Essential Information for Human Subjects Research Teams Related to COVID-19
Last updated June 18, 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:Essential information for Human Subjects Research Teams Related to COVID-19
For the most up-to-date information visit the links below:
Resuming In-Person Activities and New Enrollment
- Announcement from Homewood IRB’s Institutional Official and KSAS Interim Dean – Plan for the Return of Research with Human Participants through the Homewood IRB
- JHU Return to Research Guidance – Please review the University’s guidance regarding the resumption of research activities. Part Five contains the plan for Human Subjects Research and outlines the Phase Plan for resuming research with human participants. Specific guidance is provided for research occurring in clinical and non-clinical space, as well as research taking place outside of Johns Hopkins facilities including community-based facilities and in participant homes.
- FAQs Related to Resuming Research with Human Participants
- Process for Preparing Plans for Homewood IRB PIs who Supervise Research 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 research staff. (to be added)
- Homewood Human Subjects Research Restart Committee (HHSRRC) – 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 on a specific Homewood IRB protocol. Note the Johns Hopkins School of Medicine and the School of Public Health IRBs have their own research restart process. Studies for which there is no in-person interaction, studies that can be modified by submitting a change in research to the HIRB to permanently alter the study so it may proceed without in-person interaction, and COVID-19 related research are exempt from this reopening process. The submission of this application (one required per protocol) will put you in a queue to have your request reviewed by the HHSRRC. The HHSRRC must approve your study to move forward to the HIRB for permission to restart your human subjects research.
- Click Here for the Homewood Human Subjects Research Restart Application. Email the form to HIRB@jhu.edu when complete.
- Petition Forms for Requests to Resume In-Person Activities and New Enrollment –These forms 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 begin to submit these forms as part of a request to resume in-person interaction/new enrollment for previously approved research and new applications after the University announces the phased human subjects research restart date.
- Petition to begin In-Person Human Subjects Research Activities and New Enrollment in a New Research Study (to be added). This form should be used for any new application where the research has not received initial IRB approval. Once approval by the HHSRRC has been secured, this form should be uploaded in the Finalize section of the eHIRB application. This form should be used for all new applications (convened, expedited, exempt, and NHSR) that have not been approved by the HIRB and new applications that have been initially reviewed and Deferred or Approved Pending Revisions but not yet approved.
- Petition to Resume In-Person Human Subjects Research Activities and New Enrollment in a Previously Approved Research Study (to be added). This form should be used to submit a petition for any research study that has been previously approved by the HIRB. 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 HHSRRC has been secured, this form should be uploaded in a Change in research application in the Finalize section of eHIRB.
- Return to Campus Guide – https://hub.jhu.edu/assets/uploads/sites/2/2020/05/JHU-Return-to-Campus-Guide.pdf
- Planning for the Research of Clinical Research – https://ictr.johnshopkins.edu/coronavirus/planning-for-restart/
Online Training Resources for Study Teams:
- Safe at Work During the COVID-19 Pandemic – This course is available through JHU’s myLearning.
COVID-19 Related Guidance and Research Requirements:
- HUMAN SUBJECT RESEARCH PHASED CONTINGENCY PLAN – PHASE 3: Effective 3/22/2020 – IMPORTANT: PLEASE REVIEW. Please click here for the current contingency plan for human subjects research that all JHU researchers must immediately implement as of 3/16/2020.
- 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.
- COVID-19 FAQs – This page includes frequently asked questions and responses related to COVID-19. Please monitor this page daily for new information.
- 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.
- 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.
Forms and Instructions for COVID-19 Related Research:
- Request Form for Continuation of In-Person Research Activities for Tier 2 Studies
- FAQs for Research Participants during the Coronavirus Pandemic (the virus that causes COVID19)
- NIH FAQs Related to COVID-19
Updates from the Homewood IRB Office:
Homewood IRB Staff 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 homewoodirb.jhu.edu/about/contact/ . If you have a general question please send an email to email@example.com or leave a message at 410-516-6580. 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 firstname.lastname@example.org or leave a message at 410-516-6580 and you will receive a response as quickly as possible.