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COVID-19 FAQs

June 2021

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. Are there any new research studies that will be prioritized by the IRBs?
Q6. Is the IRB continuing to meet to review new applications and further study actions?
Q7. 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?
Q2. Do non-clinical home visits need to be documented in a special way?

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. I have exhausted all options provided for remote monitoring visits but my sponsor insists an in-person visit is required for my study. What steps do I need to take to determine if an onsite monitoring visit is necessary?
Q5. The monitor will need to access IDS for IP accountability, how is that arranged?
Q6. If the monitor needs to access the ICTR facilities, how is that arranged?
Q7. Are there alternatives to onsite facility tours?
Q8. 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?

H. Quality Improvement Projects

Q1. I have a QI project that involves direct in person interaction but I believe I can modify my project to convert to telephone or electronic procedures. Do I have to submit a change in research to my QI project?
Q2. 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?
​​​​​Q3. I have a quality improvement project that focuses on clinical care in hospital units. Our work does not involve interactions with patients but includes observations on the units and provider focus groups. Are we permitted to continue our work?

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

Q1. Are there any requirements related to recruitment of JHU/JHHS employees for COVID-19 related research studies/PHSA?
Q2. Why is a centralized website being used?
Q3. Is there a link to the centralized website?
Q4. How do I submit a posting for the centralized website?
Q5. Will HR need to approve the recruitment of JHHS/JHU Employees?
Q6. Are there any other approvals needed for COVID-19 related research involving JHU/JHHS employees?
Q7. How do I obtain approval from Dr. Links?
Q8. Where do I upload the COVID-19 Employee Recruitment Information Form and COVID-19 Study Summary Form?
Q9. Does this apply to a change in research for a COVID-19 study/PHSA that will add JHU/JHHS employees?
Q10. Do I have to use the centralized website?
Q11. Can I request an alternative recruitment method?

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 Assistant Dean for Human Research Protections, Megan Singleton at msingl16@jhmi.edu when emailing the help desk with urgent requests for review of COVID-19 related submissions. The JHM IRB has formulated an Emergency Response IRB and is prepared to address time-sensitive submissions related to COVID-19. The Emergency Response IRB meets regularly and time sensitive submissions will be assessed to the next available agenda when determined to be ready for review.

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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. Are there any new research studies that will be prioritized by the IRBs?

A. Yes. Tier 1 studies that involve COVID 19, whether or not the studies provide a direct personal benefit to study participants, will be prioritized. The IRB will not approve any COVID related study for which the risk/benefit ratio is not reasonable and will consider the risks of data collection in that analysis.

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Q6.  Is the IRB continuing to meet to review new applications and further study actions?

A. Yes, all IRBs are continuing to meet on their regular schedule, using zoom, to review new applications and further study actions submitted through eIRB.

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Q7. 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. Use this link to the ICTR website https://ictr.johnshopkins.edu/coronavirus, click on Tips for Research Teams and use your JHED credentials to log in. The latest phone screen algorithm can be accessed on this page.

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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.

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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. Unless the IRB, Sidney Kimmel Cancer Center or Johns Hopkins All Children’s Hospital review Committee approved your research to continue enrolling, you should not be enrolling any new participants. If you have approval to continue enrolling, 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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Q2. Do non-clinical home visits need to be documented in a special way?

A. Unless your study is approved to enroll new participants or a study to continue in-person research visits approved by the IRB, Sidney Kimmel Cancer Center or Johns Hopkins All Children’s Hospital Review Committee, you should not be conducting home visits. If you are approved to continue home visits, these should be recorded in your research record using your usual standard procedures. Only home visits implemented in place of on-site research visits that may have occurred in a clinical facility need to be documented in EPIC.

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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. All external monitor onsite visits for clinical research protocols should continue to occur remotely unless an onsite visit is absolutely necessary.

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

A. First, refer to any existing contingency plan established by the sponsor or CRO. Check with the CRO or sponsor to discuss how the monitoring visit can be postponed to a later date, or arrange with the CRO or sponsor to implement interim remote-monitoring procedures, where study data and other materials can be securely reviewed electronically or by other non-in-person means.

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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.

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.  I have exhausted all options provided for remote monitoring visits but my sponsor insists an in-person visit is required for my study. What steps do I need to take to determine if an onsite monitoring visit is necessary?

A. In the event that an onsite monitoring visit is necessary, the PI should consider what the visit will require. The PI and study team will not only have to comply with JHH policies pertaining to the COVID-19 pandemic, but also coordinate with all departments or groups they may need to access while onsite. This tool can assist in thinking through the necessary logistics. The PI and study team must comply with the most current health system protocols in place for the COVID-19 pandemic. The PI will be responsible to assure appropriate protections regarding staffing, space use, PPE utilization, and screening procedures are applied for all individuals entering Hopkins facilities.

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Q5. 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. 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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Q6. 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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Q7. 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 via Renee Cover (rcover1@jhmi.edu). IDS is developing a video of the pharmacy in lieu of onsite tours, contact IDS for availability.

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Q8. 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. 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.

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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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H. Quality Improvement Projects

Q1. I have a QI project that involves direct in person interaction but I believe I can modify my project to convert to telephone or electronic procedures. Do I have to submit a change in research to my QI project?

A. No. Changes made to convert in-person activities to remote procedures because of COVID-19 restrictions can be made without submitting a change in research.

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Q2. 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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Q3. I have a quality improvement project that focuses on clinical care in hospital units. Our work does not involve interactions with patients but includes observations on the units and provider focus groups. Are we permitted to continue our work?

A. No, unless you submit a change in research to the JHM IRB to resume in-person research related interactions.  

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

Q1. Are there any requirements related to recruitment of JHU/JHHS employees for COVID-19 related research studies/PHSA?

A: There are many COVID-19 research studies/PHSA that request to recruit employees. To prevent Johns Hopkins Health System and Johns Hopkins University employees from feeling pressured to participate, new requirements have been developed for recruiting these populations. These requirements include a) posting of a study description on a centralized website where employees can review all participation options and b) submission of a detailed recruitment plan to the IRB justifying the specific recruitment approaches proposed for the study, and the proposed recruitment material.

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Q2. Why is a centralized website being used?

A: The centralized website is being used to maintain an up-to-date list of COVID-19 research and PHSA specifically recruiting employees.  It will allow employees access to a summary of each project to compare projects and make a decision on whether or not to participate.

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Q3: Is there a link to the centralized website?

A: The link to the centralized website is located here: https://ictr.johnshopkins.edu/coronavirus/hcw-studies

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Q4. How do I submit a posting for the centralized website?

A: All recruitment material posted on the website must be approved by the IRB.  To secure this approval, complete the COVID-19 Employee Recruitment Information Form and Study Summary Form and upload them to the eIRB application in section 20 item 1. The IRB will provide an approved, final copy of the recruitment material to the ICTR for posting.

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Q5. Will HR need to approve the recruitment of JHHS/JHU Employees?

A: Generally, individual HR approval is not required as long as the recruitment material and COVID-19 research study/PHSA activity is approved by the JHM IRB.

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Q6. Are there any other approvals needed for COVID-19 related research involving JHU/JHHS employees?

A: If your study or PHSA will share data about JHU/JHHS employees with an external organization, then approval from Dr. Jon Links, JHU Chief Compliance Officer, will be required.

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Q7. How do I obtain approval from Dr. Links?

A: To obtain approval, send an email request to jlinks1@jhu.edu with the eIRB application number, a copy of your IRB protocol and any consent form that may be used for the study/PHSA. Upload a copy of Dr. Links’ approval email to section 20 item 2 of the eIRB application prior to submitting the application to the IRB. 

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Q8. Where do I upload the COVID-19 Employee Recruitment Information Form and COVID-19 Study Summary Form?

A: Both forms must be uploaded to the eIRB application in section 20 item 1 before submitting the application to the IRB.

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Q9. Does this apply to a change in research for a COVID-19 study/PHSA that will add JHU/JHHS employees?

A: Yes, all COVID-19 studies and PHSA recruiting JHU/JHHS employees via a new application or Change in Research must abide by these guidelines.

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Q10. Do I have to use the centralized website?

A: Yes, all COVID-19 studies and PHSA recruiting JHU/JHHS employees must post a description of the study on the centralized website.

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Q11. Can I request an alternative recruitment method?

A: Yes, in addition to posting on the centralized website, you can request alternative methods of recruitment. The alternative methods must be reviewed and approved by the JHM IRB along with any planned recruitment materials for distribution. If you wish to propose alternative recruitment methods, you must address the following in the eIRB application section 13 item 2, and upload all recruitment materials to section 13 item 7:

    1. Confirmation that no one will be directly recruited by a supervisor
    2. A rationale for the specific recruitment strategies proposed
    3. An explanation as to how the proposed recruitment strategies ensure the potential for employees to feel influenced/pressured to participate have been minimized
    4. If paper recruitment materials will be distributed, you must follow HEIC guidelines [limit paper posting, for more permanent recruitment materials laminate or use something that can be wiped clean]
    5. The recruitment materials you upload for review must include the link to the centralized website, https://ictr.johnshopkins.edu/coronavirus/hcw-studies .
    6. The materials you upload for review must be clear about all the requirements of participation [including sharing of test results, etc. as applicable]

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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:

  1. 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.
  2. The study sponsor has required COVID-19 testing.
  3. 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.

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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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