Plans for Johns Hopkins University School of Medicine Principal Investigators
who Supervise Staff involved in Human Participant Research
The university is adopting a phased plan for re-opening human participant research in line with its overall plan for re-opening. Individual research protocols will be reviewed for re-opening by committees at each school. This form is targeting 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 this form, principal investigators should consider all research staff who report to them as well as trainees where “non-clinical” space is their primary workspace. Principal investigators should report on all staff including those already designated as essential personnel and those working exclusively on COVID studies.
Please note, this 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. For shared work spaces the occupancy should not exceed 1 person per 100 square feet.
- 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.
Process
- Principal investigators complete this form online.
- When completed, the form will be transmitted to principal investigator’s department.
- Departmental Research Restart Committees will review the submissions with input as needed from the School of Medicine.
- After review the Principal investigator will receive an email confirming the plan has approval.
Additional Information about This Form
- This form is separate from the processes to submit your human participant protocols for review for reopening. The documents are covering different aspects of human participant research.
- This form primarily asks for information on staff. The Human Subjects Research Protocol Restart Committee that reviews protocols will explicitly review the research participant experience and availability of clinical resources to support the research.
- For PIs who share or pool staff, the PI who has the primary responsibility for the oversight of the research staff should submit the plan.
- After review and any needed modifications, the Principal Investigator will receive an email confirming the plan has approval.
- If you have questions about this survey, please contact your Departmental Research Restart Review Committee or Gail Daumit, gdaumit@jhmi.edu. For technical questions about the survey, please contact Mia Terkowitz, mterkow1@jhmi.edu.
If you are not able to complete this form in one sitting, you may return to it later by pressing "next" to save your responses and re-opening the form in the same device and browser in which you started the form. If you are submitting a new version of the form, you will be asked to complete the entire form and to specify a version number.
Prior to completing this form, please review the FAQ document: https://ictr.johnshopkins.edu/wp-content/uploads/faq-survey-form-6-12-20-1.pdf