In This Section      
 

COVID-19 FAQs

May 2020

A. Restrictions on Human Subjects Research:
Q1. Are there any restrictions on human subjects research activities?
Q2. What are the current Phase 3 restrictions under the Contingency Plan for Human Subjects Research?
Q3. Is there any way to continue in-person activities for Tier 2 research in Phase 3?
Q4. How do I submit a petition to continue in-person activities for a Tier 1 study?
Q5. What if I have an urgent request for an in-person encounter next week?
Q6. How can I submit a request to continue in-person encounters if I have a pending change in research application in eIRB?
Q7. If I have a Tier 1 study and I believe there is a compelling reason to allow for continued enrollment, how do I petition to the IRB to consider this request?
Q8. Can I enroll new participants in my research?
Q9. Do I have to notify the IRB to determine which Tier my protocols fall into?
Q10. Should the IRB be notified if a study is not complying with the mandatory Phase 3 restrictions?  
Q11. If the target sample for my exempt educational research is nurses, medical students or employees (e.g. residents, or fellows), do I need to pause this activity until COVID-19 research restrictions are lifted?
Q12. If I have an approved Tier 3 study and will be seeing a patient clinically anyway can I still do the in-person research consent and draw the research blood? If the patient was already consented, can I draw the research blood if it is obtained the same time as a clinical blood draw?

B. Making Adjustments to your Research Procedures
Q1. Do I need to submit a change in research to implement the changes required by the new Tier Plan?
Q2. If I have a Tier 2 or Tier 3 study that could be modified to ensure the study is conducted without in person interaction do I need to submit a change in research?
Q3. Do we need to move non-clinical follow up appointments to zoom or telephone calls now?
Q4. How can I get study drugs to participants who can’t come in to pick it up?
Q5. Should I consider delaying or cancelling any research procedures at this time?
Q6.  My study’s industry sponsor wants me to submit a change-in-research to get IRB approval, even though the change is temporary and in response to the COVID-19 emergency, what should I do?
Q7. Are there any considerations for moving school-based educational research online?

C. 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?

D. 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?

E. Working with External IRBs:

Q1. I am relying on an external IRB. What are my requirements for reporting changes made to comply with the new phased Tier Plan?
Q2. My study relies on an external IRB, do I need to report temporary COVID-19 related changes to the JHM IRB?
Q3. Johns Hopkins is the single IRB (sIRB) for my multisite study. Do relying sites have to follow Johns Hopkins restrictions?

F. 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?

G. 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?

H. 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?

I. 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?

A. Restrictions on Human Subjects Research:

Q1. Are there any restrictions on human subjects research activities?

A. Yes. In order to ensure the safety of our research participants and our community, Johns Hopkins University has adopted a tiered approach to research which outlines the types of activities that may occur or must be paused based on the type of research. Please click here for detailed information. Principal Investigators should consider each of their protocols, and decide which tier each falls into. If you have questions, please consult with the IRB.

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Q2. What are the current Phase 3 restrictions under the Contingency Plan for Human Subjects Research?

A. Please refer back to our classification of research protocols into the three tiers.

Effective 04/03/2020, the Phase 3 restrictions for human subjects research are as follows:

  • Tier 1 studies must cease any in-person visits specifically for research purposes that require subjects to travel from an out of state location where the Governor, District authority or responsible national government has issued a no travel order. 

    All other in-person interactions may only continue for Tier 1 studies if the PI presents a compelling justification to continue these interactions and the petition to continue is approved by the IRB. Studies that are cancer-related or conducted at JH-ACH must seek the approval to continue in-person activities from their respective review committees.
  • Tier 2 studies must now stop all in-person interactions/interventions. The IRB will no longer consider petitions to continue in-person interactions/interventions. Researchers may continue activities that do not require in-person visits. They do not have to petition to continue research activities that are not conducted in-person.
  • Research restrictions for Tier 3 studies have not changed and remain in effect.

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Q3. Is there any way to continue in-person activities for Tier 2 research in Phase 3?

A. No, the new Institution restrictions, effective 04/03/2020, mandates that all in-person activities for Tier 2 research must stop.  The IRB will not consider petitions to continue in-person activities for Tier 2 research. Any petitions the IRB previously approved for Tier 2 studies are only valid through April 2, 2020. In-person visits scheduled for 4/3/2020 or later must be cancelled.

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Q4. How do I submit a petition to continue in-person activities for a Tier 1 study?

A. In order for the IRB to grant approval to continue in-person activities for a Tier 1 study, the PI must submit a change in research application. The application must include the petition document, available on the IRB website. The petition should be uploaded in Section 20 Question 2. The following language must be included in Section 1 (General Information) Question 3 as the summary of changes:

“COVID-19 Phase 3 Tier 1 continuation request. This is a petition for in-person activities to continue for this research”.

Petitions to continue in-person research activities for Tier 1 studies must be reviewed by the convened IRB.

Cancer-related research protocols or studies conducted at JH-ACH must seek the approval to continue in-person activities from their respective review committees. Petitions to continue activities for Tier 1 studies should not be submitted to the IRB for these studies.

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Q5. What if I have an urgent request for an in-person encounter next week?

A. You should submit the petition as quickly as possible and send an email to the IRB help desk (jhmeirb@jhmi.edu) for immediate attention. Please include the protocol number (begins with NA_ or IRB00) in all communication.

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Q6. How can I submit a request to continue in-person encounters if I have a pending change in research application in eIRB?

A. You should withdraw the pending change in research, or request to have it withdrawn using the Request to Withdraw activity on the application workspace, depending on where it is in the system. After it is withdrawn, you will be able to submit the change in research for the petition.

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Q7. If I have a Tier 1 study and I believe there is a compelling reason to allow for continued enrollment, how do I petition to the IRB to consider this request?

A. You must submit a change in research application and outline the reason you believe enrollment should continue in the summary of changes, Section 1 Question 3. The request to approve continued enrollment would be reviewed for the study as a whole rather than on a participant by participant basis. Also in the summary, include the phrase “COVID-19 RELATED SUMBISSION”. Requests must be reviewed by the convened IRB. Guidelines must be followed for studies seeking an appeal until such time as an appeal is granted.

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 neil@jhmi.edu .

Requests for new enrollment submitted to these committees for approval do not also need to be submitted to the IRB for review.

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Q8. Can I enroll new participants in my research?

A. Tier 1 Studies

  • For previously approved studies, PIs must pause on enrolling new research participants for Tier 1 studies unless there is a compelling reason. PIs may petition the IRB by submitting a change in research application if they believe there is a compelling reason for permitting enrollment. For oncology related research, these requests should be submitted to the Sidney Kimmel Comprehensive Cancer Center review committee. For research conducted at Johns Hopkins All Children’s Hospital, these requests should be submitted to Neil Goldenberg at neil@jhmi.edu.

  • For new protocols seeking initial approval, PIs should provide this justification with their submission. The IRBs may determine that there is compelling reason to permit new enrollment involving in-person interaction at the time of approval.

Tier 2 Studies

  • For previously approved studies, PIs may not enroll new participants in research categorized Tier 2 unless the study is already approved to be conducted completely without in-person interaction, or is changed to ensure it does not include in-person interaction through submission of a change in research application. See Section B, Q 2 below.
  • For new protocol applications seeking initial approval, the IRB will only permit research to proceed if it involves no in-person interaction.

Tier 3 Studies

  • For previously approved studies in which all study procedures are conducted remotely and were approved with a remote consent process (e.g. oral, electronic), study procedures and new enrollment may continue without submitting any change to the IRB.
  • For previously approved studies in which you could modify the study to ensure all activities, including consenting and enrollment, are conducted remotely without in-person interaction, enrollment may continue but may require a change in research. See Section B, Q 2 below.
  • For new protocol applications seeking initial approval, the IRB will only permit research to proceed if it involves no in-person interaction, including the consent process.

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Q9. Do I have to notify the IRB to determine which Tier my protocols fall into?

A. No. Principal Investigators should consider each of their protocols, and decide which tier each falls into. If they have questions, they should consult with their responsible IRB.

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Q10. Should the IRB be notified if a study is not complying with the mandatory Phase 3 restrictions?  

A. Health system personnel and research team members can challenge the PIs determination of whether a study qualifies as Tier 1 or Tier 2. Study team members and health system personnel may submit a report directly to the IRB if they are concerned that a study is not adhering to the mandatory Phase 3 restrictions. Reports will be handled confidentially. If the IRB receives such a report it may require a CIR to make a final Tier determination.

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Q11. If the target sample for my exempt educational research is nurses, medical students or employees (e.g. residents, or fellows), do I need to pause this activity until COVID-19 research restrictions are lifted?

A. You must pause all in-person interactions for all research participants. Data collection that does not involve in-person interactions may continue.

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Q12. If I have an approved Tier 3 study and will be seeing a patient clinically anyway can I still do the in-person research consent and draw the research blood? If the patient was already consented, can I draw the research blood if it is obtained the same time as a clinical blood draw?

A. No, for Tier 3 research, all in-person interactions with participants must stop regardless of whether they are being seen for clinical reasons. The restrictions have been put into place with consideration for risk to participants, research teams and risks of using resources for research that may be needed for clinical care.

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B. Making Adjustments to your Research Procedures

Q1. Do I need to submit a change in research to implement the changes required by the new Tier Plan?

A. Because Johns Hopkins University is directing its researchers to execute emergency changes in response to the national COVID 19 state of emergency and local health care directives to reduce all but essential research interactions, so long as you abide by the Tier Plan, you need not seek a prospective change in research from your respective JHU IRB and may report these as deviations from protocol in accordance with our JHU IRB’s deviation reporting policies. You should record these emergency Protocol Deviations, which warrant future reporting to the IRB as part of your next Continuing Review; documentation should indicate these deviations were required by the COVID-19 emergency. For temporary changes in the protocol for active participants you are not required to report these changes now via a Change in Research. IRB staff/committees are ready to respond to questions. 

Please note: For research conducted under INDs or IDEs, sponsor reporting requirements and FDA reporting requirements are different from IRB reporting requirements. Please consult with the FDA’s guidance on COVID-19 and clinical trials and check with your study sponsors to be sure you have met all reporting requirements.

Please Note: Changes in Research not specifically related to the directives of the Tier Plan still require approval by the respective JHU IRB.

Principal Investigators should consider each of their protocols, and decide which tier each falls into. If they have questions, they should consult with their responsible IRB.

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Q2. If I have a Tier 2 or Tier 3 study that could be modified to ensure the study is conducted without in person interaction do I need to submit a change in research?

A. Whether or not a change in research is required will depend on whether the change in procedure requires a new type of consent process.  For example, if the study involved an in-person interview for which the IRB previously approved an oral or electronic consent process (waiver of documentation of consent) and it is feasible to change the interview to be done remotely (by telephone or Zoom) using the same or similar consent process, no change in research would be required.  If, however, the IRB previously approved the study with a written consent process and it is feasible to change the procedures to be done remotely, including the consenting procedures, the change would have to be submitted to the IRB for approval through a change in research. In this circumstance because the enrollment of new subjects would require a new type of consent process (remote instead of written), the IRB must approve the change in consent process along with any required consent documents (e.g. oral consent script).  

Please Note: If the IRB has approved a written consent process requiring a signature, the process may only be transitioned to an oral consent (waiver of documentation of consent, i.e. without signature) if it meets the regulatory criteria defined by DHHS and/or FDA.  Generally, a written consent is required if a study presents more than minimal risk.  You may not transition such studies to an oral consent process.  When submitting a change in research to alter the consent process, please make clear in the change in research summary whether the proposed alteration to the consent process will only be used while COVID-19 restrictions are in place, or will continue after the restrictions are lifted. The change in research should describe the new consent process and upload any appropriate documents (e.g., oral consent script). If the new process will continue after the restrictions are lifted, remove the old consent processes and consent form. If they will not continue after restrictions are lifted, do not remove the current consent process or documents. If the new consent process will only be in place until the restrictions are lifted, you will have to submit a change in research when the restrictions are lifted to remove the temporary process.

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Q3. Do we need to move non-clinical follow up appointments to zoom or telephone calls now?

A. The safety of your study team members and the research participants should be first priority. If your research is categorized as a Tier 2 or Tier 3, you must stop in-person visits. For studies that are categorized in Tier 1, in-person activities may only continue if the PI submits a petition indicating there is a compelling justification to continue in-person activities and this petition is approved by the IRB or SKCCC or JH-ACH review committees. Study teams should consider other alternatives (such as zoom, skype or phone call) that will allow the research to continue without causing unnecessary exposures.

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Q4. 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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Q5. Should I consider delaying or cancelling any research procedures at this time?

A. Please consult the Contingency Plan for Human Subjects Research to determine if your research procedures must be delayed or cancelled at this time. If your study falls within Tier 1, you may submit a change in research to petition the IRB to continue in-person visits.  Special consideration should be given to populations that may be particularly vulnerable such as older adults or those with compromised immune systems. For industry sponsored studies, study teams should communicate the mandatory tier structure and consult with the sponsor or CRO when making changes to research procedures.

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Q6.  My study’s industry sponsor wants me to submit a change-in-research to get IRB approval, even though the change is temporary and in response to the COVID-19 emergency, what should I do?

A.  Although you are not required to submit a change-in-research, you are advised to communicate with your sponsor about JHM’s directions for temporary COVID-19 related changes to the research.  If the sponsor still requires IRB approval, submit a change-in-research via eIRB, and indicate in the application that the proposed change is related to COVID-19.  If the IRB approves this change, it is considered permanent, and a subsequent change-in-research would be necessary to remove COVID-19 related changes.

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Q7. 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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C. 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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D. 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 is a Tier 1 study and was approved for new enrollment, or a Tier 1 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 a Tier 1 study approved to enroll new participants, or a Tier 1 study and your petition to continue in-person research visits was 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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E. Working with External IRBs:

Q1. I am relying on an external IRB. What are my requirements for reporting changes made to comply with the new phased Tier Plan?

A. Investigators relying on an External IRB should contact the Reviewing IRB and lead site investigator to determine if any changes you are making to comply with the JHU COVID-19 plan must be submitted to the Reviewing IRB prior to implementation. Please note, while the JHU IRBs do not require submission of these changes for IRB approval prior to implementation and will accept report of those changes at continuing review as protocol deviations, other reviewing IRBs may have not have adopted this policy.

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Q2.  My study relies on an external IRB, do I need to report temporary COVID-19 related changes to the JHM IRB?

A.  Yes. Any COVID-19 related deviations should be reported to the JHM IRB using the progress report further study action. This should be submitted at the same time as you submit the external IRB’s re-approval letter for the study (e.g. at the time of continuing review). The log submitted to the JHM IRB 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). 

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Q3. 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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F. 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 no longer occur in Tier 2 or Tier 3 studies. Home visits may continue in Tier 1 studies 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 a Tier 1 study approved to enroll new participants, or a Tier 1 study and  your petition to continue in-person research visits was 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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G. 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 must be postponed until at least June 30, 2020. We will inform the research community if the date for this requirement needs to be extended.

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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, no earlier than June 30, 2020, 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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H. 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. Under the Institution’s Tier plan for human subject research, this change is being made to avoid immediate hazard in response to the COVID- 19 emergency. 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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I. 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, the Institution has restricted all in-person interactions, and this includes QI projects. If the project does not involve in-person interactions, you may continue the project.

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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, the Institution has restricted all in-person interactions, and this includes QI projects. Only essential personnel are permitted to be on any of the campuses at this time.

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