Announcement from the Vice Dean for Clinical Investigation
COVID Clinical Research Update
April 3, 2020
As the COVID-19 epidemic continues to grow we are writing to provide important updates for research involving human participants.
- New enrollment and continued in-person research activities are now only permitted for Tier 1 studies.
- PIs can no longer make their own determination that their study qualifies as Tier 1. In all cases, where continued in-person activities or new enrollment is desired, prior approval must be obtained from either the IRB, SKCCC (for cancer-related research) or the JH-ACH review committee (for research conducted at Johns Hopkins All Children’s Hospital).
- Even within Tier 1 where continued in-person activities are approved, no in-person research-only visits are permitted where research participants are traveling from a location where the Governor, District authority or responsible national government has issued a no travel order. For example a research participant could not travel for a research only biopsy from a location with travel restrictions. If the participant was scheduled for a clinical follow-up visit an in-person research activity could occur at this visit.
- The IRB will no longer accept requests to continue in-person activities for Tier 2 studies.
- As previously announced, research activities may continue for studies in Tier 2 and Tier 3 provided that the activities do not involve any in-person interaction.
Important Considerations for Continued Study Activities
Personal Protective Equipment (PPE)
PPE continues to be a valuable resource. Johns Hopkins Medicine is proactively managing use because of high probability of increasing demand in the future weeks ahead. Study teams approved to continue in-person research activities must be mindful that use of PPE is prioritized for clinical care purposes and should not be diverted for research use. If you have a need for PPE for critical research please contact Dr. Daniel Ford.
COVID related research continues to be prioritized as we work to contribute to the prevention, mitigation and treatment of this disease.
All protocols are reviewed by the Johns Hopkins Clinical Research Coordinating Committee before submission to the IRB. The IRB has set up a COVID IRB committee that is scheduled to meet daily. Active COVID protocols are listed on this website. https://ictr.johnshopkins.edu/coronavirus/covid-johns-hopkins-clinical-research-coordinating-committee/
Please check the ICTR’s website for updates frequently as new opportunities to contribute to COVID-19 research will be posted on this site.
Daniel E. Ford, MD, MPH
David M. Levine Professor of Medicine
Vice Dean for Clinical Investigation