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

Last Updated June 1, 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.

For the most up-to-date information visit the links below:

COVID-Related Guidance and Research Requirements:

Forms and Instructions for COVID-9 Related Research:

  • eForm S for Secondary Use of Data from the JH CROWN Registry for COVID-19 Research - This form should be used for secondary research with COVID-19 related data provisioned from the JH CROWN COVID 19 Data Repository.

  • eForm S for COVID-19 Phase I Pilot Projects - This form should be used for secondary research with COVID-19 related biospecimens designated for Phase I Pilot Projects. Samples and data for these pilot projects will only be provisioned with approval of the JHU COVID-19 Biospecimen Oversight Committee. Please do not submit this form prior to having obtained permission from the Biospecimen Oversight Committee.

  • eForm S for COVID-19 Projects involving Data and Biospecimens  - This form should be used for secondary research with COVID-19 related biospecimens drawn from Protocol # IRB00248332 - Johns Hopkins COVID-19 Remnant Specimen Repository or Protocol # IRB00245545 - Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI)] that may also draw data from IRB00247569 - The COVID Precision Medicine Analytics Platform (PMAP) Registry (JH-CROWN). Samples and data for these pilot projects will only be provisioned with approval of the JHU COVID-19 Biospecimen Oversight Committee. Please do not submit this form prior to having obtained permission from the Biospecimen Oversight Committee.

  • Documentation Form for COVID-19 related Research Using an Oral Consent Process

  • Guidance for Informed Consent for COVID-19 Related Research - This document outlines step by step instructions for consenting research participants for minimal risk and greater than minimal risk studies related to COVID-19.

  • Supplemental Form for COVID-19 Research - This form is required for all COVID-19 related research that involves direct interaction and intervention with participants with suspected or confirmed COVID-19. Please complete the form and upload in Section 20, Item 2.

  • Protocol Synopsis Template for COVID-19 Related Interventional Research - A Draft Synopsis must be submitted with each COVID-19 application that involves a therapeutic intervention. Completed drafts should be uploaded within the IRB application in Section 20, Item 2. Please ensure the total length of the synopsis does not exceed 1 page.

  • COVID-19 Study Information Sheet for Employees: This form is required for all COVID-19 related research and public health surveillance activity (PHSA) that involves recruitment of any Johns Hopkins Health System or University employees. This form serves as an information sheet for employees who may be interested in joining a COVID-19 research study/PHSA. Please complete the form and upload in the eIRB application, Section 20 Item 1. Once approved by the IRB, this form will be posted on a centralized website for employees to review their options.

  • COVID-19 Study Summary Form: This form is required for all COVID-19 related research or public health surveillance activity (PHSA) that involves recruitment of Johns Hopkins Health Care Workers. This form describes the key features of the COVID-19 research study/PHSA, and the data compiled in this form will be entered into a table used as a tool for employees to compare options to participate in research and PHSA. Please complete the form and upload in the eIRB application, Section 20 Item 1.

Documents for Research Participants:

Additional Resources:

Archived Announcements:

Updates from the Office of Human Subjects Research:

OHSR Working Remotely

The IRB staff are working remotely as of 03/13/2020 and are available during regular business hours. In-person office hours are cancelled until further notice. 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 jhmeirb@jhmi.edu or leave a message at 410-502-2092. While working remotely, we will make every effort to respond as quickly as possible.

IRB Office Hours

Effective 03/13/2020 all IRB staff are working remotely and are not available for in-person meetings. If you have a question please send an email to jhmeirb@jhmi.edu or leave a message at 410-502-2092 and you will receive a response as quickly as possible.

Compliance Monitoring Visits

In light of University precautions related to COVID-19, the Compliance Monitoring Program (CMP) has cancelled all monitoring visits.  At this time, no new compliance monitoring visits will be scheduled until after June 30, 2020.  On-site monitoring visits will be rescheduled once restrictions on in-person meetings and recommendations for social distancing have been lifted. The Compliance Monitoring Program team members are available via email and telephone for questions. Please be sure that all applicable institutional and regulatory requirements for human subjects research continue to be followed, and that proper documentation practices are maintained. Please refer to the JHM IRB website for CMP contact information.

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

In keeping with the University’s recent guidance to reduce the number of in-person meetings where possible, we feel it is important to cancel the March and April eIRB 101 training sessions. If you were taking the course to satisfy the in-person activity requirement for Principal Investigator Human Subject Recertification, the IRB can grant an extension to complete training. Please email JHMeIRB@jhmi.edu for assistance with your compliance training requirement.