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Protecting Human Subjects in Research at MetroHealth

Welcome to the MetroHealth IRB Homepage

The Institutional Review Board (IRB) is a federally mandated committee responsible for overseeing research involving human participants. The mission of the IRB is to protect the rights and welfare of research participants. To do so, the IRB relies on the ethical principles identified in the Belmont Report (respect for persons, beneficence, non-maleficence and justice) when reviewing research projects, along with applicable federal regulations. We have been AAHRPP accredited since 2007. 

Please note- all users must have an electronic IRB (eIRB) account. To log in, please click the "Login" button at the top-right of the page and follow the instructions from there. If you do not have an account, then to request an eIRB account, please click on the following link and submit the required information (note: account registration is not an automatic process):  IRB User Access Requests (smartsheet.com)

Announcements

4/27/2023: Effective April 27, 2023, at the direction of the Institutional Official, the IRB will begin administratively closing any expired studies that have not responded to requests to submit a continuing review. Over the next few weeks, IRB staff will be reaching out to study teams who have expired studies to request that a continuing review be filed. Up to 2 reminder emails will be sent by the IRB staff. If no continuing review is submitted within 4 weeks of the initial IRB staff reminder email, then the study will be administratively closed; however, the Principal Investigator will NOT be permitted to submit any new studies to the IRB for 6 months. A second instance of not submitting a continuing review on time will result in the Principal Investigator no longer being able to conduct human subjects research at MetroHealth. 

4/17/2023: There is currently an error occurring with the eIRB system related to the "Finalize Updates" button for single IRB/reliant review studies. This has been reported to the eIRB system vendor. Please reach out to IRB staff if you receive an error message in submitting these updates so that these may be submitted on your behalf in the meantime. Thank you. 

3/23/2023: Effective April 1, 2023, the role of IRB Chairperson will be transitioning from Dr. Ann Avery to Dr. Ashish Aneja. Additionally, the role of the IRB Institutional Official will be transitioning from Dr. Brian Mercer to Dr. Richard Blinkhorn. Dr. Catherine Curley will now be the Department of Medicine Reviewer for the eIRB system. Please contact the HRPP Manager if you have any questions. 

Additionally, the eIRB system has now been enabled to allow for Principal Investigators to designate a "PI Proxy" for their studies, which is a study team member who is delegated the role of performing PI responsibilities in the eIRB system on the official study PI’s behalf. This includes submitting applications (i.e., new studies, continuing reviews, modifications, and MODCRs) for IRB review, resubmitting an application if changes are requested by the department reviewer or IRB, and copying a previously created study. Assigning the role of PI proxy DOES NOT shift the ultimate responsibility for the conduct of the study from the official study PI to the PI Proxy. The study PI is still ultimately responsible for the study. For full guidance on the PI proxy option, please review the “PI Proxy Guidance Document” present on the IRB website by clicking the IRB tab in your eIRB dashboard >> Library >> General. Please contact an IRB staff member if you have any questions. 

2/23/2023: The IRB has recently uploaded and revised several documents related to the single IRB/reliant review process. Additional documents and guidance related to this process will be revised and uploaded to the IRB website in the coming weeks. Please be sure to check the "Library" tab under the "IRB" tab on the IRB website to make sure that you are obtaining the most recent versions of available forms. It is recommended to review the "Research Community Training - Single IRB" PowerPoint document present under "Guides" in the "IRB" >> "Help Center" tab of the website for a general overview of the single IRB/reliant review process and how to submit these requests going forward. It is also recommended to use the "IRB Shell Study Checklist" present under "Checklists" in the "IRB" >> "Library" tab of the website for studies where MetroHealth is relying on an external IRB to ensure that your shell study application is completed correctly prior to submitting to the IRB for review. Please reach out to IRB staff if you have any questions.

2/2/2023: The issue related to continuing review reminder notifications not sending from the eIRB system for certain studies has been resolved by the eIRB system vendor. Reminder notifications will be generated from the eIRB system at 90, 60, and 30 days before the study expires. It is still recommended that study teams check the status and pending expiration date of each of their studies as soon as possible in order to ensure they submit required Continuing Reviews in sufficient time to prevent study expiration. Please contact India Eaton if you are still not receiving reminder notifications on your studies at these intervals. 

1/26/2023: Please note that the notification email sent from the IRB system will no longer come from "no-reply@huronclick.com" but rather "no-reply@metrohealth.org". This change will hopefully prevent these notices from being routed to your spam folder. It is recommended to add "no-reply@metrohealth.org" to your email contacts to ensure that you receive all communications from the eIRB system.

10/7/2022 (updated 2/2/2023): Starting on 10/10/2022, any single IRB and non-industry-sponsored studies 1) sending data outside of MetroHealth and/or 2) using devices/technology/mobile apps/etc. to capture data will need to complete the research-related data sharing risk assessment (RDSRA) process as required by MHS Privacy and the Research Administration Business Office (RABO) prior to receiving IRB full approval. For applicable studies, the IRB will issue a "modifications required to secure approval" letter with instructions on how to complete this process. Information about this process has been uploaded to the IRB Library under "General". Please contact MHS Privacy, RABO, or IRB staff if you have any questions about this process.

9/28/2022 (updated 10/7/2022): The IRB's ICF & HIPAA template has been updated to reflect the changes to the Revised Common Rule from the Office for Human Research Protections (OHRP), which is the basis for IRB review. Changes to consent forms as required by OHRP include the following: 

-Key study information presented at the beginning of the consent form

-Indicating if test results will be disclosed to participants

-When identifiable information or biospecimens are collected, then stating: a) if identifiers may be removed before the information or biospecimens are used for future research without additional consent OR b) if the information or biospecimens will not be used for future research

-If biospecimens are collected, then stating: a) if the biospecimens will involve commercial profit and if the subject will share in this profit AND b) if the study includes whole genomic sequencing

Changes have also been made by the MetroHealth Legal Department to the costs and injury language as well. The updated template along with an instructions sheet has been uploaded to the IRB Library under "Templates". The new template will be required to be used starting on 10/17/2022. For any studies currently in review that are submitted to the IRB before 10/17/2022, the previous template can be used; however, IRB staff may request that the elements from the Revised Common Rule be added to the template. Additionally, for any studies approved after the Revised Common Rule came into effect on January 21, 2019, if a modification is filed for the study, then IRB staff may request updates to the consent form to reflect the requirements for and to comply with the Revised Common Rule. Please contact IRB staff if you have any questions regarding these changes.

8/4/2022:  The IRB has created a new template protocol for chart review studies as well as studies using a non-return cover memo as the method for informed consent. This new template protocol can be found in IRB >> Library >> Templates. Please contact an IRB staff member if you have any questions regarding which protocol template should be used. The IRB has also created a guidance document called "IRB Basic Guide" with tips regarding how to minimize common mistakes we are seeing in submissions. This guidance document can be found in IRB >> Help Center >> Guides. Please contact an IRB staff member if you have any questions regarding your submissions. 

The IRB is working 100% remotely and no longer on Main Campus. You may get in contact with us via the methods below. 

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