Announcement from the Vice Dean for Clinical Investigation

Johns Hopkins School of Medicine Clinical Research Restart Update

 

July 17, 2020

Clinical research activity at Johns Hopkins continues to increase as Johns Hopkins Medicine reopens. With the cooperation of many research teams and the dedication of people on multiple committees, we have seen thoughtful approaches to reopening that are balancing safety of research participants and staff with the benefits of new information that our research protocols provide.

Our research restart committees are reviewing applications within days and have no substantial backups.  We have given therapeutic protocols the opportunity to open first but we are now broadening the types of protocols that can be submitted.  We are accepting observational protocols where data collection occurs during clinical visits.  We expect to accept additional protocols sometime in the near future.

In the next few weeks we will be asking research teams to complete “pulse surveys” on your experience with restarting research. These brief surveys provide essential information about whether we are being successful enrolling and completing research protocols across our broad research enterprise.

We want to support all research teams to successfully open up their clinical research protocols as soon as possible.  If you are still facing significant barriers please reach out to the groups listed below.

 

Clinical Research Space Reviews

Over 300 plans for research staff to return to a safe work space have been submitted and are either approved or under review by Departmental Research Restart Review Committees. The form and FAQ are posted at https://ictr.johnshopkins.edu/coronavirus/researchrestart/  As a reminder, for shared spaces/offices, the occupancy should not exceed 1 person/100 square ft.

 

Human Subjects Research Protocol Review and Approval

The Human Subjects Research Protocol Restart Committee (HSRPRC) has completed review of 276 submissions and is currently reviewing an additional 47 submissions.  In parallel, the designated Sidney Kimmel Comprehensive Cancer Center restart subcommittee has reviewed and prioritized their second wave for clinical research restart, leading to a total of 187 protocols identified to move forward to the IRB.  Over half of these protocols have been approved by the IRB to restart.  As a reminder, in addition to therapeutic or interventional studies conducted in Johns Hopkins clinical facilities, the HSRPRC will accept applications for restart for studies that meet the following criteria: Observational or other minimal risk studies where ALL in-person procedures occur during routine standard of care clinical visits or during research visits previously approved to restart which have minimal participant interaction in terms of duration or activity (e.g., collection of blood or other biospecimens, research quality vital signs).  More information on the HSRPRC, including access to the application form, can be found on the IRB website at: https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information.html/index.html

 

IRB Protocol Review and Approval

The IRB continues to review requests to resume in-person activities/new enrollment for studies that have received approval from a designated research restart committee. The forms for submitting these requests and FAQs about the process are available at https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information/index.html  To date the IRB has approved 231 petitions to resume in-person interactions/new enrollment.

The IRB’s website is updated regularly with new information to assist researchers with the restart process. Please visit the FAQs for Resuming Research with Human Participants at https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information/resuming_research_faq.html for answers to your restart questions. Investigators who need assistance are encouraged to register for virtual office hours, held twice weekly to assist research teams with their restart questions. For more information about virtual office hours please visit the IRB’s website at https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information/index.html.

 

 

Thank you,

Daniel E. Ford, MD, MPH
David M. Levine Professor of Medicine
Vice Dean for Clinical Investigation
Director, Institute for Clinical and Translational Research