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.
Q2. Can I enroll new participants in my research?
A. 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 have a compelling reason for permitting enrollment.
You may not enroll new participants in research categorized as Tier 2 or Tier 3, unless the study is already approved to be conducted completely online or by phone, or is changed to ensure it does not include in-person interaction through submission of a change in research application.
Q3. 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: 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.
Q4. 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 will be reviewed in order of priority. Guidelines must be followed for studies seeking an appeal until such time as an appeal is granted.
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 and may be submitted through all Phases. 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.
Q6. Do I have to notify the IRB to determine which Tier my protocols fall into?
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.
Q7. 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 a Tier that does not require that research procedures be stopped/cancelled please carefully consider the specifics of the study population and the potential risks and benefits to the participants and research staff before conducting the 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.[back to top] Q5. Do I need to indicate in my new application, change in research or protocol event if the submission is related to COVID-19?
Q8. 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.
Q9. 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 firstname.lastname@example.org and follow that with a phone call to 410-516-6580. If available, please include your eHIRB protocol number in the email to the help desk. Please cc the Director of the Homewood IRB, Laura Evans, at email@example.com when emailing the help desk with urgent requests for review of COVID-19 related submissions. The Homewood IRB has formulated an Emergency Response IRB and is prepared to address time-sensitive submissions related to COVID-19.
Q10. Should the Johns Hopkins 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); or JHURA@jhu.edu (all others).
Q11. What kind of changes do I have to submit for IRB review prior to implementation?
A. If investigators wish to modify an ongoing IRB-approved research study, they must submit a request to the IRB and receive IRB approval before implementing the proposed modification, unless the change is designed to eliminate an apparent immediate hazard to subjects (45 CFR 46.103(b)(4); 21 CFR 312.66). If the investigators change the research in order to eliminate apparent immediate hazards to subjects without prior IRB approval, they should report those changes promptly to the IRB (within 10 days). This change must be documented in the research file. For studies that are FDA regulated, you should promptly notify the study sponsor.
Q12. Do I have to call all participants before they come in for a scheduled research visit?
A. Yes, according to the Johns Hopkins Medicine Healthcare Epidemiology and Infection Control all individuals coming in for a visit, whether clinical or research related, must be pre-screened prior to the visit. We urge all research teams to 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 should be screened again when they arrive on site.
Q13. 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.
Q14. 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.
Q15. 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.
Q16. 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, where the clinical team will perform screening already it is appropriate to defer to the clinical team and not repeat the screen.
Q17. 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.
Q18. 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.
Q19. Do non-clinical home visits need to be documented in a special way?
A. No, 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.
Q20. 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 three, you must not conduct face-to-face visits. For studies that are categorized in tier one and two, there is no mandate to stop follow-up appointments at this time. Study teams should consider other alternatives (such as zoom, skype or phone call) that will allow the research to continue without causing unnecessary exposures.
Q21. 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.
Q22. Are there any restrictions on research home visits already included in your approved research protocol?
A. There is currently no restrictions on home visits for research purposes. 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.
Q23. 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 April 20th. We will inform the research community if the date for this requirement needs to be extended.
Q24. 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 April 20, 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.
Q25. 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.
Q26. 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.
Q27. 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.