COVID-19 & HSRRC
This JHSPH Resource page serves to help investigators navigate the COVID-19 situation as it affects human subjects research (HSR).
The University is implementing the JHU Return to Research Guidance, which provides comprehensive resources regarding return to on-campus research activity; part five focuses on human subjects research. All human subjects research conducted by JHU investigators must comply with the requirements and restrictions promulgated by this guidance and be alert to changes as the University responds to the challenges COVID poses over time.
Obtaining PPE Stock from JHSPH Office of Facilities Management Service Request Center
The School has worked to streamline a process for ordering PPE stock (hand sanitizer, face shields, masks, gowns, etc.) needed for research activities. The process is described in the September 24, 2020 memo from the Office of Facilities Management, using the BSPH PPE Stock Order Form. If you have questions, contact the Facilities Service Request Center 5-FSR1 (410-955-3771).
JHSPH IRB Requirements
Recording and Reporting Changes and Decisions During Emergency Response Period
For all studies approved for active data collection between March, 2020, and June, 2020, the JHSPH IRB did not require investigators to submit amendments reporting changes in data collection from in person to remote data collection. It is important to record and report the actions taken during this time and when. The IRB requires investigators submitting PHIRST2.0 Continuing Review/Progress Report for studies actively collecting data from human subjects to upload a Research Record for Changes in Response to COVID19 as part of their response to Question 8.
All studies that made changes without submitting an amendment, and which will go forward with procedures not currently described in the research plan, should be formally amended in PHIRST 2.0 so that the research plan reflects current data collection activities.
Human Subjects Research Restart Committee (HSRRC) Requirements
The Bloomberg School has established a Human Subjects Research Restart Committee (HS-RRC) which is responsible for overseeing plans for all research studies that involve in-person research activity. HS-RRC started reviewing submitted plans in mid-July. The details about this process are described in the FAQs below.
A Principal Investigator (PI) must not begin or resume HSR interactions with research participants unless they fall within activities permitted under JHU Return to Research Guidance AND have approval from HS-RRC. PIs who continued in-person research activities during the Emergency period must also submit a plan. To submit a plan:
For New Research Applications and Amendments that Add In-Person Activities:
· Complete the SAFE HUMAN SUBJECT RESEARCH (HSR): PROTOCOL PLAN FOR IN-PERSON RESEARCH ACTIVITY for activities permitted to resume under JHU Return to Research Guidance.
·Upload the Safe HSR Protocol Plan form into Miscellaneous Documents in your PHIRST submission. The IRB Analyst working on your submission will facilitate triage to the HSRRC for review once the application meets IRB requirements. The HSRRC review requirement will be treated as an Ancillary Review and will be finalized as part of the overall IRB submission approval. The final IRB approval will include both an IRB approval letter and an HSRRC approval letter.
For Ongoing Studies Needing HSRRC review:
· Open the research application in PHIRST2.0 and upload the Safe HSR Protocol Plan form, with any other required documents, as an “Other Administrative Submission”, then submit it to the IRB.
· IRB staff will send the submission to HS-RRC reviewers, who may send questions or concerns to PIs through the PHIRST system. They may discuss individual submissions in a committee setting or independently.
· When the plan is approved, PIs will be notified through the PHIRST system.
If the activities proposed are permitted by JHU Return to Research Guidance, PIs may begin study activity as soon as they receive approval.
Approved SAFE HSR Protocol Plans stand as part of the research file; PIs do not need to submit Amendments to revise research plans to incorporate the details included in these plans. However, any change to data collection procedures must be recorded in the PI’s research plan. Submit an Amendment Application to ensure that the research plan accurately reflects research activities.
JHSPH Practice Requirements
Assistant Dean for Public Health Practice, Beth Resnick, is overseeing in-person restart activities that involve practice projects, especially those involving JHSPH students. See the Safe Research & Practice Restart Resources for more information on those requirements.
Training for Study Staff
The CITI Training platform offers a course called “COVID-19: Back to Campus 2020-2021 and Remote Contact Tracing”. This course is available to JHSPH investigators through the JHSPH institutional account. Feel free to use it for staff training. Use this “How to Access the COVID-19: Back to Campus” course guide to help you choose this CITI offering.
Guidance Documents and HSRRC Forms:
- Safe HSR Resumption FAQs
- Safe HSR Protocol Model Plans:
- CDC guidelines on "Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19
- Jhpiego Guidance: Planning and Implementation of Human Studies During COVID-19 Pandemic
New Consent language for drug and device (including diagnostics) studies seeking to treat, diagnose, or prevent COVID 19 under the Public Readiness and Emergency Preparedness Declaration (PREP)
CDC Guidance on how to make a cloth face covering: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-to-make-cloth-face-covering.html.
Lancet article about optimal social distancing: 2 meters is better than 1. https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2931142-9
Remote Data Collection:
Paying Research Participants Using Venmo:
- Expanded Forms of Payment for Human Subject Research Participants During COVID19 Pandemic
- Guidelines for Using Venmo
- Acknowledgement by DBO of Approval to Utilize Venmo for Research Participant Payments
Documents to Help Study Participants:
FAQs providing COVID 19 information for participants and mental health and other resources for U.S. based participants, with a focus on the Baltimore area. Studies conducted internationally and outside of Baltimore may use this FAQ as a guide to what resources to think about and look for.
JHSPH - IRB
Resources for research teams. Note: you must have JH OneDrive Access to see the folder - be sure to be logged in with JHED ID to access
OneDrive Folder – Research COVID 19 Screening Forms
Examples of screening tools that can be used by research staff to evaluate research participants for symptoms of COVID 19
OneDrive Folder – Remote Data Collection
Resources on how to set up a google voice account and collect data remotely using REDCap.
COVID-19 Digital Library
Primarily outward/public facing materials on COVID-19, news from JH on outbreak response
Compendium of official University guidance materials on prevention, operations, travel, messages (log of all JHU-wide messages), info for undergrads, and research preparedness.
COVID Funding Opportunities
Running list of funding announcements
All links go to the HUB pages – main page and direct links to each of the sub pages
MEDICINE – IRB
Essential information for Human Subjects Research Teams Related to COVID-19
Compendium of announcements; link to JHU HUB Research Preparedness Human Subjects page; link to FAQs; links to guidance on communicating risks to research subjects.