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OFFICE OF HUMAN SUBJECTS RESEARCH

Institutional Review Board

Essential information for Human Subjects Research Teams Related to COVID-19

May 2022

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. 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 may be accessed below:

Requirements for New Applications:

All research activity must be reviewed and approved by the JHM IRB before commencing. When you submit your application to the JHM 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, and 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 following:

FAQs related to Resuming Research with Human Participants

Requirements for COVID-Related Research:

Clinical research coordinating committee - The Johns Hopkins COVID-19 Clinical Research Coordinating Committee. This committee will support the office of Human Subjects Research by prioritizing Therapeutic Adult Inpatient protocols post-IRB approval in order to help protect our patients. For more information about this committee please visit: https://ictr.johnshopkins.edu/covid-research-center/review-committees/ccrcc/

Forms and Instructions for COVID-Related Research:

COVID-Related Guidance and Research Requirements:

Resources:

Online Training Resources for Study Teams:

Documents for Research Participants:

  • Research Participant COVID-19 Risk Information Documents - Please visit this page to download the following IRB-approved documents- 1) An information sheet to be used to communicate risks related to COVID-19 to research participants and 2) Guidelines for communicating study changes related to COVID-19 to research participants.

Additional Resources:

Updates from the Office of Human Subjects Research:

Emergency Response IRB

The Emergency Response IRB is dedicated to the review of COVID-19 related new protocol applications, and change in research applications for currently approved research adding some aspect of COVID-19 related research. For more information...

OHSR Working Remotely

The IRB staff have a designation of a remote office. 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 IRB website at https://www.hopkinsmedicine.org/institutional_review_board/about/contact.html.

If you have a general question please send an email to [email protected] . We will make every effort to respond as quickly as possible.

You can also contact us by MS Teams and “request a consult service”. If you would like to request a consult, please see the following link.

Compliance Monitoring Visits

The Compliance Monitoring Program (CMP) is permanently working off-site and all monitoring activity is conducted remotely. Studies will continue to be selected for monitoring based on existing selection process. On a case-by-case basis, the CMP will conduct some routine, priority, pre-enrollment, and directed audits, in-person. Overall, the CMP will continue to provide research education and support to the JHU research community.

The CMP team members are available via email at [email protected] for questions. Please refer to the JHM IRB website for contact information for individual CMP team members.

For more information about the CMP, please click here https://www.hopkinsmedicine.org/institutional_review_board/about/compliance_monitoring/

Good Clinical Practice Training

The Fundamentals of Good Clinical Practice course will continue to be offered via Zoom. Registration can accomplished via the following link: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=339728. Registrants will be sent details via an email on how to access and login to the Zoom system. This web-based session will still qualify for the in-person training requirement for investigator re-certification, in addition to the NIH GCP certification requirement.

eIRB 101 Training

eIRB101 Training is available virtually on the third Friday of each month. Please use the following to register: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=358053

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