Announcement from the Vice Dean for Clinical Investigation
Plan for the Return of Research with Human Participants at Johns Hopkins
June 12, 2020
As efforts are underway to carefully consider the re-opening of activities across the University and Health System it is important that our research community prepares for a return of non-COVID-19 related research. While we do not yet know the exact time when restrictions for research with human participants will be lifted, we know that grant submissions, contract negotiations, and IRB activity have remained at a high level. Many research teams have maintained remote contact with research participants and we are all waiting to restart our important research programs.
As clinical activity resumes at Johns Hopkins facilities, coordination between research and clinical activities is important to limit density and ensure appropriate resource allocation. Our plan for restarting is based on the principles set forth in University’s guidelines for phased re-opening of research. This includes protecting all staff, trainees and research participants, facilitating a gradual reopening, and synchronizing with requirements based on the Governor’s office and regulations related to restart of clinical operations in the health system. Further details about the clinical research restart plan, including details about the specific phases for resumption of clinical research will be forthcoming.
Our goal is to increase research activity involving human participants in a safe, phased, systematic approach with consideration for the following:
- Providing a safe and supportive research experience for our research participants
- Creating a work environment where both social distancing and appropriate use of personal protective equipment (PPE) keeps our research staff healthy
- Integrating research into a health care system that is still feeling the strain of the COVID-19 epidemic where supplies and service areas may be limited
In light of these considerations, it is important that we prioritize the re-opening of research and that the first research protocols to restart are those where research participants can directly benefit and where delays to research re-start have direct consequences for participants. Thus, the initial Phase of Clinical Research Restart aligned with Phase 1 of the University plan will focus on therapeutic trials/Interventional studies with potential for direct benefit to study participants conducted in Johns Hopkins clinical facilities. Studies with limited or no prospect of direct benefit will not be included in Phase 1. Studies for which there is no in-person interaction, studies that can be modified by submitting a change in research to the IRB to permanently alter the study so it may proceed without in-person interaction, and COVID-19 related research are exempt from this re-opening process.
The following steps will be required to restart clinical research:
- Submit a Human Subjects Research Re-opening Plan for research staff to return to campus.
- This process is similar to the process that the lab research community is completing and requires that research teams submit a plan for staff to return to a safe work space when it is required to complete necessary research. This process applies only to non-clinical work spaces and is not required for staff working within clinical space. Departmental Research Restart Committees will approve the plans with input as needed from the School of Medicine. Approval is required before research staff can return to the proposed workspaces. The workspace form and instructions will be forthcoming later today.
- Apply to the Human Subjects Research Protocol Restart Committee or a designated subcommittee (Sidney Kimmel Comprehensive Cancer Center or Johns Hopkins All Children’s Hospital) for permission to restart research on a specific protocol. The highest priority will be given to PIs with therapeutic trials with potential for direct benefit to study participants conducted in Johns Hopkins clinical facilities where no standard of care options exist.
- These committees will approve that the research team has developed a plan that protects research staff, protects research participants and has a plan for coordinating with clinical and university resources. These Committees will review and provide required approval to restart both ongoing research and new studies. More information on the submission process can be found on the IRB website (https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information.html/index.html).
- Once the Human Subjects Research Protocol Restart Committee has approved your study to move forward to the IRB, apply to the IRB for permission to restart human subjects research. Applications to the IRB will not be accepted until protocols have received approval by a designated restart committee.
- The IRB must determine if any action is required related to changes to the conduct of the study that occurred during the COVID reduction period and will assess if all necessary changes to minimize research participant risk have been implemented. Additional information about the submission process to the IRB will be forthcoming on the IRB’s website.
At this time the specific date(s) when JHU will initiate and progress through the various phases of the restart are not known. However, research teams should complete step 1 for any clinical research staff that require access to campus during the initial Phase of the University Research Restart Plan and step 2 for therapeutic protocols conducted at Johns Hopkins facilities, starting with those where no standard of care options are available. The applications for step 1 and step 2 will be available later today.
The ICTR website (https://ictr.johnshopkins.edu/coronavirus/researchrestart/) will contain the links to the forms required for restarting. Please check this website regularly for any updates to the process for restarting human subjects research.
As we reopen our comprehensive clinical research program I know we will work together to identify and address any barriers as quickly as possible. I appreciate your resilience during this time and your commitment to your participants and staff. We have worked for many years to gain the trust of our research participants by providing them with a safe and respectful experience. I fully expect we will efficiently get back to this same position and continue our excellence in clinical research discovery.
Daniel E. Ford, MD, MPH
David M. Levine Professor of Medicine
Vice Dean for Clinical Investigation