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Essential information for Human Subjects Research Teams Related to COVID-19
Last Updated August 25, 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:
Resuming In-Person Activities and New Enrollment
The University is now in Phase 1 of resuming research activities involving in-person interaction with human participants. As of August 3, 2020, the types of research activities eligible to be opened for in person interaction/new enrollment in Phase 1 will be expanded.
As of 8/3/2020, all studies are eligible for the restart process with the following exceptions:
- Studies that include research participant group activities (greater than 1 research participant plus a parent or LAR not sharing the same household seen at one time)
- Studies that include high risk aerosolizing procedures (such as sputum induction, pulmonary function tests in nonclinical space, sputum culture, pulmonary exercise test)
Studies that involve group activities and/or high risk aerosolizing procedures are not eligible for restart at this time.
Please visit this website often for new information about research restart.
- Announcements from the Vice Dean for Clinical Investigation
- October 2, 2020 - Clinical Research Restart Progress
- July 31, 2020 - Johns Hopkins School of Medicine Clinical Research Restart Update
- July 17, 2020 - Johns Hopkins School of Medicine Clinical Research Restart Update
- June 12, 2020 - Plan for the Return of Research with Human Participants at Johns Hopkins
- June 19, 2020 - Johns Hopkins School of Medicine Clinical Research Restart Update
- June 26, 2020 - Johns Hopkins School of Medicine Clinical Research Restart Update
- FAQs related to Resuming Research with Human Participants
- JHU Return to Research Guidance - Please review the University’s guidance regarding the resumption of research activities. Part Five contains the plan for Clinical and Human Subjects Research and outlines the Phase Plan for resuming research with human participants. Specific guidance is provided for research occurring in Johns Hopkins clinical facilities, non-clinical Johns Hopkins managed facilities and research taking place outside of Johns Hopkins facilities including community-based facilities and in participant homes.
Step 1: Submit an Application for Restart to a Designated Protocol Restart Committee - A Human Subjects Research Restart Application is required as the first step of the process to receive permission to restart (or start) in-person interactions with research participants. There are 5 designated Protocol Restart Committees – the Sidney Kimmel Comprehensive Cancer Center Committee, the Johns Hopkins All Children’s Hospital Committee, the KKI Committee, the School of Nursing Committee and the School of Medicine’s Human Subjects Research Protocol Restart Committee (the HSRPRC).
Researchers conducting research subject to the KKI, SKCCC or JH-ACH restart review should work with those committees directly to obtain the necessary approvals for restart. All other researchers must submit an application for restart to the HSRPRC. Studies for which there is no in-person interaction, studies that can be modified by submitting a change in research to the IRB to permanently alter the study so that it may proceed without in-person interaction, and COVID-19 related research are exempt from this re-opening process. The Submission of this application (one required per protocol) will put you in a queue to have your request reviewed by the Human Subjects Research Protocol Restart Committee (the HSRPRC). The HSRPRC must approve your study to move forward to the IRB for permission to restart clinical research.
Please click here for answers to FAQs about the Protocol Restart Committee review process.
Please click here for a copy of the questions to help you to prepare to submit your application in Qualtrics.
Qualtrics Human Subjects Research Restart Application: Human Subjects Research Protocol Restart Application
Step 2: Submit a Petition to Resume/Begin In-Person Activities and New Enrollment: The IRB has developed petition forms that must be used to submit requests to the IRB to resume in-person activities and new enrollment for previously approved research and new applications. Study teams may submit these forms as part of a request to resume in-person interaction/new enrollment for previously approved research and new applications once they have secured approval from their designated research restart committee.
Petition to Begin In-Person Human Subjects Research Activities and New Enrollment in a New Research Study: This form should be used for any new application where the research has not received initial IRB approval. Once approval by the appropriate Protocol Restart Committee has been secured, this form should be uploaded in the New Application in Section 20, Item 2. This form should be used for all new applications (convened, expedited, exempt and NHSR/QI) that have not been approved by the IRB and new applications that have been initially reviewed and Tabled or Approved with Administrative Changes but not yet approved.
Petition to Resume In-Person Human Subjects Research Activities and New Enrollment in a Previously Approved Study: This form should be used to submit a petition for any research study that has been previously approved by the IRB. This includes research studies approved since March 2020 where the stamped consent form was not released due to the restrictions on research with human participants. Once approval by the appropriate Protocol Restart Committee has been secured this form should be uploaded in a Change in Research Application in Section 1, Item 1 of the Change in Research.
Process for Preparing Plans for Johns Hopkins University School of Medicine Principal Investigators who Supervise Staff Involved in Human Participant Research - This form is for principal investigators to complete in order to provide plans for a safe work space for clinical research staff.
- Return to Campus Guide - https://hub.jhu.edu/assets/uploads/sites/2/2020/05/JHU-Return-to-Campus-Guide.pdf
Planning for the Restart of Clinical Research - https://ictr.johnshopkins.edu/coronavirus/planning-for-restart/
Online Training Resources for Study Teams:
Care Delivery in the COVID Pandemic course - This course, available in My Learning, reviews guidelines related to COVID-19 that will assist with the ramping up of clinic visit volumes in a manner that ensures patient needs and safety, staff safety and well-being, and in line with the tripartite mission (patient care, teaching and research).
- Infection Prevention for Clinical Areas – This course reviews essential protective practices for JHM Staff and patients during the COVID-19 pandemic.
The IRB staff will be holding virtual office hours via zoom twice weekly to help answer questions from study teams related to the first phase of resuming in-person research activities and new enrollment. The virtual office hours will begin the week of 6/22/2020 and are currently planned to run through the week of 7/27/2020 with additional sessions added if needed. Study team members interested in joining a virtual office hour session may submit an email request to the IRB’s Help Desk at firstname.lastname@example.org. Study team members may sign up for one time slot. Sessions are capped at 15 attendees. Once you have registered, an email confirming zoom details will be provided.
Virtual office hours:
Tuesdays 10:00am – 10:55am and 11:05am – 12:00pm
Thursdays 12:00pm – 12:55pm 1:05pm - 2:00pm
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.
PPE Recommendation during the COVID-19 Pandemic for Ambulatory Settings - Please consult this guidance for specific PPE guidelines. It is the expectation that the same guidelines are applied for research procedures as occurs in the clinical setting for clinical procedures.
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. Updated guidance for these visits goes into effect as of September 1, 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.
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.
For step-by-step instructions for completing an eIRB application using this eForm, please click HERE.
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:
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 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 email@example.com 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. In lieu of in-person meetings, the OHSR offers virtual office hours Tuesdays (10 am – 12 pm) and Thursdays (12 pm – 2 pm) to answer research-related and application specific questions. One hour sessions are scheduled at 10 am and 11 am on Tuesday and 12 pm and 1 pm on Thursday.
If you wish to sign up for a virtual office hours session, please email the eIRB Help Desk at jhmeIRB@jhmi.edu with your preferred availability and you will receive an email confirmation with session access details. Please note that start times for all office hours sessions are 10 am and 11 am on Tuesday and 12 pm and 1 pm on Thursday. Due to the virtual nature of the sessions, additional start times and appointment times are not available.
Compliance Monitoring Visits
Due to current institutional restrictions on in-person monitoring related to the COVID-19 pandemic, the Compliance Monitoring Program (CMP) is transitioning to remote visits. In the future the CMP may resume in-person visits with remote visits remaining an option, where necessary. The CMP will continue to conduct routine, priority, pre-enrollment, and directed audits, and provide research education and support to the JHU research community. The CMP team members are available via email at JHM_OHRP_CMP@jh.edu for questions. Please refer to the JHM IRB website for contact information for specific study team members. Studies will continue to be selected for monitoring based on existing selection process. 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 August 21st. September 18th, and October 16th. Please use the following to register: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=358053