinical settings will follow up-to-date guidance for working in those settings.
    • Research staff working in office and other environments must maintain social distancing practices of being 6 feet apart and masking unless working alone in private offices with closed doors.

Today we write to inform you that the portal for submitting this form is open https://jhmi.co1.qualtrics.com/jfe/form/SV_dj4u01QByidlmYt

 

The Process:
  1. Principal investigators complete this form online.
  2. When completed, the form will be transmitted to principal investigator’s department.
  3. Departmental Research Restart Committees will review the submissions with input as needed from the School of Medicine.
  4. After review the Principal investigator will receive an email confirming the plan has approval.
  5. For PIs who share or pool staff, the PI who has the primary responsibility for the oversight of the research staff person should submit the plan.

We have posted a FAQ for the form here:

https://ictr.johnshopkins.edu/wp-content/uploads/faq-survey-form-6-12-20-1.pdf

For technical questions about the form submission please contact Mia Terkowitz. mterkow1@jhmi.edu.

For questions about your research space or the review process please contact your Departmental Restart Committee representative or Gail Daumit gdaumit@jhmi.edu.

The Sidney Kimmel Cancer Center and All Children’s Hospital will be using an internal process and principal investigators do not need to complete this form.

Thank you very much for working with us on the reopening process. We realize it is challenging, and we look forward to supporting you resuming your important clinical research work.

 

Sincerely,

Daniel E. Ford, MD, MPH
David M. Levine Professor of Medicine
Vice Dean for Clinical Investigation

Gail Daumit, MD, MHS
Vice Chair of Research Department of Medicine