Announcement from the Vice Dean for Clinical Investigation- Clinical Research Restart Progress
At this time all clinical research protocols are eligible for restart except those with high risk aerosolizing procedures or in person group interventions.
October 2, 2020
The central SOM restart committee continues to receive about 50 applications per week. The Clinical Research Restart Committees and the IRB have approved 1163 protocols for restart. It is difficult to know how many protocols that were paused are still preparing to restart but we would recommend teams close or reopen their protocols. There is no substantial delay for either committee to review the applications.
Our data in CRMS indicate the rate of current enrollment in clinical trials is about 50% of the rate before the COVID-19 epidemic. This suggests significant room to increase our enrollment in clinical trials.
We are using Pulse surveys to have some sense of research teams’ current experience. Around 40 research teams have completed the survey. Responses indicate that most teams find recruitment and retention somewhat more difficult than before the COVID pandemic. They report gaining trust of patients and arranging visits being common barriers. Almost 90% indicated the environment was safe for research participants and that Johns Hopkins should continue to expand clinical research activities. Please continue to complete these surveys to help us determine why enrollment rates remain low. We are also holding a number of informal town halls to learn more about the experiences of research teams so please look for these notices on the ICTR website.
New Resources for Research Teams
New Support for Remote Consent Process
To enable the research consent process to occur remotely, we have signed a contract with DocuSign, a Part 11 compliant e-consent tool that may be used to document the research consent process that meets all FDA requirements. The implementation of DocuSign is being overseen by a Steering Committee dedicated to ensuring research teams have the training, support and tools needed to use DocuSign effectively. Two initial pilot studies will begin using DocuSign in October. Feedback from the pilots will help enable broad roll-out of DocuSign. If no barriers are found we expect DocuSign to be broadly available around December 1. We will provide guidance on how the econsent REDCap process complements the DocuSign approach.
New Support for Payment of Research Participants
We are aware that research teams have been frustrated by the available methods to pay research participants or reimburse them for travel. A university committee is in the final stages of selecting a new vendor who should provide a streamlined approach that will be easier for research teams and more acceptable for research participants.
Task Force on Diversity, Equity and Inclusion in Research
Daniel Ford has asked Mary Catherine Beach and Megan Singleton to Co-Chair a Task Force essential to the mission of Johns Hopkins. This task force has been convened to examine issues around diversity, equity and inclusion in research at the Johns Hopkins Medical Institutions. The task force includes four subcommittees that will focus on how these issues impact research participants in relation to gender, race and ethnicity, language barriers and disabilities such as learning, hearing, visual, or physical impairments. The subcommittees are chaired by Tanjala Purnell, Vered Stearns, Sharon Solomon and Kathleen Page. Each subcommittee is charged with defining a vision for diversity, equity and inclusion in research, examining current policies and practices that promote or inhibit this vision, and making recommendations to ensure the vision may be achieved. As the Task Force progresses through their work there will be opportunities for the broad research community to provide input.
COVID-19 Related Resources
ICTR COVID-19 Clinical Research Center
The ICTR has opened a new COVID-19 Clinical Research Center directed by Mark Sulkowski. The Center includes support for recruitment and conduct of studies. Two new Clinical Research Units (Bayview Medical Center and Greenspring Station outpatient center) are open for research on patients that are COVID +. Please follow the ICTR website to learn about additional resources as they become available. There will be a town hall from 12N-1PM on October 14 to describe the best ways to work with the new Center.
COVID-19 Testing in Asymptomatic Research Participants
In certain circumstances COVID-19 testing may be determined to be appropriate as a requirement for research participation. Requirements for testing may change based on COVID+ rates in the community, University and health system guidelines, and participant expectations. Following Johns Hopkins Health System guidelines negative COVID-19 tests would be required 72 hours before they participate in the research protocol. Testing for asymptomatic research participants may be required in the following situations:
- The study sponsor requires COVID-19 testing to establish eligibility or as a required study procedure.
- The study includes procedures for which clinically, testing in asymptomatic individuals is recommended or required. Click https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_testing_absence_of_symptoms.pdf for current Johns Hopkins Health System guidelines for testing in the absence of symptoms.
- The study includes procedures that involve aerosolization, exercise or forced ventilation.
- The study includes overnight stays or admissions.
- The IRB determines that testing is necessary to minimize the risks of the study. Factors the IRB may consider include a) prolonged exposures with frequent or continuous participant-staff interaction, especially if in close proximity and/or an enclosed space, b) the vulnerability of the targeted population (e.g. the participant is receiving an immune-suppressant medication or unable to accurately report COVID symptoms), and c) the ability of participants to follow standard safety protocols (e.g. safe distancing, avoiding groups, etc.).
In cases where COVID-19 testing is required, research teams should follow this process:
- Order the COVID-19 test through EPIC. The person who orders the test can select asymptomatic testing and check the “IRB Required Testing” option. The research participant will have all the same options for multiple testing locations, Saturday hours, self testing (swab in their car), turnaround time of 48 hours or less as do patients getting COVID-19 testing before clinical procedures. COVID-19 testing that is ordered in this manner and documented in EPIC will be charged to the relevant study account so the participant and their insurance will not be billed.
- Develop a plan for informing potential research participants about the requirement for COVID -19 testing, including the risks/benefits of COVID-19 testing and how positive COVID-19 test results may impact study participation. In certain cases the sponsor may revise the consent form to include this information. Alternatively, an IRB-approved oral consent script or consent form for COVID-19 testing may be used.
- Ensure there is a plan in place to follow- up on COVID-19 test results and not proceed with the research procedures until the test results have been reviewed.
Please Note: Study teams may accept test results from any testing participants seek outside of Johns Hopkins Health System, as long as documentation of the test result is provided by the participant to the study team. However, in these cases, the participants may be responsible for covering the costs of any charges for the testing.
Research teams can work with the Clinical Research Support Services Office to establish the process for paying for the test and how the research sponsor will be billed for the cost of the test.
Study teams requiring assistance with developing plans for testing are encouraged to register for the IRB’s 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 ( https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information/index.html ) or contact the IRB’s help desk at email@example.com.
Daniel E. Ford, MD, MPH
David M. Levine Professor of Medicine
Vice Dean for Clinical Investigation
Director, Institute for Clinical and Translational Research