Essential Information for Human Subjects Research Teams Related to COVID-19
Last updated October 2021
For the most up-to-date information visit JHU’s Return to Research webpage.
Our primary concern is the safety of our research participants and the research team members who work for Johns Hopkins University. Our secondary goal is to preserve the scientific integrity of the research protocols. It is important that research teams remain prepared to respond to changing circumstances related to the COVID-19 pandemic and adapt their research accordingly.
Tools and Resources for Research Teams
Restricted Research Activities
Studies that include research participant group activities (greater than 1 research participant plus a parent or legally authorized representative (LAR) not sharing the same household seen at one time) may not be initiated or restart at this time.
Note: Community or school-based observational studies, including international research, are subject to heeding all local COVID-19 recommendations and restrictions
Requirements for New Applications
All in-person research activity must be reviewed and approved by the Homewood IRB before commencing. When you submit your application to the Homewood IRB, please consider the COVID measures that will need to be implemented depending upon where your study will take place as well as any other Hopkins guidelines regarding safe conduct of research during the pandemic.
For new applications, please address the aforementioned in your protocol and any associated study documents. Please be sure to consider how to build flexibilities into your study to account for changing circumstances related to the pandemic. Examples of flexibilities include:
- Allowing either in-person or remote protocol assessments
- Using an online platform for questionnaires/surveys
- Increasing/decreasing the time window for protocol-related procedures
- Including study-related procedures with scheduled clinical visits.
Additional information about these flexibilities can be found in our FAQs. While considering building flexibilities into your study, please see the Johns Hopkins Medicine’s FAQs related to Resuming Research with Human Participants.
Requirements for Restarting Previously Approved Research that was Paused Due to COVID-19:
Previously approved research involving in-person interaction that was paused during the pandemic must be approved to restart by the Homewood IRB. To secure this approval follow these steps:
- Submit an Amendment application with a request to restart.
- In Section 1 (General Information), Item 5.0, in addition to a description of your proposed project, describe any measures you have put in place to modify your study to align with COVID restrictions in the locations where your research will occur and any other Hopkins guidelines regarding safe conduct of research during the pandemic.
- Please be sure to consider how to build flexibilities into your study to account for changing circumstances related to the pandemic. Additional information about these flexibilities can be found in our FAQs.
- Modify your study documents to incorporate any of the changes described and upload tracked and clean versions of your modified documents.
COVID-Related Guidance and Research Requirements
Online Training Resources for Study Teams
- Safe at Work During the COVID-19 Pandemic – This course is available through JHU’s myLearning.
- JHU Return to Research Website
- JHU Return to Research Guidance
- International Supplemental Guidance Related to COVID-19 – For researchers conducting research internationally, please click here for supplemental guidance regarding requirements related to COVID-19 for international research.
- Research Participant COVID-19 Risk Information Documents – Please visit this page to download the following IRB-approved documents:
- An information sheet to be used to communicate risks related to COVID-19 to research participants
- Guidelines for communicating study changes related to COVID-19 to research participants.
- COVID Electronic Payment Guidance
Updates from the Homewood IRB Office
Homewood IRB Staff Working in Hybrid Capacity. The IRB staff are working in a hybrid capacity (on-campus and remote) and are available during regular business hours. In-person office hours are available if needed.
If you have questions about your research, and you know the staff member you wish to speak with please contact them directly. There is a list of contacts on the contact page.
If you have a general question please send an email to firstname.lastname@example.org or leave a message at 410-516-6580. We will make every effort to respond as quickly as possible.