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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.The MetroHealth System IRB operates in compliance with Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) Guidelines insofar as those guidelines are consistent with the U.S. Food and Drug Administration regulations (21 CFR Parts 50 and 56) and the Department of Health and Human Services regulations (45 CFR 46) pertaining to the protection of human subjects in research.
ACCREDITATION
Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) accreditation is a public affirmation of an organization's commitment to protecting research participants. The MetroHealth System Human Subjects Protection Program has full accreditation through AAHRPP since 2007.
All users must have an electronic IRB (eIRB) account. To request an eIRB account, please click IRB User Access Requests (smartsheet.com)and submit the required information. Account registration is not an automatic process.
To log in, please click the "Login" button at the top-right of this page and follow the instructions.
The MetroHealth IRB is moving to ONE (1) convened meeting per month starting January 2025. Review the deadlines for pre-review carefully and plan accordingly.
**NEW**Data Security Plan (DSP) will be required for all NEW non-engaged, exempt, expedited, and full board studies in addition to submissions where the MetroHealth study team is relying on an external IRB.
The purpose of the DSP is for study teams to document where data will be collected, where it will be stored and whether it will be transferred outside of MetroHealth.
The DSP can be accessed in eIRB under Templates AND will replace the existing research-related risk assessment process.
The IRB will no longer include stamps of any kind on materials that are not used for documenting written consent of participating subjects.
Per IRB policy, the only document provided with an approval stamp is a document used to obtain subject consent with a signature (ICFs, minor assent forms, HIPAA authorization forms).
NOTE: MetroHealth documents that are institutionally managed, such as the Photo, Video, Audio authorization, will not receive a stamp from the IRB.
All ACTIVE, locally reviewed studies will need to be updated to reduce the risk of confusion or non-compliance at the time of Continuing Review (CR).
REMINDER: Per the Revised Common Rule, NEW expedited studies approved on or after January 21, 2019, do not require a continuation review; this also includes exempt studies or those that undergo limited IRB review.
Should you require a letter for your sponsor or any other entity for confirmation of this process, please click HERE.
After July 1st,and BEFORE a Continuing Review (CR) is next due to be submitted to the IRB, study teams will be required to file a modification to submit unstamped versions of documents from other categories and delete any duplicate documents before a study’s next continuing review can be processed.
IMPORTANT: This process must be completed by study teams and approved by the MetroHealth IRB BEFORE a continuing review is filed.
*Note: If filing a review for study closure, this process will not need to be completed before the closure review can be processed.
The MetroHealth IRB is no longer accepting jointly filed Modification/CRs. We have updated this policy to avoid lapses in study approval.
Under federal regulations all research activities must stop if the study lapses in approval. This includes all aspects of a study including recruitment, advertisement, screening, new enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information.
The MetroHealth IRB procedures involved in the evaluation and approval of a modification differ from the procedures required for a continuing review. To prevent any delay in the continuing review of your research, please submit a modification and a continuing review separately. If you have any questions, please reach out to an IRB staff member.
Attach the Modification Request form with the revised documents to the modification application in eIRB
A modification submission is required if you plan to make any changes to your research or deviate from the protocol after approval has been granted.
Such changes include, but are not limited to:
Change of principal investigator.
Increase in planned number of enrolled participants.
Changes to the inclusion/exclusion criteria.
Minor changes to the study instruments (surveys, questionnaires, etc.)
Substantive changes to the study instruments.
Changes to the informed consent documents or procedures.
Changes to recruitment materials.
Change of research or agency location.
Changes in funding sources.
Change to study procedures.
NOTE: Changes may not be implemented before your modification request has been approved by the IRB. If you implement changes before IRB approval, you will not be in compliance.
CHANGE TO IRB SUBMISSION PROCESS TO ADD A RELYING/PARTICIPATING SITE WHEN METROHEALTH (MH) WILL SERVE AS THE IRB OF RECORD/REVIEWING IRB.
INITIAL REVIEW: When the MetroHealth IRB will serve as the IRB of Record/Reviewing IRB for a Non-Exempt protocol, and wishes to add RELYING sites, the MetroHealth investigator is responsible for the following:
If required, update an existing protocol from single site to multisite via a modification.
Submit the "Reliance Agreement Request Form” (MetroHealth to Serve as the IRB of Record-Single IRB) to the Relying Site along with copy of the protocol, consent/assent, supporting documentation including recruitment material—all approved by the MetroHealth IRB. The relying site will adapt the documents to include the local context information.
Enter eIRB and create “Adding Participating Site”
Upload into eIRB, a) Completed Reliance Agreement Request Form METROHEALTH IRB to serve as IRB of Record/Single IRB; b) Tracked copy of the consent/assent which includes the relying site LOCAL CONTEXT information included; and c) if applicable, copy of the relying site’s Stand-Alone HIPAA authorization if Relying site chooses to serve as their own HIPAA Privacy Board/grant applicable waivers, recruitment material, any other site specific documents; d) PI CV from relying site
Click SUBMIT to send the submission to the MetroHealth IRB for administrative review.
MODIFICATION:
Any modifications to the study are to be processed through eIRB request-Create Modification. You will not submit these modifications on the main study page but rather within the Participating Site’s Dashboard in the eIRB system.
Once received, the MetroHealth study team will click on each relying site and click “Report Continuing Review Data.” Attach the Relying Site Continuing Review Worksheet to the “Supporting Documents” section.
Go to the main study page and click “Create Modification/CR”. Complete the CR application as applicable.
From the continuing review dashboard, click the “Sites” tab. Check the box to the farthest right to indicate that the report from the relying site is “Completed.”
Submit the CR.
The IRB will then process per normal procedures (i.e., either will undergo expedited or full board review).
REPORTABLE EVENTS:
Any reportable events that occur at a relying site must be reported to the MetroHealth IRB.
The relying site is required to report any RNIs to the MetroHealth study team in accordance with the MH IRB’s Reportable Event Guidance Document (present in IRB >> Library >> General).
The RNI should be submitted within the Site Dashboard.
CHANGE TO IRB SUBMISSION REQUIREMENTS WHEN METORHEALTH IS RELYING ON AN EXTERNAL IRB
POST INITIAL REVIEW: Personnel Changes, Modifications, Continuations, Recruitment, Reportable Events
Personnel Changes
When METROHEALTH is relying on a Non-METROHEALTH IRB, you will continue to update study personnel via a personnel change/modification in eIRB. This must be done prior to a new individual having access to subjects or their identifiable data or specimens or when an individual is no longer working on the study.
Note: A change to the METROHEALTH PI requires a Modification submission*
Modifications:
Modification reviews (including revised protocol, IB, consent [note exception below for the consent document]) will be completed and approved by the IRB of Record/Reviewing IRB. Do not submit these requests to the MetroHealth IRB.
Modifications will be submitted to the Metro IRB (Relying site) in the following circumstances only:
Updating MetroHealth research personnel, including the *MetroHealth Principal Investigator.
Change in study title.
Changes to the data security plan
When the protocol is CLOSED /INACTIVE.
Any change to the compensation in case of injury section of the consent*
*Consent Document
REVISIONS to the compensation in case of injury section MUST be submitted to the MetroHealth IRB as a modification.
A copy of the METROHEALTH local consent context language is provided to the study team with the Reliance Agreement Request form. This language includes METROHEALTH specific information including HIPAA/privacy language, compensation in case of injury, contact information etc).
The e mail notification subject line: SHORT TITLE- IRB number- PI.
The following documents are to be included with the submission:
Current protocol and ICF
Redline version of protocol and ICF
Summary of changes if sponsor provided
Continuations
Continuation reviews will be completed by the IRB of Record (non-METROHEALTH IRB).
Within 14 business days of receiving the continuation approval from the IRB of Record, the study team will SUBMIT the document via eIRB.
Recruitment/Advertisement Material:
Recruitment review will be completed by the IRB of Record. The IRB does not review or approve recruitment material for protocols when no serving as the IRB of record. Follow the IRB of record’s procedures to obtain approval of the recruitment material.
Requests for acknowledgment of External IRB Updates
METROHEALTH IRB is not responsible for providing Acknowledgement of External IRB Updates for studies using a Non-METROHEALTH IRB. Study teams should submit those documents requiring acknowledgement to the IRB of record.
Reportable Events
Submit the following events to the Non-METROHEALTH IRB per Standard Operating Procedures of the Reviewing IRB that occur with a METROHEALTH subject or at METROHEALTH:
o Unanticipated problems at METROHEALTH or from METROHEALTH subjects
o Serious adverse events with a METROHEALTH subject
o Serious or continuing noncompliance
o Injury to METROHEALTH subjects
o Major Protocol deviations at METROHEALTH
o Complaints occurring at METROHEALTH or with METROHEALTH subjects
o Changes initiated without IRB approval to eliminate apparent immediate hazard to subjects
o METROHEALTH subject incarceration
The Reviewing IRB of record will notify the METROHEALTH study team of relevant determinations.
IMPORTANT:
Any reports of unanticipated problems, serious or continuing noncompliance or subject complaints occurring at METROHEALTH or from METROHEALTH subjects MUST also be submitted to the MetroHealth IRB within 10 business days of receipt via eIRB as Reportable New Information.Documentation from the IRB of record’s decision must be attached to the RNI.
CHANGE TO IRB SUBMISSION FOR EXEMPT RESEARCH PROTOCOLS
Exempt human subjects research is a specific sub-set of “research involving human subjects” that does not require ongoing IRB oversight. Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal IRB regulations. Studies that qualify for exemption must be submitted to the IRB for review before starting the research.
Additional information on Exempt Categories can be found HERE.
The MetroHealth investigator is responsible for the following:
CHANGE TO IRB SUBMISSION PROCESS FOR METROHEALTH (MH) TO RELY ON A NON METROHEALTH IRB TO SERVE AS THE IRB OF RECORD/REVIEWING IRB
INITIAL REVIEW: When an External IRB will serve as the IRB of Record/Reviewing IRB for MetroHealth for a Non-Exempt protocol, the MetroHealth investigator is responsible for the following:
Complete sections in eIRB (see Appendix D: Reliance Agreement Request form)
Upload into eIRB, the current version of the protocol approved by the Reviewing IRB.
Upload into eIRB, the MetroHealth Specific Consent/assent form(s) tracked with the MH local context information.
Upload into eIRB, all supporting documentation and correspondence:
Local Site Documents>Q#3: Other Attachments
Reliance Agreement Request Form: Non-METROHEALTH IRB to serve as IRB of Record
Requirements for any Ancillary approvals
Original approval notice from the Reviewing IRB
If applicable, most recent continuation approval notice from the Reviewing IRB (if study has been open for >12 months)
If applicable, FDA correspondence for IND/IDE determination
If applicable, Waiver of MetroHealth Pharmacy Investigational Drug Services (MPIDS): only required when the MetroHealth Research Pharmacy will NOT be used.
Click SUBMIT to send the submission to the MetroHealth IRB for administrative review.
IMPORTANT: The study will not receive administrative approval from the MetroHealth IRB until the Reviewing IRB provides the MetroHealth Study team with an approval notice adding Metro as a RELYING SITE. Once received, UPLOAD this approval to eIRB.
PREREVIEW SUBMISSION DEADLINES and UPDATED 2024 IRB MEETING SCHEDULE
Beginning April 2024, the MetroHealth IRB meetings will take place on the 2nd and 4th Mondays of each month. This adjustment aligns with MetroHealth's HRPP Standard Operating Procedures.
Additionally, the IRB staff will close meeting agendas one week prior to the scheduled Monday IRB meeting to provide board members with appropriate time to review submission documents.
The IRB will be imposing a prereview submission deadline for all full board events (new FB studies, FB modifications, FB continuations, Non-compliance, reporting serious adverse events, unanticipated problems.) These events will be submitted to the IRB on or before the prereview submission dates noted on the Meeting Schedule. IRB staff will work with study teams during this two-week period before the agenda closure to conduct an administrative prereview.
The February and March meeting dates that do not conform to the new 2nd and 4th Monday schedule are highlighted for your attention. Also, please note that the 2nd meeting in May would fall on Memorial Day. To accommodate this, we have tentatively scheduled an IRB meeting for May 20th, if necessary, for matters that cannot wait until the next meeting in June.
The IRB will convene only once in December (12/9/24).
Note: Prereview submission deadlines and the IRB Meeting Schedule is NOT applicable for those studies where MetroHealth is relying on an outside IRB via a Reliance.
For new protocols, modifications, or continuations requiring submission to the MetroHealth convened full board please note the following:
Submissions will be placed on the agenda per the availability of reviewers from the appropriate specialty. The review of a protocol may need to be delayed to a subsequent meeting if a reviewer from the appropriate specialty is not available or if a large number of protocols are received for one meeting. If this occurs, the investigators will be contacted to determine the urgency needed for a review.
If all protocols considered for a delay in review have the same urgency for review, they will be placed on the agenda according to the submission date. It is therefore best to submit a protocol as soon as it is completed and to not wait until the deadline date. The study team will be notified of the delay prior to the meeting.
