Announcement from the Vice Dean for Clinical Investigation
Johns Hopkins School of Medicine Clinical Research Restart Update
June 26, 2020
All the applications and review processes for clinical research restart updates are functioning at full capacity. Teams should continue to promptly submit the documentation they need to restart their protocols and start recruiting research participants. There are no significant delays for time to review.
There have been many questions raised about when protocols enrolling patients for observational and biospecimen collections where all in-person procedures occur during routine clinical visits can restart. JHU leadership now agrees that these studies can be started in Phase 1. Applications to restart these observational/biospecimen collection studies can be submitted to the Humans Subjects Research Protocol Restart Committee beginning on July 13. By that time we expect that many of the therapeutic trials will have been reviewed. These studies must meet the following definition:
Observational or other minimal risk studies where ALL in-person procedures occur during routine standard of care clinical visits and have minimal participant interaction in terms of duration of activity (e.g., collection of blood or other bio-specimens, research quality vital signs).
We are recommending that protocols where K recipients are PI, there is sponsored funding, or where the biospecimen collection is tied to an event like a procedure submit their protocols first.
One consequences of the COVID-19 pandemic on clinical research has been a move to a remote consent process. Johns Hopkins research teams have been using various approaches for low risk studies but they did not have an option for high risk FDA regulated studies. We are currently in negotiation with DocuSign to provide an FDA compliant approach for remote consenting that will meet all of the compliance standards. In addition it should provide an understandable approach for research participants who might have previously had some experience with DocuSign. We hope to have DocuSign ready for use in the near future.
Clinical Research Space Review and Approval
Almost 250 plans for research staff to return to a safe work space have been submitted and are under review by Departmental Research Restart Review Committees. The form and FAQ are posted on 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 86 submissions and is currently reviewing an additional 58 submissions. In parallel, the designated Sidney Kimmel Comprehensive Cancer Center restart subcommittee has reviewed and prioritized 92 studies for clinical research restart. As a reminder, only studies conducted in Johns Hopkins clinical facilities are eligible for restart in Phase 1. 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 is now accepting 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 on the IRB’s website. To date, the IRB has approved 34 petitions to resume in-person interactions/new enrollment.
The IRB has also launched Virtual Office Hours specifically dedicated to research restart. Study team members with questions about the process may submit a request to the IRB’s Help Desk at firstname.lastname@example.org to register for Virtual Office Hours. The schedule for Virtual Office Hours is available on the IRB’s website.
Daniel E. Ford, MD, MPH
David M. Levine Professor of Medicine
Vice Dean for Clinical Investigation
Director, Institute for Clinical and Translational Research