Human Subject Research: Comprehensive Guidance
The following message was posted on March 12, 2020.
The Phase 2 plan may be accessed here.
March 12, 2020
As we make decisions on how to respond to the COVID-19 infections we want to begin by stating that our primary concern is the safety of our research participants and the research team members who work for Johns Hopkins University and Health System. Our secondary goal is to preserve the scientific integrity of the research protocols. We are providing this comprehensive guidance to all JHU researchers. Please contact your responsible IRB office for specific questions about how this may impact your protocols.
All changes to the research protocol still need to be reviewed and approved by the IRB except for the incorporation of the mandatory screening and except for changes necessary to eliminate immediate apparent hazards including those based on the risk of exposure to COVID-19. Changes implemented to eliminate immediate apparent hazards should be promptly reported to the appropriate IRB.
Research teams should take the following actions now:
Screen Research Participants for Potential Infectious Risk:
If research participants will have in-person interactions with researchers or other study participants, all study teams should immediately implement procedures to screen research participants for potential infectious risk prior to any interaction and incorporate mandatory screening prior to scheduled study visits at any Johns Hopkins facility or research site. The questions related to recent travel, contacts, and current symptoms are evolving. The latest version of screening questions should be reviewed before each encounter and utilized to decide if a research encounter should proceed. The incorporation of this mandatory screening procedure does NOT require IRB approval.
The current screening checklist which should be used by study teams to guide screening before research visits commence is available here.
Note that this checklist should be adapted by researchers conducting research in other locations to reflect local health authority guidance about referral of suspected cases.
For tips on how to respond to the changes in research practice or sharing of best practices related to the coronavirus, please check the ICTR website. The hospital epidemiology website is the best source for keeping up with how the clinical operation of JHM is addressing the COVID-19 outbreak.
- Reduce Study Visits: To the extent reasonable and appropriate, researchers should propose to replace in-person study visits with virtual study visits, using phone, email, and internet- based video technology. Please contact your JHU IRB promptly for guidance on submitting protocol amendments to address proposed changes to study procedures. If you are uncertain about whether a change requires IRB approval prior to implementation, please contact the IRB office immediately.
- Consult Travel Advisory: Given the University’s restrictions on international and essential-only domestic travel, researchers should consult the JHU COVID-19 website for up to date information.
- Develop a Script for Participants: Research teams should consider developing a script outlining for research participants how Johns Hopkins is making the environment as safe as possible when they come in for their research visit. We are working on a common description for all Johns Hopkins facilities.
Develop Contingency Plans:
Study teams should proactively prepare contingency plans for their active research protocols. These changes will require IRB approval prior to implementation. Consider whether disruption of a research protocol will impact the safety of your research participants, and how you can manage that disruption:
- Investigational Drugs – If research participants are on investigational drugs, work with the IDS to determine what the plan would be if the investigational drug could not be dispensed to your research participants. You might find a way to deliver investigational drugs to their home. If the investigational drugs cannot be dispensed to our research participants, you should make plans to transition research participants back onto their most appropriate clinically available medications. This transition should include consultations with the investigation drug service and the clinical team caring for the research participants. Where the investigational drug is administered under an external, sponsor-held IND, the sponsor should be proposing any protocol changes needed to the FDA protocol and IRB protocol to the FDA and responsible IRB.
- Consider Pausing Study Procedures: For studies where appropriate, individual investigators may choose to temporarily pause enrollment. PIs need to assess whether any reduction in staff makes it unsafe to complete the planned research procedures. Even routine research interventions might not be easy or safe if experienced staff are not available.
- Timely review of research data – If research team members are not available, integration of research care such as reviewing lab results in a timely manner might not be possible and will require special attention under the direction of the study PI. Study teams should consider the availability of appropriate back-ups to the PI to make safety assessments.
- Utilization of alternate visit options: including telephone or zoom visits for participants who are unable or unwilling to come to on-site visits.
- Home visits: Some essential research visits may require blood draws or simple measurements like BP and BMI assessments that could be accomplished with a home visit. Before moving to home visits, research teams need to consider: can the activity be done safely in the home, as PI do you acknowledge that the research staff doing the home visits have been appropriately trained, does the research staff member have any health conditions or current symptoms related to the coronavirus, and does the research participant or other individuals in the home have symptoms that would indicate a high risk of coronavirus transmission. Up to date screening questions should be utilized to make the assessment about risk of coronavirus transmission. Research teams should follow the current policy that two members of the research team be present for home visits.
- For investigators with Epic access: The research visit must be documented in Epic and include the following information: did the research participant pass the screening questions about risk for infection, what times did the research team enter and leave the house, and who else was present in the home during the visit.
Working with the IRB:
The IRB staff are available for consultation on contingency plans for active research studies. Please contact the JHU IRBs at firstname.lastname@example.org (SOM), email@example.com (Homewood), firstname.lastname@example.org (Public Health).
The IRB is actively working with study teams seeking approval for research options for individuals who test positive for COVID-19. If you are seeking information about options for COVID-19 patients please contact the IRB at email@example.com.
More specific information is available from the IRB Websites:
For the JHM IRB:
- For changes in practice related to the Clinical Research Units, please check the ICTR website .
- For tips on how to respond to the changes in research practice or sharing of best practices related to the coronavirus, please check the ICTR website.
- The hospital epidemiology website is the best source for keeping up with how the clinical operation of JHM is addressing the COVID-19 outbreak.
For the JHSPH IRB.
For the Homewood IRB: