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:

• 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 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.
• COVID-19 Related Research Involving Employees - COVID-19 related research involving JHU/JHHS employees must adhere to the research policy involving employees. Please see: Enrolling Employees in Human Subject Research Policy. In accordance with the policy research studies that directly target or are limited in enrollment to Johns Hopkins University/Johns Hopkins Health System employees will require institutional  approval.  Please contact Jon Links, Vice Provost and Chief Risk and Compliance Officer, at [email protected] to secure this approval. Please upload this approval to section 20 item 2 of the eIRB application.
• COVID Research Checklist for Inpatient and Outpatient Studies - This checklist has been developed by the COVID-19 Research Center Implementation Committee to provide study teams with a list of, and links to, many of the required elements needed for COVID study start-up. The links guide users to documents and resources needed for IRB submission, Contracts & Budgeting, order set creation, and other resources for study implementation. https://ictr.johnshopkins.edu/wp-content/uploads/COVIDResearchChecklist-v2-03082022.pdf

COVID-Related Guidance and Research Requirements:

• COVID-19 FAQs - This page includes frequently asked questions and responses related to COVID-19. 
• 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. 
• Protocol Deviation Summary Sheet - COVID-19
• Adverse Event Report Summary Sheet - COVID-19

Resources:

Online Training Resources for Study Teams:

• Safe at Work during the COVID 19 Pandemic
• Infection Prevention for Clinical Areas – This course reviews essential protective practices for JHM Staff and patients during the COVID-19 pandemic.
• Guidance for Incorporation of Telemedicine into Research with Human Participants

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:

• NIH FAQs Related to COVID-19
• Guidance: Expanded Forms of Payment for Human Subject Research Participants During the COVID 19 Pandemic
• Guidelines on Using Venmo
• Acknowledgement By DBO of Approval to Utilize Venmo for Research Participant Payments
• Oral Consent Addendum for Use of Venmo Payment
• 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 [email protected] for assistance.

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