Johns Hopkins Human Subjects Research Moves to Phase 3 of the Contingency Plan March 22
March 19, 2020
As the need for social distancing increases, the number of Johns Hopkins faculty and staff on site is decreasing even in the clinical areas. Research participants may be less willing and facing even greater risks to come to our facilities. Demands for remaining clinical care resources continue to increase, making it more difficult to safely complete research. We must prioritize safe clinical care and practices that minimize spread of COVID 19. Informed advice about how long clinical research activities will be reduced is difficult to give, as the situation is changing rapidly. As you plan for what to do with your own research protocols, our current advice is to assume there will be no decrease in restrictions for at least two months. We will update you as soon as there is any change in how the COVID-19 pandemic is impacting our local community.
What does it mean for JHU to move to Phase 3 of the Contingency Plan for Human Subjects Research?
Please refer back to our classification of research protocols into the three tiers: https://hub.jhu.edu/novel-coronavirus-information/research-preparedness/research-preparedness-human-subjects/
COVID research remains a research priority because of societal need for information. All COVID protocols must still have IRB review and approval before starting enrollment.
For Tier 1 oncology studies, the Sidney Kimmel Cancer center has developed a committee to make decisions about enrollment of new subjects at the individual patient level. Requests for oncology-related research enrollments in Baltimore or Sibley is being organized by Dr. Michael Carducci.
Johns Hopkins All Children’s Hospital (JH-ACH) is following a similar process and created a prioritization committee to review enrollment in Tier 1 protocols. All requests for review of Tier 1 protocols, to determine if enrollment may continue, should be submitted to Neil Goldenberg at firstname.lastname@example.org.
Researchers who are not affiliated with the cancer center or JH-ACH need to work with their IRB to get permission to enroll any individual in a Tier 1 study.
Given the increased risk of exposure caused by this pandemic, all Tier 2 studies must stop in-person research visits on enrolled participants unless the PI petitions the IRB and demonstrates a compelling need to continue. When PIs petition the IRB to continue in-person research activity, they should reference the issues outlined in the “Research Considerations” section of the contingency plan found here: https://www.hopkinsmedicine.org/institutional_review_board/news/letters_dean/archive/20200311_covid19.html. No new enrollment has been allowed in these Tier 2 studies and this restriction continues. Sponsors should be consulted as some sponsors have chosen to pause protocols either for continuing or new research participants.
The FDA published a statement that they are aware of how the COVID pandemic has been a disruption to clinical research and provided suggestions for management. The FDA guidance reinforces the need for the study team to document any changes to the conduct of the study. View the guidance document here: https://ictr.johnshopkins.edu/coronavirus/fda-guidance-on-conduct-of-clinical-trials-of-medical-products-during-the-covid-19-pandemic/.
As outpatient clinical areas become less resourced, consider moving the small amount of essential research to the Clinical Research Units (CRU). The CRUs remain open and staffed at this time.
Before moving any research to the new location, please contact these individuals:
- JHH Outpatient CRU Todd Brown email@example.com
- Bayview CRU Suzanne Jan De Beur firstname.lastname@example.org
The requirements for Tier 3 protocols are unchanged. Studies can only continue if they do not involve face to face interaction. IRBs do not need to approve a shift to this approach unless it requires a change in the consenting process such as moving face to face consent to telephone/online consent. For questions about changes in research, please contact your reviewing IRB.
Process for Petitioning the IRB for Continued Enrollment or Study Interventions in Tier 1 or Tier 2 Studies
We expect PIs to provide a strong and compelling statement in order to be given permission to continue their research.
For Tier 1 studies, not subject to the SKCCC or JH-ACH reviews noted above, the PI must petition the IRB to allow new enrollment. PIs with ongoing research may petition the IRB by submitting a “Change in Research Application” outlining the compelling reason for continued enrollment. For new Tier 1 protocols seeking initial approval, PIs should provide this justification with their submission so the IRB may determine whether the study may open to enrollment at the time of approval.
For Tier 2 studies, the PI may petition the IRB to permit in person study activities to continue by submitting a “Change in Research Application” outlining the compelling reason for continuing in-person study activities. Please consult the IRB’s website for tips in preparing these submissions. While the IRB will work to prioritize time sensitive requests, no in-person research procedures may continue in Tier 2 studies until the IRB has approved the request.
It may be helpful to the teams to consult this document on additional considerations related to continuation of clinical research: https://www.hopkinsmedicine.org/institutional_review_board/news/letters_dean/archive/20200311_covid19.html.
As you develop your petition, you must consider both the study team resources and the availability of health system resources such as use of radiology and nursing services. Health system personnel and research team members can challenge the PIs determination of whether a study is in Tier 1 or Tier 2. In that case, the IRB will make the final determination.
Working with the Investigational Drug Service
The FDA issued a guidance that contemplates that sponsors may determine that home delivery of study drugs may be appropriate for studies where self-administration is the typical form of administration of the drug. Before proposing to ship investigational product to study participants, you should first contact the study sponsor to determine whether they are proposing to make changes in drug delivery and whether the drug can be safely shipped and administered at home. You should also consult with IDS, which has updated its guidance https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information.html/IDS_guidance_COVID19_pandemic.pdf. Note that you must develop a plan for investigational product accountability and may only ship in accordance with hazardous shipping policies.
Identification of Essential Personnel
Identifying essential personnel for clinical research requires some thought because research team members may also have a need to provide clinical care. The goal is to limit the possibility that research staff will be too close to each other and unable to meet the social distancing needed to halt the spread of the COVID-19 virus. Work with your departments to identify essential personnel who might need to access buildings for brief tasks (such as checking freezers and briefly reviewing paper research records). If they are not listed as essential personnel, they will not have access to certain Johns Hopkins buildings.
Research Activities that Should Continue
Research teams can still work on data based activities, manuscript preparation and grant applications. At this point the IRB offices are ready to review new proposals. New proposals that involve in person interaction may be approved by the IRB but not allowed to be activated for study enrollment. New proposals that do not involve any in person interaction may be approved and activated for study enrollment.
Daniel E. Ford, MD, MPH
David M. Levine Professor of Medicine
Vice Dean for Clinical Investigation