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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:
- CURRENT GUIDANCE RELATED TO THE HUMAN RESEARCH CONTINGENCY PLAN- PHASE 3: April 3, 2020 Announcement from the Vice Dean for Clinical Investigation - Please click here for information about the current contingency plan for human subjects research that all JHU researchers must implement.
JHU Human Subject Research Coronavirus Phased Contingency Plan - Please review the phased contingency plan applicable for all JHU human subjects research.
COVID-19 FAQs - This page includes frequently asked questions and responses related to COVID-19. Please monitor this page daily for new information.
Investigational Drug Service Guidance for COVID-19 Pandemic - The following information provides guidance for the Investigational Drug Service (IDS) operations during the COVID-19 pandemic. As situations evolve this information may be updated.
JHU COVID-19 Requirements for Visits by External Monitors and Site Initiation Visits - Please review the new requirements related to onsite site initiation visits and visits by external monitors. All such visits must be postponed until at least June 30, 2020.
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.
JHU SOM Clinical Research Visit Guidelines during the COVID Pandemic - The purpose of this document is to provide guidelines for clinical research visits during the COVID-19 pandemic in a manner that is coordinated across the enterprise, ensures research participant needs and safety, staff safety and well-being, and congruence with the JHU SOM mission. Clinical research teams must familiarize themselves with all relevant guidelines and workflows in the clinical locations where research participants will be seen. As the needs related to research restart will be dynamic, this document may be revised as needed. Study teams should check back regularly for updates.
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.
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:
- 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.
- FAQs for Research Participants during the Coronavirus Pandemic (the virus that causes COVID19)
COVID-19 Rapid Response Consult (CRRC) service - The BEAD Core has launched a COVID-19 Rapid Response Consult (CRRC) service in collaboration with the CADRE (COVID-19 And Data Research Evaluation). With this service the BEAD Core is poised to help with any SARS CoV-2/COVID-19 related research and specifically, with access to JH-CROWN PMAP registry by assisting with scientific research questions, study design and statistical analyses. The attached process document lays out some of the basic steps. Contact BEADCore@jhmi.edu for assistance.
HUMAN SUBJECT RESEARCH CONTINGENCY PLAN - PHASE 3: Effective 3/22/2020 - IMPORTANT: PLEASE REVIEW. Please click here for information about the current contingency plan for human subjects research that all JHU researchers must immediately implement as of 3/22/2020.
- Important Announcement from the JHU IRBs related to Coronavirus and Research with Human Participants - Please review this important notice from the JHU IRBs outlining considerations related to Coronavirus and Research with Human Participants. This notice contains information about mandatory screening and developing contingency plans for active research studies.
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 firstname.lastname@example.org 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 email@example.com 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.