Single & Central IRB

RSS

For applications with due dates on or after Jan 25, 2018, and contract solicitations published on or after Jan 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt Human Subjects Research(HSR) funded by the NIH, will use a single Institutional Review Board(sIRB) to conduct the ethical review required for the protection of human subjects.
This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt HSR. It does not apply to career development, research training or fellowship awards. Implementation of the NIH sIRB policy is expected to reduce unnecessary administrative burdens and systemic inefficiencies while maintaining appropriate human subjects protections.
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The UNMC sIRB team serves as resource for UNMC and external site study teams collaborating on multi-site projects.
Our mission is to provide high quality, timely IRB review for multi-site HSR.
Please speak with an sIRB analyst prior to submitting an sIRB request. Any questions regarding applications, fee schedules, consultations, and more please contact the sIRB team at sirb@unmc.edu.
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For multi-center studies, the central IRB (cIRB) is the IRB that conducts reviews on behalf of all study sites that agree to participate in the centralized review process. For sites at institutions that have an IRB that would ordinarily review research conducted at the site, the cIRB should reach agreement with the individual institutions participating in centralized review and those institutions' IRBs about how to apportion the review responsibilities between local IRBs and the cIRB (21 CFR 56.114).

Glossary

Cede Review

An institution agrees to transfer IRB review and oversight authority for specified research to another institution’s IRB (reviewing IRB).

cIRB

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Lead Site

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Lead Principal Investigator (Lead Site PI)

The study wide lead Principal Investigator with ultimate responsibility for the conduct and integrity of multisite research.

Local Context
Participating Site (pSite)

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Participating Site Principal Investigator (pSite PI)

The lead investigator at each institution participating in multisite research usually responsible for the conduct of the research at the participating institution.

Reliance

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Reliance Agreement (also known as an Authorization Agreement)

An agreement between two Organizations engaged in human subject research that documents respective authorities, roles, responsibilities, and communication between the reviewing and relying IRBs.

Reliance Negotiation

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Relying Institution

A participating Institution that cedes IRB review to the IRB of record (reviewing IRB) designated under a Reliance Agreement.

Relying IRB

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Reviewing IRB

The IRB which is responsible for conducting IRB review and approval as described in 45 CFR 46.109 for cooperative human subject research.

sIRB

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sIRB - What is Single IRB?

Single IRB is a model of IRB review that is intended to streamline and reduce administrative burden on IRBs reviewing multisite studies. In a single IRB model, one IRB serves as the reviewing IRB or “IRB of Record” and the participating site (pSite) IRBs serve as relying IRBs. The responsibilities of each IRB are outlined in a document called a reliance agreement.

For more information on the history of single IRB (sIRB) review and sIRB review at UNMC, see each section below:

Single Site Research:

Below is a model of single site research, or research that is only taking place at one site.

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Multi-site Research:

Historically, multisite research was overseen by multiple independent IRBs. This often led to differences in IRB review and outcomes across sites.

Below is a model of historical multisite research, or research that took place at more than one site.

multi_site_research.png

Single IRB Review Requirement:

The requirement for single IRB review originated from the NIH single IRB policy and the Revised Common Rule.

From the NIH:

"expectation that all [domestic] sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health will use a single Institutional Review Board (sIRB)" (NOT-OD-16-094, June 2016)

For more information on the NIH Single IRB Policy visit: https://grants.nih.gov/policy/humansubjects/single-irb-policy-multi-site-research.htm.

For Guidance on exceptions to the NIH Single IRB Policy, visit: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-003.html

From the Revised Common Rule:

"Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB …" (§_.114(b)(1))

For more information on the Revised Common Rule's Single IRB Requirement, visit: https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46#46.114.

For a list of Common Rule Departments and Agencies, visit: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html

For information on Common Rule Exception Determinations, visit: https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-requirement/index.html#exceptions

In short, this means that studies that are federally funded and taking place at more than one site are now required to use a single IRB as the IRB of record. There are many circumstances where it is not clear if a specific study requires single IRB review or if an exception may apply. In these cases, please email sirb@unmc.edu for assistance at the earliest opportunity.

Note: Participating site IRBs are still involved in the single IRB process and have their own local requirements, but the responsibility for the regulatory component of review is ceded to the single IRB. Each IRB’s responsibilities are outlined in a document called a Reliance Agreement. More information on reliance can be found in the sIRB Reliance section below.

Single IRB Review Models:

Some groups were already utilizing a single IRB model prior to the requirement (e.g., commercial IRBs).

Below is a simplified model of how some commercial IRBs handle multisite research. Many will interact directly with the sponsor, perform IRB review activities, and then push approvals to all sites simultaneously.

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Below is another model of how a single IRB may handle multisite research. In this example, the sponsor works with each site PI and study team independently. Each site submits their own application to the single IRB for review and receives separate approvals.

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sIRB Review at UNMC:

Single IRB Review at UNMC is broken out into two main parts. First, the overall study and lead site-specific requirements are reviewed. After overall study and lead site approval, participating sites (pSites) are onboarded and approved on a rolling basis.

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Note: pSite IRB processes are not included in the above models. Please contact your pSite IRB directly with questions.

sIRB - UNMC process

The UNMC sIRB Process is captured in the diagram below.

sirb_process.png

Contact sirb@unmc.edu with any UNMC sIRB process questions.

sIRB - Submission deadlines

sIRB Submission Deadlines for New Submissions, Previously Tabled Protocols and Requests for Change

sIRB Full Board Submission Deadline – 9 am

Submission Deadline Date of sIRB Meeting
2/6/2025 2/14/2025
3/6/2025 3/14/2025
4/3/2025 4/11/2025
5/1/2025 5/9/2025
6/5/2025 6/13/2025
7/3/2025 7/11/2025
7/31/2025 8/8/2025
9/4/2025 9/12/2025
10/2/2025 10/10/2025
11/6/2025 11/14/2025
12/4/2025 12/12/2025
12/31/2025 1/9/2026

sIRB - Reliance

Reliance refers to an arrangement where an IRB allows another IRB to perform review and approval of a study.

The UNMC IRB uses the term “single IRB” or “sIRB” to indicate that UNMC is serving as the reviewing IRB (i.e., the IRB of record) of a multisite study.

Reliance Agreement

A reliance agreement is a formal, written document that provides a mechanism for an institution engaged in research to delegate IRB review to another IRB. This document generally outlines the responsibility of the single IRB and the participating site. Often the reliance agreement is accompanied by addenda or other forms that are designed to further clarify responsibilities or collect pSite local context information.

Reliance agreements come in many formats. They may also be called:

UNMC's Preferred Reliance Agreement Format

UNMC is a SMART IRB participating site and strongly prefers to document reliance using the SMART IRB Online Reliance System (SMART IRB ORS). In addition, we ask that sites complete the SMART IRB Implementation Checklist. This will be provided during the reliance negotiation.

Note: SMART IRB is not an IRB, but a tool that IRBs use to document reliance.

Note: The UNMC sIRB Team has elected to initiate and maintain requests in the SMART IRB ORS, rather than have the lead site investigator or study team create requests. Please contact sirb@unmc.edu with questions.

If a site is not a SMART IRB participating institution, other reliance formats will be made available for use during the reliance negotiation.

Reliance Negotiation

The term reliance negotiation refers to the process of the reviewing and relying IRB representatives communicating and agreeing to the reliance agreement format and terms. The UNMC sIRB Team will initiate the negotiation during the pSite Onboarding stage of review.

sIRB - Fees

For information regarding the fee schedule for Single IRB studies, please contact sirb@unmc.edu.

cIRB - What is Central IRB?

The UNMC IRB uses the term “central IRB” or “cIRB” to indicate that the reviewing IRB (i.e., the IRB of record) of a multisite study is external to UNMC.

The UNMC IRB has contracted with two commercial IRBs, Advarra and WCG. In addition, the UNMC IRB partners with consortium, academic, and medical center IRBs nationwide.

For more details around the use of a cIRB, including when the use of an external central IRB is not permitted, see UNMC HRPP Policy 1.4 (UNMC Ceding Review to an External Central IRB).

cIRB - UNMC Process

Note: When requesting cIRB review, study teams must satisfy the requirements of each IRB and the funding agency or sponsor (as applicable), prior to initiating the research.

UNMC cIRB Initial Review Process

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External cIRB Process

Funding Agency/ Sponsor Process

Post-acceptance Study Activities

In general, the external IRB of record will be responsible for reviewing most study activities. In some cases, these may also need to be submitted to the UNMC IRB.

Things to submit to the external cIRB:

Note: In most cases, submit to the external IRB. If determined to be necessary, the external cIRB will notify the UNMC IRB directly or request the study team notify the UNMC IRB.

Things to submit to the UNMC IRB:

Note: personnel are NOT permitted to work on a study until UNMC IRB approval is received.

Note: Send a notification in the message portal, indicating the study is now closed. Upload applicable documentation.

cIRB - Reliance

When requesting to rely on an external IRB, the UNMC IRB will assess the external IRB’s qualifications in accordance with HRPP Policy 1.4 (UNMC Ceding Review to an External Central IRB). The UNMC IRB may request information related, but not limited, to:

The UNMC IRB strongly prefers to document reliance using the SMART IRB Online Reliance System. UNMC has several reliance templates based on institution type available for use. Other reliance formats are approved on a case-by-case basis.

SMARTirb Logo

cIRB - Fees

In line with most other academic medical centers and universities, the Office of Regulatory Affairs and the IRB charges an initial submission and an annual continuing review fee for commercial and industry sponsored protocols.

Central IRB:

effective 7/1/2021 Initial Submission Annual Continuing Reviews
Central IRB Review $3000 N/A

Commercial/Industry Sponsored Research Protocols:

effective 7/1/2021 Initial Submission Annual Continuing Reviews
Full Board $3000 $1250
Expedited $2000 $1000

Center for Nutrition & Health Impact

Please contact sirb@unmc.edu for more information.

Single IRB:

Please contact sirb@unmc.edu for more information.

cIRB - Forms & Links

Note: the UNMC IRB cannot answer questions related to external IRB processes or applications. Contact the external IRB's helpdesk or designated representative directly for assistance.

For questions regarding UNMC cIRB processes or applications, please contact sirb@unmc.edu.

Advarra

Advarra has requested the UNMC IRB number be added to the application as follows:

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Contact Information Sheet

The UNMC IRB recognizes that not all central IRB consent templates have the option to add local study contacts. The cIRB application in RSS now has the option to build a “Contact Information Sheet” to be provided to subjects along with the approved consent documents.

***Older studies within RSS may not have this functionality. The Contact Information Sheet Template may be downloaded for manual completion.

Miscellaneous central IRBs

NCI CIRB

NMDP

SMART IRB

WCG

If requesting revisions to the template consent language, the University of Nebraska – WCG ICF Checklist must be completed and signed by the study’s lead UNMC IRB representative.