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

Last Updated July, 31, 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
  • 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. Please be careful to utilize the correct form when submitting a petition to the IRB. 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 Researchhttps://ictr.johnshopkins.edu/coronavirus/planning-for-restart/

  • Online Training Resources for Study Teams:

  • IRB Virtual Office Hours related to Resuming In-Person Research Activities and New Enrollment

    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 jhmeirb@jhmi.edu. 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.

  • Guidance for Incorporation of Telemedicine into Research with Human Participants 

  • Re-opening guidelines for the F.M. Kirby Center Human scanning MRI facility

  • Re-opening guidelines for the JHU MRI Research Center

  • 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:

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

    • For step-by-step instructions for completing an eIRB application using this eForm, please click HERE

  • 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.

  • Protocol Deviation Summary Sheet - COVID-19 

  • Adverse Event Report Summary Sheet - COVID-19 

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 physical 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

eIRB101 Training is available virtually on June 19th and July 17th. Please use the following to register: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=358053