Q1. 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.
Q2. Do I need to indicate in my new application, amendment, or reportable event if the submission is related to COVID-19?
A. Yes. It is important the IRB is able to accurately track all new applications, reportable 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 Amendments please include this phrase in the summary of changes, Section 1, Item 5.0.
- For reportable event reports, please include this phrase in Section 1, Question 2.0.
Q3. What should I do if I have a new application, amendment, or reportable event that is related to COVID-19 that may need to be reviewed urgently?
A. If you need a new application, amendment, or reportable 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. Please include your eHIRB protocol number in the email to the help desk. Please cc the Director, Homewood IRB, Laura Evans, at email@example.com when emailing the help desk with urgent requests for review of COVID-19 related submissions.
Q4. 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: Bara@jhu.edu (KSAS) or JHURA@jhu.edu (all others).
Q5. 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).
Q6. 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.
Q7. 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.
Q8. 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.
Q9. 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 Homewood campus 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.
Q10. Do I have to submit an amendment 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.
Q11. Where can I get the most up-to-date phone screen algorithm for calling participants?
A. Use this link to the ICTR website, 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.
Q12. 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.
Q13. 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. 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.
Q14. Do home visits need to be documented in a special way?
If you are approved to continue home visits, these should be recorded in your research record using your usual standard procedures.
Q15. 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.
Q16. 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.
Q17. 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 Reportable Event further study action (FSA) in eHIRB. Please file the report 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.