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COVID-19 FAQs

May 2022

A. Making Adjustments to your Research Procedures
Q1. How can I get study drugs to participants who can’t come in to pick it up?
Q2. Are there any considerations for moving school-based educational research online?

B. Submitting COVID-19 Related Research to the IRB
Q1. Do I need to indicate in my new application, change in research or protocol event if the submission is related to COVID-19?
Q2. What should I do if I have a new application, change in research or protocol event that is related to COVID-19 that may need to be reviewed urgently?
Q3. Should my research administration office be notified when sponsored studies are put on hold due to COVID-19?
Q4. What will happen if I can’t meet my accrual goals due to COVID-19 restrictions?
Q5. When is Institutional Biosafety Committee (IBC) approval required for studies collecting biospecimens from subjects with COVID-19?

C. Participant Screening:

Q1. Do I have to call to pre-screen all participants before they come in for a scheduled research visit?
Q2. Do I have to submit a change in research application to add the COVID-19 screening questions to my protocol?
Q3. Where can I get the most up-to-date phone screen algorithm for calling participants?
Q4. Should I print the phone screen algorithm and give it to study coordinators to use?
Q5. If a patient is coming in for a visit that is primarily for clinical care and may incorporate research procedures can the research team defer to the clinical team for the screening?
Q6. If patients are at the clinic for clinical purposes and a study team member approaches them afterward, do we have to ask them the screening questions before proceeding with further conversation?
Q7. For teams that do not use EPIC, can they simply document the results of a negative screening in the research record? Should it be documented somewhere else since the screen was not directly part of the research protocol?

D. Single IRB (sIRB) Studies:

Q1. Johns Hopkins is the single IRB (sIRB) for my multisite study. Do relying sites have to follow Johns Hopkins restrictions?

E. In-Home Visits:

Q1. Are there any restrictions on research home visits already included in your approved research protocol?

F. Monitoring Visits:

Q1. My study receives scheduled monitoring visits from outside monitors from the study sponsor or contract research organization (CRO). What should I tell the CRO or sponsor monitors about visiting Johns Hopkins Hospital or other JHU location?
Q2. Are there any alternatives to in-person monitoring visits?
Q3. Are there existing resources that monitors and sponsors can use to access study source data?
Q4. The monitor will need to access IDS for IP accountability, how is that arranged?
Q5. If the monitor needs to access the ICTR facilities, how is that arranged?
Q6. Are there alternatives to onsite facility tours?
Q7. Who should I contact with questions?

G. Reporting COVID-19 related deviations to the IRB

Q1. My IRB approved study involves in-person visits, but because of the COVID-19 emergency, we have moved to an alternative means of interacting with our enrolled participants using electronic questionnaires instead of paper. Is this a deviation and how do I report and document this?
Q2. My IRB approved study only requires me to submit a progress report, instead of a Continuing Review Application, is there anything different in the way I report any COVID-19 related deviations in a progress report?
Q3. My IRB approved study does not require a Continuing Review or a progress report. How do I document any COVID-19 related changes that did not require IRB approval?
Q4. What should I do if there is a known research-related COVID exposure that impacts a research participant or study team member?

H. Quality Improvement Projects

Q1. I have an approved application for a student project that was determined to be Quality Improvement by the IRB. Since this is not research, are there restrictions on my project?

I. Requirements for COVID-19 Related Research and Public Health Surveillance Activity (PHSA) Targeting JHU/JHHS Employees

Q1. What are the COVID-19 requirements for research targeting JHU/JHHS Employees?

J. COVID Testing for Asymptomatic Research Participants

Q1. When may COVID testing be required for asymptomatic research participants?
Q2. In cases where COVID-19 testing is required, what steps should research teams follow?
Q3. Can study teams accept test results from outside testing?
Q4. Who can I work with to establish the process for paying for the test?
Q5: Are point of care tests available for testing of asymptomatic research participants?

A. Making Adjustments to your Research Procedures

 

Q1. How can I get study drugs to participants who can’t come in to pick it up?

A. If home visits are not practical or possible, you should contact the Investigational Drug Service and your sponsor to develop an alternative plan for getting drug to the participant. Please note that shipping study drugs to participants is subject to state and federal laws.

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Q2. Are there any considerations for moving school-based educational research online?

A. You must first consult each school system where the research is taking place, as each system may have different requirements and guidelines on contact of previously enrolled participants, re-consent, study-specific data collection procedures, and data protections. Some school systems may have paused all human subjects research activities or only certain types of activities. Based on the new information, you must submit a change in research (amendment) application that includes, at minimum, acknowledgement to follow any relevant local school-system requirements, revised school/principal permission letters, updated consent, assent, and parental consent forms, modified data collection instruments, an updated data security plan, and other IRB approval letter(s), if applicable.

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B. Submitting COVID-19 Related Research to the IRB

Q1. Do I need to indicate in my new application, change in research or protocol event if the submission is related to COVID-19?

A. Yes. It is important the IRB is able to accurately track all new applications, protocol events and changes in research related to COVID-19. Please insert the following phrase in each COVID-19 related application “COVID-19 RELATED SUBMISSION”

See below for specific instructions for each application type:

  • For new applications include this phrase in the study title
  • For changes in research please include this phrase in the summary of changes, Section 1, Item 3.
  • For protocol event reports, please include this phrase in Section 2, Question 12.

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Q2. What should I do if I have a new application, change in research or protocol event that is related to COVID-19 that may need to be reviewed urgently?

A. If you need a new application, change in research or protocol event related to COVID-19 reviewed by the IRB urgently, prior to submission please send an email to the IRB help desk at jhmeirb@jhmi.edu and follow that with a phone call to 410-502-2092. Please include your eIRB protocol number in the email to the help desk. Please cc the Associate Director of Operations, Ken Borst, at kborst1@jhmi.edu when emailing the help desk with urgent requests for review of COVID-19 related submissions.

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Q3. Should my research administration office be notified when sponsored studies are put on hold due to COVID-19?

A. Yes. Please notify your research administration office if a study, funded by a sponsored award is placed on hold. Notification may be sent to: ORA@jhmi.edu (SOM including for industry funded clinical trials); Bara@jhu.edu (KSAS); JHURA@jhu.edu (all others), or Swismer1@jhmi.edu (JH-ACH)

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Q4. What will happen if I can’t meet my accrual goals due to COVID-19 restrictions?

A. The IRB will keep this in mind when reviewing future continuing review applications. You should include a detailed explanation as to why you were not able to meet the accrual goals.

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Q5. When is Institutional Biosafety Committee (IBC) approval required for studies collecting biospecimens from subjects with COVID-19?

A. CDC requirements for virus handling differ depending on the work being done with the virus. As such, the specifics of your study activity may trigger different JHU Biosafety requirements. Please use the following rubric for determining which Biosafety approvals/registrations will be required for studies collecting biospecimens from subjects with COVID-19:

Will the specimens be used for any purpose other than analysis or diagnosis by a clinical laboratory?

  • If no Only a Human Tissue Registration from Biosafety will be required.
  • If yes Will the samples, whether collected via standard clinical care or specifically for research, be retained for future research, or used for some other research purpose, including but not limited to the isolation or culturing of the virus or other investigational purpose?
    • If yes­ – Will the Hopkins investigator only hold the samples collected temporarily so that they may be shipped to a sponsor or other outside entity for retention or performance of these activities?
      • If yes - Only a Human Tissue Registration from Biosafety will be required.
      • If no (and the retention for future research and/or the research activity will occur at JHM) – BOTH a Human Tissue Registration AND a Pathogen/Infectious Agent Registration approved by the IBC will be required. You must select "Potential infectious agents or viral-based vectors” in eIRB section 24 (Institutional Biosafety Committee) and upload documentation of IBC approval where prompted.

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C. Participant Screening:

Q1. Do I have to call to pre-screen all participants before they come in for a scheduled research visit?

A. Yes, if your study was approved for new enrollment, or a study approved for continued in-person visits, you must pre-screen all participants prior to the visit. You must call participants prior to their visit to the hospital to screen them before they arrive and cancel visits for those that give positive responses to the phone screen. Participants must be screened again when they arrive on site.

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Q2. Do I have to submit a change in research application to add the COVID-19 screening questions to my protocol?

A. No, this is an enterprise-wide screening procedure, not limited to human subject research. The screening can be implemented without approval by the IRB.

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Q3. Where can I get the most up-to-date phone screen algorithm for calling participants?

A.  The latest phone screen algorithm can be accessed on this page: https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_phone_triage.pdf . 

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Q4. Should I print the phone screen algorithm and give it to study coordinators to use?

A. No, you should go to the ICTR page daily to get the latest version of the algorithm. The link to the ICTR website is located here: COVID-19 Clinical Research Center - Institute for Clinical and Translational Research (johnshopkins.edu).

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Q5. If a patient is coming in for a visit that is primarily for clinical care and may incorporate research procedures can the research team defer to the clinical team for the screening?

A. Yes. If your study is approved to enroll new participants or a study that involves in-person research visits approved by the IRB, Sidney Kimmel Cancer Center or Johns Hopkins All Children’s Hospital Review Committee, where the clinical team will perform screening already, it is appropriate to defer to the clinical team and not repeat the screen.

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Q6. If patients are at the clinic for clinical purposes and a study team member approaches them afterward, do we have to ask them the screening questions before proceeding with further conversation?

A. Duplicate screening for research is not needed if clinical screening has occurred in the same visit.

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Q7. For teams that do not use EPIC, can they simply document the results of a negative screening in the research record? Should it be documented somewhere else since the screen was not directly part of the research protocol?

A. The screening results should be documented in EPIC, if the individual has an EPIC record for which you have access, so the data are easily available. Although less desirable, if EPIC documentation is not possible, a brief note documenting the screening took place should be made in the research record. However, the results of the screener should not be formally incorporated in the research record as this screening is not being performed for research.

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D. Single IRB (sIRB) studies:

Q1. Johns Hopkins is the single IRB (sIRB) for my multisite study. Do relying sites have to follow Johns Hopkins restrictions?

A: Johns Hopkins restrictions on human subjects research apply to Johns Hopkins research only. For multisite research where Johns Hopkins serves as the single IRB for other non-Hopkins sites, the Johns Hopkins /lead site PI should take inventory of each relying sites’ local policies/procedures and assess whether activities can continue at those sites. If a relying site decides that research activities at that site must stop or be limited, the JHM IRB cannot override that decision. The site only needs to report their local restrictions if their local IRB requires submission to JHM IRB.

In addition, we understand that some relying sites do not have local IRBs. Their organizational/hospital, rather than a local IRB, is responsible for setting the conditions based on local resources, how large the COVID-19 incidence is, and other local factors. Although local circumstances may vary, multisite PIs are encouraged to this broadly about their study as a whole and consider implementing restrictions that could accommodate the circumstances at all sites. As local circumstances may change on a daily basis, developing a study-wide plan that accommodates all site restrictions may be easier to manage.

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E. In-Home Visits:

Q1. Are there any restrictions on research home visits already included in your approved research protocol?

A. Home visits for research purposes may occur if continued activities are approved by the IRB, SKCCC or JH-ACH.   You are strongly encouraged to consider the specifics of the study population and the potential risks and benefits to the participants and research staff before conducting the visits. If you are doing home visits, you must conduct the COVID screening prior to and at each visit.

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F. Monitoring Visits:

Q1. My study receives scheduled monitoring visits from outside monitors from the study sponsor or contract research organization (CRO). What should I tell the CRO or sponsor monitors about visiting Johns Hopkins Hospital or other JHU location?

A. Please refer the study sponsor or contract research organization to the JHU COVID-19 Requirements for Visits by External Monitors and Site Initiation Visits. Remote monitoring remains the preferred approach and should be used when possible, however, in-person monitoring visits are allowed in accordance with current Johns Hopkins safety protocols. Study teams should be aware of current Johns Hopkins safety protocols which may impact whether an outside monitor can be on campus and follow all safety protocols as applicable. Study teams have had success shifty to remote visit. For specific resources see question three (3) below.

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Q2. Are there any alternatives to in-person monitoring visits?

A. Many study teams have successfully shifted to remote monitoring visits with the CRO or sponsor where study data and other materials can be securely reviewed electronically or by other non-in-person means. This can be done by utilizing platforms like Zoom or MSTeams to have remote calls with monitors. There are several options for remote monitoring accessible to JHM research staff which are addressed in Q3 below.

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Q3. Are there existing resources that monitors and sponsors can use to access study source data?

A. Yes. Sponsor and monitors outside JHU may utilize CareLink, a Web-based portal that permits real-time access to research participants’ electronic medical records (EMR), lab results and imaging reports. Study monitors are granted view-only access to a list of patients pre-populated in CareLink by the Johns Hopkins study team for monitoring. Study monitors will not have any capability to lookup other patients in the EMR besides those on the list. Use of the CareLink system is monitored by the study team.

Additionally, if study teams plan to share study documents or files with monitors refer to the FAQ which details the appropriate ways to share files. https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/file_sharing_with_monitors.html

Please see the following link for more information about CareLink and refer to the start-up guides: https://www.hopkinsmedicine.org/CareLink/research-study-monitoring.html

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Q4.  The monitor will need to access IDS for IP accountability, how is that arranged?

A. Contact the IDS directly for the appropriate campus (https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/pharm_jhh.html) to schedule an appointment for the monitor in advance of onsite monitoring. IDS space is limited and monitors may not be allowed in the pharmacy due to COVID-19 procedures and safety protocols. Plan accordingly, since IDS availability for scheduling is limited. Requests will be addressed as soon as possible, however, an advance notice of at least 10-14 days will be needed to finalize appointments, prepare for the visits, or to gather information.

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Q5. If the monitor needs to access the ICTR facilities, how is that arranged?

A. Contact ICTR faculties directly to schedule a time to visit the unit.

  • East Baltimore Campus Clinical Research Unit (CRU): Mary De'Jarnette (mdejarn1@jhu.edu)
  • JHBMC Bayview Clinical Research Unit (CRU): Marcie Dawson (mdawso13@jhmi.edu)
  • East Baltimore Campus Pediatric Clinical Research Unit (PCRU): Shaneeta Scott (sscott29@jhmi.edu)

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Q6. Are there alternatives to onsite facility tours?

A. Video or stills of the space/facilities may be possible to acquire to share information about space with monitors provided the video/stills captures only the facilities and no PHI, patients or employees and is approved by the facility director. If there are questions pertaining to use of video or stills contact IROC committee at cameraoncampus@jhmi.edu

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Q7. Who should I contact with questions?

A. You can contact the Compliance Monitoring Program at JHM_OHRP_CMP@jh.edu with any questions.

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G. Reporting COVID-19 related deviations to the IRB

Q1. My IRB approved study involves in-person visits, but because of the COVID-19 emergency, we have moved to an alternative means of interacting with our enrolled participants using electronic questionnaires instead of paper. Is this a deviation and how do I report and document this?

A. For reporting purposes, please log all “remote visits” in your deviation log, and submit it to the IRB at the next continuing review. For those visits conducted remotely, in the log, you may combine all incidents into one entry, listing the range of affected participants (e.g., participants 020-050), and the applicable visit numbers (e.g., visits 5-10) or dates (e.g., 4/1/2020-5/1/2020). Also, please indicate in the log that the deviation was in response to the COVID 19 Emergency.

For documentation purposes, please include a note-to-file, which can be inserted into your regulatory file or added to each participant’s research record, that the transition to a remote visit process. This information will be helpful for study sponsors and monitors.

If you will continue with remote visits, you must submit a change in research application to incorporate the changes into the protocol procedures. 

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Q2. My IRB approved study only requires me to submit a progress report, instead of a Continuing Review Application, is there anything different in the way I report any COVID-19 related deviations in a progress report?

A. No.  Follow the same process you would use to report COVID-19 related changes in a Continuing Review Application. Please see the answer above.

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Q3. My IRB approved study does not require a Continuing Review or a progress report. How do I document any COVID-19 related changes that did not require IRB approval?

A. Any COVID-19 related changes should be logged and related documentation uploaded to the IRB using the Problem Event Report (PER) action in eIRB. Once the COVID-19 restrictions are lifted, please file PER within 60 days.   

This log should include which participants were affected, the date(s) of the implemented changes, and other applicable information (e.g., the visits impacted by the change).  Please also place this document in your regulatory file/binder.

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Q4. What should I do if there is a known research-related COVID exposure that impacts a research participant or study team member?

A. If there is a research-related COVID exposure, the study team should immediately follow this procedure:

  1. Report the potential exposure to the JHU contact tracing team at: https://covidinfo.jhu.edu/health-safety/johns-hopkins-covid-19-call-center/ to determine if testing is recommended for any study team members/participants who may have been exposed.
  2. Notify the participant of the potential exposure and provide participants with any instructions shared by the contact tracing team.
  3. Submit a Protocol Event Report (PER) to the JHM IRB via a “Further Study Action” in the electronic eIRB system. In the PER, the PI should include the following: where the exposure occurred; whether appropriate protective gear was worn; whether the impacted individual(s) was notified of the potential risk; what follow-up action was required and was COVID transmitted. If corrective actions are needed to alter study practices to minimize future exposures, the corrective action plan must also be described in the protocol event report.

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H. Quality Improvement Projects

Q1. I have an approved application for a student project that was determined to be Quality Improvement by the IRB. Since this is not research, are there restrictions on my project?

A.  Yes. If the project does not involve in-person interactions, you may continue the project. If your project was on hold due to the in-person restrictions and you wish to resume in-person interaction, please submit a change in research to the JHM IRB. To secure this approval follow these steps:

  1. Submit a change in research application (CIR) with a request to restart.
  2. In Section 1 (General Information), Item 1 of the CIR, select “Petition to Restart”. You do not need to upload any forms.
  3. In Section 1 (General Information), Item 3 of the CIR describe any measures you have put in place to modify your study to align with COVID restrictions in the locations where your project will occur and any other Hopkins guidelines regarding safe conduct of research during the pandemic.
  4. Please be sure to consider how to build flexibilities into your study to account for changing circumstances related to the pandemic. Additional information about these flexibilities can be found in our FAQs. 
  5. Modify your study documents to incorporate any of the changes described and upload tracked and clean versions of your modified documents.

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I. Requirements for COVID-19 Related Research and Public Health Surveillance Activity (PHSA) Targeting JHU/JHHS Employees

Q1. What are the COVID-19 requirements for research targeting JHU/JHHS Employees?

A. COVID-19 related research involving JHU/JHHS employees must adhere to the research policy involving employees. Please see: "Enrolling Employees in Human Subject Research Policy".  In accordance with the policy research studies that directly target or are limited in enrollment to Johns Hopkins University/Johns Hopkins Health System employees will require institutional  approval.  Please contact Jon Links, Vice Provost and Chief Risk and Compliance Officer, at jlinks1@jhu.edu to secure this approval. Please upload this approval to section 20 item 2 of the eIRB application.

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J. COVID Testing for Asymptomatic Research Participants

Q1. When may COVID testing be required for asymptomatic research participants?

Testing for asymptomatic research participants may be required in the following situations:

  • The study includes procedures for which clinically, testing in asymptomatic individuals is required. Click PowerPoint Presentation (insidehopkinsmedicine.org) for current Johns Hopkins Health System guidelines for testing in the absence of symptoms. *
  • The study sponsor has required COVID-19 testing.
  • The IRB determines that testing is necessary to minimize the risks of the study. The IRB may consider factors such as the ability of participants to follow standard safety protocols (e.g. wearing PPE, safe distancing, avoiding groups, etc.) in determining whether testing may be required to minimize the risks of the study.

*Where appropriate and when in alignment with clinical guidelines, vaccination may be considered as an alternative to testing.

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Q2. In cases where COVID-19 testing is required, what steps should research teams follow?

  1. 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.
  2. 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.
  3. 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.

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Q3. Can study teams accept test results from outside testing?

Yes. 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.

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Q4. Who can I work with to establish the process for paying for the test?

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.

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Q5: Are point of care tests available for testing of asymptomatic research participants?

Point of care testing may be appropriate for certain studies. To learn whether a POC test may be appropriate and available for your study, please complete a new test request at the following link. Your request for use of a point of care test will be evaluated and if approved, information will be provided about associated costs. A CIR must be submitted to add point of care testing for asymptomatic research participants to your protocol prior to implementation.

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