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

June 2021

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:

Restricted Research Activities:

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) may not be initiated or restart at this time.

Requirements for New Applications:

All in-person 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 Restarting Previously Approved Research that was Paused Due to COVID-19:

Previously approved research involving in-person interaction that was paused during the pandemic must be approved to restart by the JHM IRB. To secure this approval follow these steps:

1. Submit a change in research application (CIR) with a request to restart.
2. In Section 1 (General Information), Item 1 check “Petition to Restart”. You do not need to upload any forms.
3. In Section 1 (General Information), Item 3 describe any measures you have put in place to modify your study to align with COVID restrictions in the locations where your research will occur and any other Hopkins guidelines regarding safe conduct of research during the pandemic.
4. Please be sure to consider how to build flexibilities into your study to account for changing circumstances related to the pandemic. Additional information about these flexibilities can be found in our FAQs.
5. Modify your study documents to incorporate any of the changes described and upload tracked and clean versions of your modified documents.

Requirements for COVID-Related Research:

For COVID related research, you will need to obtain the appropriate pre-review committee approval before the JHM IRB can approve your study. The appropriate approval will depend on your research. Please see as follows:

Pre-review committee approvals:

Clinical research coordinating committee: The Johns Hopkins COVID-19 Clinical Research Coordinating Committee. This committee will support the office of Human Subjects Research in prioritizing protocols for emergency review and approval as well as facilitating collaboration in order to protect our patients and critical resources. https://ictr.johnshopkins.edu/coronavirus/covid-johns-hopkins-clinical-research-coordinating-committee/

CADRE: The CADRE Committee guides investigators to the most efficient path for accessing data. Whenever feasible, CADRE will recommend that the investigator use existing data sources such as the new JH-CROWN: The COVID Precision Medicine Analytics Platform (PMAP) Registry (JH-CROWN). https://ictr.johnshopkins.edu/coronavirus/cadre/

Biospecimen Oversight Committee: The COVID-19 Biospecimen Committee evaluates requests from researchers for accessing serum or plasma from COVID-19 patients. The committee’s default position will be for investigators to receive premade specimen collections for pilot studies with requests for custom made collections considered after pilot studies are completed. https://ictr.johnshopkins.edu/coronavirus/biospecimencommittee/

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 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.

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 will 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.

COVID-Related Guidance and Research Requirements:

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 June 24, 2021.

Protocol Deviation Summary Sheet - COVID-19

Adverse Event Report Summary Sheet - COVID-19

Resources:

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).

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

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

Re-opening guidelines for the JHU MRI Research Center

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)

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 BEADCore@jhmi.edu 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 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. 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 the third Friday of each month. Please use the following to register: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=358053