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Clinical Research Restart Guidelines - July 31 Update
Subject: Johns Hopkins School of Medicine Clinical Research Restart Update July 31, 2020
From: Daniel Ford, M.D., M.P.H., Vice Dean for Clinical Information
We have important news to share with the Johns Hopkins research community. We are ready to expand the scope of protocols that can be restarted. For a full description of the human subjects research restart plan, please see the attached Human Subjects Research Restart Guidelines that will soon be posted to the Hub within the overall University Research Restart Plan.
Starting August 3, 2020 all protocols are eligible for reopening except those that include research participant group activities (greater than 1 research participant plus a parent or LAR not sharing the same household seen at one time) or include high risk aerosolizing procedures (such as sputum induction, pulmonary function tests in nonclinical space, sputum culture, pulmonary exercise test). The setting for the procedure, the ability of the research participant to cooperate with instructions, and the procedure itself will be factored into the determination regarding the procedures that qualify as high risk aerosolizing procedures. Research teams may also decide to eliminate these procedures from the protocol so research activity can move ahead.
Please carefully review the section titled “JHU Return to Research Guidance” on the IRB website at: https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information.html/index.html . This section includes resources prepared to guide study teams through the restart process. We will now accept protocols that did not fall into our previous posted categories. If you have submitted this type of study previously and received an automated response from Qualtrics saying that the HSRPRC was not accepting applications for studies such as this for restart at this time, please access the updated HSRPRC survey which is currently available and resubmit the application so we have the necessary information required for review. The Restart Committees and IRB will continue to prioritize studies with potential benefit for research participants.
Human Subjects Research Protocol Review and Approval
The Human Subjects Research Protocol Restart Committee (HSRPRC) has completed review of 476 submissions. In parallel, the designated Sidney Kimmel Comprehensive Cancer Center restart subcommittee has reviewed and prioritized their third wave for clinical research restart, leading to a total of 309 protocols identified to move forward to the IRB. More information on the HSRPRC, including access to the application form, can be found on the IRB website listed above.
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 on the IRB’s website ( https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information/index.html ). To date the IRB has approved 346 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 for answers ( https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information/resuming_research_faq.html ) 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.
Clinical Research Space Reviews
Over 330 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 the ICTR website. https://ictr.johnshopkins.edu/coronavirus/researchrestart/ As a reminder, for shared spaces/offices, the occupancy should not exceed 1 person/100 square ft.
Daniel E. Ford, MD, MPH
David M. Levine Professor of Medicine
Vice Dean for Clinical Investigation
Director, Institute for Clinical and Translational Research